Kornimate/medical-research-clean huggingface dataset:
controlled ventilation ct in cf infants

Conditions: Cystic Fibrosis

Summary: the objective of the study is to implement a new method of performing chest ct imaging in young children with cystic fibrosis at packard children's hospital. this technique will be used to evaluate early lung disease comparing quantitative chest ct air trapping and airway measurements with lung function measurements in infants, toddlers, and young children with chronic lung disease.


Eligibility criteria:
inclusion criteria: 1. infants and young children (age \~ 2/3 months to \< 5 years) 2. diagnosed with cystic fibrosis with either 2 identified cftr gene mutations, or a positive sweat chloride 3. informed consent by parent or legal guardian. 4. ability to comply with study visit procedures as judged by the investigator. exclusion criteria: 1. acute wheezing and/or respiratory distress at either study visit. 2. acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset in 1 week preceding study visit. 3. oxygen saturation \< 90% on room air at study visit. 4. any medical condition that in the opinion of the investigator precludes subject participation.
effect of vitamin c in autologous stem cell transplantations

Conditions: Myeloma Multiple; Lymphoma

Summary: in the study the investigators will randomize patients that receive an autologous stem cell transplantation for myeloma or lymphoma for treatment with vitamin c or placebo during 6 weeks. primary endpoint will be immune recovery.

rationale: recent studies showed that ascorbic acid (aa) stimulates proliferation and maturation of t lymphocytes and natural killer (nk) cells. chemotherapy results in depletion of those cells and thereby an increased infection rate. a pilot study showed low levels of aa in the plasma of several patients after chemotherapy followed by autologous stem cell transplantation for hematological malignancies. aa supplementation could be beneficial to the recovery of the immune system in these patients. objective: the aim of this study is to examine the effect of vitamin c supplementation on immune recovery in patients with autologous stem cell transplantation. the aim of the run-in phase of the study is to examine the effect of intravenous vitamin c supplementation on plasma concentrations of vitamin c in patients with autologous stem cell transplantation at day 14 in order to be sure that in the intervention study accurate aa plasma levels will be present. study design: run-in phase, followed by randomized controlled trial study population: all participants will be adults (minimally 18 years old) that are planed to receive an autologous stem cell transplantation for multiple myeloma or lymphoma and are recruited at the mumc+. in total there will be 3 expected (run-in phase) + 44 (randomized controlled trial) participants. main study parameters/endpoints: primary endpoints will be aa plasma level on day 14 (run-in phase) and the day of neutrophil recovery after stem cell transplantation (randomized-controlled phase). secondary endpoints will be aa leukocyte levels, infection rate, duration of hospital stay, side effects of chemotherapy, overall survival, coagulation parameters, platelet reactivity, fibrinolysis and quality of life. nature and extent of the burden and risks associated with participation, benefit and group relatedness: aa supplementation could be beneficial for the immune recovery in the participants of this study. the risks associated with participation in this study are low. vitamin c supplementation is safe and hardly has any documented side effects.

Eligibility criteria:
inclusion criteria: * 18 years or older * written informed consent * diagnosis of malignant lymphoma or multiple myeloma * require chemotherapy plus autologous stem cell transplantation as standard of care for the disease at that stage * central venous catheter in place or planned exclusion criteria: * inability to understand the nature and extent of the trial and the procedures required * history of kidney stones * kidney failure requiring dialysis or egfr \<30 ml/min. (cdk-epi formula) * history of g6pd deficiency * life expectancy \< 1 month * use of immunosuppressive medication other than chemotherapy and corticosteroids

Keywords: vitamin c ascorbate ascorbic acid autologous stem cell transplantation
risankizumab in children with crohn's disease (risakids)

Conditions: Crohn Disease

Summary: the goal of this observational study is to to prospectively explore the real life short (12 weeks) and longer term (54 weeks) clinical, biochemical and endoscopic outcomes of risankizumab in pediatric cd. this is a 1-year prospective multi-center cohort study of children commencing on risankizumab for pediatric cd with 2 years extension for long-term follow-up. the investigators will record clinical manifestations, blood markers and fecal calprotectin, with monitoring for safety signals including infusion and injection site reactions, pyrexia and infections at various intervals as outlined below. the investigators will also include calprotectin monitoring and fecal sample collection for microbiome and serum samples for drug levels. according to available budget, the investigators will also collect fecal and serum samples for metabolome. samples collection is optional, thus failure of bio-samples collection will not exclude patients from the study.


Eligibility criteria:
inclusion criteria: * children under the age of 18 years, * patients diagnosed with cd. * patients commenced on risankizumab by treating physician (at least one dose), either alone or in combination with any other cd medications, at any stage of the disease. exclusion criteria: \* there will be no exclusion criteria to this study.
nutritional markers in normal and hyperemesis pregnancies

Conditions: Hyperemesis Gravidarum; Pregnancy

Summary: this study evaluate the rate of nausea and nutritional status in patients with hyperemesis gravidarum (severe nausea and vomiting in pregnancy) and healthy pregnant women using a questionnaire (puqe-score), self-reported food/drink intake form and blood test. the investigators aim for developing normal range of prealbumin measurements (reference values) during first trimester of pregnancy.

women affected with hyperemesis gravidarum are at severe nutritional risk. reference values for biochemical parameters evaluating nutritional status during early pregnancy needs to be determined. the investigators will compare clinical nutritional parameters (weight gain/weight loss) with rate of nausea (puqe-questionnaire), self-reported nutritional intake form and biochemical measurements (prealbumin) in women admitted to hospital with hyperemesis gravidarum and healthy pregnant women. for hyperemesis patients measurements will be repeated at discharge.

Eligibility criteria:
inclusion criteria: * pregnant women \< 16 weeks of gestation * admitted to hospital for hyperemesis gravidarum (hg group) with nausea and vomiting in pregnancy with at least two of following criteria; weight loss, dehydration, fluid-/electrolyte disturbances, ketonuria exclusion criteria: * non-viable pregnancy diagnosed at time of inclusion * unable to understand norwegian * puqe-score \>= 13 (control group) * nausea an vomiting in pregnancy caused by other conditions than hyperemesis gravidarum

Keywords: nutrition hyperemesis gravidarum prealbumin questionnaire
impact of mortality salience on treatment decisions

Conditions: Urological Cancer

Summary: the goal of this clinical trial is to learn if mortality salience has an impact on treatment decisions in urologists and patients with urological cancer. the main questions it aims to answer are: does mortality salience lead to more aggressive treatment decisions in a) urologists and b) patients with urological cancer? which factors predict more aggressive treatment decisions a) in urologists and b) in patients with urological cancer? is the fear of cancer recurrence-1 (fcr-1) in german language a valid screening tool for fear of cancer progression in patients with urological cancer? researchers will compare a mortality salience trigger to control questions to see if mortality salience leads to more aggressive treatment decisions. participants will: answer the mortality attitudes personality survey (maps) to trigger mortality salience and, in three borderline case vignettes, provide information on how likely they would be to choose a more aggressive therapy.

background: harmful overtreatment is a major problem in oncology. unconscious fear of death (mortality salience) could increase the likelihood of a physician or patient decision in favor of aggressive therapy and thus contribute to overtreatment. methods: conduction of two randomized controlled trials: 1. online survey of n = 260 urological patients, 2. paper questionnaire survey of n = 260 urological cancer inpatients. intervention group: triggering of mortality salience with two open questions on death, control group: two open questions on dental treatment. the primary endpoint is the probability of opting for aggressive treatment in three questions on a treatment decision likert scale from 0 to 10). in both studies, the evaluation is carried out as a comparison of means using a two-sided t-test. secondary endpoints are further factors associated with a decision in favor of aggressive therapy. result: an increase in the probability of a decision in favor of the more aggressive therapy as a result of triggering mortality salience is expected with an effect size of d = .35. discussion: in order to avoid harmful overtreatment due to unconscious fear of death, doctors could undergo training to deal with their existential fears - this could take place as part of communication training. for cancer patients, this confrontation can take place as part of psycho-oncology training.

Eligibility criteria:
study 1) urologists inclusion criteria: * sufficient cognitive ability * german language skills exclusion criteria: * none study 2) patients inclusion criteria: * urological cancer (icd-10: c60, c61, c62, c63, c64, c65, c66, c67, c68) * age at least 18 years * german language skills * sufficient cognitive ability * capacity to consent exclusion criteria: * none

Keywords: urological cancer mortality salience fear of death psycho-oncology decision making death anxiety
irreversible electroporation(ire) for unresectable extremities neoplasms

Conditions: Extremities Neoplasms

Summary: the purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (ire) for unresectable extremities neoplasms.

by enrolling patients with unresectable extremites neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous ire for unresectable extremities neoplasms.

Eligibility criteria:
inclusion criteria: * extremities neoplasms diagnosed by positive biopsy or non-invasive criteria, * not suitable for surgical resection, * eastern cooperative oncology group (ecog) score of 0-1, * a prothrombin time ratio \> 50%, * platelet count \> 80x10\^9/l, * ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post nanoknife procedure, * able to comprehend and willing to sign the written informed consent form (icf), * have a life expectancy of at least 3 months. exclusion criteria: * cardiac insufficiency, ongoing coronary artery disease or arrhythmia, * any active implanted device (eg pacemaker), * women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, * have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the nanoknife™ ledc system, * are in the opinion of the investigator unable to comply with the visit schedule and protocol evaluations.

Keywords: irreversible electroporation unresectable extremities
validation of a questionnaire assessing quality of life in children with amblyopia and strabismus

Conditions: Amblyopia; Strabismus

Summary: the validation of a french questionnaire is very important to assess rigorously and objectively the impact of the treatments of strabismus and amblyopia on children quality of life.


Eligibility criteria:
inclusion criteria: * children with a status of strabismus or not strabismus made by a specialized ophthalmologist * children with a status of amblyopia or not amblyopia made by a specialized ophthalmologist * signed consent of parents exclusion criteria: * ocular pathology (except for isolated ametropia) * evolutive paralytic strabismus * antecedent of surgery for strabismus * strabismus surgery in the past 6 months * disease with possible impact on the child's answers, such as severe neurologic troubles) * poor knowledge of french language
a trial of shr3162 combined with apatinib mesylate tablets or shr3162 monotherapy in patients with metastatic castration resistant prostate cancer

Conditions: Metastatic Castration Resistant Prostate Cancer

Summary: main research purpose: to evaluate the effectiveness of fluzoparib combined with apatinib mesylate in the treatment of patients with metastatic castration-resistant prostate cancer.


Eligibility criteria:
inclusion criteria: 1. voluntary participation and written informed consent; 2. age ≥18 years old; 3. pathologically diagnosed metastatic castration-resistant prostate adenocarcinoma; 4. it is confirmed by the central laboratory based on tumor tissue or ctdna detection that it is accompanied by germline or system homologous recombination repair-related gene mutations (cohorts 4) or not accompanied by homologous recombination repair-related gene mutations (cohort 2); 5. eastern cooperative oncology group (ecog) performance status of 0-1; 6. has a life expectancy of ≥ 12 weeks. exclusion criteria: 1. past (within 5 years) or concurrently suffering from other malignant tumors, except for cured skin basal cell carcinoma; 2. subjects have used parp inhibitors in the past, including but not limited to olaparib, niraparib, and lukapanib; or have used apatinib in the past; or have received mitoxantrone and cyclophosphamide in the past treatment with amide or platinum-containing chemotherapeutics; 3. severe bone injury caused by tumor bone metastasis, pathological fractures or spinal cord compression in important parts that occurred within 6 months before being informed or is expected to occur in the near future; 4. the subject has cancerous meningitis, or untreated central nervous system metastasis; 5. those who cannot swallow pills normally, or have abnormal gastrointestinal function, which may affect drug absorption by the researcher; 6. subjects with congenital or acquired immune deficiencies (such as hiv infection), or active hepatitis (hepatitis b reference: hbsag positive and hbv dna ≥500 iu/ml; hepatitis c reference: hcv antibody positive and hcv virus copy number\> upper limit of normal ); 7. according to the judgment of the investigator, the subject has other factors that may cause the study to be terminated halfway, such as other serious diseases (including mental illness) that require combined treatment, severe laboratory abnormalities, family or society, etc. factors that will affect the safety of subjects or the collection of data and samples.
major pelvic hemorrhage in complex surgery

Conditions: Pelvic Bleeding

Summary: hemorrhage is a challenging complication of pelvic surgery. in this study, the investigators aimed to analyze the causes, management, and outcomes of major pelvic hemorrhage in patients undergoing complex abdomino-pelvic surgery. participants who had a major intraoperative pelvic hemorrhage during complex abdomino-pelvic surgery at 11 tertiary referral centers were included. participant characteristics, causes of hemorrhage, management strategies, and outcomes including morbidity and mortality analyses were evaluated.


Eligibility criteria:
inclusion criteria: * patients who had major pelvic bleeding during complex abdominopelvic surgery * patients operated in hospitals where over 225 colorectal cases were performed every year exclusion criteria: * patients operated for palliative intent
brief acceptance-based retention intervention for newly diagnosed hiv patients

Conditions: HIV/AIDS

Summary: the overall aim of this program of research is to test a newly developed intervention, acceptance-based behavior therapy (abbt), to improve hiv patients' commitment to medical care. the purpose of the proposed project is to establish the efficacy of abbt and examine its mechanisms of action. to achieve the specific aims, the investigators will conduct a randomized clinical trial (n = 270), with two treatment arms: abbt vs. an attention-matched hiv education control condition.

drop-out rates from medical clinics in the first months following linkage to hiv care are as high as 50%, with 31-46% of patients dropping out after the first visit. people living with hiv (plwh) who are not consistently retained in care are at risk for: delayed antiretroviral treatment (art) initiation, reduced art adherence, unsuppressed viremia, and mortality. moreover, poor retention means effective art cannot be leveraged to prevent further hiv transmission. the objective of this study is to conduct a fully powered, randomized controlled trial (rct) to assess the efficacy of a brief, 2-session acceptance-based behavioral therapy (abbt) intervention to enhance retention in hiv care. the aims of this proposal are: (1) to test, in a 2-arm rct, the efficacy of the abbt intervention on retention in care and virologic suppression (primary outcomes); and, art adherence, disclosure of hiv status, perceived social support, hiv stigmatization (secondary outcomes), relative to an enhanced-treatment-as-usual condition; and, (2) to examine the degree to which retention in hiv care and virologic suppression are mediated by (a) increased hiv acceptance (and decreased hiv experiential avoidance) and (b) increased willingness to disclose hiv status. the sample will consist of 270 hiv patients who are new to care.

Eligibility criteria:
inclusion criteria: 1. hiv+ 2. ≥18 years old 3. entering hiv medical care services for the first time (that is, not transferring hiv care from another location) 4. able to speak and read english at the level to be able to complete the study procedures 5. have telephone access. exclusion criteria: 1. cognitively impaired

Keywords: medication adherence treatment adherence hiv acceptance and commitment therapy retention
effect of galactooligosaccharides on incidence of atopic manifestations in infants

Conditions: Atopic Dermatitis

Summary: addition of prebiotic galactooligosaccharides to hypoallergenic starter formula would lead to decreased allergic (atopic) symptoms in nonbreastfed infants with a positive history of allergy in family


Eligibility criteria:
inclusion criteria: * nonbreastfed eutrophic infants of corresponding gestational age * presence of a positive family allergic anamnesis in parents or siblings (atopic eczema, allergic rhinitis or bronchial asthma) exclusion criteria: * children with serious disease, * breastfed children * children fed another formula then the ones used

Keywords: interventional doubleblind randomised pediatric prebiotic atopic dermatitis infant
the function of pet molecular imaging targeting fibroblast activation protein in the hepatobiliary malignancies

Conditions: Hepatobiliary Diseases

Summary: patients with high clinical suspicion of hepatobiliary malignancies should undergo pet/ct examination with two imaging agents, 68ga-fapi (fibroblast activation protein inhibitor) and 18f-fdg within one week, and collect tumor tissue. finally, the pet/ct results were compared with the pathology report to evaluate the role of 68ga-fapi pet/ct imaging in the diagnosis of hepatobiliary malignancies

patients with high clinical suspicion of hepatobiliary malignancies should undergo pet/ct examination with two imaging agents, 68ga-fapi (fibroblast activation protein inhibitor) and 18f-fdg within one week. after comprehensive clinical evaluation, if the patient can be treated with surgery, surgery will be performed, and the patient's pathological specimens will be collected after surgery ; if the patient has no possibility of surgery, ultrasound-guided needle biopsy is performed, and biopsy specimens are collected. finally, the pet/ct results were compared with the pathology report to evaluate the application value of 68ga-fapi pet/ct imaging in the diagnosis and staging of hepatobiliary malignant tumors, and to analyze the guiding significance for the treatment decision of hepatobiliary malignant tumors.

Eligibility criteria:
inclusion criteria: 1. voluntarily participate and sign a written informed consent; 2. 18-80 years old (inclusive) male or female; 3. patients with high clinical suspicion of hepatobiliary malignancy in combination with medical history and imaging studies, etc. 4. those who obtained pathological diagnosis results through needle biopsy or surgical resection; 5. have willingness and ability to participate in all research procedures. exclusion criteria: 1. women who are pregnant or breastfeeding; 2. those who are known to be allergic to the imaging agent 68ga-fapi or its excipients; 3. those who have a history of other malignant tumors in the past; 4. before the injection of 18f-fdg, the fasting blood glucose level exceeds 11.0mmol/l; 5. patients with claustrophobia; 6. those who cannot tolerate lying down for 15-30 minutes; 7. the researchers believe that it is not suitable to participate in this clinical trial; 8. those who have participated in clinical trials or are participating in other clinical trials within the past month
safety of leo 43204 for actinic keratosis applied on face/chest, scalp and trunk/extremities, respectively

Conditions: Actinic Keratosis

Summary: the objective of the trial is to investigate the safety of leo 43204 0.018%, 0.037% and 0.1% for actinic keratosis applied once daily for three consecutive days on face/chest, scalp and trunk/extremities, respectively.


Eligibility criteria:
inclusion criteria: subjects with 5 to 20 clinically typical, visible and, discrete, nonhyperkeratotic and non-hypertrophic aks within a selected treatment area of sun-damaged skin on either: * the full face * the full balding scalp * a contiguous area of approximately 250 cm2 on trunk or extremities exclusion criteria: location of the treatment area (full face, full balding scalp or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected basal cell carcinoma (bcc) or scc. previously assigned treatment in this clinical trial or previously participated in a clinical trial in the leo 43204 programme. treatment with ingenol mebutate gel in the selected treatment area within the last 12 months lesions in the treatment area that have: atypical clinical appearance (e.g. cutaneous horns) and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).