Kornimate/medical-research-clean huggingface dataset:
trachoma amelioration in northern amhara (tana)

Conditions: Trachoma; Chlamydia

Summary: the who has initiated a program to eliminate trachoma, blinding eye infection caused by chlamydia trachomatis, in large part by mass distributions of oral azithromycin. the proposed study will determine the frequency and treatment target of community-wide mass antibiotic treatment. we will also study the impact of mass antibiotic distribution on antibiotic-resistance in pneumococcus.

the proposed study is a group-randomized trial to determine the frequency and treatment target of community-wide mass antibiotic treatment to eliminate trachoma. we will also study the impact of community-wide antibiotic distribution on antibiotic-resistance in pneumococcus. communities in goncha siso enese district of east gojam zone, ethiopia will be randomly assigned to different treatment schemes and monitored to study the following research questions: specific aim 1. to determine whether biannual mass treatments is more likely to eliminate ocular chlamydia from hyper-endemic communities than annual mass treatments. specific aim 2. to determine whether children form a core group for the transmission of trachoma. specific aim 3. to determine whether latrine construction prevents the return of infection into a community after mass treatment. specific aim 4. to determine the effect of mass azithromycin treatments on antibiotic resistance in pneumococcus and the reduction in mortality. specific aim 5. to determine whether annual mass treatments are more likely to eliminate ocular chlamydia from hyper-endemic communities than biennial mass treatments.

Eligibility criteria:
inclusion criteria: • all residents residing in the state-teams which are randomly selected for this study. exclusion criteria: * pregnant women * children under 6 months of age * all those who are allergic to macrolides or azalides * refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion) individuals in these three exclusion criteria will not be given the study antibiotic azithromycin, but offered the current who-recommended alternative treatment to azithromycin for active trachoma, which is 1% tetracycline eye ointment, to be used twice a day, topically to both eyes, for six weeks. note that the exclusion criteria refer to the exclusion to the treatment drug, but not to the monitoring, treatment of trachoma, and examinations.

Keywords: bacterial infections chlamydia infections eye diseases
recell® system combined with meshed autograft for reduction of donor skin harvesting in soft tissue reconstruction

Conditions: Full-thickness Skin Defects; Degloving Injuries; Crush Injuries; Laceration of Skin; Surgical Wound; Skin Cancer; Cellulitis; Infection; Necrotizing Fasciitis; Gun Shot Wound

Summary: a prospective randomized within-subject controlled study to compare the clinical performance of conventional autografting with and without the recell system on acute non-burn full-thickness skin defects.


Eligibility criteria:
inclusion criteria: 1. the patient requires autografting for treatment of an acute full-thickness skin defect (e.g., trauma- or surgery-related). 2. the maximum area requiring autografting is 50% total body surface area (tbsa). 3. two comparable areas requiring autografting, each at least 160 cm2 (or 320 cm2 contiguous), excluding face and genitalia. when hands or joints are included in the treatment areas, comparability of treatment areas means that each area (recell and control) must include the same contralateral joint and/or hand. 4. the patient is at least 5 years of age. 5. the patient (or parent/guardian) is willing and able to comply with all compulsory study procedures and visit schedule. 6. the patient agrees to abstain from any other treatment (e.g., external fixation) of the study treatment areas for the duration of his/her participation the study (1 year). 7. the patient agrees to abstain from enrollment in any other interventional clinical trial for the duration of his/her participation the study (1 year). 8. in the opinion of the investigator, the patient and/or guardian must be able to: 1. understand the full nature and purpose of the study, including possible risks and adverse events, 2. understand instructions, and 3. provide voluntary informed written consent. exclusion criteria: 1. not able to understand english or spanish. 2. the area requiring autografting sustained a burn injury. 3. the treatment area has previously failed to heal subsequent to surgical intervention for closure. 4. the patient is unable to follow the protocol requirements. 5. the patient has a condition that in the investigator's opinion may compromise patient safety or trial objectives. 6. current use of medications that in the investigator's opinion may compromise patient safety or trial objectives. 7. the patient has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (hartmann's) solution. 8. the patient is pregnant or breast-feeding (pregnancy test should be performed in accordance with local institutional requirements). 9. life expectancy is less than 1 year.
identification of novel inflammation-related biomarkers for early detection of anthracycline-induced cardiotoxicity in breast cancer patients

Conditions: Cardiotoxicity; Breast Cancer; Heart Failure

Summary: this study aims to identify possible set of inflammatory biomarkers before, during and after anthracycline-based chemotherapy in breast cancer patients to identify (sub)clinical chemotherapy-related cardiac dysfunctioncrcd to identify patients who would benefit from additional cardioprotective therapy.


Eligibility criteria:
inclusion criteria: * initial diagnosis of breast cancer * planned anthracycline-based therapy * first-line chemotherapy * first visit before initiation of chemotherapy exclusion criteria: * previous chemotherapy * medical history of cardiac disease * inflammation-modulating medication * medication with ras inhibitors * pregnancy * autoimmune disease * drug addictions * unwilling or unable to provide informed consent
a study of 5 fluorouracil and the anti-tumor activity of adh300004 and 5 fluorouracil in subjects with incurable solid tumors

Conditions: Neoplasms

Summary: 5 fluorouracil (5 fu), one of the most actively investigated anti-cancer drugs, is rapidly inactivated by the enzyme dihydropyrimidine dehydrogenase (dpd). adh300004 blocks dpd. this study will test the safety and effects of oral adh300004 14 hours prior to oral 5 fu in subjects with refractory solid tumors.


Eligibility criteria:
inclusion criteria: * signed written informed consent * \> or = 18 years of age * advanced or metastatic solid tumors: part 1: histologically proven advanced or metastatic solid tumors refractory to standard therapy or for which no standard therapy exists part 2: histologically proven advanced and/or metastatic solid tumor of one of the following 6 histologies, that is refractory to standard curative therapy or for which no curative therapy exists: hcc, nsclc, gastric cancer, cervical cancer, prostate cancer, and breast cancer * radiologically documented measurable or evaluable (non-measurable) disease * adequate performance status and organ function, as evidenced by hematologic and biochemical blood testing * willing to not receive fluoropyrimidine containing chemotherapy for 8 weeks after the last dose of adh300004 in this study exclusion criteria: * cytotoxic chemotherapy, radiotherapy, or investigational drug within 28 days prior to study entry * non-cytotoxic cancer therapy within 14 days prior to study entry * portal hypertension with bleeding esophageal or gastric varices within the past 3 months * ascites that is refractory to conservative management * inability to take oral medication * active peptic ulcer disease * known hypersensitivity to 5-fu or adh300004 * stroke, major surgery, or other major tissue injury within 30 days before study entry

Keywords: cancer tumors neoplasms anticarcinogenic agents antineoplastic agents dihydrouracil dehydrogenase (nadp)
use of acupuncture for dental pain: testing a model

Conditions: Tooth, Impacted

Summary: this study is testing the safety and effectiveness of acupuncture in controlling pain related to the removal of partially impacted mandibular third molars. acupuncture is the chinese art of healing by inserting needles into the skin. participants ages 18 - 40 are given an initial x-ray to determine if one lower molar is partially bony impacted. eligible participants will then undergo standard oral surgery to remove the impacted molar. a local anesthetic will be used prior to surgery. directly after surgery the participant will be assigned to one of three groups. participants will not be able to select which group they are assigned. participants will receive either real or sham (fake) acupuncture as a treatment for post-extraction pain. after the initial acupuncture treatment, participants are required to remain for six hours at the dental site to be monitored. if a participants discomfort is measured as moderate or higher then a second acupuncture treatment will be administered. all participants will be administered questionnaires during the day of surgery. participants will also be required to complete two diaries during the seven days following surgery. on the seventh day, participants return to have stitches removed and hand in completed diaries.


Eligibility criteria:
inclusion criteria: * at least one lower mandibular molar with partial bony impaction * general good health * minimum body weight of 99 lbs. * able to read and write in english
a retrospective review of floseal use in total shoulder arthroplasty

Conditions: Total Shoulder Arthroplasty; Glenohumeral Osteoarthritis

Summary: the proposed study aims to objectively assess 2-year clinical and radiographic results for the rate of glenoid component loosening in total shoulder arthroplasty (tsa). this retrospective radiographic review will provide evidence for equivalence or superiority in curtailing loosening, a known complication in arthroplasty, when a hemostatic agent is utilized in conjunction with cement at the glenoid.


Eligibility criteria:
inclusion criteria: * patients must have completed at least 2 years follow-up following their total shoulder replacement * patients must have had radiographic imaging obtained at that 2 years exclusion criteria: * patients less than 21 years of age * patients who have been imprisoned since the time of surgery * patients who are mentally impaired
effects of mandala coloring on premenstrual syndrome

Conditions: Premenstrual Syndrome

Summary: this research was planned as a randomized controlled experimental study in order to reduce premenstrual syndrome symptoms of women with premenstrual syndrome.

occurs in the luteal phase and decreases or declines significantly with the onset of menstruation; physical such as breast tenderness, headache, bloating; premenstrual syndrome is a health problem with more than 150 psychological and behavioral symptoms such as anger outbursts, irritability, anxiety, mood fluctuations, sleep and eating disorders. symptoms experienced during the premenstrual period lead to results such as mood/affective disorder in women, deterioration in daily life activities and social relations, an increase in negative health behaviors, as well as low academic performance in students, decreased participation in classes, getting low grades in exams, and not showing up for exams.since its etiology is unclear, no specific treatment method can be found, and non-pharmacological therapies such as stress control, lifestyle changes, exercise and complementary therapies such as evening primrose oil, chasteberry and acupuncture are applied in its management. psychiatrist carl gustav jung discovered the psychic healing transformations created by mandala painting, one of the art therapy methods, through his own experience and that of his patients. various studies have determined that mandala coloring improves physical and psychological symptoms, but no studies have been conducted with pms.

Eligibility criteria:
inclusion criteria: * volunteering to participate in the research * fully answering survey and scale forms. * ability to read and understand turkish * being between the ages of 18 and 30 years * having regular menstruation (between 21 and 35 days) * having 45 or more from pmss exclusion criteria: * unwilling to continue working * having any problem that prevents communication (such as hearing, speaking, and understanding abilities), * having a gynecological disease (abnormal uterine bleeding, uterine fibroids, ovarian cysts, hormonal treatment, etc.) * having a chronic or physical illness * having a mental illness * being under psychiatric treatment (pharmacotherapy or psychotherapy) * taking medication for menopausal symptoms * using one of the pharmacological or non-pharmacological methods to reduce premenstrual symptoms (cocs, acupressure, homeopathy, etc.)

Keywords: premenstrual syndrome mandala coloring
de quervain's disease in the acute phase:a study aimed at evaluating the effectiveness of standard physiotherapy treatment (handguide), compared to experimental treatment after performing ultrasound-guided infiltrative therapy.

Conditions: De Quervain Disease; Hand Tenosynovitis

Summary: the objective of the study is to compare pain reduction and disability reduction in two groups of patients diagnosed with de quervain syndrome who will undergo ultrasound-guided infiltrative treatment with corticosteroid as per normal clinical practice: * the control group will subsequently be subjected to a standard treatment based on the european guidelines of the handguide group, * the experimental group will subsequently carry out a program of eccentric exercises.


Eligibility criteria:
inclusion criteria: * patients of both sexes with a minimum age of 18 years; * medical diagnosis of de quervain syndrome assessed through orthopedic clinical examination e confirmation by ultrasound; * signing of the informed consent and participation in the study. exclusion criteria: * patients who are not self-sufficient or not able to understand and want; * presence of other pathologies in the hand affected by de quervain pathology, such as intersection syndrome, neuropathies, fractures, rhizoarthrosis, arthrosis of the radio-carpal or intercarpal joint, intercarpal instability, cervical radiculopathy, rheumatic or metabolic pathologies; * pregnant or breastfeeding women.

Keywords: hand rehabilitation
concomitant association of ultrafractionated brain irradiation - temozolomide in inoperable primary glioblastoma multiforme

Conditions: Glioblastoma Multiforme

Summary: the main purpose of this study is the evaluation of concomitant association of ultrafractionated irradiation and temodal® in patients with inoperable primary glioblastoma multiforme; study of tolerance and objective response rate. the secondary purposes of this study are the evaluation of progression free survival, global survival and tolerance through toxicity study. the therapeutic response according to methylation or not of mgmt is also evaluated.


Eligibility criteria:
inclusion criteria: * giving their informed consent * having a supratentorial malignant glioma, either grade 4 of st. anne/mayo grading, or glioblastoma multiforme according to who classification * having an inoperable brain tumor (diagnosed by stereotactic biopsy) * having a general status, evaluated by karnofsky scale, \>60 * having a life expectancy \>3 months * not having previously had a brain irradiation and/or adjuvant or neo-adjuvant chemotherapy * potentially having another cancer, if histology and clinical history are available for comparison * being able to take oral tablets * no hiv disease * satisfactory hematology, hepatic and renal functions: polymorphonuclear neutrophils \>1500/mm3, platelets \>100000/mm3, hb \>8g/dl, creatinemia ≤1.5 times upper normal value, total bilirubin \<1.5 times upper normal value, asat and alat \<3 times upper normal value * for women of childbearing potential, a contraception is given exclusion criteria: * having an under tentorial malignant glioma (brain stem and/or cerebellum), grade 4 of st. anne/mayo grading * having a karnofsky score \<60 * having a life expectancy \<3 months * having had a brain irradiation or an adjuvant or neoadjuvant chemotherapy * refusing any additional therapy * having a non-malignant but serious systemic disease or uncontrolled active infection * having a severe psychiatric disorder * not having signed the informed consent * pregnant or breastfeeding woman
study of pharmacotherapy of psychotic depression

Conditions: Major Depressive Disorder With Psychotic Features

Summary: this study will determine the effectiveness of combining selective serotonin reuptake inhibitors (ssris) with antipsychotic medications in the treatment of psychotic depression.

approximately 25% of people who are admitted to hospitals for depression suffer from psychotic depression. people with psychotic depression experience hallucinations,and, more commonly delusions, in addition to major depression. psychotic experiences may be either congruent with the theme of depression or incongruent, without an apparent relationship to feeling depressed. this study will determine the effectiveness of combining a selective serotonin reuptake inhibitor (ssri) with antipsychotic medication in the treatment of psychotic depression accompanied by at least one identifiable delusion. the study will also evaluate the difference in treatment response of young adults versus geriatric patients. this double-blind study will last a total of 12 weeks. participants will be randomly assigned to receive either olanzapine, an atypical antipsychotic drug, combined with sertraline, an ssri, or olanzapine alone. following baseline assessments, study visits will occur weekly until week 6, and then bi-weekly until week 12. participants who do not respond to either treatment may leave the study at any time. participants who achieve either partial or full response may participate in an additional 20-week study.

Eligibility criteria:
inclusion criteria: * major depressive disorder, single or recurrent, with psychotic features exclusion criteria: * history of substance abuse or dependence within the 3 months prior to enrollment * acute or unstable medical illness * diagnosis of schizophrenia or other psychotic disorders * pregnant * intolerance to ssris or olanzapine

Keywords: major depressive disorder with psychotic features delusional depression randomized trial combination treatment ssri atypical antipsychotic
job strain, ambulatory blood pressure and hypertension

Conditions: Cardiovascular Diseases; Cerebrovascular Accident; Hypertension; Heart Diseases

Summary: to analyze the association between an objective measure of "job strain" and risk of stroke, and change in ambulatory blood pressure.

background: cardiovascular disease accounts for 43 percent of all deaths in the united states. hypertension affects as many as 50 million americans, however the causes of essential hypertension are not well known. a new cvd risk factor ("job strain") has emerged as a potential major cause of essential hypertension. by 1995, over 20 studies had found significant positive relationships between "job strain" and cvd, coronary heart disease, all-cause mortality or hypertension. "job strain" is defined as high psychological workload demands combined with low"decision latitude". an expanded concept of "job strain" which included low workplace social support ("iso-strain") was developed and examined in the study. important questions remained to be answered about "job strain", cvd and hypertension. in most studies, "job strain" was only measured at one point in time, while, in fact, cumulative exposure to "job strain" was believed to be the risk factor. in addition, most studies relied on self-report measures of "job strain". also, no studies specifically examined risk of stroke and "job strain". design narrative: data from the cornell university cohort study of psychosocial factors and cardiovascular disease and the columbia university-northern manhattan stroke study were analyzed. the study had five specific aims, including to determine whether: blood pressure levels were associated with cumulative exposure to "job strain"; differences in blood pressure increases were associated with an objective measure of "job strain"; increased risk of stroke was associated with an objective measure of "job strain"; changes in psychological variables over time were associated with job characteristics; changes in cvd risk factors (other than hypertension) were associated with job characteristics. paul landsbergis also constructed measures of cumulative exposure to "job strain" and determined their association with blood pressure, and analyzed the association between job characteristics and change in psychological variables and cardiovascular disease (cvd) risk factors. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
oncosil pancreatic cancer post-marketing clinical registry - italy

Conditions: Locally Advanced Pancreatic Adenocarcinoma

Summary: the ospritaly patient registry has been developed to assess the performance and safety of the oncosil™ device when used within the approved indication of unresectable, locally advanced pancreatic cancer, in combination with gemcitabine-based chemotherapy, within a real-world observational registry.


Eligibility criteria:
inclusion criteria: 1. patients who are eligible for and undergo oncosil™ implantation at an eligible treatment facility according to the approved oncosil™ system instructions for use (ifu), as part of their clinical care. 2. patients who have completed and signed the patient informed consent form (picf) for the ospritaly patient registry. exclusion criteria: 1. patients participating in an interventional clinical study (company or investigator-sponsored). 2. use of an investigational agent at the time of enrolment.