Kornimate/medical-research-clean huggingface dataset:
efficacy and tolerability of artesunate amodiaquine versus chloroquine in the treatment of uncomplicated plasmodium vivax malaria

Conditions: Malaria

Summary: primary objective: - to demonstrate the non-inferiority of corrected adequate clinical and parasitological response at day 28 of artesunate amodiaquine (asaq) versus chloroquine secondary objectives: * to assess the non inferiority on the same way as the main criteria: * at day 28 before corrected cure rate * at day 14 and day 42 before and after corrected cure rate * to compare the two groups of treatment in terms of: * efficacy: * proportion of aparasitaemic patients at 24, 48 an 72 hours * proportion of afebrile patients at 24, 48 and 72 hours * percentage of gametocyte carriers during follow-up * evolution of the mean of gametocytes during the 42 days of follow-up * evolution of haemoglobin value between day 0 and day 7, day 0 and day 28 * clinical and biological tolerability: * proportion of any adverse event * biological safety: haematology (red blood cells, haemoglobin, white blood cells, neutrophils, platelets), biochemistry (creatinine, transaminases (alanine amino transferase/alt), bilirubins) * ecg (electro encephalogram) (day 0, day 3,day 28) only for patients 10 years old and above

each patient will be followed for a period of 42 days

Eligibility criteria:
inclusion criteria: * adults and children over 6 months old and bodyweight \> 5 kg * able to be treated by oral route * axillary temperature ≥ 37,5 c or history of fever during the previous 2 days * symptomatic biologically confirmed plasmodium vivax mono-infection, with parasitemia from 250 to 100000 parasites /µl of blood * written informed consent of the patients and for children written informed consent of the parents/legal representative for children. children able to understand the objectives and the risks of the study will sign an assent form. exclusion criteria: * known project of leaving the investigator site area during the follow-up period (42 days) * hypersensitivity to one of the investigational medicinal products or to any of the excipients * intake of an antimalarial treatment in the previous 30 days * history of hepatic and (or) haematological impairment during treatment with amodiaquine * blurred vision suggesting a retinopathy * presence of at least one danger sign of malaria * pregnant or breast-feeding women * women with childbearing potential not willing to use an effective contraceptive method(s) for the duration of the study * known severe concomitant or underlying disease the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
a study of taci-antibody fusion protein injection (rc18) in subjects with primary sjögren's syndrome

Conditions: Primary Sjögren's Syndrome

Summary: the purpose of this study is to initially observe the safety and effectivity of rc18 in participants with primary sjögren's syndrome.


Eligibility criteria:
inclusion criteria: * voluntarily signed informed consent ; * patient with primary sjögren's syndrome according to the european - american consensus group criteria. * seropositive at screening for anti-ro/sjögren's syndrome type a(ssa) antibodies * essdai score ≥ 5. exclusion criteria: * diagnosis of secondary sjogren's syndrome, such as rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis and other autoimmune diseases; * abnormal laboratory parameters need to be excluded, including but not limited to: * immunosuppressive agents were used within 4 weeks prior to randomization.; * the use of hydroxychloroquine was allowed during the trial, and the pre-randomized drug regimen was stable for less than 12 weeks; * use of biological agents for targeted therapy in the first 6 months of randomization; * treatment of primary sjogren's syndrome with traditional chinese medicine and proprietary chinese medicine within 4 weeks before randomization; * the use of saliva-stimulating drugs within 7 days prior to randomization; * sodium hyaluronate eye drops, artificial tears can be used, and the stability time of the randomized pre-medication scheme is less than 4 weeks; * intravenous immunoglobulin therapy or plasma exchange therapy within 6 months before randomization; * infection with herpes zoster or hiv and hepatitis c virus(hcv) antibody positive; * currently suffering from active hepatitis or severe liver lesions and history; * malignant tumor patients ; * combined with involvement of important organs or neuropathy; * have participated in any clinical trial in the first 28 days of the initial screening or 5 times half-life period of the study compound (taking the time for the shorter). * pregnant , lactating women and men or women who have birth plans during the research; * investigator considers candidates not appropriating for the study
mcat with ha and sctg compared with sctg alone for treatment of multiple gingival recession: clinical trial

Conditions: Gingival Recession

Summary: microsurgical tunneling flap procedures using connective tissue grafts (ctg) are predictable for treating teeth with gingival recessions. cross-linked hyaluronic acid can be used in conjunction with subepithelial palatal connective tissue grafts to improve postsurgical results. the aim of this study is to evaluate clinically the use of tunnel technique with ctg and cross-linked hyaluronic acid in addition to ctg alone for the treatment of multiple gingival recessions.

the treatment of multiple adjacent recession appears to be challenging for the clinician due to large surgical field, variation in teeth position in the dental arch (prominent roots), variation in recession size, thin phenotype and insufficient keratinized tissue in many teeth. surgical treatment of all multiple recession in one dental arch during one session appears to be optimum. surgical treatment time is longer, however patient doesn't need to undergo multiple surgeries, pharmacological therapies and postsurgical instructions. esthetic concern seems to be one of the most common complaints from patients. among utilized surgical techniques tunneling flap procedures using connective tissue grafts (ctg) with or without biologics such as an enamel matrix derivative (emd) or hyaluronic acid (ha) provided the most successful outcomes for the treatment. cross-linked hyaluronic acid can be used in conjunction with subepithelial palatal connective tissue grafts to improve postsurgical results and improving healing process. the aim of this study is to evaluate clinically the use of tunnel technique with ctg and cross-linked hyaluronic acid in addition to ctg alone for the treatment of multiple gingival recessions.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * bilateral multiple gingival recessions in homologous teeth exclusion criteria: * full-mouth plaque index ≥ 20% (ainamo \& bay 1975) * full-mouth sulcus bleeding index ≥ 15% (mühlemann \& son 1971) * smoking * systemic diseases with compromised healing potential of infectious diseases * drugs affecting periodontal health / healing * pregnant and lactating females * previous periodontal surgery in the area

Keywords: connective tissue graft tunneling flap procedure hyaluronic acid
outcomes of high-volume saline irrigation vs povidone-iodine solution cleaning of iowi in preventing ssis in emergency laparotomies

Conditions: Surgical Site Infection; Surgical Wound; Surgical Incision; Emergency Laparotomies; Laparotomies; Post Operative Wound Infection; Wound Infection; Seroma

Summary: the goal of this clinical trial is to compare the outcomes of high-volume saline irrigation vs povidone-iodine solution cleaning of the intraoperative incision wound in preventing superficial surgical site infections in patients undergoing emergency laparotomies. the main question it aims to answer are: * incidence of ssi after intervention * length of hospital stay participants will be randomly assigned to two groups receiving either of the two groups: group a: 1000ml of iowi with saline solution prior to incision closure group b: the incisional wound will be closed conventionally without irrigation. researchers will compare groups a( experimental group) and b (control group) to compare the incidence of superficial surgical site infections after intervention.


Eligibility criteria:
inclusion criteria: * • patients undergoing emergency laparotomy under the care of surgical-6 unit of dr. ruth k. m. pfau civil hospital karachi * the age of patients should be between 18-60 years old. exclusion criteria: * diabetic patients * immune-suppressed patients * patients taking steroids * patients undergoing chemo-radiotherapy. * pregnant females * previous abdominal surgery within the last 30 days. * presence of concurrent abdominal wall infections. * trauma laparotomies * large bowel perforations
intervention to promote advance care planning for older adults in the emergency department

Conditions: Emergency Medicine; Advance Care Planning

Summary: there is an urgent need to increase advance care planning among older adults in order to ensure that patients receive care of the end of life that is consistent with their values and preferences. emergency departments (eds) provide an opportunity to reach a large proportion of older adults who have not yet completed advance care planning at a time when they are likely to recognize the need for such planning. the purpose of this pilot is to examine the potential of a video-supported intervention initiated during the emergency department visit to promote advance care planning.

the overarching goal of this project is to understand the impact of an ed-initiated intervention on the promotion of advance care planning (acp) among older adults. participants are given either a short informational handout on the process and choices involved in acp or watch a 6-minute video about acp. the video describes cardiopulmonary resuscitation (cpr), breathing tube placement, and mechanical breathing support in addition to the general process of acp. following the video, patients in the intervention will also have an email sent to their primary care provider. the email will inform the primary care provider that the patient has watched a video about acp, include a brief synopsis of the video, and provide instructions as to how to document the patient's preferences in the hospital's electronic health record in a way that will be accessible to other providers. outcomes will include documentation of end-of-life care preferences in the electronic health records and patient-reported conversation with their provider as well as conversations with loved ones.

Eligibility criteria:
inclusion criteria: * ability to provide informed consent * ability to communicate in english * age 65-79 years with a serious medical illness: (1) established diagnosis of metastatic cancer, advanced heart failure, chronic obstructive lung disease, end stage liver disease, end stage renal disease, (2) unable to walk or requires human assistance with walking, (3) two hospitalizations within the last 6 months * age 80 years or older exclusion criteria: * critically ill (emergency severity index = 1) * cognitively impaired based on six item screener \< 4 or lack the capacity to consent * currently enrolled in hospice or comfort care program * no working phone number * non english speaker

Keywords: advance care planning older adults emergency department
a retrospective observational study of hemoglobin levels in patients with renal anemia treated with mircera (methoxy polyethylene glycol-epoetin beta)

Conditions: Anemia, Kidney Disease, Chronic

Summary: this retrospective observational study will evaluate the hemoglobin levels in patients with renal anemia over 6 months treatment with mircera (methoxy polyethylene glycol-epoetin beta).


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * renal anemia treated with mircera for at least 6 months before entering study exclusion criteria: * patients who refuse or are incapable of giving their written informed consent to retrospective data collection
docetaxel 2-weeks regimen in the treatment of her2 negative metastatic breast cancer

Conditions: Breast Cancer

Summary: a randomized, controlled clinical trial comparing the efficacy and safety of a single agent docetaxel 2-weeks regimen in the treatment of her2 negative metastatic breast cancer to a 3-weeks regimen

docetaxel 2-weeks regimen:docetaxel 50mg/m2 docetaxel 3-weeks regimen:docetaxel 75mg/m2

Eligibility criteria:
inclusion criteria: * signed informed consent * the age is above 18 years of age, \<70 years old * the diagnosis of breast cancer was confirmed by cytological examination or pathological examination. her2-negative * clinical stage was metastatic breast cancer or locally advanced breast cancer. * must have at least one measurable lesion, according to recistv1.1. * eastern cooperative oncology group performance status (ecog ps)=0\~2 * docetaxel or paclitaxel can been used in initial treatment or in the past for locally advanced, recurrent or metastatic lesions,if used must been proved effective, and recent progress over 6 months. * the basic function of normal bone marrow * functions of liver and kidney is normal * expectation of life is more than 3 months * agreed to take contraceptive measures during treatment exclusion criteria: * the patient had a history of allergy to taxanes or their components. * recent progress of taxanes in 6 months. * in the elution period of other chemotherapy regimens. * severe coagulopathy. * her2 positive breast cancer * previous toxicity was not recovered to 0-1 degrees * central nervous system metastasis had not controlled yet * pregnancy or lactation * there are uncontrolled infection, myocardial infarction, thrombosis, etc. * there are uncontrolled chronic diseases such as diabetes, hypertension, peptic ulcer, chronic hepatitis, mental disease; * hiv infection * patients with other malignant tumor history, except the healed skin basal cell carcinoma and carcinoma of uterine cervix; * researchers believe that is not suitable for the study

Keywords: therapy breast cancer docetaxel metastasis
a meditation intervention on subconcussive head impacts

Conditions: Head Injury Trauma

Summary: the purpose of this research is to explore potential methods of rehabilitating changes observed from repetitive head impacts. participation in this study will involve functional magnetic resonance (fmri) imaging, aerobic testing, heart rate variability (hrv) wrist monitor, hypercapnia challenge, a meditation rehabilitation intervention, and filling out survey information concerning subjective well-being.

college athletes: at each study visit, participants will undergo an fmri-cerebrovascular reactivity (cvr) challenge scanning session as well as an aerobic exercise test on a stationary bike. during the cvr-fmri scan, the participant will wear a mask that will deliver a blend of oxygen and nitrogen at varying amounts while lying in an mri scanner. during the aerobic stationary bike assessment, the participant will pedal at a steady state against applied resistance for 10 minutes while wearing an ecg heart rate monitor to observe heart rate. a biostrap heart rate variability (hrv) wrist monitor will be provided which will be worn daily. the data from the monitor, concerning hrv and sleep, will be collected. the participant will answer a brief survey concerning the previous night's sleep. after the conclusion of the sport's season, there will be a follow up scanning session. after the post-season scan, the participant will participate in a breath work meditation intervention over the following two months, twice a week for a 30 minute meditation session. high school athletes: participants will be given a biostrap hrv monitor which will be worn daily. the data from the monitor, concerning hrv and sleep, will be collected. the participant will answer a brief survey concerning the previous night's sleep. high school athletes will be randomized into one of two study groups, the control group or the intervention group. the intervention group will receive guided meditation over 2 months (twice a week for 30 mins each session), and will ride a stationary bike at 3 time points. the control group will proceed about their lives normally.

Eligibility criteria:
inclusion criteria: * participants recruited for this study will be comprised of adolescent and young adult athletes (age-range 13-25) engaged in high school or college contact athletics who are enrolled in an ongoing nih funded study of subconcussive head impact exposure (whitlow: r01 ns091602), which acquires pre- and post-season mri scans and cognitive testing. exclusion criteria: * athletes will be excluded from the study if they suffer a concussion over the sports season or during the course of the proposed mediation intervention study. athletes will be excluded if they experience claustrophobia entering an mri scanner.

Keywords: sub-concussive head impacts meditation adolescent athletes young adult athletes
targeting the gut to improve seizure control in cdkl5 deficiency disorder (cdd)

Conditions: CDKL5

Summary: standard anti-seizure medications have limited efficacy in seizure control in cyclin-dependent kinase-like 5 deficiency disorder (cdd). the study will investigate whether targeting the gut-microbiota-brain axis in cdd patients can alleviate seizures and ameliorate other comorbidities.

cdd is a neurodevelopmental condition characterized by infantile-onset epilepsy, developmental delays, intellectual and motor disabilities, sleep disturbances, and cortical visual impairment. currently, there is no treatment for cdd, and epilepsy is a prominent and severe feature of the disorder. standard anti-seizure medications have limited efficacy in seizure control, leading to detrimental effects on cognitive and motor development in cdd. the gut-brain axis has gained attention in epilepsy research, prompted by evidence of gastrointestinal (gi) symptoms in people with epilepsy. studies have demonstrated significant changes in gut microbial composition in animal models and between individuals with epilepsy and healthy subjects. notably, cdd patients experience gi problems, and we discovered that they exhibit alterations in their gut microbiota compared to healthy individuals. the study will investigate whether supplementing cdd patients with alpha-lactalbum and prebiotics alone or with post-biotics can improve neurological features and modulate microbiota composition.

Eligibility criteria:
inclusion criteria: clinical diagnosis of cdd and demonstrated cdkl5 pathogenic variant; drug-resistant seizures; ensured participation of a caregiver; willingness to sign the informed consent. exclusion criteria: organic gi disorders (i.e., food allergies, celiac disease); special diets; percutaneous endoscopic gastrostomy tube; use of antibiotics or probiotics in the previous month.

Keywords: epilepsy, gut microbiota, sleep disorders
role of early versus late switch to lapatinib-capecitabine

Conditions: Cancer

Summary: the study will be conducted as a multicenter prospective observational cohort study, trying to cover almost all brazilian states, in a population of erbb2 positive metastatic breast cancer patients, whose disease has progressed after trastuzumab-containing regimen, comparing outcomes in two groups: group 1: patients receiving lapatinib-capecitabine immediately after 1st trastuzumab progression (second line treatment), and group 2: patients receiving lapatinib-capecitabine after 2 or more lines of treatment after 1st trastuzumab progression (third line or greater).

all cases of erbb2 positive metastatic breast cancer, receiving approved standard treatment with lapatinib-capecitabine, after trastuzumab-containing regimen progression in community setting can participate in this observational study, for a period of 12 months of observation since the start of the lapatinib-capecitabine treatment.

Eligibility criteria:
* women with erbb2+ mbc (erbb2 expression confirmed by immunohistochemistry or fish/cish, either in the primary tumor or in the metastasis, according to the institution's common practice); * older than 18 years old; * have received prior treatment with trastuzumab-containing regimen for erbb2+ breast cancer; * progressing after trastuzumab-containing regimen either used for the treatment of metastatic disease or progressing after adjuvant /neoadjuvant trastuzumab treatment; * eligible to start standard treatment with lapatinib-capecitabine at conventional doses, in the community setting; * signed consent to participate and release information for this study.

Keywords: lapatinib observational study trastuzumab brazil metastatic breast cancer
bedside ultrasound assisted pediatric lumbar puncture

Conditions: Infant/ Neonate Lumbar Puncture

Summary: this is a prospective, randomized study evaluating the efficacy of bedside ultrasound assisted lumbar puncture in pediatric patients

comparison of bedside ultrasound assisted lumbar puncture to traditional anatomical landmark approach in neonates and young infants requiring lumbar puncture

Eligibility criteria:
inclusion criteria: * any patient 0-12 months old requiring a lumbar puncture in the pediatric emergency department or inpatient pediatric floor is eligible to participate in the study exclusion criteria: * previous back surgeries * parent/ guardian inability to understand informed consent * parent/guardian refusal of informed consent.

Keywords: pediatric lumbar puncture ultrasonography efficacy