Kornimate/medical-research-clean huggingface dataset:
an open-label safety study of memantine in pediatric patients with autism, asperger's disorder, or pervasive developmental disorder not otherwise specified (pdd-nos)

Conditions: Autism Spectrum Disorder (ASD); Autism; Autistic Disorder; Asperger's Disorder; Asperger's; Pediatric Autism; Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

Summary: the purpose of this study is to evaluate the safety and tolerability of memantine in pediatric (6-12 years old) patients with autism, asperger's disorder, or pervasive developmental disorder not otherwise specified (pdd-nos) and to identify responders for participation in a follow-up randomized withdrawal study.

this 50-week multicenter and multinational clinical study is comprised of a 2-week screening period, a 6-week open-label dose-titration period followed by a variable duration maintenance period (up to 42 weeks). patients with at least 12 weeks of investigational product exposure who meet the protocol specified responder criterion at two consecutive visits separated by at least two weeks are eligible to transition to a randomized withdrawal study. a responder is defined as a patient who demonstrates at least a 10 point improvement (reduction in score) in the social responsiveness scale (srs) total raw score relative to the visit 1 total raw score. weight based dose limits were selected in this study to ensure that exposure in terms of area under the curve (auc) was less than the predefined limit of 2100 ng·h/ml which represents a 10-fold lower exposure than observed at the no observed adverse effect level (noael) of 15 mg/kg/day in juvenile rats. the weight-based dose limits in this study were as follows: * group a: ≥ 60 kg; maximum 15 mg/day * group b: 40-59 kg; maximum 9 mg/day * group c: 20-39 kg; maximum 6 mg/day * group d: \< 20 kg; maximum 3 mg/day

Eligibility criteria:
inclusion criteria: 1. male or female outpatients. 2. age of 6-12. 3. meet diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) diagnostic criteria for autism, asperger's disorder, or pervasive developmental disorder not otherwise specified (pdd-nos) 4. have a family that is sufficiently organized and stable to guarantee adequate safety monitoring and continuous attendance to clinic visits for the duration of the study exclusion criteria: 1. have enrolled in study mem-md-57a 2. medical conditions that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient's well-being. 3. participation in any other clinical investigation using an experimental drug within 30 days of screening. 4. having any primary psychiatric (axis i) diagnosis other than autism, asperger's disorder, and pdd-nos. 5. meeting dsm-iv-tr criteria for bipolar i disorder, psychotic disorder not otherwise specified, posttraumatic stress disorder, schizophrenia, or major depressive disorder within the past 6 months

Keywords: autism spectrum disorder (asd) autism autistic disorder asperger's disorder asperger's pervasive developmental disorder not otherwise specified (pdd-nos) memantine pediatric disorder
organizational skill training (ost) in schools

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Summary: the primary aim of this project is to address the need for an effective school-based intervention for elementary school-aged students with organization, time management, and planning (otmp) deficits by adapting an evidence-supported clinic-based intervention so that it can be implemented in school settings. investigators are learning to adapt an individual, clinic based program (ost-c) for children diagnosed with attention deficit hyperactive disorder (adhd) to children with otmp problems. investigators will be collecting data . to this end, investigators will be collecting data on implementation (such as feasibility and acceptability), program development (what changes to the individual ost-c program were made based on findings during this study) and limited outcome data (repeated measures collection and pre- and post-treatment collection on a small sample, no control group).


Eligibility criteria:
inclusion criteria: * children will be recruited based on their parents' interest level in having them participate in a program to improve their organizational skills. * investigators will consider feedback from their 3rd to 5th grade general education or inclusion classroom teacher based on otmp problems difficulties that interfere with functioning (difficulty in morning routine or end-of-day packing up routine, a high percentage of incomplete or missing assignments, messy desk or seat sack). * investigators will not use specific cutoffs on normed measures for determining eligibility based on these difficulties, as the intention is to develop a program that can be easily disseminated. * availability to attend twice-weekly sessions with the otmp trainer either during the school day (during a time when they would not be pulled from academic content) or during after-school hours. exclusion criteria: * children with mental retardation will not participate in the study, due to the difficulty they would likely have understanding the content of the sessions.

Keywords: organization, time management, and planning (otmp)
health professionals perspective on suicide

Conditions: Suicide; Suicide, Attempted; Completed Suicide; Suicide Prevention

Summary: the aim is to investigate how health professionals view/respond towards suicidal patients, what was their attitude, experiences and difficulties/challenges they faced while dealing with suicidal patients (whether successful or unsuccessful), and what measures/methods are optimal or could be used to prevent suicide from the perspective of mental and non mental health professionals through concurrent mixed methods study approach.


Eligibility criteria:
inclusion criteria: * health professionals having at least 1 year of experience in dealing with suicide cases irrespective of the outcome will be included. * qualification of health professionals should be at least mbbs with permanent pmdcp registration. * health professionals who are willing to participate voluntarily and provide written informed consent will be included. exclusion criteria: * health professionals with prior and present history of psychiatric consultation will be excluded. * health professionals without direct experience in handling suicidal patients will be excluded. * nurses and paramedical staff will be excluded from the study.
developing a mri-based deep learning model to predict mmr status

Conditions: Endometrial Cancer

Summary: in order to develop a convenient, cheap and comprehensive method to preoperatively predict dmmr and reduce the number of people requiring dmmr-related immunohistochemical or genetic testing after surgery, this study aims to establish a deep learning model based on mri to predict the mmr status of endometrial cancer. patients diagnosed with endometrial cancer after surgery and who had completed pelvic mri before surgery were collected. deep learning was used to combine the clinical model with mr image data to build the model. roc curves were constructed for the testing group, internal verification group and external verification group, and the area under roc curves were calculated to evaluate the diagnostic effect and stability of the model. the dual threshold triage strategy was used to screen out the pmmr population (below the lower threshold), dmmr population (above the upper threshold) and the uncertain part of the population (between the thresholds).

in this study, patients diagnosed with endometrial cancer after surgery and who had completed pelvic mri before surgery were collected from 2017 to 2022. it is expected to collect 500 cases in our hospital, which are divided into 375 cases (experimental group) and 125 cases (internal verification group). 100 cases of sun yat-sen university cancer center for external verification. clinical data (age, gender, bmi, ca125, ca19-9, mr-t staging, immunohistochemical results of mmr-related proteins) of the study population were collected and logistics regression analysis was conducted to establish clinical models. extract, segment, integrate and enhance mr image data. deep learning was used to combine the clinical model with mr image data to build the model. roc curves were constructed for the testing group, internal verification group and external verification group, and the area under roc curves were calculated to evaluate the diagnostic effect and stability of the model. the dual threshold triage strategy was used to screen out the pmmr population (below the lower threshold), dmmr population (above the upper threshold) and the uncertain part of the population (between the thresholds). if the predictive score is above the lower threshold, the patient is advised to undergo further immunohistochemical or genetic testing to confirm mmr status or dmmr type

Eligibility criteria:
inclusion criteria: * patients diagnosed with endometrial cancer after surgery and who had completed pelvic mri before surgery from 2017 to 2022 exclusion criteria: * (1) there was no immunohistochemical detection result of mmr-related protein; (2) radiotherapy and chemotherapy before mri; (3) small tumors that are difficult to identify on the image (\<5mm) ; (4) the t2-weighted imaging quality is insufficient to plot roi, such as obvious motion artifacts; (5) there are other gynecological malignancies

Keywords: deep learning, mmr, mri
determination of prostate-specific antigen in capillary blood (psa-cap)

Conditions: Prostate Cancer

Summary: the aim of the psa-cap study is to test the comparability of measurements of total psa in serum from venipuncture and in serum from capillary blood using anonymized diagnostic blood samples from patients. furthermore, a stability test of the samples is carried out after storage at room temperature for 24, 72/96 and 168 hours. particular attention is paid to the comparability of the measurement results and the influence of the transportation time.

interventions that are conducted with the psa-cap trial are the collection of capillary blood (6 droplets) from the fingertip during regular psa testing in venous blood. psa is measured in the serum fraction of both samples (capillary and venous) using the established routine procedure, either immediately or after simulation of common transport conditions (intermediate storage for 24; 72/96 h and 168 h at 22 °c). control measurements include parameters of cell lysis (ldh, hil check) and general protein stability (albumin). the patient samples used are anonymized at the source by means of a consecutive series of numbers. the anonymized result groups are compared.

Eligibility criteria:
inclusion criteria: * men aged from 45 to 70 years * informed consent for psa measurement for prostate cancer screening exclusion criteria: * patients unable to give consent

Keywords: prostate cancer prostate specific antigen
n-acetylcysteine vs placebo as adjunctive treatment in pediatric leukemia

Conditions: Lymphoblastic Leukemia, Acute, Childhood

Summary: the goal of this clinical trial is to analyze the effect of n-acetylcysteine administration towards blood oxidant level, transaminase enzyme, and bilirubin level in all children who undergo induction phase of chemotherapy. the main question it aims to answer is whether n-acetylcysteine can decrease oxidative stress level and reduce hepatotoxicity complication. participants will be evaluated for mda level, transaminase enzymes and bilirubin level before, during, and after the chemotherapy. participants will be given capsules containing 600mg of n-acetylcysteine as adjunctive treatment during the 6 weeks induction phase of chemotherapy. researchers will compare the lab results to the placebo group to see if there is any significant difference in the results.

the current study has been designed as a randomized single-blind placebo-controlled clinical trial. sample size calculation for the study was 18 newly diagnosed all children in each group using the numerical unpaired two groups data analysis formula. subjects were recruited from newly diagnosed children with all and will start the induction phase of chemotherapy both in hospital ward and outpatient clinic in the child health department at cipto mangunkusumo hospital from august to december 2020. subjects' parents received an explanation about the study, including the objective and benefits of the study, and also the procedure which will be held. parents were then asked about the willingness to join the study and signed the form. subjects were randomized consecutively and distributed into two groups. randomization was done by a third person to decide the distribution of the subjects based on the serial number of randomization. subjects in treatment group will be given capsules containing 600 mg of nac and subjects in the control group will be given capsules containing placebo (lactose) as the adjunctive treatment during the 6 week induction phase of chemotherapy. both of the medicines were prepared by the installation of pharmacy in cipto mangunkusumo national hospital with the same type and same color of capsules. nac will be administered during the induction phase of chemotherapy starting in the first week until 6 weeks. this study will analyze change of mda levels, transaminase enzyme levels, and bilirubin levels before and after the 6th week of the induction phase of chemotherapy.

Eligibility criteria:
inclusion criteria: * newly diagnosed all-standard risk children who will undergo the induction phase of chemotherapy from 1st week until 6th week * parents agreed to participate in the study and signed the informed consent exclusion criteria: * subjects with allergy or contraindicated to consuming n-acetylcysteine * subjects with liver dysfunction based on clinical and laboratory tests diagnosed before joining the study * subjects who already consume other antioxidants (vitamin a, vitamin c, and vitamin e).

Keywords: malondialdehyde n-acetylcysteine oxidative stress
metaverse-based healthy life program for youth

Conditions: Health Risk Behaviors; Healthy Lifestyle; Non Communicable Diseases; Health-Related Behavior; Healthy Eating Index; Healthy Nutrition; Physical Inactivity; Stress, Emotional

Summary: this study was planned within the scope of the call titled "non-communicable diseases risk reduction in adolescence and youth (global alliance for chronic diseases - gacd)" with identity number horizon-hlth-2022-disease-07-03. the purpose of this project; is to determine the effect of the metaverse-based healthy life program to be developed in the project to support youths in decreasing future risks of developing non-communicable diseases (ncds) and in gaining healthy lifestyle behaviors (hlbs).

the project consists of three phases. phase 1 testing the content, quality, reliability, and usability of the "metaverse-based healthy life program for youth" to be developed within the scope of the project phase 2 identifying youth at high risk of chronic non-communicable diseases in the research population phase 3 evaluating the effect of "metaverse-based healthy life program for youth" implementation on inculcating healthy lifestyle behaviors in youth

Eligibility criteria:
inclusion criteria: * being a university student in the project partner countries and not older than 24, * having a score of 130 or lower on the hlbs ii in the first stage of the research, * determining that bmi ≥ 25-34.99 kg/m2 in the first stage of the research and * using a smartwatch during the research, * accepting to participate in the research voluntarily exclusion criteria: * having chronic diseases (asthma, diabetes, heart, kidney failure, hypertension, cancer, etc.) * those who have a drug that they use constantly * having a psychiatric diagnosis (depression, anxiety, bipolar disorder, schizophrenia, etc.) * having a disease that prevents the use of metaverse (vertigo, vision, hearing, etc.)
usefulness of the evaluation of the rosc with carotid ultrasound during cpr

Conditions: Cardiopulmonary Arrest

Summary: the current cardiopulmonary resuscitation(cpr) guidelines recommend that the heart rhythm be checked every two minutes during cpr for cardiac arrest patients. also it is very important to stop compressing the chest in less than 10 seconds when checking heart rhythm and pulse. however, manual palpation, which is used as a standard for return of spontaneous circulation(rosc), has been reported that the accuracy is not high in several studies. it is quite often necessary to perform pulse palpation for longer than the 10 second recommended by the guidelines to make a judgment. recently, a case study was published in which the presence of spontaneous circulation was confirmed by evaluating the carotid artery compressibility and pulsatility with an ultrasound probe when checking the rhythm of cardiac arrest patients. however, there has been no clinical study on actual cardiac arrest patients.

the current cardiopulmonary resuscitation(cpr) guidelines recommend that the heart rhythm be checked every two minutes during cpr for cardiac arrest patients. also it is very important to stop compressing the chest in less than 10 seconds when checking heart rhythm and pulse. however, manual palpation, which is used as a standard for return of spontaneous circulation(rosc), has been reported that the accuracy is not high in several studies. it is quite often necessary to perform pulse palpation for longer than the 10 second recommended by the guidelines to make a judgment. ultrasound is a key technique that guides to discern and treat causes of cardiac arrest patients. recently, a case study was published in which the presence of spontaneous circulation was confirmed by evaluating the carotid artery compressibility and pulsatility with an ultrasound probe when checking the rhythm of cardiac arrest patients. however, this is just a case study. there has been no clinical study on actual cardiac arrest patients whether it is possible to accurately determine the rosc by evaluating the carotid artery compressibility and pulsatility by ultrasound. also there has been no clinical studies on actual cardiac arrest patients comparing the time taken to evaluate the rosc of carotid ultrasound and manual palpation.

Eligibility criteria:
inclusion criteria: * patients who underwent cpr among cardiac arrest patients 18 years of age or older who visit the emergency room * patients who applied carotid ultrasound to determine the presence of carotid artery compression and pulse exclusion criteria: * patients who have stated their intention to do not resuscitation for future treatment (including cardiopulmonary resuscitation) * patients who have difficulty applying carotid ultrasound due to head and neck trauma * patients who have difficulty applying carotid ultrasound due to deformed neck structure by surgery or head and neck cancer * return of spontaneous circulation before ultrasound application * patients who could not evaluate carotid artery compressibility and pulsatility by ultrasound
a phase 3 lot to lot consistency study of live oral cholera vaccine, pxvx0200 in healthy adults

Conditions: Cholera

Summary: the primary goal of this phase iii study is to compare 3 lots for consistency of manufacture.

the primary goal of this phase iii study is to compare three lots for consistency of manufacture.

Eligibility criteria:
inclusion criteria: * healthy men or women, * age 18 to 45 years inclusive; * normal medical history and physical examination * women must have a negative pregnancy test. exclusion criteria: * travel to a cholera endemic area in the previous 5 years; * abnormal stool pattern or regular use of laxatives; * currently active unstable or undiagnosed medical conditions * current or recent antibiotic use; * pregnancy or nursing; * previously received a licensed or investigational cholera vaccine * history of cholera or enterotoxigenic e. coli infection * history of guillain-barré syndrome * received or plans to receive any other licensed vaccines, except for seasonal influenza * recipient of bone marrow or solid organ transplant * malignancy (excluding non-melanotic skin cancers) or lymphoproliferative disorders diagnosed or treated during the past 5 years * use of systemic chemotherapy in the previous 5 years prior to the study * any immunosuppressive medical condition
feasibility study of intraperitoneal bevacizumab for palliation of intractable malignant ascites

Conditions: Malignant Ascites

Summary: this study will evaluate the safety and efficacy of intraperitoneal administration of bevacizumab to prevent the recurrence of malignant ascites. ten patients will receive intraperitoneal bevacizumab 200 mg in 250 ml of normal saline for infusion every two weeks for up to six weeks, or a maximum of three treatments.

this protocol describes a pilot study to assess whether intraperitoneal bevacizumab infusion is safe and improves the time to repeat paracentesis. in patients with non-draining malignant peritoneal effusion, published data suggests that the average time to repeat paracentesis in malignant ascites is 10-13 days. the investigators' treatment will be considered potentially efficacious if the median time to repeat paracentesis is greater than 14 days.

Eligibility criteria:
inclusion criteria: * patients will be included in the case of: * eastern cooperative oncology group performance status (ecog ps) ≤ 2 * participants must be 18 years of age or older * have ascites of malignant disease * have symptoms related to ascites * ascites index above 0.05 (ai ˃ 0.05) * be an english speaking patient or have an interpreter available * be able to understand and comply with all study requirements and the implications of off-label use of intraperitoneal bevacizumab * have had at least two paracentesis within the last 4 weeks exclusion criteria: * patients will be excluded in the case of: * ascites due to non-malignant cause * concurrent treatment with systemic chemotherapy that has a realistic chance of controlling the ascites * concurrent treatment with intraperitoneal bevacizumab * life expectancy of less than 2 weeks * a history of bowel perforation or fistula * symptoms or signs suggestive of bacterial peritonitis * child's c cirrhosis * uncontrolled hypertension * surgery within 28 days of catheter treatment * evidence of coagulopathy * symptoms suggestive of bowel obstruction * major surgery, open biopsy or significant traumatic injury within seven (7) days of first study drug--including neurosurgery. * inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements. * concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements * patients who are pregnant or lactating (females of childbearing potential must have a negative pregnancy test prior to participation) * patients with pre-existing 3 + or greater urine dipstick reading proteinuria

Keywords: necessary paracentesis for symptom control