Kornimate/medical-research-clean huggingface dataset:
a phase ii study of zt002 injection with subjects with overweight or obesity

Conditions: Overweight or Obesity

Summary: this study will evaluate the percentage change from baseline in weight after 24 weeks of treatment with zt002 injection in subjects with overweight/obesity.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years and ≤ 75 years. * bmi ≥28 kg/m², or 24 kg/m2 ≤ bmi \< 28 kg/m2 with at least one comorbidity (pre-diabetes, hypertension, hyperlipidemia, fatty liver, obstructive sleep apnoea syndrome due to overweight, weight-bearing joint pain, etc.) * weight change is not more than 5% with diet and exercise control alone within 3 months prior to screening. exclusion criteria: * previous diagnosis of diabetes; or hba1c ≥ 6. 5% or fasting blood glucose ≥ 7.0 mmol/l at screening. * have used medicines or treatments that affect weight within 3 months prior to screening. * history of acute or chronic pancreatitis. * personal or family (parents, children, and siblings) history of medullary thyroid cancer (mtc) or multiple endocrine neoplasia type ii (men2). * history of definite mental disease within 2 years prior to screening or prior suicidal tendency or suicidal behavir; or phq-9 scale score is ≥ 15 at screening; or c-ssrs questionnaire is either class 4 or 5 at screening.
invasive candidiasis in saudi icus

Conditions: Invasive Candidiasis

Summary: epidemiology and clinical outcomes of invasive candidiasis in critically ill patients in saudi arabia is not well studied. this observational study objectives include to determine the epidemiology, risk factors and outcomes of invasive candida infection in critically ill patients in saudi arabia.


Eligibility criteria:
inclusion criteria: * adult patients (\> 18 years) * develop invasive candidiasis as per prespecified definitions during icu stay * in addition, patients who had invasive candidiasis within 72 hours of icu admission will be included exclusion criteria: * diagnosis of invasive candidiasis (definite or probable) more than 72 hours before icu admission. * diagnosis of invasive candidiasis (definite or probable) within 72 hours of icu admission, but the admission to icu for an unrelated reason. * readmission to the icu during the same hospitalization with invasive candidiasis occurring during one of the previous admissions.

Keywords: candidiasis critically ill outcomes
litt followed by hypofractionated rt for recurrent gliomas

Conditions: Glioblastoma; Brain Tumor; Glioma; Neoplasms

Summary: the purpose of this study is to evaluate the treatment regimen of using laser interstitial thermal therapy (litt) and hypo-fractionated radiation therapy to treat patients with recurrent gliomas.

radiation therapy is preferably used as an adjunct to surgery for patients with a newly diagnosed or recurrent glioblastoma. litt offers an alternative to surgical resection, and due to its minimally invasive nature, does not delay initiating radiation therapy. another advantage of litt prior to radiation therapy is the ability to obtain a tissue diagnosis of recurrent tumor prior to initiating radiation therapy.

Eligibility criteria:
inclusion criteria: 1. patients with history of a who grade ii-iv glioma with radiographic evidence of recurrent or progressive tumor * patient must have received prior radiation therapy for initial treatment of glioma * patients with any number of recurrences are allowed as long as the patient has not undergone re-irradiation 2. brain mri with contrast demonstrates an enhancing tumor ≤ 6 cm in largest diameter within 60 days prior to registration 3. history and physical including neurological exam within 30 days prior to registration 4. karnofsky performance status ≥ 60% within 30 days prior to registration 5. age ≥ 22 years old 6. minimum interval since completion of prior radiation treatment is 8 weeks * patients will only receive re-irradiation if pathology from litt is consistent with recurrent tumor 7. patients must have signed an approved informed consent 8. patients with the potential for pregnancy or impregnating their partner must agree to practice effective contraceptive methods to avoid conception while on study and for 6 months after study completion. 9. female patients of child-bearing potential must have a negative pregnancy test within 28 days prior to study registration. exclusion criteria: 1. patients that are not surgical candidates for stereotactic biopsy or laser ablation 2. patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following: * history or presence of serious uncontrolled ventricular or significant arrhythmias. * any of the following within 6 months prior to registration: myocardial infarction, severe/unstable angina, coronary artery bypass graft, congestive heart failure, cerebrovascular accident, transient ischemic attack , pulmonary embolism 3. infratentorial tumor or evidence of leptomeningeal spread 4. inability to undergo a mri 5. pregnant or breast-feeding women

Keywords: gliomas, laser interstitial thermal therapy, brain, brain tumor, radiotherapy, proton therapy, hypofractionated radiation therapy, malignant, glioblastoma
assessment of knowledge, attitude, and practice of minimal intervention dentistry in a group of dental interns

Conditions: Pediatric Dentistry

Summary: minimal intervention dentistry (mid) is a modern medical approach that aims to maximize preservation of healthy dental tissues. when operative intervention is required it is as minimally invasive as possible. this study will assess the knowledge of a group of dental interns regarding minimal intervention dentistry in egypt and whether this knowledge is translated into positive attitude and practice among them.

healthy oral tissues enable the child to eat, speak and socialize which contributes to general wellbeing. dental caries during childhood is a major public health problem and throughout the 20th century, the dominant practice patterns of managing dental caries relied on the purely surgical approach of g.v black such as the concept of "extension for prevention". one of the drawbacks of this approach is an unnecessary removal of healthy oral tissues. comprehensive knowledge of dental cariology, advances in dental restorative materials and modern diagnostic devices are changing pediatric restorative dentistry. minimal intervention dentistry (mid) is a modern medical approach that aims to maximize preservation of healthy dental tissues based on individualized patient care of early detection of disease, risk assessment diagnosis, and prevention. when operative intervention is required it is as minimally invasive as possible. there is insufficient information about knowledge and practice of modern dental approaches including minimal intervention dentistry among dental interns in egypt. available studies concerned with this subject were not done in egypt. due to this shortage of information, the application of mid in the egyptian society cannot be fully assessed, and problems associated with its practice cannot be identified and solved. this shortage of information may also deprive children of getting benefits of mid. thus; this study will assess the knowledge of a group of dental interns regarding minimal intervention dentistry in egypt, and whether this knowledge is translated into positive attitude and practice among them. knowledge, attitude, and practice (kap) surveys can be used to identify knowledge gaps and culturally related misconceptions of new health approaches or interventions. they can determine factors influencing behaviors that are not known, and how and why people practice certain health behaviors. kap surveys can be also used to identify needs, problems and barriers, as well as solutions for improving quality and accessibility of health services by studying factors and possible determinants influencing treatment decisions. this study aims to identify deficiencies (if present) in knowledge, attitude, and practice of mid among a group of dental interns in egypt.

Eligibility criteria:
inclusion criteria: * dental interns attending pediatric dentistry in the faculty of dentistry, cairo university. exclusion criteria: * interns refusing to participate in the study.
biomarkers in samples from young patients with acute myeloid leukemia

Conditions: Leukemia

Summary: rationale: studying bone marrow samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this research study is studying biomarkers in samples from young patients with acute myeloid leukemia.

objectives: * to compare the frequency of germline telomerase mutations in pediatric patients with acute myeloid leukemia (aml) demonstrating prolonged myelosuppression, defined as ≥ 1 episode \> 35 days of neutrophil count recovery after chemotherapy, to the pediatric patients with the expected myelosuppression, defined as consistently \< 35 days of neutrophil count recovery after chemotherapy. * to assess association between telomerase mutations and incidence of grade 3 or 4 mucositis, relapse, and death. * to compare germline (remission) telomere length in pediatric aml patients demonstrating delayed bone marrow recovery with the pediatric patients with consistently expected recovery. * to assess whether a correlation between telomere length and incidence of grade 3 or 4 mucositis, relapse, and death exist. outline: this is a multicenter study. cryopreserved bone marrow samples are analyzed for dna sequencing and mutation by sanger-based sequencing methods, quantitative pcr, and seqman pro (lasergene from dnastar). results are then compared with previously published data and existing databases to determine the allele frequency in control populations.

Eligibility criteria:
disease characteristics: * diagnosis of acute myeloid leukemia * enrolled on ccg-2961 and meeting 1 of the following criteria: * more than 35 days to recover to an anc \> 500/mm³ after any course of chemotherapy * consistently recovered \ 500/mm³ after all courses of chemotherapy * available cryopreserved cell from diagnostic and end-of-therapy samples patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: childhood acute myeloid leukemia/other myeloid malignancies childhood acute erythroleukemia (m6) childhood acute megakaryocytic leukemia (m7) childhood acute monoblastic leukemia (m5a) childhood acute monocytic leukemia (m5b) childhood acute myeloblastic leukemia without maturation (m1) childhood acute myelomonocytic leukemia (m4) childhood acute myeloblastic leukemia with maturation (m2)
dose-finding study of novel erythropoiesis stimulating protein (nesp) for the treatment of anaemia in subjects with solid tumours receiving multicycle chemotherapy

Conditions: Anemia; Solid Tumors

Summary: the purpose of this study is to assess the safety of nesp administered by sc injection in subjects with solid tumours and anaemia receiving multicycle chemotherapy. subjects in this study enter one of two schedules: schedule 1 or schedule 2. schedule 1 is a sequential dose escalation study which consists of parts a and b. part a is the initial treatment phase, where the clinically effective dose (ced) of nesp administered every 3 weeks will be determined after 12 weeks of treatment. part b is an optional 12-week, open-label, dose-maintenance phase that follows part a. schedule 2 is a parallel dose-finding study and also consists of parts a and b. part a is the initial treatment phase, where the ced of nesp administered every 4 weeks will be determined after 12 weeks of treatment. part b is an optional 12-week, open-label, dose-maintenance phase that follows part a.


Eligibility criteria:
inclusion criteria: * subject with solid tumour(s) * anaemia (hgb less than or equal to 11.0 g/dl * planned to receive cyclic chemotherapy * at least 6-month life expectancy * eastern cooperative oncology group (ecog) status of 0 to 2 * adequate renal and liver function * at least 18 years of age exclusion criteria: * central nervous system disease * iron deficiency * received more than 2 rbc transfusions within 4 weeks before randomisation or any rbc transfusion within 2 weeks before randomisation * received recombinant human erythropoietin (rhuepo) therapy within 8 weeks before randomisation * history of any seizure disorder * cardiac disease * active infection or inflammatory disease * known positive test for hiv infection * known primary haematologic disorder which could cause anaemia * use of other investigational agent(s)/device(s) * pregnant or breast feeding * known hypersensitivity to any recombinant mammalian derived product

Keywords: anemia solid tumors multicycle chemotherapy nesp
randomized trial of concomitant chemotherapy in patients with locally advanced hnscc treated by radiotherapy-erbitux

Conditions: HNSCC

Summary: the aim of the trial is to study the efficacy of adding concomitant chemotherapy (carboplatin/5fu) to erbitux-radiotherapy in patients with locally advanced head and neck cancer.


Eligibility criteria:
inclusion criteria: * squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, larynx * stage iii - iv (t0-t4, n0-n2b, m0) * not resected * karnofsky ps\>=80 * informed consent signed exclusion criteria: * contra indication to chemotherapy or cetuximab

Keywords: stage iii stage iv locally advanced
efficacy and safety of artacent™ for treatment resistant lower extremity venous and diabetic ulcers

Conditions: Venous Ulcer; Foot Ulcer, Diabetic

Summary: this study will compare the proportion of patients who have wound closure within 12 weeks as well as the time to wound closure in patients receiving artacent™ versus standard of care for treatment of non-healing lower extremity wounds. the recurrence of healed wounds will be assessed at 6 months via a telephone survey

this study is to document the efficacy of artacent™ human amniotic membrane (artacent) in the treatment of diabetic and vascular lower extremity ulcers. the study will add to the currently available literature by also assessing the impact of treatment on quality of life and on heal economic outcomes. finally the study will follow patients for longer than previous studies and will obtain data on healing and recurrence at 6 months. the objectives of this study are 1) to compare artacent to standard of care (soc) in the treatment of non-healing lower extremity ulcers and 2) to evaluate the impact of treatment on patient quality of life. health economic outcomes will also be collected. the proportion of patients receiving artacent who have wound closure with 12 weeks will be compared to those patients receiving soc only will be compared. a comparison of time to wound closure will also be compared between the two populations. patients who are randomized to the soc group (control) and require further treatment at 12 weeks due to incomplete wound healing, may receive treatment with artacent if the investigator determines that to be a potentially beneficial option.

Eligibility criteria:
inclusion criteria: * age 18 years or older * able and willing to give consent and to comply with study * lower extremity ulcer between 1 and 25 cm2 point after the 4 week run-in period * has received documented soc treatment for 4 weeks or greater duration resulting in \<50% reduction in the ulcer size * no clinical signs of infection at the ulcer site * serum creatinine below 3.0 mg/dl * serum hga1c below 12% * adequate circulation to the affected limb with abi between 0.7 and 1.2 or tri-/bi-phasic arterial waveforms at the ankle of the affected leg. exclusion criteria: * is participating in another wound study * has a charcot foot * has previously received a different biological graft on the target foot * has more than one lower extremity ulcer * has an ulcer that probes to bone or involves tendon, muscle, joint capsule or has sinus tracts * is currently receiving radiation or chemotherapy * has an autoimmune connective tissue disorder * is taking any medication known to be an immune system modulator * is pregnant or is considering becoming pregnant within the next 6 months
music therapy for speech and prosody in autistic children (mtspac)

Conditions: Autism; Language Delay; Speech Disorders in Children

Summary: this research is a single-blind randomized controlled trial, where the investigators plan to recruit 40 children with autism, randomly divided into two groups. the music therapy intervention group will receive an hour of group music therapy in addition to traditional language therapy. the control group will receive only traditional language therapy. the trial will last for 8 weeks, and participants in both groups will be assessed before and after the trial. during the study, the investigators will use professional recording equipment to record their speech and use the speech analysis software to objectively compare whether there are significant differences in prosody between the two groups of children with autism before and after the intervention. besides the acoustic measurement the investigators also assess the language abilities autism trait performance, adaptive function, emotional behavior, and parent-child stress levels.

this research is a single-blind randomized controlled trial, where the investigators plan to recruit 40 children with autism, randomly divided into two groups. the music therapy intervention group will receive an hour of group music therapy in addition to traditional language therapy. the control group will receive only traditional language therapy. the trial will last for 8 weeks, and participants in both groups will be assessed before and after the trial. during the study, the investigators will use professional recording equipment to record their speech and use the speech analysis software to objectively compare whether there are significant differences in prosody between the two groups of children with autism before and after the intervention. besides the acoustic measurement the investigators also assess the language abilities autism trait performance, adaptive function, emotional behavior, and parent-child stress levels. the study hypothesizes that music therapy can contribute to improving language development delays in children with autism and may enhance their language development further by ameliorating prosody abnormalities. the investigators hope that this research can propose more diversified therapeutic methods for language development in children with autism.

Eligibility criteria:
inclusion criteria: * children with autism * aged 3-5 y/o * children with speech delay (t-score of preschool language scale \< 40) * mandarin as first language exclusion criteria: * children with other neurological diseases * children without verbal output * children with articulation or voice disorder
emotional processing in healthy volunteers in the presence of an investigational anxiolytic

Conditions: Depressive Disorder and Anxiety Disorders

Summary: this will be a phase i, single centre, randomised, double blind, double-dummy, placebo controlled, parallel group single-dose study in healthy volunteers. the purpose of this study is to assess the effect of a single-dose administration of gsk424887, a potent, selective competitive antagonist of the human neurokinin 1 (nk1) receptor and a potent inhibitor of the human serotonin transporter (sert), at the maximum dosage of 100 mg versus placebo and versus citalopram (20 mg) on emotional processing in healthy male volunteers. pharmacokinetics and safety following oral administration of gsk424887 will be also evaluated. an emotional test battery (etb) previously used to characterise the effects of antidepressants on positive and negative emotion processing in healthy volunteers and patients will be used. we hypothesise that gsk424887 will modulate emotional information processing acutely. we anticipate that these effects may be manifest at sub-effective levels of nk1 and sert receptor occupancy, thus providing pharmacodynamic evidence of the synergistic interaction of the two mechanisms in humans.


Eligibility criteria:
inclusion criteria: 1. healthy males with no neurological, or history of psychiatric illness 2. aged between 18 and 45 years 3. agree to use contraception 4. bmi range of 18 to 33 kg/m² 5. fluent english speakers 6. non smoker or light smoker exclusion criteria: 1. positive pre-study drug/alcohol screen or regular alcohol consumption 2. positive pre-study hepatitis b surface antigen or positive hepatitis c antibody result within 3 months of screening 3. on prescription or non prescription drug 4. exposure to more than four new chemical entities within 12 months prior to the first dosing day 5. consumption of large amounts of caffeinated drinks 6. significant hearing impairment 7. previous experience of the emotional test battery experimental procedures

Keywords: healthy volunteers anxiety disorder neuropsychological tests
rituximab in primary lymphocyte predominant hodgkin´s disease(ripl)

Conditions: Lymphocyte Predominant Hodgkin´s Lymphoma (LPHD)

Summary: first line therapy for patients with lymphocyte predominant hodgkin´s disease (lphd) in clinical stage ia using the monoclonal anti-cd20 antibody rituximab


Eligibility criteria:
inclusion criteria: * lymphocyte predominant hodgkin´s lymphoma (histologically proven) * clinical stage ia (without risk factors: large mediastinal mass, extranodal involvement, esr \> 50mm/h) * age 18 - 75 * who performance status 0-3 * normal organ function * written informed consent exclusion criteria: * classical hodgkin´s lymphoma * composite lymphoma * leucocytes \< 3000/µl * thrombocytes \< 100.000/µl

Keywords: lymphoma lphd rituximab