Kornimate/medical-research-clean huggingface dataset:
a study of ro5503781 as a single agent or in combination with cytarabine in participants with acute myelogenous leukemia

Conditions: Myelogenous Leukemia, Acute

Summary: this phase 1/1b, open-label study will evaluate the safety and pharmacokinetics of escalating doses of ro5503781 as a single agent or in combination with cytarabine in participants with acute myelogenous leukemia. in part 1, ro5503781 will be administered in escalating doses as a single agent, and in part 2, ro5503781 will be administered in combination with cytarabine. an optional part 3 in which ro5503781 will be administered with cytarabine and anthracycline may be considered . in part 4, the safety and pharmacokinetic profile of an optimized formulation of ro5503781 in combination with cytarabine will be assessed.


Eligibility criteria:
inclusion criteria: * documented/confirmed acute myelogenous leukemia (aml), except for acute promyelocytic leukemia * eastern cooperative oncology group (ecog) performance status 0 to 2 in part 1 and part 2, participants enrolled in the extension/tail portion, part 3 and part 4 must have an ecog performance status of 0 or 1 * all non-hematological adverse events of any prior chemotherapy, surgery or radiotherapy must have resolved to national cancer institute-common terminology criteria for adverse events (nci-ctcae) grade less than or equal to (\</=) 2 prior to starting therapy * adequate hepatic and renal function * willing to submit the blood sampling and bone marrow sampling required by protocol additional inclusion criteria for parts 1-4 may apply. exclusion criteria: * participants receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy within 14 days of first receipt of study drug, with the exception of hydroxyurea as defined in protocol * history of allergic or toxic reactions attributed to cytarabine (part 2) or history of allergic reactions to components of the formulated product * current evidence of central nervous system (cns) leukemia * participants with severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study * participants with evidence of electrolyte imbalance greater than or equal to (\>/=) grade 2 which cannot be corrected prior to study initiation * pregnant or breastfeeding women * human immunodeficiency virus (hiv) - positive participants receiving anti-retroviral therapy * participants who refuse to potentially receive blood products and/or have a hypersensitivity to blood products additional exclusion criteria for parts 1-4 may apply.
strategy for maintenance of hiv suppression with once daily integrate inhibitor+darunavir/ritonavir in children

Conditions: HIV Infection

Summary: a two-arm, phase 2/3 multicentre, open-label, randomised study evaluating safety and antiviral effect of current standard antiretroviral therapy compared to once daily integrase inhibitor administered with darunavir/ritonavir (drv/r) in hiv-1 infected, virologically suppressed paediatric participants.

a two arm parallel group, non-inferiority, open-label, multi-centre, randomised controlled trial.

Eligibility criteria:
inclusion criteria: 1. hiv-1 infected children aged ≥ 12 years old and weighing ≥40kg\* at the screening visit 2. aged 12 to \< 18 years old\*\* 3. parents or guardians, and children where appropriate, willing and able to give informed consent and to adhere to the protocol 4. children must have all hiv-1 rna viral loads \<50c/ml for at least 12 months with a minimum of two separate results before screening. 5. children on a 3-drug pi/r or nnrti containing regimen for at least 24 weeks 6. children/parents/guardians prepared to switch if randomised to once daily integrase inhibitor + drv/rtv arm 7. children and parents prepared to restart the current art regimen after simplification if viral load restart criteria are met (see section 5.5) 8. be affiliated or beneficiary to health social security scheme (in countries where this is mandatory) * initially enrolment will be of participants ≥ 12 years old and ≥40kg only. dtg 50 mg will be supplied by viiv healthcare. * as more data become available on younger children, a protocol amendment is planned to include younger children and/or lower weight bands. exclusion criteria: 1. receiving or requiring agents with interactions with drv, rtv, or any once daily integrase inhibitor (appendix 14) 2. evidence of resistance to drv or integrase inhibitors (for participants in clinical sites where resistance testing is standard of care) 3. previous exposure to integrase inhibitors for more than 2 weeks 4. intercurrent illness (randomisation can take place after the illness resolves) 5. creatinine ≥ 1.8uln or alt ≥ 5uln or alt ≥ 3uln and bilirubin ≥2uln at screening. 6. patients with severe hepatic impairment or unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of gilbert's syndrome or asymptomatic gallstones) 7. diagnosis of tuberculosis and on anti-tuberculosis treatment (children can be enrolled after successful tuberculosis treatment) 8. hepatitis b or hepatitis c co-infection 9. pregnancy or risk of pregnancy in girls of child-bearing potential unless committed to taking effective contraception 10. history or presence of known allergy or some other contraindication to the study drugs or their components as described in the smpc
to determine how different doses of tadalafil work on getting and keeping an erection 26 or 36 hours after taking

Conditions: Impotence

Summary: study to see how effective different doses of tadalafil are for getting and keeping an erection when sex is attempted after a certain number of hours.


Eligibility criteria:
inclusion criteria: * at least 3 months history of erectile dysfunction (ed) * anticipate a monogamous relationship with a female sexual partner * be able to make minimum required sexual intercourse attempts * abstain from using any other ed treatment exclusion criteria: * history of other primary sexual disorder * treatment with nitrates * have a penile implant or clinically significant penile deformity * history of certain heart problems * do not meet certain lab value reference ranges
health surveillance at constructor university bremen (cub) 2025

Conditions: Social Isolation or Loneliness; Anxiety; Anxiety Depression (Mild or Not Persistent); Health Behavior; Observational Study

Summary: the aim of health surveillance 2025 is to analyze and describe the state of health of students at constructor university, key influencing factors and individual resources.

the aim of health surveillance 2025 is to analyze and describe the state of health of students at constructor university (cu), key influencing factors and individual resources. in areas where there is a need for action, the health surveillance can provide detailed insights and/or in-depth analyses. the health surveillance thus provides information on health-related topics and delivers scientifically sound information as a basis for health-promoting discussions in the subsequent follow-up process at various levels (e.g. faculties and departments). in addition, the health surveillance 2025 at cu contributes to comparability with surveys at other german universities through the use of validated and standardized measuring instruments. main hypotheses are 1. the health surveillance 2025 gives insights into state of health of students at cu, key influencing factors and individual resources. 2. with the health surveillance 2025 the health-promotion at cu can be guided and promotion of mental health (including the reduction of loneliness and discrimination) can be strengthened. 3. the health of students, their perceived loneliness and discrimination/minorization (disadvantage) interrelates with participation in health promoting activities? 4. recommendations can be derived for qualification and skills training of multipliers for health-promoting behavior (e.g., j-peers)?

Eligibility criteria:
inclusion criteria: * english language skills * reading and writing skills * internet access * student status * consent to participate in the study exclusion criteria: * illiteracy * massively limited cognitive abilities i.e. linguistic components of the digital offerings must be able to be used, and questionnaires completed, or interviews participated in)

Keywords: healthy students health literacy disability age gender study characteristics phq-4 self-efficacy satisfaction with life scale (swls) subjective health status student satisfaction ucla-ls hei-stress
follow-up after surgical treatment of peri-implantitis

Conditions: Peri-Implantitis

Summary: the objective of this prospective clinical study was to evaluate the 3-year outcomes of anti-infective surgical treatment of peri-implantitis when a regular supportive peri-implant therapy (spit) programme was followed.

the patients enrolled in this prospective study all received surgical treatment for peri-implantitis at one of 2 treatment centres (specialist periodontal practice, molndal and gothenburg, public dental health services, region vastra gotaland, sweden) and were enrolled between october 2010 and december 2013.). all were treated by experienced periodontists. details of the peri-implantitis treatment protocol have been described in a previous publication reporting on the 12-month clinical and radiographic treatment outcomes, registered at clinicaltrials.gov (nct01857804) and approved by the regional ethical committee, gothenburg, sweden (dnr. 654-10).

Eligibility criteria:
inclusion criteria: * all patients who received surgical treatment for peri-implantitis for 3 years ago exclusion criteria: -

Keywords: peri-implantitis surgical therapy follow-up supportive peri-implant therapy
effects of low protein diet supplemented keto-/amino acid in preventing the progression of chronic kidney disease (ckd)- elpd study

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to determine whether low protein diet and very low protein diet supplemented keto-/amino acid is effective in preventing the progression of chronic kidney disease (ckd , stage 3b and 4).

dietary protein restriction represents a basic therapeutic approach in chronic kidney disease(ckd), by reducing the accumulation of nitrogen catabolic substances, and by delaying the progress of ckd and proteinuria, but the effects of the different degree's protein diet on the renal progression remain to be determined. the aim of this study is to evaluate the efficacy of low protein diet and α-keto acid tablet in retard the progress of ckd. this is a randomized, open-label, prospective study, 120 patients who meet inclusion and exclusion criteria will be randomized into three groups at the ratio of 1:1:1. group i patients will receive low protein diet(0.6g/kg bw), group ii will receive low protein diet supplemented with α-keto acid, while group iii will take very low protein diet(0.3g/kg bw) supplemented with α-keto acid. the changes of glomerular filtration rate in ckd will be evaluated after 1 year treatment.

Eligibility criteria:
inclusion criteria: * patients with chronic kidney disease in stage 3b and 4(15ml/min/1.73m2\<gfr\<45 ml/min/1.73m2, estimated by epi formula) receiving conservative treatment for ckd exclusion criteria: * with diagnosis of diabetic mellitus; * incapable of following study requirements to control diet; * glomerular filtration rate \< 15 ml/min/1.73m2; * hypercalcemia or hyperkalemia (\> normal upper limit); * other serious disease(eg.heart,lung,brain) within the last 3 months; * cardiac failure stage iv nyha; * with cirrhosis of liver or obvious symptoms of liver diseases, alt or ast two times normal upper limit; * severe edema or serous cavity effusion; * drug abuse; * final diagnosis of malignant tumor; * receiving the long-term systematic steroid hormone or immunosuppressive agents(eg. cyclophosphamidum,cyclosporine, prograf,azathioprine) treatment; * gestation already, prepares to be pregnant in the period of the trial, lactating women; * participate in other product clinical trial within 30 days prior to this trial
a double-blind, randomized, placebo-controlled, multicenter study to assess the efficacy and safety of orally administered sp-303 for the treatment of diarrhea in acquired immunodeficiency syndrome (aids) patients

Conditions: Diarrhea; HIV Infections

Summary: to evaluate the efficacy, safety, and durability of response of sp-303 in decreasing stool weight in aids patients with diarrhea over 6 days of treatment.


Eligibility criteria:
inclusion criteria patients must have: * hiv infection meeting cdc criteria for aids. * history of diarrhea for greater than or equal to 14 days prior to screening period (day 1). required: - on stable medical regimen.

Keywords: diarrhea acquired immunodeficiency syndrome
effectiveness and security testing of a mobile app

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: to assess the effectiveness and security of a mobile app (beta version) for self-managing emotion dysregulation in a pragmatic randomized controlled trial with 80 adolescents with attention-deficit/hyperactivity disorder comparing 40 patients with treatment as usual (tau) with 40 patients with tau plus the mobile app


Eligibility criteria:
inclusion criteria: * dsm-5 (diagnostic and statistical manual of mental disorders, fifth edition) of attention-deficit/hyperactivity disorder * high emotion dysregulation severity * aged 14 to 17 years * outpatient setting (consorci sanitari del maresme exclusion criteria: * comorbidity with mental retardation * comorbidity with psychotic disorder * comorbidity with autism spectrum disorder
effectiveness of spa treatment, outpatient physiotherapy and no physiotherapy in spine osteoarthritis

Conditions: Spine Osteoarthritis; Spa Resorts

Summary: in the first study group will participate patients with spine osteoarthritis who will be treated in polish spas in subcarpathian region. complex physiotherapy including balneotherapy will be applied in study group participants. in the second study group will participate patients with spine osteoarthritis who will be treated in outpatient treatment. complex physiotherapy without balneotherapy will be applied in second study group participants. in the control group will participate patients with spine osteoarthritis who will not have applied physiotherapy nor balneotherapy during observation. in all patients will be evaluated quality of life, level of pain intensity and health assessment.

the following questionnaires will be used: original socio-demographic data questionnaire, the vas (visual analogue scale) pain severity rating scale, the modified laitinen pain questionnaire, the life satisfaction questionnaire lisat-9 and the haq: health assesment questionnaire. questionnaires will be completed: before the beginning of therapy, one month and six months after the end of therapy. questionnaires in control group will be completed: in the beginning of observation and in the same time intervals as in study groups.

Eligibility criteria:
inclusion criteria: * spine osteoarthritis exclusion criteria: * no consent to participate in the study

Keywords: balneotherapy health resorts quality of life
long-term safety and efficacy evaluation of lunsekimig in adult participants with chronic rhinosinusitis with nasal polyps (crswnp) who completed a previous lunsekimig crswnp study

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Summary: this is a single-arm extension study to investigate the long-term safety, tolerability, and efficacy of lunsekimig in adult participants with inadequately controlled crswnp who have completed a previous lunsekimig crswnp clinical study (also referred to as the parent study act18207). the study duration will be up to approximately 56 weeks per participant, 52 weeks of treatment period, and 4 weeks of follow-up.


Eligibility criteria:
inclusion criteria: * participants who have completed the treatment period and the follow up period in crswnp lunsekimig parent study, including eos visit, as per protocol. * participants receiving therapy with intranasal mometasone furoate nasal spray (mfns). * participants who are able and willing to participate in this extension study, and to comply with requested study visits and procedures. exclusion criteria: participants are excluded from the study if any of the following criteria apply: * prior hypersensitivity reaction to lunsekimig or to any of the excipients used in the presentation or in preparation for administration of lunsekimig, or other allergy that, in the opinion of the investigator, contraindicates participation in the study. * concurrent participation in any clinical study other than the parent study, including non-interventional studies. * participants who, during their participation in the parent study, developed an adverse event (ae) or a serious adverse event (sae) deemed related to lunsekimig, which in the opinion of the investigator could indicate that continued treatment with lunsekimig may present an unreasonable risk for the participant note: the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
influence of inhaler compliance on the treatment of asthma patients

Conditions: Pulmonary Disease; Asthma

Summary: the major goal of "influence of inhaler compliance on the treatment of asthma patients" is to explore compliance rate outcome in adult asthmatic patients (20-80 years old) with mild to moderate persistent asthma according to american thoracic society (ats) definition and diagnosis. the major endpoints include: 1. to increase the adherence rate of treatment by reminder intervention with correctly monitor patients' adherence rate by asthma supportive kits 2. eventually achieve best asthma care and management. all participants will use asthma supportive kits for 24 weeks and return visit on week 5, 12, 24. based on collected data, the study compares intervention and control group to see if active reminder intervention may effectively alter compliance rate, and corresponding outcomes, e.g., asthma control status, acute exacerbation events.

1. upon enrollment, the all patients will be educated and equipped with asthma supportive kits, which is a electronic device attaches to an mdi medicine. 2. the asthma supportive kit registers every puff taken when the patient uses his/her mdi. the records are monitored by study nurses and calculated compliance ratio on rolling basis. 3. by enrollment, the patient is randomly assigned to intervention and control group. for the intervention group in each study phases, when the given compliance ratio drops below 80% (as monitored by asthma supportive kit), the study nurse will actively engage to remind on medicine taking. for the control group, the compliance ratio is calculated but to active engagement is applied. 4. all the patients adheres with regular asthma treatment mechanism, regardless to group assigned.

Eligibility criteria:
inclusion criteria: 1. adult asthmatic patients (20-80 years old) 2. with mild to moderate persistent asthma according to ats definition and diagnosis 3. willing to use budesonide+formoterol. 4. adequately use inhaler 5. without evident intentional non-adherence 6. agree asthma is a common and potentially serious chronic disease 7. willing to sign informed consent form exclusion criteria: 1. inadequately use inhaler 2. disagree asthma is a common and potentially serious chronic disease 3. with uncontrolled systemic diseases, such as hypertension, heart failure, renal failure, de-compensated liver cirrhosis, etc.;
treatment prioritisation and cost-effectiveness analysis for hbv cure - real-world evidence from a territory-wide cohort

Conditions: Chronic Hepatitis B

Summary: a number of hepatitis b virus (hbv) cure regimens including antisense oligonucleotide (aso) and small interfering rna (sirna) are under vigorous clinical development and the efficacy and safety will soon be available for regulatory approval. patients most in need should be prioritised to receive hbv cure regimen to maximise its clinical benefits and speed up hepatitis elimination.

a territory-wide cohort study of all patients with chronic hepatitis b who have achieved functional cure of hbv. real-world data will be used to estimate the risk of hcc, hepatic decompensation, and liver-related death for the subsequent simulation of hcc risk in particular populations of patients who achieved hbv cure. literature search also be performed in parallel to cross-validate the estimates in untreated patients, and treated patients with incomplete or complete viral suppression with different stages of fibrosis based on existing literature. an optional systematic review and meta-analysis may be performed the address these issues.

Eligibility criteria:
inclusion criteria: 1. patients with chronic hepatitis b, i.e. hepatitis b surface antigen (hbsag) or hbv dna positive for two times at least 6 months apart, and 2. patients achieved hbv cure, i.e. hbsag turned negative 3. aged 18 years old or above. exclusion criteria: 1. patients with missing age and gender 2. serious medical illnesses or malignancy with life expectancy \&lt;1 year 3. age \&lt; 18 years

Keywords: cost-effectiveness analysis hbv cure
effects of antenatal exercises in primagravida

Conditions: Pregnancy Related

Summary: the goal of this randomized control trial is to determine the effects of antenatal exercises on low back pain in primagravida. the main questions it aims to answer are whether supervised antenatal exercises have an effect on low back pain and depression in primagravida.

females usually tend to avoid physical activity during pregnancy. concept of antenatal exercises and its effects on low back pain or antenatal depression is yet not common amongst pregnant females in pakistan. low back pain and antenatal depression are common in pregnancy. these can have an impact on both their own health and the health of their unborn child. understanding the benefits of antenatal exercises will encourage pregnant females to engage in regular physical activity. the results of this study will help physical therapists to implement effective exercise interventions for this population.

Eligibility criteria:
inclusion criteria: * primagravida * single pregnancy * diagnosed for risk of prenatal depression on edps \>10 * pregnancy related low back pain score of 3 to 8 on nprs for at least 2 weeks. * females in 2nd trimester of pregnancy exclusion criteria: * any present or previous pelvic floor dysfunctions diagnosed by health professionals. * any physical disability causing inability to perform physical exercises. * any contraindications to physical activity according to acog * pelvic girdle pain (anterior: pubic symphysis, posterior: si joint pain, gluteal pain, piriformis syndrome). * rheumatoid disorders. * low back pain with radiation * not engaged in regular exercise.

Keywords: pregnancy related antenatal depression low back pain
pain assessment in the perioperative area

Conditions: Pain, Procedural

Summary: this study is mainly focusing on reducing the pain scores during iv cannulation in pediatric population in the preoperative period. applying emla cream is a well-known fact world wide. we would like to study the effect of ultrasound waves in the penetration of the given drung into the skin so that we could achieve the effect of the drug quickly.

to assess the intensity of pain in children in the perioperative area during iv cannulation using a combination of emla cream and low-frequency usg probe. to assess the intensity of pain in children in the perioperative area during iv cannulation using a combination of emla cream and high-frequency usg probe and final comparison between these groups will assess the effect of ultrasound in the penetration of the drug into the skin.

Eligibility criteria:
inclusion criteria: * all children in the preoperative period. exclusion criteria: