Kornimate/medical-research-clean huggingface dataset:
buxue yimu pills for gynecological iron-deficiency anemia

Conditions: Iron-Deficiency Anemia

Summary: this study evaluates buxue yimu pills，ferrous sulfate and the addition of buxue yimu pills to ferrous sulfate in the treatment of iron-deficiency anemia in adults women. one third of participanta will receive buxue yimu pills, one third of participanta will receive buxue yimu pills, one third of participanta will receive ferrous sulfate，and the another third will receive buxue yimu pills and ferrous sulfate in combination.

buxue yimu pills, ferrous sulfate each improve anemia, but they do so by different machanisms. we generally treat patients with uncomplicated iron deficiency anemia with oral iron due to the ease of administration，and ferrous sulfate is one of the most commonly used drugs. buxue yimu pills consists of multiple chinses herbs including angelica sinensis，astragalus，donkey-hide gelatin，herba leonuri，citrus etc., which gains widespread application in the treatment after women's abortion or operations of uterine cavity. based on the characteristics above, we try to explore its clinical application value in gynecological iron-deficiency anemia.

Eligibility criteria:
inclusion criteria: * subject is a female between the age of 18 and 50. * subject suffers from mild to moderate anemia with a hemoglobin between 80g/l and 110 g/l. * subject has definite gynecological etiological factors of iron deficiency * subject provides written informed consent. exclusion criteria: * subject underwent chronic digestive tract inflammation，uncontrolled digestive or urinary system bleeding. * subject has other complications in addition to gynecological diseases leading to iron deficiency，such as hemorrhagic diseases of hematologic system，parasitic diseases like ancylostomiasis，chronic intravascular hemolysis，mechanical hemolysis like prosthetic valve，renal dysfunction and hemodialysis. * subject is pregnant or lactating. * subject has a severe systemic disease, such as cardiovascular system * subject has a history of malignancy or radiotherapy. * subject has undergone any iron deficiency anemia treatment including iron supplements or blood transfusion within 1month prior to randomization. * subject has mental disorder incapable of elementary cooperations. * subject has participated in other clinical researches of medicine within 1month prior to randomization.

Keywords: iron-deficiency anemia buxue yimu pills ferrous sulfate clinical observations adult women metabonomics
safety and tolerability of 4975 in the treatment of moderate to severe knee pain due to osteoarthritis (oa)

Conditions: Osteoarthritis of the Knee

Summary: this study will evaluate dosing regimens of 4975 in terms of safety and tolerability when delivered as an intra-articular injection in the knee. secondary objectives will be to explore the efficacy of 4975 in terms of onset, extent and duration of pain relief.

this is a single site study. the study drug, 4975, will be administered in various dosing regimens by intra-articular injection followed by an observation period of up to 12 weeks. pain in the treated knee will be assessed before, during and after administration of the study drug.

Eligibility criteria:
inclusion criteria: * male or female patients aged 40 years or over. * body mass index (bmi) of 35 or less. * history of oa of the knee for at least 1 year and has experienced pain in the target area for at least six months. * x-ray of the target knee. * willing and able to complete the study procedures. exclusion criteria: * female patients who are pregnant or lactating or who plan to get pregnant. * clinically significant form of joint disease other than oa. * medical condition that could adversely impact the patient's participation, safety or affect the conduct of the study. * prior major trauma in the target knee or major surgeries such as partial or total knee arthroplasty. * arthroscopic surgery on the target knee within 6 months.

Keywords: osteoarthritis, knee
imaging and omics for cardiovascular risk during nasa deep space missions

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to develop new approaches for screening astronauts for cardiovascular risk during deep space missions.

the purpose of this study is to develop new approaches for screening astronauts for cardiovascular risk during deep space missions. in this protocol, two different forms of imaging will be used to evaluate coronary plaque development (ct coronary angiography) and microvascular function (myocardial contrast echocardiography) to stratify cv risk. based on this stratification, "omic" patterns (targeted metabolomics, lipidomic, and whole genome sequencing) will be assessed to determine whether there are any patterns that can add to existing predictive models. outcomes measures will involve correlation of "omic" patterns to incremental risk scaling from lowest (no plaque and normal endothelial function) to highest (+ plaque and endothelial dysfunction).

Eligibility criteria:
inclusion criteria: * patients referred for clinically indicated ct coronary angiography within 6 months * no obstructive coronary plaque and an agatston score of 0 or at least one obstructive coronary plaque \<50% diameter and one other high risk feature on ct-a (positive remodeling, scattered calcification, low hounsfield units, or "napkin ring" sign. exclusion criteria: * known cad or other atherosclerotic disease * valvular heart disease (moderate or more) and congenital heart disease * heart failure * pregnancy * allergy to ultrasound contrast agent. * right to left shunt
development and evaluation of an artificial intelligence model for the diagnosis of aeroallergies

Conditions: Allergy

Summary: to improve accuracy and take out human error, hippo dx previously developed s.p.a.t., an automated skin prick test. now, hippo dx will develop and evaluate a s.p.a.t. artificial intelligence (ai) medical software to support physicians in the read out of the test results from an automated skin prick test. in this study 700 images will be collected to develop the ai model, an additional 200 images will be collected to evaluate performance of the ai model. in a last independent cohort of 100 patients, performance of read-out by the physician will be compared with read out by the physician supported by the s.p.a.t. ai medical software. the primary endpoint is the accuracy of the maximal wheal size measurement by s.p.a.t. ai versus the maximal wheal size measurement by the physician. it is a prospective multicentric study that will include 1000 study participants from different countries.


Eligibility criteria:
inclusion criteria: - adults aged 18 years or above, consulting the outpatient clinic for an allergy diagnosis to aeroallergens will be included. exclusion criteria: * skin pathology like chronic or exuberant urticaria, dermographism, chronic dermatitis that needs daily treatment * use of antihistaminic medication \< 7 days before the start of the study * use of tricyclic antidepressants (antihistamine activity) \< 7 days before the start of the study * use of topical corticoids on the forearm \< 7 days before the start of the study * use of omalizumab \< 6 months before the start of the study * pregnancy: there is a remote possibility of inducing a systemic allergic reaction that could induce uterine contractions or necessitate the use of epinephrine (thought to cause constriction of the umbilical artery) * incapacitated individuals * individuals who do not speak the local language (dutch - french) * individuals who cannot read or write
phase1/2 study of iph6501 in patients with relapsed /refractory b-cell non-hodgkin lymphoma

Conditions: Non Hodgkin Lymphoma

Summary: this is an international, first-in-human, multicenter, open-label phase 1/2 study to evaluate the safety profile, tolerability of iph6501, and determine the recommended phase 2 dose (rp2d) for patients with b-cell non-hodgkin lymphoma.

in phase 1 - dose finding, patients with advanced histologically confirmed, documented cd20+ b-cell non-hodgkin lymphoma (nhl) will be enrolled. the dose finding part will include 2 sub-parts: dose escalation will determine the maximum tolerated dose (mtd) or the highest tested dose, dose assessment will determine rp2d. in phase 2 - dose expansion, one or more cohorts will be selected with patients with subtypes of advanced histologically confirmed, documented cd20+ b-cell non-hodgkin lymphoma.

Eligibility criteria:
main inclusion criteria * patients with advanced histologically confirmed, documented cd20+ b-cell non-hodgkin's lymphoma (nhl) including the following types defined by who 2016: diffuse large b cell lymphoma (dlbcl); high grade; thymic; follicular lymphoma (fl); mantle cell lymphoma (mcl); marginal zone lymphoma (mzl) * relapsed, progressive and/or refractory disease without established alternative therapy * must have received at least 2 prior systemic therapies including at a minimum anti-cd20 antibody therapy (e.g., rituximab) potentially in combination with chemotherapy and/or relapsed after autologous stem cell rescue. * eastern cooperative oncology group (ecog) performance status of ≤ 2 * adequate organ and hematological function * able to provide a fresh biopsy from a safely accessible site (or historical biopsy), per investigator determination. main exclusion criteria * patients with another invasive malignancy in the last 2 years * prior chemotherapy, immunotherapy or other anti-cancer therapy within less than 4 weeks before study drug administration. * autologous stem cell transplant or treatment with car-t (chimeric antigen receptor t-cell) cell therapy within 100 days prior to first dose of study drug * subjects with brain or subdural metastases are not eligible, nor those with history of central nervous system (cns) lymphoma * current or past history of cns disease, such as stroke, epilepsy, cns vasculitis, or neurodegenerative disease. * known history of infection with human immunodeficiency virus (hiv) or hepatitis b or c * major surgery within 4 weeks before the first dose of study drug * comorbidities including diabetes, cardiovascular diseases, immunodeficiencies/autoimmune condition * pregnant / breastfeeding woman

Keywords: anket® nk cell engager tetraspecific nk cell engager
a clinical study of the acrysof® iq edf intraocular lens (iol)

Conditions: Cataract

Summary: the purpose of the study is to demonstrate the safety and performance of the acrysof® iq edf iol.

both eyes will be implanted. the second eye implantation will occur a minimum of 7 calendar days and a maximum of 28 calendar days from the first eye implantation.

Eligibility criteria:
inclusion criteria: * able to understand and sign an independent ethics committee (iec)/ institutional review board (irb) approved informed consent form; * diagnosed with cataract in both eyes; * planned cataract removal by routine small incision surgery; * calculated iol power is within the clinical study supply range (18.0-25.0 diopter (d) in 0.5 d steps); * preoperative regular astigmatism of less than 1.0 d. exclusion criteria: * pregnancy or lactation current or planned during the course of the study; * history of anterior segment (corneal, anterior chamber, sulcus) or posterior segment (uveal, vitreo-retinal) pathology including retinal vascular occlusive disease, retinal detachment or peripheral retinal laser photocoagulation, age-related macular degeneration (armd), glaucoma (uncontrolled or controlled with medication) or ocular hypertension, diabetic retinopathy, retinitis pigmentosa and any optic nerve pathology.
fecal microbiota transplantation for ulcerative colitis

Conditions: Ulcerative Colitis

Summary: fecal microbiota therapy (fmt) is an emerging treatment for gastrointestinal disorders marked by an imbalance in the intestinal microbial flora (dysbiosis). it is hypothesized to work by shifting the recipient's microbiota toward a eubiotic microbial community that resists colonization by pathogenic organisms or decreases its inherent inflammatory properties. several studies now report its efficacy in treatment of severe clostridium difficile colitis. preliminary studies using fmt in ulcerative colitis (uc) have also met with some success. this is corroborated by several lines of evidence suggesting dysbiosis plays an important role in uc pathogenesis. while a recent study using fmt in patients with irritable bowel syndrome (ibs) and constipation found transplants persist for up to 2 years, the extent to which the microbiota is alterable in uc is not known. indeed, there may be particular genetic or immunologic factors in uc leading to selection pressure preventing a change in the microbiota. as an initial step into investigating the potential efficacy of stool transplants for ulcerative colitis (uc), the investigators propose to determine the feasibility and stability of transplanted microbiota in a series of 10 patients with mild to moderate uc.


Eligibility criteria:
inclusion criteria: * mild to moderate uc. exclusion criteria: * antibiotic exposure in the last 3 months. * biologic or immunomodulatory therapy within the last 3 months. * corticosteroid therapy or probiotics within the last 2 weeks. * severely active disease (defined as mayo scores of 10 or greater, or patients with endoscopic disease activity scores of 3 or greater).
use of chamomilla recutita in mucositis

Conditions: Mucositis

Summary: to determine the chamomilla recutita solution dose needed to reduce the intensity and evolution time of oral mucositis in adult subjects submitted to hsct.

population: adult subjects, submitted to hematopoietic stem cell transplantation (hsct) at a cancer hospital in the interior of são paulo state. the following inclusion criteria were adopted for sample selection purposes: subjects over 18 years of age, candidates for allogeneic hsct and with intact oral cavity on the first day of conditioning. subjects will be excluded if they present any adverse reaction to the active principles of chamomilla recutita; receive oral or intravenous anticoagulation therapy; use oral or systemic topical anti-inflammatory medication; receive any other type of intervention for mucositis not included in the standard oral care protocol.

Eligibility criteria:
inclusion criteria: * subjects over 18 years of age; * candidates for allogeneic hsct; * with intact oral cavity on the first day of conditioning. exclusion criteria: * present any adverse reaction to the active principles of chamomilla recutita; * receive oral or intravenous anticoagulation therapy; * use oral or systemic topical anti-inflammatory medication; * receive any other type of intervention for mucositis not included in the standard oral care protocol.

Keywords: mucositis chamomilla therapeutics
smoking cessation in alcoholism treatment

Conditions: Alcoholism; Smoking

Summary: this study is designed to increase understanding of the processes that affect the treatment outcome of individuals with both alcohol and nicotine dependence. treatment outcome methodology will be combined with a computerized self-monitoring methodology to examine the extent to which smoking serves as a cue for alcohol craving and/or as a response to alcohol craving in treated alcoholics. subjects will be veterans participating in the substance abuse day programs at the newington and west haven campuses of the va connecticut healthcare system. nonveteran women will be recruited from the community and enrolled in the day program. subjects will be randomly assigned to one of the following two conditions: (1) intensive smoking cessation therapy (counseling plus nicotine replacement using nicotine patches) concurrent with alcohol treatment, or (2) brief smoking cessation advice concurrent with alcohol treatment.


Eligibility criteria:
inclusion criteria: * meets criteria for alcohol dependence within the past three months, and criteria for nicotine dependence. * smoking at least 10 or more cigarettes per day for the past year. * seeking treatment for both alcohol and nicotine dependence. * minimum 1 week of alcohol abstinence and substance abuse day treatment attendance. * willing to provide names of two individuals who can help locate the subject at follow-up. * willing to provide name of one individual who can provide collateral information about alcohol and tobacco use. exclusion criteria: * other substance use disorder meeting criteria for dependence. * acute medical or psychiatric disorder requiring inpatient treatment. * taking medications known to influence alcohol urges (naltrexone, disulfiram). * medical problems that would contraindicate nicotine patch use. * allergy or hypersensitivity to nicotine or to adhesives used in transdermal delivery systems. * use of other nicotine products such as cigars, pipes, or smokeless tobacco. * severe generalized skin disorder. * myocardial infarction within 3 months prior to study entry. * unstable angina. * pregnant or lactating females, or females who are not practicing a medically accepted form of contraception. * impaired vision or hearing which would interfere with using a hand-held computer. * reading ability below fifth grade level. * lack of reliable transportation to the treatment site, or living more than 1 hour from treatment site. * homeless or unstable residence. * plan for future admission to residential treatment.
photodynamic therapy with pd p 506 a compared with placebo-pdt for the treatment of ak

Conditions: Actinic Keratosis

Summary: the aim of this study is to investigate whether pd p 506 a-pdt is effective in treating mild to moderate ak lesions located on the head.

actinic keratosis (ak) is a pre-cancerous skin abnormality usually caused by sun exposure. actinic keratoses occur most commonly in fair skin, especially in the elderly. they mainly occur in sun-exposed skin areas like head and hands. it is standard of care to remove ak when diagnosed, which can be achieved by either physical ablation, chemotherapeutic agents or photodynamic therapy (pdt). a direct comparison versus placebo which is necessary for the exact quantification of the effect of pd p 506 a has not yet been performed and is subject of this study protocol.

Eligibility criteria:
inclusion criteria: * written informed consent * caucasian patients * diagnosis of actinic keratosis (ak) with at least three locally separated lesions located on head and/or face (hairless areas) * selected ak study lesions have clearly defined margins and are mild to moderate * the distance between the study lesion borders is \> 1.0 cm * maximum diameter of each study lesion is 1.8 cm * skin sun sensitivity type i to iv according to fitzpatrick exclusion criteria: * pdt non-responder * pre-treatment of the ak lesions eligible for study procedures with pharmaceuticals approved for the treatment of ak during the 4 weeks preceding pdt * pre-treatment of the ak lesions eligible for study procedures during the 2 weeks preceding pdt with keratolytic agents e.g. tca, urea or salicylic acid containing formulations * pre-treatment with hypericin during the 2 weeks preceding pdt * treatment with systemic retinoids during the 3 months preceding pdt * treatment with cytostatics or radiation during the 3 months preceding pdt * female patients of childbearing potential * patients with clinically relevant suppression of the immune system * diagnosis of porphyria * skin diseases that might interfere with response evaluation of study pdt * skin sun sensitivity type v or vi according to fitzpatrick * known intolerance to one or more of the ingredients of the study medication * dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent * simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding inclusion * suspected lack of compliance

Keywords: ak pdt
intravenous iron isomaltoside 1000 (monofer®) compared with oral iron in the treatment of postgastrectomy anemia: an open-label randomized controlled trial

Conditions: Post Gastrectomy Anemia

Summary: iron deficiency anemia is a common complication in patients who underwent gastrectomy and leads to a deterioration in patient's quality of life. therefore iron supplementation is one of the important treatments in postgastrectomy patients. taking an oral iron is an option for iron supplementation, but the postgastrectomy patients has poor absorption of iron due to their anatomic change. accordingly, intravenous iron supplementation has been emerged as another treatment option, but there are only a few studies to evaluate the efficacy of intravenous iron supplementation compared with oral iron in patients underwent gastrectomy. therefore, this study aims to evaluate the iron supplementation method as intravenous injection of iron isomaltoside compared with oral iron in the treatment of postgastrectomy anemia. gastric cancer patients who underwent curative gastrectomy more than 1 year ago and hemoglobin level lower than 11 g/dl will be included in this trial. after the registration, the patients will be randomly assigned to intravenous iron (n = 179) or oral iron groups (n = 179). calculated dose of iron isomaltoside using ganzoni formula will be injected intravenously in intravenous iron group and 160 mg/day of ferrous sulfate for 12 weeks will be taken in oral iron group. hemoglobin and iron profiles at baseline and weeks 2, 4, 8, and 12 and quality of life score at baseline and weeks 12 period will be evaluated.


Eligibility criteria:
inclusion criteria: * patients ≥20 years of age * underwent gastrectomy for stage i or ii of primary gastric adenocarcinoma * hb ≤11.0 g/dl at least one year after surgery * willingness to participate after signing informed consent exclusion criteria: * calculated dosage using the ganzoni formula \>1,500 mg * any medical condition may have caused the patient to be unsuitable for the completion of the study or placed the patient at potential risk from being in the study * underwent chemotherapy or on chemotherapy * drug hypersensitivity to iron isomaltoside * active acute or chronic infections * known intolerance to oral iron treatment * history of anemia due to extensive bleeding or causes other than iron deficiency * untreated vitamin b12 or folate deficiency * blood transfusion, erythropoiesis stimulating agents(esa), oral iron or intravenous iron treatment within 4 weeks prior to screening * history of bone marrow suppression treatment, active hepatitis b or c, hiv or hematologic disorder other than iron deficiency * iron overload, hematochromatosis or hemosiderosis * pregnancy or nursing * creatinine clearance rate using cockcroft-gault formula \<30 ml/min * participation in any other clinical study within one month prior to screening