Kornimate/medical-research-clean huggingface dataset:
clinical study on the treatment of postpartum anemia with compound e jiao jiang(cejj）

Conditions: Postpartum Anemia

Summary: the goal of this clinical trial\] is to compare the effect of compound e jiao jiang(cejj）combined with iron decoction on postpartum anemia.the main questions it aims to answer are: to evaluate the effectiveness of compound e jiao jiang(cejj） in the treatment of postpartum anemia. to evaluate the safety of compound e jiao jiang(cejj） in the treatment of postpartum anemia. to explore the effect of compound ejiao decoction on improving anxiety, depression, sleep and fatigue in postpartum anemia patients. participants will be randomly assigned (like flipping a coin) to either the trial group or the control group (with a 50% chance of being assigned to either group), where the trial group will receive the compound e jiao jiang(cejj） + ferrous succinate tablet, and the control group will receive the compound e jiao jiang(cejj）placebo + ferrous succinate tablet. the compound e jiao jiang(cejj）placebo is the same/similar to the compound e jiao jiang(cejj） in terms of appearance, smell and taste, but has no therapeutic effect.and participants need to return to the research center on time for relevant examinations according to the protocol requirements.


Eligibility criteria:
inclusion criteria: 1. patients diagnosed with mild or moderate anemia (70g/l≤hb \< 110g/l) within 1 week postpartum and suitable for oral drug therapy; 2. age 18-45 years old (including 18 and 45); 3. those who do not use other iron agents and chinese medicine/chinese medicine preparations that have the effect of invigorating qi and nourishing blood during the study; 4. sign the subject's informed consent voluntarily. exclusion criteria: 1. postpartum hemorrhage and blood transfusion treatment; 2. those who received intramuscular/intravenous iron therapy or transfused blood products/human blood albumin and other plasma volume dilators within 3 months prior to screening; 3. patients who have taken blood tonics within 1 week before screening, including other iron preparations and chinese medicine or chinese medicine preparations; 4. people with previous blood diseases such as sickle cell anemia, thalassemia, aplastic anemia, megaloblastic anemia; 5. severe preeclampsia during pregnancy; 6. abortion occurs in this pregnancy; 7. patients with a serious digestive disease, cardiovascular disease, immune system disease, or serious mental disorder that the investigator believes may adversely affect the safety of the subject and/or the effectiveness of the investigational drug; 8. severe hepatic and renal insufficiency (alt \>2×uln, aspartate aminotransferase (ast)\>2×uln, urea (urea)/ urea nitrogen (bun)\>2×uln, creatinine (cr)\>1×uln); 9. people with a history of alcoholism, drug abuse, or drug abuse; 10. allergic to the experimental drug or known ingredient; 11. participants who had participated in other clinical trials within 3 months before screening; 12. those who, according to the judgment of the investigator, consider it inappropriate to participate in this clinical trial.
regenerative therapy with autologous stromal vascular fraction derived mesenchymal stem cells and platelet-rich plasma to treat complex perianal diseases

Conditions: Perianal Fistula; Perianal Crohn Disease; Anal Fissure; Rectovaginal Fistula; Perianal Fistula Due to Crohn's Disease

Summary: consecutive patients with complex anal fistula were prospectively followed for 12 months. routine mri was performed before and at 4 and 12 months after surgery. continence was assessed likewise using a validated questionnaire. fistula were drained with setons prior surgery. svf was harvested from subcutaneous abdominal fat and prp from peripheral blood. distal fistulectomy to the sphincter was performed and the wound left open, while the internal orifice was closed. svf-prp was injected around the fistula. patients showered their excision wound until dry. outcomes were reported as median \& interquartile range (iqr)


Eligibility criteria:
inclusion criteria: perianal fistula perianal fissure anovaginal fistula rectovaginal fistula perianal crohn's disease exclusion criteria: -
lipid-lowering effect of plant stanol yogurt

Conditions: Hypercholesterolemia; Hyperlipidemias; Dyslipidemias

Summary: to determine the effect of investigational products on serum ldl cholesterol.

efficacy of plant stanols as esters on ldl-cholesterol reduction is well documented. ldl-cholesterol lowering efficacy of the ingredient administered in a yogurt is less well known. study was monitored by foodfiles

Eligibility criteria:
inclusion criteria: * subjects must voluntarily sign the informed consent * subjects must be male or female aged 20 to 70 years * subjects must have a serum total cholesterol concentration of 5.2 - 7.5 mmol/l ( 205 - 290 mg/dl) at the screening visit (visit 1, -2 week) exclusion criteria: * subjects using lipid lowering medication * subjects using ezetimibe * subjects with bile acid sequestrant medication * subjects with statin therapy * subjects using other medication significantly influencing on lipid values * subjects with diagnosis type 1 or type 2 diabetes * severe obesity (bmi\>35.0 kg/m2) * serum fasting triglycerides \> 4.0 mmol/l * subjects with any hepatic or renal disorder according to medical history * subjects who have history of myocardial infarction or unstable angina pectoris within six months prior to screening * subjects who have history of coronary artery bypass graft or percutaneous transluminal coronary angioplasty within six months prior to screening * subjects who have history of temporal ischemic attack or stroke within six months prior to screening * subjects who have a history of cancer or other malignant disease within the past five years * subjects with abnormal values of health screening variables measured at screening visit: serum gamma-glutamyltransferase\> 2 x upper limit, serum alkaline phosphatase\> 2 x upper limit or other abnormality in laboratory evaluations considered as clinically significant in the opinion of the study physician * subjects who are consuming more than 15 portions of alcohol / week * subjects who are pregnant or lactating * subjects using benecol, becelpro.activ, danacol or other plant sterol enriched products within 30 days before visit 2 * subjects with severe lactose intolerance, milk allergy or any other intolerance to the ingredients of test products * celiac disease
validation of self testing using the insti multiplex hiv1/2 syphilis antibody test

Conditions: Hiv; Syphilis

Summary: this study aims to validate the percent agreement of the insti multiplex human immunodeficiency (hiv) 1/2 syphilis antibody (ab) test (insti poct) when used as a self-test by patients compared to conventional serologic testing.


Eligibility criteria:
branch #1: participants known to have an hiv infection - inclusion criteria: • previously documented positive hiv serology branch #2: participants known to have a history of syphilis infection - inclusion criteria: • documented positive syphilis serology branch #3: participants with no known hiv or syphilis infections - inclusion criteria: • no documented positive hiv or syphilis serology exclusion criteria: unable to speak and understand english
appetite and related factors in patients with als

Conditions: Amyotrophic Lateral Sclerosis

Summary: chinese cnaq scale was used to evaluate the appetite changes of chinese als patients; objective to investigate the related factors of appetite changes in als patients; objective to investigate the effect of anorexia on the progression and survival of als patients.

1. with the consent of the original author, the scale was translated and back translated, and the chinese version of the scale was determined after communication and confirmation with the original author. 2. cnaq was used to measure the appetite of the patients, and hads was used to measure the anxiety and depression of the patients; 3. analyze the proportion of loss of appetite in als group, compare the differences of clinical characteristics such as alsfrs-r score, weight, bmi value, cognitive status such as ecas score between patients with loss of appetite and patients without loss of appetite in als group, and conduct correlation analysis. 4. the patients were followed up every three months until they were unable to eat or end-point events (invasive ventilator or death), and the correlation between cnaq and disease progression and survival was analyzed.

Eligibility criteria:
inclusion criteria: * als patients diagnosed as probable, or definite according to the revised el escorial criteria exclusion criteria: * there are other chronic consumption diseases such as severe digestive system diseases, thyroid diseases, diabetes and so on.
64cu-llp2a for imaging multiple myeloma

Conditions: Multiple Myeloma

Summary: the investigators are performing a trial with goals to demonstrate the feasibility of imaging multiple myeloma (mm) patients with 64cu-llp2a-positron emission tomography (pet)/magnetic resonance (mr). the investigators suggest that 64cu-llp2a will allow for an accurate molecular imaging of mm lesions, which will have an important impact on early stage disease detection and in the long term on the initiation and choice of therapy in these patients.


Eligibility criteria:
inclusion criteria: * adult patients 18 years of age or older with clinically or pathologically defined mm in accordance with international myeloma working group or as stated in office note / clinical assessment from treating physician. \*all types of active myeloma are eligible including both newly diagnosed and previously treated provided plans are to start a new treatment or restart a prior treatment. * healthy volunteer subjects: adult 18 years of age or older with no known hematologic disorder such as anemia, leukemia, etc. who is considered healthy based on assessment by pi. (cohort 1 only). * able to give informed consent. * does not have any exclusions related to pet/mr imaging: no implanted medical devices such as: pacemaker, defibrillator, neurostimulator, artificial heart valve, cerebral aneurysm clips, no accidental exposure to metal fragments (if applicable) * if applicable for administration of contrast with mri imaging subject must have a calculated gfr of at least 60 mg/ml/1.73 m\^2. * not currently pregnant or nursing: subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 64cu-llp2a) is negative. exclusion criteria: * patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years. * unable to tolerate up to 90 min of pet/mr or pet/ct imaging per imaging session.
combined coronary and cerebral angiography and intervention for coronary and cerebrovascular atherosclerosis

Conditions: Coronary Stenosis; Cerebral Stenosis

Summary: intracranial atherosclerosis is common vascular lesion in asian acute stroke patients and intracranial atherosclerosis patients have high rate of coronary artery disease (cad). moreover, several studies showed obvious association of cad and cerebrovascular stenosis, which had been proved to increase the risk of stroke after coronary revascularization including coronary bypass surgery or percutaneous coronary intervention. in addition, the efficacy and safety of combined coronary and cerebral intervention are not fully investigated. hence, the aim of this study is to evaluate the prevalence and characteristics of coronary and cerebrovascular arteriosclerosis as measured by combined coronary and cerebral angiography, explore the relationship between inflammation, atherosclerosis-related markers and coronary and cerebral atherosclerosis and compare the efficacy and safety of simultaneous or staged coronary and cerebral interventional strategy in chinese patients. the coronary angiography and cerebrovascular angiography are performed for all participants. the combined strategy for coronary and cerebrovascular angiography is carried out routinely in the investigators institutions. simultaneous strategy is considered as that performed via the same access and within the same day. staged strategy is intended as that performed within 7 days from the first procedure. the sequence of angiographies is established on an individual patient basis by the cardiovascular and neurointerventional team according to clinical symptoms of the patients and after coronary or cerebrovascular angiography. after combined coronary and cerebral angiography, simultaneous or staged interventional strategy will be performed in patients with severe coronary and cerebral stenosis. blood sample is obtained from artery sheath when performing coronary or cerebral angiography. lipid levels, inflammation and atherosclerosis-related markers will be measured in this study.


Eligibility criteria:
inclusion criteria: 1. age 20-80 years old; 2. patients with clinical indication for coronary angiography; 3. patients with suspected cerebrovascular atherosclerosis; 4. written informed consent. exclusion criteria: 1. patients who have symptomatic congestive heart failure (new york heart association class iii or iv) 2. patients who develop acute myocardial infarction 3. the presence of severe liver disease including chronic active hepatitis, or chronic jaundice with hyperbilirubinemia 4. patients with renal dysfunction, or with nephrotic syndrome 5. patients with cancer 6. unable or unwilling to comply with protocol requirements, or deemed by the investigator to be unfit for the study.
alzheimer's disease long-term follow-up study (alf study)

Conditions: Alzheimer's Disease

Summary: open study for efficacy and safety of donepezil treatment during 48 weeks


Eligibility criteria:
inclusion criteria * men or women aged 40 to 90 * diagnosis of dementia according to dsm-iv * diagnosis of probable ad as defined by nincds-adrda criteria * mild to moderate ad at baseline, as defined by mmse score of 10 to 26 * patients were generally healthy and ambulatory or ambulatory aided * patients did not take acetylcholinesterase inhibitor 4 weeks before screening * patients have useful mri results 3 months before screening exclusion * if they have evidence of tia or major infarction * epilepsy patients * if they have evidence of other degenerative or psychiatric disorder, other serious disorder, alcoholism or drug abuse * if they sensitive to acetylcholinesterase * if they taken concomitant medication which were not allowed
effect of different remineralizing agents on white spot lesions treatment in children

Conditions: White Spot Lesion of Tooth

Summary: one hundred children with white spot lesions on their teeth were divivided into 5 groups of different remineralizing agents to assess their effect on color change and remineralization

children having at least one tooth clinically diagnosed by white spot lesion were randomly allocated to five groups. group one: no treatment was applied (negative control). group two: fluoride gel was applied for 5 minutes (positive control). group three: casein phosphopeptide-amorphous calcium phosphate (cpp-acp) (mi paste) was applied for 5 minutes. group four: casein phosphopeptide-amorphous calcium phosphate (cpp-acp) + fluoride (mi paste plus) were applied for 5 minutes. group five: nano hydroxyapatite paste (apagard primo toothpaste) was be applied for 5 minutes. all children involved in this study were instructed to brush their teeth under the supervision of the researcher before the application of the studied agent. each agent was applied to the labial surfaces of each tooth affected with white spot lesion for 5 minutes after cleaning and drying with a cotton roll using an applicator tip. after each application, children were instructed not to eat or drink for one hour. this application was be repeated in-office after one then after two weeks then after six weeks. participants received a sterilized pouch containing a sterile container with one of the pastes according to the study group for home application. the application of the paste was carried out under parental supervision and was asked to apply each of the pastes at home three times a day till the end of the study

Eligibility criteria:
inclusion criteria: 1. presence of at least one tooth affected by white spot lesion. 2. good oral hygiene and regular tooth brushing at least twice daily. exclusion criteria: 1. unwillingness to be randomly assigned to 1 of the 3 treatment groups. 2. presence of abnormal oral, medical, or mental condition. 3. presence of any milk-related allergies. 4. presence of dentin caries or enamel hypoplasia on maxillary anterior teeth. 5. presence of periodontal pockets around maxillary anterior teeth.

Keywords: white spots remineralization caries children
topical treatment of cutaneous leishmaniasis with wr 279,396: a phase 2 study in the old world

Conditions: Cutaneous Leishmaniasis

Summary: this study is to determine the effectiveness and safety of wr 279,396, a topical cream for the treatment of cutaneous leishmaniasis. this study is to be conducted with a placebo control under double-blind conditions in a local population group in tunisia where leishmaniasis is endemic.

wr 279,396 is a paromomycin-based topical cream that has shown some suggestion of being effective for the treatment of non-serious, non-complicated cutaneous leishmaniasis in previous clinical studies. the goal of this study is to expand those observations in a larger, more rigorous study to clearly define the efficacy of this product and collect information about adverse effects. subjects will be randomized to receive either wr 279,396 or vehicle placebo; applied twice a day for 20 days.

Eligibility criteria:
inclusion criteria: * age 5-75 years * lesions must measure at least 1 cm and be primarily ulcerative * have cutaneous leishmaniasis proven parasitologically in the lesion selected for study * must have given written informed consent to participate in the study exclusion criteria: * known drug intolerance to aminoglycosides in the patient or immediate family * previous use of antileishmanial drugs (within 3 months) or present use of routinely nephrotoxic or ototoxic drugs * patients with tuberculosis under treatment * potential for follow-up: have less than 7 months time remaining in present address and/or plan to leave the area for more than 30 days * extent of disease: more than 5 lesions or lesion equal to or greater than 5 cm or a lesion less than 5 cm from the eye, or a lesion in the face that, in the opinion of the attending dermatologist could potentially cause significant disfigurement * location of disease: mucosal involvement * disseminated disease: clinically significant lymphadenitis with nodules that are painful and greater than 1 cm in size in the lymphatic drainage of the ulcer * concomitant medical problems: significant medical problems of the kidney or liver as determined by history and by the following laboratory studies: * hearing abnormality * ongoing pregnancy or have plans to become pregnant * females of child bearing age (tunisia only) * signs or symptoms of peripheral neuropathy kidney: clinically significant abnormalities of urine analysis, serum levels of creatinine, bun, total proteins greater than the upper limit of normal for the laboratory. liver: ast or alt greater than the upper limit of normal for the laboratory general: glucose, na+, or k+ greater than the upper limit of normal for the laboratory

Keywords: cutaneous leishmaniasis topical treatment safety efficacy
a multi-center study to investigate the safety, tolerability, pharmacodynamics and pharmacokinetics of r7103 following repeated inhalation in patients with moderate-to-severe chronic obstructive pulmonary disease

Conditions: COPD

Summary: this study will assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of ro5024118 following repeated inhalation in patients with moderate-to-severe chronic obstructive pulmonary disease (copd). patients will be randomized to receive multiple inhaled doses of r7103, as compared with placebo. the target sample size is approximately 30 individuals.


Eligibility criteria:
inclusion criteria: * male and female patients 40-70 years of age, inclusive. * body mass index 18-32 kg/m2, inclusive. * female patients must be surgically sterile or post menopausal for the past year confirmed by a negative hormone panel. male patients and their partners of childbearing potential must use two methods of contraception, one of which must be a barrier method for the duration of the study and for 7 days after last dose. * diagnosis of moderate-to-severe copd (gold stage ii-iii). exclusion criteria: * current smoker or history of smoking in the last three months. * use of continuous daily long term oxygen therapy or requirement for oxygen therapy during exercise. * history of cardiac conduction abnormalities or ventricular tachyarrhythmias. * exacerbation of copd within 8 weeks before first dosing.
evaluation of ave5026 as compared to enoxaparin for the prevention of thromboembolism in patients undergoing elective knee replacement surgery

Conditions: Venous Thromboembolism

Summary: the primary objective was to compare the efficacy of semuloparin sodium (ave5026) with enoxaparin for the prevention of venous thromboembolic events \[vte\] in patients undergoing elective knee replacement surgery. the secondary objectives were to evaluate the safety of ave5026 in patients undergoing elective knee replacement surgery, and to document ave5026 exposure in this population.

randomization had to take place just prior the first study drug injection (randomization ratio 1:1). the total duration of observation per participant was 35-42 days from surgery broken down as follows: * 7 to 10-day double-blind treatment period; * 28 to 35-day follow-up period. mandatory bilateral venography of the lower limbs had to be performed 7 to 11 days after surgery.

Eligibility criteria:
inclusion criteria: - knee replacement surgery or revision of at least one component of a knee prosthesis implanted ≥ 6 months prior to study entry. exclusion criteria: * any major orthopedic surgeries in the 3 months prior to study; * deep vein thrombosis or pulmonary embolism within the last 12 months, or known post-phlebitic syndrome; * any contraindications to the performance of venography; * high risk of bleeding; * know allergy to heparin, or enoxaparin, or pork products; * end stage renal disease or patient on dialysis. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: knee surgery vte prevention