Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of azithromycin to treat cutaneous leishmaniasis

Conditions: Cutaneous Leishmaniasis

Summary: the adequate treatment of the american tegumentary leishmaniasis is crucial since the disease, differently from the caused by the old world species, is painful and not self-healing and may lead to the disfiguring mucosal involvement. so far, pentavalent antimony compounds have been considered the treatment of choice for cutaneous leishmaniasis (cl), however, these drugs present high frequency of side effects and important disadvantages as parenteral administration and need for careful renal and cardiac monitoring. azithromycin is a macrolide antibiotic, non-expensive, largely commercially available that has shown in-vitro and in vivo activity against different species of leishmania. the main objective of this study is to evaluate the efficacy and safety of oral azithromycin for the treatment of cl. the efficacy of oral treatment of azithromycin 500 mg/day for 20 days is going to be compared with the standard treatment of intramuscular injections of 20 mg/kg/day of pentavalent antimonials (glucantime®) for 20 days in patients with cl from two endemic regions of brazil: the metropolitan region of belo horizonte and montes claros (mg)in the southeast brazil and in corte de pedras (bahia), northeastern brazil. the patients follow up lasts for 12 months.

included a new site (university estadual de montes claros - unimontes) in 7 june 2010. the site was included due the need to achieve more patients. the anvisa (national agency of sanitary surveillance) approved these site in march 2011 and the start of activities is planned for june 2011.

Eligibility criteria:
inclusion criteria: * patients older than 14 and younger than 65 years old * skin lesions with clinical suggestion of cutaneous leishmaniasis and positive leishmanin skin test(montenegro test)or parasitological (direct observation of leishmania amastigotes, leishmania in vitro culture from aspirates, histopathological) and molecular(polymerase chain reaction - pcr)samples. * no use of oral potentially antileishmanial drugs, or topics throughout the term of the current injury. * absence of disseminated leishmaniasis. * absence of mucosal involvement. * agreement to participate in the study and signed the informed consent. exclusion criteria: * diabetes mellitus, kidney diseases, liver or cardiac diseases, tuberculosis, malaria. * pregnancy * lactating mothers * breast feeding * cutaneous lesion with bacterial infection for which antibiotics need to be prescribed * more than six cutaneous lesions * previous history of cutaneous or mucosal leishmaniasis * use of drugs with potential pharmacological interactions with antimonials as anti-arrhythmic or tricycle anti-depressives * previous intolerance to azithromycin or other macrolides or n-methylglucamine * abusive alcohol ingestion according to the cage questionnaire

Keywords: cutaneous leishmaniasis azithromycin n- methyl glucamine
totally endoscopic ablation of atrial fibrillation

Conditions: Atrial Fibrillation

Summary: primary objective to evaluate the efficiency of totally endoscopic ablation of af compared to rate control management of af. secondary objectives does totally endoscopic ablation: * reduce atrial fibrillation symptoms? * increase working capacity and improve quality of life? * improve atrial function? * reduce the risk for stroke?

this is a randomized open controlled single centre study that involves 60 patients (men and women) over the age of 50 years with longstanding persistent af of more than one year duration and in the absence of other severe cardiopulmonary disease. one of the participating investigators informs the patient, both verbally and in writing, about the study and what participation in the study involves. the patient will be given time to ask questions and to consider study participation and can be enrolled in the study after signing and dating written informed consent. study duration per patient is 12 months. after inclusion, the patient will be divided into one of two groups, treatment group or control group, according to block wise randomization. the patient will be asked to complete two health related questionnaires sf 36 and scl and a transthoracic echocardiography will be conducted together with an exercise test. the patients will thereafter be assessed according to randomisation. irrespective of group, the patients will be rescheduled for a visit within two months for totally endoscopic ablation and reveal implantation or just reveal implantation (control group). all patients will then be assessed during follow-ups after 1, 3, 6 and 12 months.

Eligibility criteria:
inclusion criteria: 1. age \> 50 years 2. longstanding persistent af of \> 1 year duration 3. severe symptoms related to af 4. have signed and dated informed consent. 5. willing and able to comply with the protocol for the duration of the trial. exclusion criteria: 1. severe ischemic heart disease or heart valve disease 2. thrombus formation in left atrial appendage 3. intolerance to warfarin medication 4. advanced pulmonary disease, fev 1 \< 1.5 litre 5. left atrial diameter \> 60 mm 6. body mass index (bmi) \> 35 kg/m2 7. previous pulmonary or heart surgery 8. participation in another clinical trial within the last 30 days prior to enrollment

Keywords: atrial fibrillation ablation thoracoscopy atrial function
graft-versus-host disease prevention in treating patients who are undergoing bone marrow transplantation

Conditions: Graft Versus Host Disease; Leukemia; Lymphoma

Summary: rationale: bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. sometimes the transplanted cells can make an immune response against normal tissues. methotrexate and cyclosporine may prevent this from happening. purpose: phase iii trial to study the effectiveness of treatment with methotrexate and cyclosporine after bone marrow transplantation to provide protection against acute graft-versus-host disease.

objectives: i. determine the efficacy of a combination of methotrexate and cyclosporine, administered after grafting, to prevent the development of acute graft versus host disease (gvhd) in patients undergoing allogeneic bone marrow transplantation. outline: patients receive methotrexate iv on days 1,3,6, and 11. patients also receive cyclosporine iv twice a day until the patient is eating, then it is administered orally twice a day. cyclosporine begins on day -1 and continues until day 180. the dose is reduced beginning on day 50. projected accrual: accrual will continue until further notice.

Eligibility criteria:
disease characteristics: ongoing bone marrow transplantation from hla-matched siblings or hla non-identical family members or unrelated donor patient characteristics: age: any age performance status: not specified life expectancy: not severely limited by disease other than leukemia hematopoietic: not specified hepatic: no severe hepatic disease renal: no history of hemorrhagic cystitis no renal disease cardiovascular no symptomatic cardiac disease other: no contraindication to the use of cyclosporine or methotrexate prior concurrent therapy: no concurrent experimental treatment on other gvhd prophylaxis studies

Keywords: recurrent childhood acute lymphoblastic leukemia childhood non-hodgkin lymphoma recurrent childhood lymphoblastic lymphoma recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia recurrent adult non-hodgkin lymphoma graft versus host disease
study of individualized instruction versus pamphlet in systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: objectives: i. evaluate an educational program that has been pretested for cultural appropriateness and literacy requirements in patients with systemic lupus erythematosus (sle). ii. assess the impact of this educational program on patients with sle, with an emphasis on recognizing cardinal symptoms, coping with fatigue, regulating medications, and communicating with the physician.

protocol outline: patients are randomly assigned to 1 of 2 groups. one group participates in an educational program administered and coordinated by a health educator. the program includes 1 or 2 educational sessions emphasizing practical advice, each lasting approximately 1.5 hours; social support from a patient-identified management partner; and behavioral reinforcement from health center staff, the patient partner, and written and audio materials. the control group receives patient educational materials consistent with usual care (pamphlets). patients are followed at 6, 12, 24, and 36 months.

Eligibility criteria:
protocol entry criteria: confirmed systemic lupus erythematosus (sle) using american college of rheumatology criteria recruitment from the medical college of virginia sle registry

Keywords: arthritis & connective tissue diseases disease-related problem/condition educational needs immunologic disorders and infectious disorders rare disease systemic lupus erythematosus
the accuracy of computer software prediction of soft tissue profile for patients undergoing fixed orthodontic treatment

Conditions: Dental Malocclusion

Summary: a clinical study to evaluate the accuracy of computer software in predicting soft tissue profile changes in patients undergoing fixed orthodontic treatment

the computer software programs exhibit certain soft tissue simulation . the purpose of the study to assess the accuracy of computer software in predicting profile changes in patients undergoing fixed orthodontic treatment

Eligibility criteria:
the inclusion criteria included: * patient undergo fixed orthodontic treatment with the edgewise technique. * skeletal class i. * dental class i or ii or iii. * final class i occlusion without spacing or crowding, with normal overjet and overbite (2-4 mm) * availability of full diagnostic and therapeutic records before to and following orthodontic treatment, including medical and dental history, dental casts, panoramic and cephalometric x-rays, and photographic photographs. the exclusion criteria included: * missing tooth or significant bolton discrepancies (more than 3 mm). * craniofacial syndromes or skeletal abnormalities. * failed orthodontic treatment in the past. * cosmetic or reconstructive facial surgery during orthodontic treatment, or up to a year beforehand. * using drugs that could reduce the volume of soft tissues.

Keywords: vto orthodontic software prediction
anticoagulant and antiplatelet agents in patients undergoing vitreoretinal surgery

Conditions: Retinal Detachment

Summary: purpose: to establish the prevalence of anticoagulant, aspirin, and clopidogrel use in patients undergoing vitreoretinal surgery, and to compare the outcome of peribulbar anesthesia between users and non-users.


Eligibility criteria:
inclusion criteria: * take or no anticoagulant treatment before surgery, * vitreoretinal surgery exclusion criteria:none * no surgery * anesthetic complication

Keywords: anticoagulant agents antiplatelet agents vitreoretinal surgery patients suffered from retinal detachment
intraoperative methadone for postoperative pain in patients undergoing tonsillectomy

Conditions: Postoperative Pain

Summary: a randomized controlled trial evaluating the efficacy and safety of single-shot intraoperative methadone for postoperative pain in patients undergoing tonsillectomy. fentanyl is used as an active comparator

this study is an investigator-initiated, prospective, randomised controlled trial with two arms: an intervention arm (methadone) and a control arm (fentanyl). patients scheduled for tonsillectomy at randers regional hospital, denmark, will be approached for study participation. patients are randomised in a 1:1 ratio in blocks of varying sizes (between 4 and 8) to receive either intraoperative methadone or fentanyl. the randomisation assignment will be handled by the hospital pharmacy using a web-based central randomisation procedure (www.sealedenvelope.com). the study drug will be prepared by the hospital pharmacy at aarhus university hospital and delivered as kits with identical appearance, marked with the randomization number (1-130). on the day of surgery, a kit will be opened and a 10 ml syringe with study drug (methadone 2 mg/ml or fentanyl 30 microgram/ml or ) will prepared by a health care professional (nurse or medical doctor not involved in the study or the treatment of patients). once prepared, the blinded study drug will be given to and handled by one of the research team members and administered after induction of anesthesia and prior to surgery the dose of the study drug will be administered as intravenous bolus dose in equipotent doses (0.2 mg/kg / 3 μg/kg) corresponding to 1 ml for every 10 kg of ideal body weight (women: height (cm) - 105. men: height (cm) - 100)) after induction of anaesthesia and before the start of surgery. postoperative data will be obtained by reviewing hospital records, by interview and electronic questionnaires sent by email.

Eligibility criteria:
inclusion criteria: * all patients (≥18 years) scheduled for elective tonsillectomy exclusion criteria: * american society of anaesthesiologists (asa) physical status iv or v * allergy to study drugs * daily use of opioids 7 days prior to surgery * inability to provide informed consent * severe respiratory insufficiency * heart failure * acute alcohol intoxication/delirium tremens * increased intracranial pressure * acute liver disease * liver insufficiency * kidney insufficiency * treatment with rifampicin * treatment with any drug prolonging the qt-interval * pregnancy (every female not using contraceptives will be screened with urine human choriogonadotropin) * breastfeeding

Keywords: postoperative pain methadone
adaptive interventions for prevention/intervention for youth substance abuse

Conditions: Substance Use

Summary: the main aim of this formative study is to test and iteratively refine a new mobile phone app, which delivers assessments and tailored intervention content. the study will use social media advertisements to recruit a total of 40 youth between the ages of 16-24 years. those screening positive for past-month binge drinking or marijuana use will be invited to complete a baseline survey, download and use the app for 30 days, and complete a follow-up survey about the app functionality, design and content, and preliminary outcomes (intentions and importance of reducing use).

previously, the study team developed a prototype mobile application which utilized novel engagement strategies to enhance user adherence with daily and weekly survey assessments. the new app developed for this study extends the previous app by featuring the capability to also deliver tailored health intervention. as part of the app, users are prompted to complete brief daily and weekly assessments for 30 days. for each completed assessment, users earn small financial rewards and points to unlock new fish that populate a virtual aquarium in the app. the app also features push notifications with survey reminders and life insights (or graphs plotting data collected over time) to increase user engagement with the app. additionally, each day, users are randomized to receive intervention content (see the "interventions" section for more information) tailored on their recent assessment responses. after 30 days of using the app, participants will be asked to complete a follow-up survey; data collected will provide preliminary feedback regarding the feasibility and effectiveness of using the app to deliver substance use intervention content to affected youth.

Eligibility criteria:
inclusion criteria: 1. have an iphone smartphone on which the app can be downloaded 2. self-reported past-month binge drinking (4/5 or more drinks on one occasion, tailored by sex) or any past-month marijuana use without a medical marijuana card 3. meet study verification criteria (i.e., use of captcha, ip address checks, social media checks). exclusion criteria: 1. unable to understand english

Keywords: substance use mobile health
a dose-finding study of opc-6535 in patients with active ulcerative colitis

Conditions: Colitis, Ulcerative

Summary: the purpose of this study is to examine the safety and efficacy of opc-6535 (tetomilast) and to determine its optimal dose by once-daily oral administration at 0, 12.5, 25, or 50 mg for 8 weeks in combination with a fixed oral dose of 5-aminosalicylic acid (5-asa) in patients with active ulcerative colitis.


Eligibility criteria:
inclusion criteria: * patients with active ulcerative colitis * patients who have been receiving an oral 5-asa formulation at a fixed regimen and at a fixed dose * either inpatient or outpatient exclusion criteria: * patients who have a history of intestinal resection (other than appendiceal resection) * patients who have a complication of malignant tumor * female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the study period

Keywords: opc-6535 ulcerative colitis
examining feasibility, acceptability, and sustainability of a novel personalized smartphone intervention for suicide - randomized trial

Conditions: Suicide and Self-harm; Suicide; Suicide, Attempted; Suicidal Ideation

Summary: the primary aim of the present study is leverage existing infrastructure to develop novel technological features for a novel personalized smartphone intervention system, called the mobile application to prevent suicide (maps), and to establish feasibility, acceptability, safety, and estimate key parameters for primary outcomes (i.e., suicidal ideation and behavior; re-hospitalization), and target mechanisms.


Eligibility criteria:
inclusion criteria: * presence of suicidal ideation and/or suicidal behavior in the past month * between the ages of 18 and 70 * able to read, write, and understand english well enough to complete study procedures * owns a smartphone exclusion criteria: * current psychotic or manic symptoms severe enough to interfere with completion of study procedures
efficacy and safety study of anti-adhesion product in the prevention of intraperitoneal adhesions

Conditions: Intraperitoneal Adhesions

Summary: the objective of this study was to evaluate the efficacy of the anti-adhesion product (aap) in preventing or reducing post-operative adhesion formation and re-formation in a subject population having abdominal surgery and being left with a rectal stump and a temporary stoma from a first procedure and scheduled for a laparoscopy/ laparotomy as a second procedure in the normal treatment of the subjects' disease. in both study groups, surgical measures to prevent adhesions were taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves. in the investigational product group, aap was applied to the rectal stump and the incision line while no specific additional treatment was applied in the control group. the surgeon assessed preexisting adhesions during the first surgery. newly developed and re-formed adhesions were evaluated during the second surgery by a surgeon or assistant who did not know the result of randomization. the safety of the study drug was also monitored.


Eligibility criteria:
inclusion criteria: * written informed consent obtained from the subject or the subject's legally authorized representative prior to study entry * male or female subjects \> 18 years of age * subjects undergoing abdominal surgery with the possibility that a rectal stump would remain due to one or more of the following reasons: inflammatory bowel diseases, neoplasm, colon diverticulitis, colonic obstruction, colon polyposis, peritoneal trauma, fistula, incontinence, or other reasons * subjects for whom a second abdominal surgery is planned within approximately eight months of the first surgical procedure. exclusion criteria: pre operative: * pregnancy and lactation period * subjects concurrently participating in another clinical trial with a drug or a device * subjects who have participated in a clinical trial with a drug or a device within 30 days prior to this study * subjects who have had abdominal/pelvic surgery within six months prior to this study * subjects who have received or will receive (approximately within the next eight months) abdominal/pelvic irradiation intra operative: * subjects with peritonitis * subjects with gastrointestinal metastatic cancer, or cancer growing per continuitatem into surrounding tissues * subjects treated with hemostatic agents (e.g. fibrin sealant, collagen, oxidized cellulose) during the first surgery * subjects treated with adhesion prevention agents other than the anti-adhesion product (aap) (e.g. intergel® adhesion prevention solution, seprafilm® membrane) during the first surgery * subjects with major fecal contamination needing an abdominal lavage during the first surgery
efficacy of mazdutide for treating pcos

Conditions: Polycystic Ovary Syndrome

Summary: the goal of this clinical trial is to learn the efficacy of mazdutide in treating obese female adults diagnosed with polycystic ovary syndrome (pcos). the main question it aims to answer is: does mazdutide lower the free androgen index (fai) in obese female adults with pcos? participants will take mazdutide once every week for 24 weeks and visit the clinic once every 4 weeks for checkups and tests.


Eligibility criteria:
inclusion criteria: * bmi≥28kg/m2 * no plan for pregnancy in the coming 8 months after enrollment * patients should meet at least two of the three criteria according to the 2023 international evidence-based guideline for pcos : 1. irregular cycles and ovulatory dysfunction: \ 35 days or \ 90 days for any one cycle 2. polycystic ovaries: ≥20 follicles in at least one of two ovaries (diameter\<10mm), confirmed by ultrasound 3. biochemical hyperandrogenism: total testosterone\>1.67 nmol/l or clinical hyperandrogenism: modified ferriman gallwey score (mfg)\>4 exclusion criteria: * previous history of acute or chronic pancreatitis or pancreatic injury * previous history or family history of medullary thyroid cancer, multiple endocrine neoplasia type 2a or 2b * severe hypertriglyceridemia (tg\>5mmol/l) * type 1 or type 2 diabetes mellitus * other endocrine diseases that can cause secondary pcos, including but not limited to: 21 hydroxylase deficiency, prolactinoma, hypothyroidism, cushing's syndrome, etc * pregnancy or breast-feeding * patients with other serious diseases affecting heart, liver, kidney, or other major organs * patients with any type of cancer