Kornimate/medical-research-clean huggingface dataset:
a clinical study on ozone autohemotherapy for the treatment of acute ischemic stroke

Conditions: Acute Ischemic Cerebrovascular Disease

Summary: clinical studies applying ozonated autohemotherapy to treat acute cerebrovascular diseases have validated the safety and efficacy of this treatment, as well as explored its mechanism of action.


Eligibility criteria:
inclusion criteria: 1. confirmed by cranial ct or mri examination, first-ever stroke, hospital admission within \<24 hours of symptom onset, 2. age \>18 years, 3. nihss score between 4 and 15, 4. toast classification as large artery atherosclerosis, 5. complete clinical records, minimum follow-up period of ≥3 months post-discharge, 6. willingness to undergo brachial blood puncture treatment, and provision of informed consent exclusion criteria: 1. other neurological disorders, cerebral infarction caused by vertebral-basilar artery disease, cardioembolic stroke, or large-vessel vasculitis, acute or chronic infectious diseases, autoimmune or hematologic disorders, malignant tumors, mental abnormalities, severe heart, liver, or kidney dysfunction, intracerebral hemorrhage, and craniocerebral surgery history. 2. contraindications for ozone therapy included hyperthyroidism, favism, severe coagulation disorders, and abnormal puncture site barriers
prevention of oral mucositis in head and neck cancer.

Conditions: Oral Mucositis

Summary: oral mucositis (om) consists in the painful inflammation and ulceration of the mucous membranes lining the digestive tract, lasting between 7 and 98 days; and starts as an acute inflammation of oral mucosa, tongue, and pharynx after rt exposure. gel x spray is a product based on zinc gluconate. it could be helpful to achieve the prevention of oral mucositis and, in case of om manifestation, the reduction of oral pain symptoms and to accelerate the healing process of oral mucositis ulcerations. the aim of this study is to demonstrate the efficacy of the treatment with gel x to reduce the incidence of oral mucositis, in comparison with sodium bicarbonate.


Eligibility criteria:
inclusion criteria: * patients with diagnosis of the following hnc: oral cavity, pharynx, unknown primary, salivary glands, undergoing local radiotherapy for curative purpose * patients with diagnosis of hnc: oral cavity, pharynx, unknown primary, salivary glands, undergoing local radiotherapy as an adjuvant to surgical resection * patients able self-apply the product. exclusion criteria: * patients with documented contraindication to any of the components of "gel x" (there included eccipients): water, saccharin sodium, pvp, taurine, zinc gluconate, peg-40, hydrogenated castor oil, pullulan, flavors * patients with any neurological and psychiatric condition having an influence on the ability to self-apply the treatment * patients participating to other clinical studies
translation of an intervention for violence among adolescents in emergency departments

Conditions: Violence

Summary: the translation study aims to refine and package intervention and training materials essential to translating an efficacious emergency department (ed) based brief intervention (bi) for violence (saferteens) for two delivery methods: by ed staff on site or by therapist remotely. the study will take place in two phases. during the effectiveness phase, we will determine the effectiveness of the interventions \[on-site therapist delivered bi + text messages (n=133); remote therapy delivered bi + text messages (n=133)\], as compared to a usual care control (brochure; n=133), on violence outcomes at 3 months. note that tailored text messages will be delivered daily for the first month post-discharge, and three times per week in the second month post-discharge to the bi groups. during the implementation phase, components of the re-aim model will be assessed over a 4-month period.

participants who screen positive for the study during the effectiveness phase, will be randomized to either the therapy or control at a rate of 2:1. whether the participant receives the on-site therapist or the remote therapist will depend on day of week or shift. over the course of the study, the proportion of shifts covered by on-site verses remote therapists will be balanced for seasonality and time of day (evening vs. day time).

Eligibility criteria:
inclusion criteria: * youth (ages 14-18) presenting to the hurley medical center (hmc) ed who are medically stable. patients classified by medical staff as having unstable vital signs or "level 1" trauma (e.g., unconscious, in need of immediate lifesaving procedures such as surgery), will be approached during their inpatient stay after stabilization (4% based on prior work); * access to a parent or guardian for consent among adolescents ages 14-17 (over 90% based on our prior work). * positive past 3 month violence screen criteria: youth will be eligible for the study if they endorse on self-report computer survey past three month violence perpetration exclusion criteria: * youth who do not understand english * youth deemed unable to provide informed assent/consent by ed or research staff * prisoners at time of ed presentation. * youth who present to the ed as victims of sexual abuse or child abuse
study of cbl0137 in combination with ipilimumab and nivolumab therapy in melanoma

Conditions: Locally Advanced or Metastatic Melanoma

Summary: phase i, open label, dose-escalation, and safety study designed to assess the safety and biologic activity of the investigational agent cbl0137 in combination with standard of care drugs, ipilimumab and nivolumab in sequential cohorts of adult patients with locally advanced and metastatic melanoma who are candidates for immune checkpoint blockade and have tumors accessible for serial biopsies.

the primary objectives will be initial assessment of safety and tolerability of the combination of cbl0137 with nivolumab and ipilimumab.

Eligibility criteria:
inclusion criteria: 1. patients must have: 1. pathologically proven stage iii melanoma with one or more macroscopic lymph node metastases (measurable according to recist v. 1.1) amenable to biopsy and/or surgery or: 2. patients considered to have stage iii or stage iv disease amenable to serial biopsies as determined by the treating physician. note: patients with in-transit metastasis may be eligible after surgical consultation if not surgical candidates. 3. patients must have disease amenable to and must be willing to undergo protocol-directed repeat biopsies and blood draws. 2. age \> 18 years 3. ecog performance status 0 or 1 4. patients must have normal organ and marrow function exclusion criteria: 1. patients may not be receiving any other investigational agents 2. patients with a known active autoimmune disease 3. prior treatment with ctla-4 or pd1/pd-l1 pathway targeted systemic treatment 4. concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids 5. patients with ongoing diarrhea (\> 4 bowel movements/day) unresolved despite medical and best supportive care in the two weeks preceding therapy
relation between muscle mass, total body fat, visceral fat, waist hip ratio and sleeping hours in patient with nonspecific back pain

Conditions: Obesity; Back Pain; Sleep

Summary: objective: to find out if there are a relation between muscle mass, total body fat, visceral fat, waist hip ratio and sleeping hours in patient with nonspecific back pain. design: cross sectional study. subjects: 30 male and female patients with age ranged from 25 to 40 years old diagnosed as nonspecific low back pain will participate in this study. main measures: the outcome measures will be including the assessment of muscle mass, total body fat, visceral fat, waist hip ratio and sleeping hours. results: the results will be analyzed via co relation test.

objective: to find out if there are a relation between muscle mass, total body fat, visceral fat, waist hip ratio and sleeping hours in patient with nonspecific back pain. methods: * tatinia bioelectric impedance device used for measurement of muscle mass total body fat and visceral fat * waist hip ratio measured by tape measurement the waist-hip ratio or waist-to-hip ratio (whr) is the dimensionless ratio of the circumference of the waist to that of the hips. this is calculated as waist measurement divided by hip measurement (w⁄h). participants 30 male and female patient will participate in this study

Eligibility criteria:
inclusion criteria: * •adulthood with low back pain * their ages will range from 20-40 years old. * all of them suffer from mild to moderate degree of low back pain. * the subjects complain from low back pain for 1 month ago exclusion criteria: exclusion criteria were a history of any of the following condition: * inflammatory diseases or any rheumatic disorders, * a history of vertebral fractures * surgical spinal fixation. * •any neurological disorders like ms
the quality of life and direct financial costs associated with home ventilation of children: a prospective study

Conditions: Children Receiving Ventilation at Home for Chronic Illness or Disease

Summary: the investigators wish to learn about the quality of life (qol) of children needing long term home ventilation and also that of their regular caregivers. in addition, the investigators will monitor the extra health-related expenses these families must meet. data will be collected using two age-specific questionnaires of qol plus a third one validated for assessing chronic health care costs. questionnaires will be administered at an initial face to face meeting, supplemented by two telephone follow-up calls, to monitor medical expenses, one and two months later.


Eligibility criteria:
inclusion criteria: all families, or appointed guardians, caring for children that need home ventilatory support will be eligible for enrollment exclusion criteria: refusal to join the study

Keywords: home ventilation
study to evaluate the pharmacokinetic interaction between pla-695 and methotrexate in adults with rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: the purpose of this study is to determine if pla-695 changes the blood concentrations of methotrexate when administered together.


Eligibility criteria:
inclusion criteria: * men or women of nonchildbearing potential with rheumatoid arthritis (ra), aged 18 to 75 years * ra disease onset after 16 years of age and has had the disease for at least 6 months * must be receiving a stable, well-tolerated oral dose of methotrexate (5 to 25 mg) taken once weekly for at least 3 months exclusion criteria: * evidence of unstable clinically significant disease
efficacy of clorazepate for the treatment of migraine attack in the emergency room

Conditions: Migraine; Migraine Without Aura; Migraine with Aura; Headache

Summary: the purpose of this study is to evaluate the efficacy of clorazepate in addition to the usual medication for treating migraine attack in the emergency room

each patient will receive the usual migraine treatment: iv ketoprofen 100 mg and, if he suffers nausea and/or vomiting, additional iv metoclopramide 10 mg. depending on randomization assignment, patient will receive additional placebo (standard treatment arm) or additional iv clorazepate 20 mg (study arm). the central pharmacy will be responsible for preparing the medications, using a double-blind protocol.

Eligibility criteria:
inclusion criteria: * age from 18 to 70 * patient suffering migraine or probable migraine (diagnosis made by neurologist according to ihcd3) * present migraine attack lasting ≤ 72 hours * headache intensity moderate or severe on the verbal ordinal scale (4 levels: no headache, mild, moderate or severe) * patient requiring parenteral treatment * affiliation to the french health-care system "sécurité sociale" exclusion criteria: * abnormalities of neurological exam, seizure, fever (≥ 38°c), and/or sbp≥180 and/or dbp≥110 mmhg * suspicion of secondary headache * inability to understand the consent or scales * pregnancy or breast-feeding * known respiratory or liver insufficiency * acute alcohol consumption or alcoholism * myasthenia * patient requiering treatment with sumatriptan sc, particularly in the event of failure of an anti-inflammatory drug at an effective dose taken within 6 hours * recent use of benzodiazepines (\< 24h diazepam, clonazepam, clorazepate ; \< 6h alprazolam, lorazepam, midazolam) * recent use of pain killers (\< 2h) * contraindication to any of the investigational medication * contraindication to intravenous access * previous participation to this study
high-risk obstetrical patient intervention utilizing the contraceptive choice project script

Conditions: Diabetes; Contraception

Summary: high-risk obstetrical patient intervention to promote birth interval spacing utilizing the contraceptive choice project script to reduce unintended subsequent pregnancies (hibiscus) is a collaborative study utilizing qualitative methods to assess the acceptability including a family planning specialist's postpartum contraception counseling during and after prenatal care among latina obstetric women with pre-gestational diabetes. the investigators will compare the effectiveness of hibiscus versus usual contraceptive counseling on long-acting reversible contraception (larc) use at 3 months postpartum.

the purpose of this research is to address this gap in long-acting reversible contraception (larc) counseling among latinas who have pregnancies complicated by pre-gestational diabetes in order to promote optimal birth-to-pregnancy spacing and planned pregnancies with optimal glucose control. the investigators will utilize contraceptive choice project which was larc focused counseling script and removed the cost of contraception. this study had a larc utilization of 75% compared to the national use of larc of 7.2% the investigators will conduct a pilot randomized controlled trial among latina obstetrics patients with pre-gestational diabetes involving a prenatal and postpartum visit with a family planning specialist versus usual contraceptive counseling. the family planning specialist counseling will utilize the contraceptive choice project script promoting larc, 18 month birth-to-pregnancy recommendation and preconception counseling. the intervention's name is hibiscus.

Eligibility criteria:
inclusion criteria: * latina obstetric women * pre-gestational diabetes * obtaining prenatal care in the high-risk obstetrical clinic - diabetes in pregnancy exclusion criteria: * desires sterilization

Keywords: diabetes contraception prenatal counseling
mycophenolate mofetil for treatment of relapses of wegener's disease or microscopic polyangiitis (mpa)

Conditions: Wegener's Granulomatosis; Vasculitis

Summary: the purpose of this study is to determine the efficacy and safety of a new drug, mycophenolate mofetil, for the treatment of relapses of anca-associated vasculitis (wegener's granulomatosis or microscopic polyangiitis). therefore, we compare the standard therapy with cyclophosphamide to mycophenolate mofetil. the investigators expect mycophenolate mofetil to be less toxic and almost equally effective as cyclophosphamide.

treatment of anca-associated vasculitis consists of two phases: remission induction with highly effective, but also relatively toxic drugs, and, secondly, after remission is achieved, maintenance therapy with less toxic drugs. the standard induction therapy of a relapse of wegener's granulomatosis or microscopic polyangiitis consists of the combination of cyclophosphamide and prednisolone. although this induction therapy is very effective, it is very toxic as well. searching for an alternative for cyclophosphamide, we will test the efficacy and safety of a new combination therapy with mycophenolate mofetil and prednisolone. we will compare the effect and safety of the standard induction therapy with the new therapy. when relapses occur, patients will be randomized for either the standard therapy with cyclophosphamide or for mycophenolate mofetil.

Eligibility criteria:
inclusion criteria: * first or second relapse anca-associated vasculitis * pr3- or mpo-anca antibodies present or histological proof of relapse * adult exclusion criteria: * severe alveolar bleeding or (imminent) respiratory failure * renal failure (serum creatinine \>500 umol/l or dialysis) * maintenance therapy before start of study consisting of: cyclophosphamide \> 100 mg/day or prednisolone \>25 mg/day * intolerance or allergy for cyclophosphamide, mycophenolate mofetil or azathioprine * gravidity or inadequate anticonception

Keywords: induction therapy anca-associated vasculitis wegener's granulomatosis microscopic polyangiitis mycophenolate mofetil cyclophosphamide
effect of digital smile design on quality of life in complete denture wearers

Conditions: Complete Edentulism

Summary: the aim of the current study protocol is to compare the effect of two complete dentures made for completely edentulous patients; one digitally constructed using digital smile design (dsd) and another one conventionally constructed on the patient's quality of life and patient's satisfaction. it is a clinical trial in which two dentures will be made for each patient, one will be digitally constructed using digital smile design (dsd) and the other one using the conventional method with a washout period of 3 weeks. each patient will receive a questionnaire "oral health impact profile -19" (ohip -19) for the edentulous patients to evaluate his satisfaction with the denture.

although the aesthetic results of digitally constructed dentures might be satisfactory for the patients, there is still little clinical evidence for the effect of using digital smile design dsd in denture construction on the patient's satisfaction. so, the objective of the current study is to find the effect of digital smile design (dsd) on quality of life in complete denture wearers compared to the conventionally created one. the current study is planned to be a crossover randomized controlled trial (rct). the principal investigator, participants and the statistician will be blinded. simple randomization of the patients in the will take place using a computer generated list (software informer, informer technologies inc) and allocated into two groups; a conventional denture followed by a digital group (cg) and a digital denture followed by a conventional one group (dg). parallel allocation in ratio 1:1 will take place. the names of the participants in both groups will be placed in closed opaque sealed envelopes according to the computer generated list of random numbers and an envelope will be allocated to each patient. for blinding and allocation concealment, a third party rather than the authors and participants will be the only one to know the key so that the authors and the participants won't know in which group the participant will be. afterwards, the authors will be informed by the randomization to be tabulated.

Eligibility criteria:
inclusion criteria: * completely edentulous patients * well formed edentulous ridge * healthy, pink, non edematous mucosa of even thickness exclusion criteria: * heavy smokers * patients with parafunctional habits, temporomandibular joint disorders or orofacial motor disorders * patients with physicological or psychiatric condition
homeopathy as an adjuvant to chemotherapy improves clinical outcome in relapsed pulmonary tuberculosis

Conditions: Pulmonary Tuberculosis

Summary: the purpose of the study is to evaluate the effect of homeopathy as an adjuvant to anti tuberculosis treatment on sputum conversion, hematological, clinical sign and symptoms of relapsed pulmonary tb.


Eligibility criteria:
inclusion criteria: relapse pulmonary tuberculosis patients with acid-fast bacilli smear positive by microscopy, using ziehlnieelsen staining as recommended by who, unfit for dots - exclusion criteria: pregnancy, clinical sign of any concomitant disease such as diabetes mellitus, acute renal failure or infectious disease including tb/hiv and hiv positive, currently or taken any alternative therapies in past 6 months
transfusion-associated microchimerism in individuals receiving a blood transfusion after a traumatic injury

Conditions: Chimerism; Blood Transfusion; Wounds and Injuries

Summary: individuals who experience a traumatic injury often have a significant amount of blood loss and may require a blood transfusion. in some individuals who receive a blood transfusion, white blood cells from the donor's blood may remain in the body for years, a condition known as microchimerism. this study will examine the reasons why microchimerism occurs in some blood transfusion recipients and not others.

approximately 20% of individuals who suffer a traumatic injury require a blood transfusion; of these, 10% to 15% experience a condition known as transfusion-associated microchimerism. this occurs when white blood cells, or leukocytes, from the donor's blood persist in the recipient long after the transfusion occurs. the genetically distinct donor cells can remain in the individual for decades, and may account for as many as 4% of the white blood cells in the recipient's body. this suggests that the donor cells are tolerated by the recipient's immune system. the purpose of this study is to examine the specific factors that predispose some blood transfusion recipients to develop microchimerism. in this study, blood samples will be collected from injured individuals who arrive at the university of california at davis medical center. individuals who receive a blood transfusion, as well as a control group of individuals who do not receive a transfusion, will be approached to enroll in the study. individuals who agree to participate will have their blood collected at days 7, 14, and 28 and months 3 and 6. study researchers will analyze the blood for evidence of microchimerism. participants with microchimerism will undergo additional blood collection at months 12, 18, 24, 30, and 36. information will be collected from all participants on health status, injury characteristics, hospital care, blood transfusion details, and blood donor characteristics.

Eligibility criteria:
inclusion criteria: * hospitalized for a traumatic injury * received at least one unit of transfused red blood cells exclusion criteria: * currently incarcerated * inadequate decision-making capacity of the participant and no available surrogate decision-maker * prior bone marrow or solid organ transplantation

Keywords: microchimerism injuries leukocytes immunologic techniques
human milk fortification in very low birth neonates

Conditions: Premature; Infant; Enteral Nutrition; Human Milk; Fortification

Summary: the purpose of this study to find out how safely we can add extra nutrients to human milk at different feeding volume.

very low birth weight babies (weight less than three pounds and three ounces) are extremely fragile and lacking important nutrition due to premature birth. they need enough calories for catch-up growth. giving adequate nutrition is very important for their growth and development. human milk is the best food, however it is not enough to provide all the required calories and nutrients for catch up growth and maintain adequate strength of the bones (bone mineralization). for premature babies, extra nutrients (human milk fortifier) are usually added to the human milk to provide adequate nutrition. these extra nutrients will be derived from cow's milk. currently, a practice of fortifying human milk varies. there is no clear information when to start adding extra nutrients to human milk.

Eligibility criteria:
inclusion criteria: * very low birth weight infants who receive human milk (mother's milk or banked donor human milk). exclusion criteria: * major congenital anomalies such as cardiac defect, neural tube defect, chromosomal abnormality and gastrointestinal defect. * died or extended to die within 48 hours of life