Kornimate/medical-research-clean huggingface dataset:
autologous natural killer t cells infusion for the treatment of cancer

Conditions: Breast Cancer; Glioma; Hepatocellular Cancer; Squamous Cell Lung Cancer; Pancreatic Cancer; Colon Cancer; Prostate Cancer

Summary: the purpose of this study is to assess the safety and effectiveness of natural killer t (nkt) cell-based autologous adoptive immunotherapy in subjects with metastatic, treatment-refractory breast cancer, glioma, hepatocellular carcinoma, squamous cell lung cancer, pancreatic cancer, colon cancer or prostate cancer.

a randomized controlled trial on the efficacy and safety of autologous natural killer t (nkt) cells infusion treatment in advanced cancer.

Eligibility criteria:
inclusion criteria:•male or female not less than 18 years of age or over 80 years of age. * life expectancy of ≥ 24 weeks as measured by the eastern cooperative oncology group (ecog) performance status. * subjects must present with one of the following disease pathologies: breast cancer, glioma, hepatocellular cancer, squamous cell lung cancer, pancreatic cancer, colon cancer or prostate cancer * the pathology must be an assessable disease (measurable by ct scan or mri) that is refractory to standard treatments (e.g., chemotherapy, radiation, etc.) * negative for hepatitis b, hepatitis c, hiv, and cmv. * subjects must present with leukocyte counts above 3,000/μl and platelet counts above 100,000/ μl. * subjects must present with minimum hemoglobin levels of 10. * if female, subject is surgically sterile (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), post menopausal (no menses \>12 months), or using a high-efficiency method of contraception such as implant, injectable, combination oral contraceptive, intrauterine device (iud) or sexual abstinence, or has a vasectomized partner. * if female of childbearing potential, subject is not pregnant, breast-feeding or planning a pregnancy during the study, and has a negative pregnancy test on screening visit. * able to comprehend and sign an informed consent document and comply with the requirements of the study. exclusion criteria:•no measurable malignant disease by ct scan or tumor markers. * life expectancy of ≤ 24 weeks as measured by the eastern cooperative oncology group (ecog) performance status. * age of less than 18 years or over 80 years of age. * documented/confirmed positive testing for hepatitis b, hepatitis c, hiv, or cmv. * prior or current history of autoimmune disease. * pregnant or lactating women. * leukocyte count \< 3,000 /μl prior to leukapheresis. * platelet count \< 100,000/μl prior to leukapheresis. * hemoglobin levels below 10. * ptt (prothrombin time) of \ than 15 seconds. * aptt (activated partial thromboplastin time) of \ than 39 seconds. * failure or refusal to sign informed consent for the study. * culture fails to meet specifications for study. * subject has any other medical condition that, in the opinion of the investigator, might significantly affect the ability to safely participate in the study or affect the conduct of the study.
assess the variability of uni-dimensional, bi-dimensional, and volumetric ct scan measurement of non-small cell lung cancer tumors

Conditions: Lung Cancer; Non Small Cell

Summary: the purpose of this study is to compare the results of two ct scans of the chest performed within minutes of each other. we will compare several different measurements of lung cancer tumors. this study will help show whether we can get accurate results when we compare measurements on different ct scans. this information is important for patients with cancer, who often have more than one ct scan during their treatment.

standard criteria for tumor response assessment have used uni-dimensional or bi-dimensional measurements as a surrogate for volume determination. modern ct scan techniques, in combination with algorithms developed at mskcc, allow the calculation of tumor volume. this protocol is designed to evaluate the reproducibility of the calculated volume of pulmonary masses on separate ct scans obtained on the same day in patients with non-small cell lung cancer (nsclc). patients with nsclc undergoing non-contrast ct scan of the chest will have a second, non-contrast ct scan of the chest performed. uni-dimensional, bi-dimensional, and volume measurements for the primary nsclc lesion will be determined on both scans and the values compared.

Eligibility criteria:
inclusion criteria: * have pathologically confirmed non-small cell lung cancer * have measurable primary pulmonary tumors ≥ 1cm * have plans for a clinically indicated non-contrast ct scan of the chest * all patients must be ≥ 18 years old exclusion criteria: * pregnant or lactating women

Keywords: lung
safety and efficacy of zolpidem in the long-term treatment of insomnia

Conditions: Chronic Insomnia

Summary: the purpose of this study is to evaluate the safety and efficacy of sublingual zolpidem during the long-term treatment of insomnia.


Eligibility criteria:
inclusion criteria: * ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms; * age between 18 to 64 years; * participants diagnosed with chronic insomnia defined by difficulty in initiating or maintaining sleep in the last 3 months for at least 3 nights a week according to dsm-v criteria and confirmed by polysomnography; * participants with difficulty in initiating or maintaining sleep parameters. exclusion criteria: * participants with clinical or laboratory diagnose of non-treated hypothyroidism or hyperthyroidism, kidney or liver failure; * known hypersensitivity to any of the formula compounds; * participants with other sleep disorders according to the international classification sleep disorders (3rd edition), example: sleep-relate breathing disorders, circadian rhythm sleep-wake disorders, parasomnias (including history of sleep-walking after hypnotic use) and sleep related movement disorders; * participants using sedatives or hypnotic medications; * participants with current diagnosis of depression or anxiety according to the diagnostic and statistical manual of mental disorders; * participants with history of drug and alcohol abuse in the past 2 years; * participants with current smoking habits during the night period; * participants who treated insomnia in the last 3 months; * participants who are pregnant, breastfeeding or planning to get pregnant or female participants with the potential to become pregnant who are not using a reliable method of contraception; * any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants; * participants with current or medical history of cancer in the last 5 years; * participants who participated in other research protocol in the last 12 months, unless the investigator judges that there may be a direct benefit to it.

Keywords: chronic insomnia sleep disorder
evaluation of reliability of cariescan pro compared with digital radiograph and icdas-ii in detection of carious lesions

Conditions: Dental Caries

Summary: the aim of this study is to evaluate the clinical performance of alternating current impedance spectroscopy (cariescan pro) in comparison with digital radiograph and icdas-ii in detection of occlusal carious lesions.

the visual examination is routinely used for detecting caries in dental clinics and was also used in recent studies comparing the efficacy of various visual aids. it has the benefit that it is quick and easy to perform, does not need expensive equipment, and can be completed without unnecessary radiation or fluorescence (ismail, et al., 2007). in the current study, icdas-ii was set as "gold standard" due to validated relationship between its codes and the histological depth of a carious lesion as in many other studies. in addition, several studies have shown good reproducibility and accuracy of icdas-ii for caries detection in permanent teeth especially caries lesions in the outer half of the enamel (gugnani, et al., 2010). bitewing radiographs are used to determine the depth of caries involvement. most often, bitewing examination is affiliated with the diagnosis of interproximal caries. it is strongly recommended that these radiographs be used in the diagnosis of occlusal caries into dentin (pitts nb et al., 1991).

Eligibility criteria:
inclusion criteria of teeth: * posterior teeth with dark shadow on occlusal surface. * vital upper or lower posterior teeth with no signs of irreversible pulpitis. * intact contact with opposing teeth. * teeth with no previous restorations in other surfaces. exclusion criteria of the teeth: * periapical pathology or signs of pulpal pathology. * tooth hypersensitivity. * possible prosthodontic restoration of teeth. * heavy occlusion and occlusal contacts or history of bruxism. * severe periodontal affection.
diastolic dysfunction and interstitial lung edema in septic patients

Conditions: Sepsis; Diastolic Dysfunction; Lung Edema; Fluid Overload

Summary: sepsis is one of the most challenging conditions with an exceptionally high mortality rate. diastolic dysfunction is common in septic patients and has been found to be associated with mortality. however, the reasons for this remain unclear. therefore, the goal of this study is to investigate diastolic dysfunction in septic patients on the intensive care unit. special attention is paid to the presence of lung edema and general edema as a potential link between diastolic dysfunction and elevated mortality in septic patients. during the septic phase daily ultrasound examinations of heart and lung will be performed as to monitor diastolic function and lung edema.


Eligibility criteria:
inclusion criteria: * patients on the intensive care unit diagnosed with sirs (systemic inflammatory response syndrome) or sepsis. exclusion criteria: * patients with hemodynamically relevant cardiac defects. * patients with mitral valve replacement. * patients with pericardial effusion. * patients with atrial fibrillation. * patients with pacemaker therapy. * patients with bmi \> 35 kg/m2. * patients with poor examination conditions for ultrasound.

Keywords: intensive care unit echocardiography
study determining safety and efficacy of avena sativa (oat) skincare products for treating skin dryness and itching in cancer patients

Conditions: Ichthyosis; Pruritus

Summary: this study will test the safety and efficacy of three topical agents containing oat kernel flour to determine how well they relieve skin dryness and itching related to cancer therapies. participants will receive a body wash, a body cream, and an anti-itch balm to use at home for 4-6 weeks.

many patients undergoing cancer therapies experience skin reactions like dry skin, rash, redness, itchiness, and hyperpigmentation. dry skin and itching are especially common for those undergoing chemotherapy and targeted treatments. skincare products containing avena sativa (oat) kernel flour have a long history of tolerance and efficacy in treating various skin conditions involving pruritus (itching) and xerosis (dry skin), as avena sativa (oat) kernel flour is known for its skin protectant properties and soothing effects on skin. this study will evaluate the safety and efficacy of a regimen of three topical agents containing avena sativa (oat) kernel flour for cancer patients experiencing mild to moderate pruritus and/or xerosis. participants will received the products at baseline (visit 1) and return to the clinical site at week 5 +/- 1 week for visit 2. in addition, questionnaires will be completed remotely between baseline and visit 2.

Eligibility criteria:
inclusion criteria: * able to read, write, speak, and understand english * has signed informed consent including photograph release * has a prior diagnosis of a solid or hematologic tumor and either: 1. is currently undergoing therapy with a systemic agent and has completed at least 3 cycles without severe skin reactions. 2. has received therapy with a systemic agent in the past 28 days. 3. is greater than 1 year status post allogeneic hematopoietic stem cell transplantation. * is undergoing one or more types of cancer treatment that are commonly known to cause mild to moderate skin reactions such as rash, dryness, and/or itching * is diagnosed with mild to moderate skin dryness (xerosis) and/or itching (pruritus). * is capable of all self-care and is up and mobile at least 50% of the day * intends to complete the study and is willing/able to follow all study instructions. exclusion criteria: * has known allergies or sensitivity to skincare products or study product ingredients. * has other skin conditions or diseases that the investigator thinks would interfere with the study or put the subject at higher risk (e.g. immunosuppressive diseases, skin infections, etc.) * has severe skin dryness, itching, or rash. * is undergoing radiation therapy. * is undergoing chemotherapy or adjuntive therapies known to commonly cause complex or severe skin reactions. * has uncontrolled diabetes. * is pregnant or planning to become pregnant during the study. * is participating in another study for which the participant is receiving a treatment or therapy (observational studies are okay). * is an employee or family member of the investigator, study site, or sponsor.

Keywords: pruritis itching dryness xerosis
influence of a silicone gel (dermatix®) on thoracic scar formation after harvesting of autologous rib cartilage

Conditions: Cicatrix, Hypertrophic; Keloid

Summary: so far the evaluation of scar treatment was based on subjective criteria. the patient groups were divided into treated versus non-treated. in this study we use patients undergoing ear reconstruction with autologous rib cartilage. the thoracic scar of harvesting the rib cartilage is routinely reopened after 3 month during second stage of reconstruction. therefore we have a ideal model of clinical, physiological and histological scar evaluation in a homologous patient group. all patients randomly treat one half of the scar with a silicone gel (dermatix). the other half is untreated as an internal control.


Eligibility criteria:
inclusion criteria: * patients with high grade microtia requiring a reconstruction with autologous rib cartilage exclusion criteria: * diabetes mellitus * vascular disease * known allergic reaction to silicone

Keywords: silicone gel cicatrix wound healing scar keloid
short course radiation treatment for patients with primary or locally recurrent retroperitoneal sarcoma prior to surgery

Conditions: Retroperitoneal Sarcoma

Summary: to determine the safety of moderately hypofractionated radiation in the treatment of primary and locally recurrent rps, based on the evaluation of acute radiation-related toxicity profile of each participant (30-day radiation toxicity)

to determine the safety of moderately hypofractionated radiation in the treatment of primary and locally recurrent rps, based on the evaluation of acute radiation-related toxicity profile of each participant (30-day radiation toxicity)

Eligibility criteria:
inclusion criteria: * participants must have a histologically confirmed sts of the retroperitoneal space or infra-peritoneal spaces of pelvis * participant must have radiologically measurable disease (recist 1.1), as confirmed by abdomino-pelvic ct or mri * participant must have primary, locally recurrent, or metastatic disease requiring treatment of the retroperitoneal mass * tumor must be suitable for radiotherapy and surgery based on pre-treatment ct scan/mri in multidisciplinary discussion with surgeon and radiation oncologist (anticipated macroscopically complete resection, r0/r1 resection) * age: 18 years or older * ecog performance status ≤2 * absence of history of bowel obstruction, mesenteric ischemia, or severe chronic inflammatory bowel disease. * normal renal function (calculated creatinine clearance ≥50 ml/min) * normal bone marrow and hepatic function (white blood cell count ≥2·5 × 10⁹ cells per l, platelet count ≥80 × 10⁹ cells per l, and total bilirubin \<2 times upper limit of normal) * women of child-bearing potential must have a negative pregnancy test within 3 weeks prior to the first day of study treatment * patients capable of childbearing/reproductive potential should use adequate contraception * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * sarcoma originating from bone structure, abdominal or gynecological viscera * any of the following histological subtypes: gastrointestinal stromal tumor, rhabdomyosarcoma, primitive neuroectodermal tumor or other small round blue cell sarcoma, osteosarcoma, chondrosarcoma, aggressive fibromatosis, or sarcomatoid or metastatic carcinoma * prior rt to the rps * prior abdominal or pelvic irradiation for other prior malignancy or other disease * prior different invasive malignancy may be eligible per the discretion of the treating investigator and review by the principal investigator (pi) * prior chemotherapy or immunotherapy within 6 weeks of start of rt * pregnant women are excluded from this study because rt has the potential for teratogenic or abortifacient effects. * hiv-positive individuals on combination antiretroviral therapy are ineligible because of the potential for increased sensitivity to rt
phase 2 trial to evaluate 18-methoxycoronaridine efficacy, safety and tolerability in cutaneous leishmaniasis patients

Conditions: Leishmaniasis; American, Cutaneous; Drug Side Effect

Summary: it is a randomized phase ii clinical study, unicentre aimed to evaluate the tolerability, safety and efficacy of 18-methoxyoronaridine as a candidate of tegumentary leishmaniasis treatment.


Eligibility criteria:
inclusion criteria: * age between 18 and 59 years of age; * clinical diagnosis of leishmaniasis with at least one ulcerated lesion with evolution time from one month; * parasitological confirmation; * women of childbearing potential should not be pregnant or breastfeeding, confirmed by examination of b-hcg (gonadotrophic-chorionic hormone beta) at the time of screening; * men and women should use barrier contraceptive methods during the course of the study; exclusion criteria: * history of any disease or comorbidities that, in the opinion of the investigator, can either put the individual at risk or influence the results and ability of the subject to participate in the study; * history or presence of gastrointestinal, hepatic, cardiac, renal disease or any other known condition that may interfere with the absorption, distribution, metabolism or excretion of the investigational product; * any evidence of underlying serious disease (cardiac, renal, hepatic or pulmonary); * pregnancy or the patient's unwillingness to use barrier contraceptive methods during and 3 months after therapy; * history of gastrointestinal ulcer disease, inflammatory bowel disease, symptoms of indigestion; * any clinically important abnormality in biochemistry, hematology, urinalysis or clinical outcomes judged by the investigator; * any positive screening result for hepatitis b antigens, hepatitis c antibodies, and human immunodeficiency virus (hiv); * any clinically significant abnormalities in the rate, or driving the resting ecg morphology that may interfere with the interpretation of the qt interval variations; * history of cancer; * history of drug abuse, judging by the investigator * history of alcohol abuse or excessive alcohol consumption, judged by the investigator; * history of smoking * history of severe allergy / hypersensitivity, judged by the investigator; * history of hypersensitivity to drugs with similar chemical structure.

Keywords: safety pharmacokynetics leishmaniasis treatment
evaluation of the automatic deformable recontouring on the daily mvct for head and neck cancer adaptive radiotherapy

Conditions: Head and Neck Cancer

Summary: this trial is a prospective, monocentric study aiming to evaluate an adaptive radiotherapy method (automatic deformable recontouring on the daily mvct (megavoltage computerized tomography)) using the precise art™ software in patients with head and neck cancer. patients will receive helical intensity-modulated radiotherapy (imrt) according to the standard recommendations (35 fractions during 7 weeks). radiotherapy will include daily repositioning mvct. for the study, patients will undergo 4 intermediate re-planning ct-scan (without injection of intravenous contrast agent) at week 3, week 4, week 5 and week 6 of treatment. 3 recontouring modalities will be evaluated for the study: * manuel recontouring (standard method) * precise art™ deformed contours * precise rtx™ deformed contours the total duration of the study for each patient will be 7 weeks.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old 2. patient with histologically proven locally advanced head and neck cancer (oropharynx, hypopharynx, larynx, nasopharynx, oral cavity, sinuses, nasal cavities, ethmoid sinus, cavum, salivary glands) 3. cancer with nodal involvement (at least t3 or involved node \>2 cm) 4. eastern cooperative oncology group performance status 0 or 1 5. no previous curative treatment for head and neck cancer (surgery and/or radiotherapy and/or chemotherapy) 6. indication of exclusive radiotherapy (+/- chemotherapy) validated in multidisciplinary meeting 7. patient affiliated to the french social security system. 8. patient must provide written informed consent prior to inclusion in the study and any study-specific procedure. exclusion criteria: 1. patient with metastatic cancer 2. eastern cooperative oncology group performance status ≥ 2 (due to comorbidities) 3. patient with recurrent disease 4. patient who required urgent surgical treatment 5. contraindications to radiotherapy 6. history of cancer within 5 years 7. patient already included in another therapeutic trial 8. pregnant or breastfeeding women 9. any psychological, familial, geographical or sociological condition potentially preventing the medical follow-up and/or study procedures 10. patient protected by law

Keywords: adaptive radiotherapy
can acupuncture be used as preparation for induction of labour

Conditions: Pregnancy Overdue - Week 41+6

Summary: the purpose of the study is to evaluate whether acupuncture can be used to ripen cervix before medicinal induction of labor or even be used as method for induction, and thereby eliminating other and more potentially harmful methods.

acupuncture has become a natural part of the range of treatments in obstetric departments in denmark, but there is only little evidence to the effect of acupuncture. many of the induction procedures currently in use in denmark also have a little risk of side effects. to mention a few: there is a increased risk of maternal and neonatal infection, bleeding, ruptured membranes and placental disruption as result of the use of endocervical balloon catheter. in connection with manual rupture of membranes there is an increased risk of umbilical prolapse, maternal and neonatal infection, affected fetal heart rate, scratches on the scalp and placental bleeding. by using misoprostol there has been seen hyperstimulation of uterus causing affected fetal heart rate. many women are asking for alternatives to the existing methods used in obstetric dept.s. in order to assess the effect, or lack of, acupuncture might have, we want to use acupuncture in the study group on acupuncture points on hands, feet, ankles and back of the head. the control group will get placebo acupuncture needles on same locations. the included women will be treated with the kind of acupuncture that counts for the group to which shes been allocated on gestational age 41+6 at 8:00 am and 2:30 pm.

Eligibility criteria:
inclusion criteria: * gestational age 41+6 * normal pregnancy, expecting a healthy baby * verified due date exclusion criteria: * women who do not speak or understand danish * multiple pregnancy * in active labour * previous sectio * maternal diseases (i.e. diabetes, preeclampsia, heart diseases) * fetal diseases (i.e. foetus mors, iugr, hydrocephalus) * previous complicated delivery i.e. low apgar score * allergic to metal * anticoagulatory treatment

Keywords: post term pregnancy acupuncture induction