Kornimate/medical-research-clean huggingface dataset:
quality of life before and after radiotherapy in patients with head and neck cancer

Conditions: Head and Neck Cancer; Quality of Life (QOL)

Summary: worldwide, head and neck cancers (hncs) are widespread (650,000 cases per year) and cause more than 330,000 deaths per year. almost all cases, about 90%, are cancers of the oral cavity, oropharynx, and larynx. in conventional clinical practice, hncs are treated primarily with radiation therapy (rt), often used in combination with surgery and/or chemotherapy. like most anti-neoplastic therapies, rt carries significant adverse effects both acute and chronic. both types of adverse effects have a significant impact on quality of life (qol). the aim of the study is to examine the worsening of qol in patients with hnc before and after cancer therapy and to assess the extent that each factor has in its worsening.


Eligibility criteria:
inclusion criteria: * patients between the ages of 18 and 75 years; * patients who presented at their first dental visit with a diagnosis of hnc. exclusion criteria: * patients who had already undergone cancer therapies (excisional surgery or chemotherapy or radiation therapy) at the time of the first dental visit; * patients with depression or social anxiety; * patients with language difficulties.

Keywords: quality of life head and neck cancer radiotherapy
evaluation of the human rotavirus vaccine at varying schedules and doses in rural ghana

Conditions: Rotavirus Gastroenteritis

Summary: the purpose of this study is to determine whether giving the human rotavirus vaccine on alternate dosing schedules will enhance the immune response to the vaccine in a low-resource, high-burden country in africa. alternate dosing schedules studied include giving the 2-dose vaccine schedule at a slightly older age and giving an additional dose of the vaccine.


Eligibility criteria:
inclusion criteria: * between 42 and 55 days of age at the time of enrollment. * healthy infant free of chronic or serious medical condition as determined by history and physical examination at the time of study enrollment. * parents/guardians of each subject are able to understand and follow study procedures and agree to participate in the study by providing parental/guardian permission. exclusion criteria: * if child has previously had intussusception or abdominal surgery. * use of any immunosuppressive drugs or immunoglobulin and/or blood product use since birth or anticipated during study period. * current enrollment in any other intervention trial or use of any investigational drug or vaccine throughout the study period. * birthweight less than 2000 grams or gestation \< 36 weeks, if this information is available. * any subject who reports plan to leave the study area before the completion of the study (i.e., relocation, migration, etc.). * another child living in the same compound is already enrolled in the trial (i.e., only one participant can be enrolled per compound). * after the rotavirus vaccine is introduced into the routine epi system in navrongo: another child in the compound is less than 16 weeks of age. * the child has received rotavirus vaccine outside of this study.
oral health-related quality of life (ohrqol) in patients with inflammatory bowel disease (ibd)

Conditions: Inflammatory Bowel Diseases; Periodontitis; Dental Caries; Tooth Loss

Summary: ibd patients have a higher risk of oral diseases that affect the oral mucosa, the teeth and the tooth supporting tissues. these conditions are often associated with pain, bleeding and impaired masticatory function which may have an impact on the oral health-related quality of life (ohrqol). however, few studies have investigated the self-evaluation of oral quality of life in ibd patients. the rare existing studies focus on very specific patients (elderly patients, patients with stomas) and do not use validated tools for the evaluation of ohrqol. we also lack data on the effect of treatments such as immunosuppressants and type of ibd on ohrqol. the aim of this study is to (i) compare oral quality of life in a cohort of ibd patients versus non-ibd patients and (ii) explore potential factors that influence oral quality of life in ibd


Eligibility criteria:
inclusion criteria: * adults ≥ 18 years of age * with crohn's disease or ulcerative colitis * able to understand and answer the questions asked exclusion criteria: * unable to understand and/or answer questions * not willing to participate in the study

Keywords: crohn disease ulcerative colitis oral diseases oral health-related quality of life self-questionnaire
restylane defyne in a stepwise treatment approach

Conditions: Lower Face Folds and Lines

Summary: this was a 12-week study to evaluate the effectiveness and safety of restylane defyne when using two different injection approaches, stepwise down-up vs. top-down, when treating the lower face.


Eligibility criteria:
inclusion criteria: * subjects willed to comply with the requirements of the study and provided a signed written informed consent * subjects willed to undergo augmentation and correction therapy in the studied indications * adult males or non-pregnant, non-breastfeeding females and women of non-child bearing potential over the age of 21 exclusion criteria: * known/previous allergy or hypersensitivity to any injectable hyaluronic acid (ha) gel or to gram-positive bacterial proteins * previous use of any permanent (non-biodegradable) treatment, lifting threads, permanent implants or autologous fat below the level of the horizontal line from the lower orbital rim * participation in any interventional clinical study within 30 days of screening
a study of ly8888ax in participants using a connected insulin management platform

Conditions: Type 1 Diabetes; Type 2 Diabetes; Type 2 Diabetes Treated With Insulin

Summary: the main purpose of this study is to assess participant adherence and glucose control while using a connected insulin management platform. approximately 50 participants will be enrolled in each country.


Eligibility criteria:
inclusion criteria: * have been diagnosed (clinically) with t1d for at least 1 year or are patients with t2d on basal bolus insulin therapy for at least 6 months * hba1c ≥8% as confirmed by point-of-care test at screening * are currently using the dexcom g6 cgm or agree to start using the dexcom g6 during the study and agree to switch to glooko rma * are currently using humalog ® insulin or another rapid acting insulin analogue (e.g., apidra® , or novorapid ® ) and agree to switch to study-provided humalog mealtime insulin for duration of trial * have been prescribed ≥3 doses of bolus insulin per day * must be taking a stable insulin dose regimen (per investigator's judgement) for at least 3 months preceding study screening * have in-home refrigeration for storage of insulin exclusion criteria: * previously used the glooko rma and/or dexcom g6 cgm and were judged by the investigator to be non-adherent * have participated, within the last 30 days, in a clinical study involving an investigational product. if the previous investigational product has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed * have previously used or have been using an approved or investigational connected pen system within the 3 months prior to screening * are currently breastfeeding, pregnant, or plan to become pregnant during the next 4-6 months * are on ultra-rapid insulin (e.g., fiasp or lyumjev) or rapid acting human insulin (i.e., humulin) for previous 3 months, at the time of screening * are currently undergoing dialysis treatment or have any other medical condition which may preclude them from participating in this trial as per the investigator's judgement * have vision loss or vision impairment that does not allow recognition of glooko rma screen features

Keywords: t1d t2d
dermacyd ph_detinlyn (lactic acid) tangerine mix - compatibility

Conditions: Hygiene

Summary: the purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product dermacyd phdetinlyn tangerine mix.none.


Eligibility criteria:
inclusion criteria: * phototype skin i,ii, iii e iv * integral skin test in the region; * willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion; exclusion inclusion: * lactation or gestation * use of antiinflammatory and/or immunossupression drugs * personnel history of atopy; * history of sensitivity or irritation for topic products; * active cutaneous disease; * use of new drugs or cosmetics during the study the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
comparison of two gait re-training modalities during a cardiac rehabilitation stay: benefit of orienteering walking

Conditions: Cardiovascular Diseases (CVD); Coronary Heart Disease (CHD); Heart Failure; Congenital Heart Disease

Summary: cardiovascular disease (cvd) is the leading cause of death in france for women and the second leading cause of death for men after cancer. they cause around 140,000 deaths every year, or almost 400 people every day throughout france. cvd also accounts for over a million hospital admissions a year, 160,000 of which are attributable to heart failure. at present, cardiovascular rehabilitation centres mainly use exercise training methods based on sessions on cycloergometers and active walking (walking on a track and/or treadmill). convinced of the added value of orienteering, we have included it in our routine treatment as part of our cardiac rehabilitation programme, in addition to sessions on cycloergometers and active walking since 2021. as there is little literature on the subject in our population of interest, the aim of this study is to provide evidence of the relevance of orienteering in the cardiac rehabilitation programme. we hypothesise that orienteering induces a similar cardiac response, amount of physical activity and perception of symptoms compared with an active walking session, while providing greater enjoyment of the activity.


Eligibility criteria:
inclusion criteria: * patients with stabilised heart disease, coronary artery disease, heart failure, post-operative stay after cardiac surgery, congenital heart disease, patients at high cardiovascular risk and obliterative arteritis of the lower limbs; * who have been informed and do not object to the study; * over 18 years of age; * participating in a cardiac rehabilitation programme; * with a walking distance of less than 3,600 metres; * able to understand and comply with the requirements of the protocol. exclusion criteria: * pregnant or breast-feeding women * persons under guardianship or trusteeship

Keywords: cardiovascular diseases cardiac rehabilitation active walking orienteering heart rate
clinical trial of postmastectomy radiotherapy in breast cancer with one to three positive nodes

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate postmastectomy radiotherapy in breast cancer patients with one to three positive nodes.

eligible breast cancer patients with mastectomy and axillary dissection are randomized into 2 groups:radiotherapy of 50 gy in 25 fractions within 5 weeks to ipsilateral chest wall and supraclavicular nodal region,and no radiotherapy. during and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.

Eligibility criteria:
inclusion criteria: * ipsilateral histologically confirmed invasive breast cancer * undergone total mastectomy and axillary dissection * t1-2 and one to three axillary lymph nodes positive * a minimum of 10 axillary nodes dissected * fit for chemotherapy(if indicated),endocrine therapy(if indicated)and postoperative irradiation * written,informed consent exclusion criteria: * patients who undergone previous irradiation to the ipsilateral chest wall and supraclavicular region * previous or concurrent malignant other than non-melanomatous skin cancer * unable or unwilling to give informed consent

Keywords: breast cancer mastectomy one to three positive nodes radiotherapy
effect of surgeon volume on outcome of pancreaticoduodenectomy

Conditions: Pancreatic Cancer; Pancreatic Surgery

Summary: the independent impact of surgeon volume on outcome of patients undergoing pancreaticoduodenectomy in a high-volume institution was assessed. a significant reduction of pancreatic fistula rate was found in the high-volume surgeon group in comparison with low-volume surgeon group. however, no difference between groups was found in mortality, major complications, and hospital stay.

objectives: to define the independent impact of surgeon volume on outcome after pancreaticoduodenectomy (pd) in a single high-volume institution. summary background data: the impact of surgeon volume on pd outcome is still controversial. so far, data available are from retrospective multi-institutional reviews, considering in-hospital mortality as the only outcome variable. methods: prospectively collected data on 610 patients who underwent pd from august 2001 to august 2009 were analyzed. cut-off value to categorize high and low-volume surgeons (hvs and lvs, respectively) was 18 pd/year. primary endpoint was operative mortality (death within 30-day post-discharge). secondary endpoints were morbidity, pancreatic fistula (pf) and length of stay. demographic, clinical, and surgical variables were recorded.

Eligibility criteria:
inclusion criteria: * patients who underwent pancreaticoduodenectomy between august 2001 and august 2009 exclusion criteria: * other type of surgery
a study of laquinimod in participants with systemic lupus erythematosus (sle) active lupus nephritis

Conditions: Lupus Nephritis

Summary: the study aims to evaluate the safety and clinical effect of daily oral treatment with laquinimod capsules in active lupus nephritis participants. this study will assess laquinimod doses of 0.5 milligrams (mg)/day and 1 mg/day in combination with standard of care treatment (mycophenolate mofetil \[mmf\] and corticosteroids). laquinimod is a novel immunomodulating drug which is currently in advanced stages of development by teva pharmaceuticals ltd. for multiple sclerosis.


Eligibility criteria:
inclusion criteria: * participants diagnosed with sle * kidney biopsy within 12 months prior to baseline with a histological diagnosis of proliferative or membranous lupus nephritis (ln) * clinically active lupus nephritis as evident by urine protein-to-creatinine ratio (upcr) of 1 or higher, for ln classes iii, iv, or class v in combination with classes iii or iv, or a upcr of 2 or higher for ln class v, at screening or any time between screening and baseline. exclusion criteria: * participants with severe renal impairment or dialysis * participants with a clinically significant or unstable medical or surgical condition * women who are pregnant or nursing or who intend to be during the study period * women of child-bearing potential who do not practice an acceptable method of birth control note: other inclusion and exclusion criteria may apply.

Keywords: systemic lupus erythematosus (sle) lupus nephritis laquinimod
feasibility study of low level light therapy for prevention of oropharyngeal mucositis in pediatric transplants patients

Conditions: Oropharyngeal Mucositis; Myeloablative Hematopoietic Cell Transplantation; Low Level Light Therapy

Summary: oral mucositis (om) is a painful and potentially debilitating acute toxicity that frequently affects children undergoing hematopoietic cell transplantation (hct). as a result of intensive conditioning with chemotherapy with or without total body irradiation, and in the case of allogeneic hct, graft-versus-host disease (gvhd) prophylaxis, patients are at risk for developing diffuse ulcerations of the oral and esophageal mucosa that result in pain and suffering, increased utilization of opioid analgesics, and the need for intravenous or total parenteral nutritional support. patients universally report om as being the worst aspect of the hct experience.a novel approach has been the use of larger light-emitting diode arrays to treat the at risk tissues from an extraoral approach, enabling exposure of the oral, oropharyngeal, and esophageal mucosa while avoiding the need for intraoral manipulation, and requiring only minimal patient cooperation. in this research study, the investigators are assessing the feasibility of providing extraorally delivered low level light therapy (lllt) for the prevention of om in children undergoing myeloablative hct.

this is an open label, single treatment arm clinical pilot study. the study is targeted to enroll twelve evaluable patients objectives: primary * determine the feasibility of providing extraoral lllt for prevention of om in pediatric patients undergoing hct secondary * determine the feasibility of collecting data using the who oral toxicity scale and chimes in pediatric patients undergoing myeloablative hct who are treated with extraoral lllt for prevention of om * evaluate the safety and tolerability of extraoral lllt for prevention of om in pediatric patients undergoing myeloablative hct

Eligibility criteria:
inclusion criteria: * scheduled to undergo myeloablative conditioning followed by autologous or allogeneic hematopoietic cell transplantation at boston children's hospital. * 4 years of age to 25 years of age. * who oral toxicity score of 0 at baseline evaluation (first day of conditioning). * ability to understand and the willingness to sign a written informed consent document (for patients under the age of 18 this applies to parent/guardian) * ability to understand and/or the willingness of their parent or legally authorized representative to sign a written informed consent document. exclusion criteria: * treatment with oral lllt within 4 weeks of hct. * participants may not be receiving any other agents intended for the prevention/management of mucositis (including palifermin and ice chips/cryotherapy). * who ≥1 at baseline evaluation.

Keywords: oropharyngeal mucositis myeloablative hematopoietic cell transplantation low level light therapy
hypertonic modulation of inflammation following injury

Conditions: Hemorrhagic Shock; Traumatic Brain Injury

Summary: this project seeks to determine the effect of prehospital resuscitation with hypertonic saline vs. conventional crystalloids on the inflammatory response after injury. the leading cause of late mortality following injury is multiple organ dysfunction syndrome (mods), which results from a dysfunctional inflammatory response after injury. previous studies suggest that hypertonic saline may be beneficial by modulating this initial response and decreasing subsequent organ injury. this project takes advantage of a unique opportunity, afforded by an nih-funded multi-center clinical trial of hypertonic resuscitation (conducted by the resuscitation outcomes consortium), to obtain blood samples from patients enrolled in this trial to analyze inflammatory responses early after hypertonic vs. conventional resuscitation. this study was an ancillary study to the main randomized clinical trial and thus prospective observational in nature the proposed study will be carried out in experiments grouped in three specific aims: aim 1 provides a thorough investigation of the immunomodulatory response following hypertonic resuscitation with regard to neutrophil, monocyte, and t cell responses at serial time points after injury and resuscitation. aim 2 comprises experiments to investigate the mechanisms by which hypertonicity may alter inflammatory cell signaling. aim 3 seeks to correlate the laboratory findings with clinical endpoints reflective of immune dysfunction including inflammation, organ failure, nosocomial infection, and sepsis. the investigators hypothesize that hypertonic resuscitation will be associated with modulation of the excessive inflammatory response seen after injury and thus will result in reduced rates of inflammatory organ injury.

this was an ancillary study to the larger clinical trials of prehospital hypertonic resuscitation conducted by the resuscitation outcomes consortium. this study investigated markers of immune function and coagulation in a subset of patients enrolled in the larger trials at two of the clinical sites. four publications detail the results please see references

Eligibility criteria:
inclusion criteria: * blunt or penetrating trauma with prehospital systolic blood pressure \ 108 or blunt trauma with prehospital glasgow coma score \<= 8 exclusion criteria: * age \< 15 yrs * known prisoners * pregnancy * ongoing cardiopulmonary resuscitation (cpr) * burns \< 20% * hypothermia \< 28 c * \> 2 liters intravenous fluid prior to study fluid administration * \> 4 hour from time of dispatch
tools for reducing inequity in acute leukemia (trial): beta testing

Conditions: Acute Leukemia; Leukemia

Summary: this study aims to test the tools for reducing inequity in acute leukemia (trial) web-based application that is designed to support participants with acute leukemia by providing information and resources about leukemia and clinical trial participation.

the goal of this single-arm pilot study is to test the trial web application which is designed to reduce inequity in clinical trial enrollment among participants with acute leukemia. the application aims to facilitate access to clinical trials and reduce barriers for underrepresented groups. the research study procedures include screening for eligibility and questionnaires. participation in this research study is expected to last about 14 weeks. it is expected about 75 people will participate in this study. the national cancer institute (nci) and american society of clinical oncology (asco) are providing funding for this study.

Eligibility criteria:
inclusion criteria: * age 18 or older * english speaking * ability to understand and willingness to sign written informed consent * clinical suspicion of acute leukemia * admitted to dfci-affiliated inpatient unit exclusion criteria: * cognitive impairment rendering the individual unable to participate in beta testing * this will be assessed by focused chart review and consultation with the patients' inpatient care team. * the following populations will be excluded: adults unable to consent, individuals who are not yet adults (infants, children, teenagers \<18 years old), prisoners. * inability to participate in in-person application testing. * patients who participated in alpha-testing through protocol 23-404 (appendix a)

Keywords: acute leukemia leukemia
homeostatic roles of eosinophils in asthma

Conditions: Asthma; Eosinophilic

Summary: the homeos study is an exploratory, observational, and monocentric research. it focuses on characterizing the homeostatic roles of eosinophils in severe asthma. the primary objective is to identify eosinophil subpopulations among different groups of severe asthmatic patients using flow cytometry. the study aims to advance understanding of eosinophil diversity, which could guide new therapeutic approaches .


Eligibility criteria:
inclusion criteria: * patients diagnosed with mild asthma with severe asthma (biologic-naïve, responders to anti-eosinophil biologic therapies and resistant to anti-eosinophil biologic therapies), control subjects without asthma * signature of informed consent * affiliation with the french social security system exclusion criteria: * non-eosinophilic asthma * coexistence of a chronic eosinophilic inflammatory condition other than asthma * other respiratory conditions (cystic fibrosis, copd, allergic bronchopulmonary aspergillosis, etc.) * treatment with corticosteroids within 10 days prior to inclusion * active smoking or a smoking history of more than 20 pack-years * pregnant women * legal incapacity or limited legal capacity * subject unlikely to cooperate with the study and/or with anticipated low cooperation as assessed by the investigator * subject without health insurance * subject currently in an exclusion period of another study or as indicated by the "national registry of volunteers."