Kornimate/medical-research-clean huggingface dataset:
infectious and non-infectious lower respiratory diseases in children with down syndrome followed in pediatric pulmonology consultations in ile-de-france

Conditions: Down Syndrome

Summary: the purpose of this study is to describe infectious and non-infectious lower respiratory tract diseases in children with down syndrome followed in pediatric pulmonology consultations in ile de france.

down syndrome is the most common chromosomal abnormality, affecting 600 to 800 births per year. it results in a clinical picture that combines developmental delay, mental deficiency, facial dysmorphism and visceral malformations. optimal medical care of down syndrome patients requires a good knowledge of the different systems affected by the disease, particularly respiratory damage. numerous articles have been published describing upper respiratory problems in children with down syndrome. on the other hand, lower respiratory problems causing significant morbidity and mortality remain underestimated and poorly understood in this population. the objective of this study is to describe lower respiratory problems in patients with t21, in order to improve their management. this study will also make it possible to describe more precisely the impact that these attacks have on down syndrome patients. this study also describe the associated extra-respiratory disorders to improve overall care finally, the respiratory care of these patients will be described, with the aim of standardizing practices.

Eligibility criteria:
inclusion criteria: * child from 0 to 17 years old * carrier of down syndrome confirmed by karyotype * having had follow-up in a pediatric pulmonology consultation for an infectious or non-infectious lower respiratory tract * not exclusively presenting upper respiratory otorhinolaryngological damage exclusion criteria: * patient under guardianship or curators * adult or holders of parental authority informed of the study and having objected to it

Keywords: down syndrome children lower respiratory diseases respiratory infection respiratory syncytial virus hemosiderosis asthma bronchiolitis
dolastatin 10 in treating patients with metastatic pancreatic cancer

Conditions: Pancreatic Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of dolastatin 10 in treating patients who have metastatic pancreatic cancer.

objectives: i. assess the antitumor activity of dolastatin 10 in patients with metastatic adenocarcinoma of the pancreas. ii. evaluate the qualitative and quantitative toxic effects of this therapy in these patients. iii. investigate the clinical pharmacology of this treatment. outline: this is an open label, multicenter study. patients receive dolastatin 10 iv bolus once every 21 days. treatment continues in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months until death. projected accrual: this study will accrue 12-37 patients within 18.5 months.

Eligibility criteria:
disease characteristics: histologically confirmed metastatic adenocarcinoma of the pancreas bidimensionally measurable lesions with sentinel lesions outside field of any prior radiation therapy no brain metastases patient characteristics: age: 18 and over performance status: zubrod 0-1 life expectancy: at least 12 weeks hematopoietic: absolute granulocyte count at least 1500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 1.5 mg/dl renal: creatinine no greater than 1.5 mg/dl cardiovascular: no active congestive heart failure no uncontrolled angina at least 6 months since prior myocardial infarction no uncontrolled hypertension other: not pregnant or nursing fertile patients must use effective contraception no concurrent serious infection at least 5 years since prior malignancy except the following: nonmelanoma skin cancer carcinoma in situ of the cervix no overt psychosis or mental disability prior concurrent therapy: biologic therapy: no concurrent biologic therapy chemotherapy: no prior chemotherapy for metastatic disease at least 6 months since prior adjuvant chemotherapy no concurrent chemotherapy endocrine therapy: not specified radiotherapy: see disease characteristics at least 6 months since prior adjuvant chemoradiation to disease at least 2 weeks since prior radiotherapy and recovered no concurrent radiotherapy surgery: at least 4 weeks since prior surgery and recovered no concurrent surgery other: at least 4 weeks since prior investigational drug (including analgesics or antiemetics) no other concurrent anticancer therapy

Keywords: recurrent pancreatic cancer adenocarcinoma of the pancreas stage iv pancreatic cancer
relationship between respiratory muscle strength, balance, trunk control, functional capacity in stroke patients

Conditions: Stroke Patients

Summary: the purpose of this study; to determine the relationship between respiratory muscle strength, balance, trunk control, functional capacity and motor functions in stroke patients and compare them with healthy individuals.

stroke is one of the most important causes of chronic disability in adults. hemiplegia and hemiparesis are common neurological conditions following stroke. neurological findings associated with hemiplegia negatively affect posture, muscle tone, motor control, voluntary motor activation and trunk muscle synergy. the effect of stroke on the respiratory system depends on the structures affected by the lesion. the continuation of normal ventilation also depends on the influence of the neuromuscular system. the interference in trunk muscle synergies brings about loss of respiratory muscle function. symptoms associated with respiratory problems, especially dyspnea, reduce exercise performance. on the other hand, motor control function losses; it disrupts the coordination of the respiratory muscles and changes the thickness of the diaphragm muscle, causing asymmetry between the affected and unaffected sides. developing asymmetry can lead to progressive loss of strength in the respiratory muscles. in the evaluation of stroke patients, measurements of the pulmonary system are rarely included. it is thought that the fact that patients do not have symptoms and/or diseases related to the pulmonary system before the development of stroke may explain the insufficient attention to respiratory evaluations. however, in a few studies, respiratory system evaluations were also made in stroke patients; it has been reported that there are effects related to pulmonary functions such as partial or total diaphragm on the affected side and weakening of intercostal and abdominal muscles.

Eligibility criteria:
inclusion criteria: * stroke individuals over the age of 18 exclusion criteria: * patients with another neurological problem (parkinson, multiple sclerosis, etc.) that will affect functionality and balance other than stroke * patients with orthopedic problems (short limbs, spine and lower extremity surgery) with pulmonary disease * patients with cooperation and communication problems

Keywords: respiratory function postural control balance
incorporating pro data into ra clinical encounters using health it

Conditions: Rheumatoid Arthritis

Summary: the goal of this pragmatic clinical trial is to learn if a new health it tool that was rolled out at ucsf health rheumatology clinics (the ra pro dashboard) can help improve the lives of individuals with rheumatoid arthritis. the ra pro dashboard displays important outcomes for individuals with rheumatoid arthritis, including disease activity, physical functioning, and pain scores in an easy-to-read, digital interface that can be displayed on the computer screen during a clinical visit. these outcomes are tracked over time, so patients and clinicians can see changes across multiple time points. additional features of the dashboard include displaying medication use over time and recent lab test results. the main questions the study aims to answer are: does displaying the dashboard during a clinical visit ... 1. reduce decisional conflict when making a medication choice? 2. improve self-efficacy in symptom management? 3. change beliefs about medications? 4. improve medication adherence? 5. improve ra outcomes such as disease activity or physical functioning? researchers will compare these outcomes in the patients of clinicians who have access to the ra pro dashboard to those who do not to see if these outcomes change over time. clinicians with access to the dashboard may choose to share it from the computer screen with patients during the clinic visit. participants will be asked to complete surveys as part of their routine clinic visits.


Eligibility criteria:
inclusion criteria: * diagnosis of rheumatoid arthritis * visits with clinicians at ucsf health clinic * at least 1 cdai score documented in ucsf ehr exclusion criteria: * unable to read, speak, or understand english * unable to provide informed consent

Keywords: electronic dashbaord patient reported outcomes
study to evaluate the efficacy and safety of aripiprazole

Conditions: Autism

Summary: * to evaluate the efficacy of flexibly dosed aripiprazole in reducing serious behavioral problems in asian children and adolescents with a diagnosis of autism spectrum disorder, as measured by change from baseline to endpoint on the irritability subscale of the aberrant behavior checklist (abc-i). * to evaluate the long-term safety and tolerability of flexibly dosed aripiprazole in the treatment of serious behavioral problems in asian children and adolescents with a diagnosis of autism spectrum disorder.

1. study design - multi-national, multi-center, 52 weeks open label, single arm design

Eligibility criteria:
inclusion criteria: * 6 to 17 years of age. * meeting the diagnostic criteria for autistic disorder specified by the diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr), with a diagnosis corroborated by the autism diagnostic interview-revised (adi-r) diagnostic instrument and demonstrated behaviors such as tantrums, aggression, self-injurious behavior, or a combination of these. * clinical global impressions (cgi) severity subscale score ≥ 4 at screening and baseline. * aberrant behavior checklist (abc) irritability subscale score ≥18 at screening and baseline. * mental age ≥ 18 months. * women of childbearing potential (wocbp) have to use an adequate method of contraception * wocbp must have had a negative serum or urine pregnancy test. * the patient and/or the designated guardian(s) or caregiver(s) who are able to comprehend and comply with the protocol requirements, in the opinion of the investigator and have consented to participate by signing an informed consent form. exclusion criteria: * current diagnosis of bipolar disorder, schizophrenia, major depressive disorder, rett's disorder, or fragile-x syndrome. * history of neuroleptic malignant syndrome. * significant risk of committing suicide based on history or routine psychiatric status examination. * history of seizure in the past 1 year. * history of severe head trauma or stroke * history or current evidence of any unstable medical conditions * patient considered treatment resistant to neuroleptic medication * patient considered treatment resistant to aripiprazole * woman who is pregnant or breastfeeding * ecg: qtc \> 475 msec * platelets ≤ 75,000/μl * hemoglobin ≤ 9 g/dl * neutrophils ≤ 1.0x10\^3/μl * aspartate or alanine transaminase (ast or alt) \> 3xuln * serum creatinine ≥ 2 mg/dl * patient weighed \< 15 kg * patient who participated in any other clinical trial within 4 weeks * patient determined to require the administration of the prohibited medications during the study period * patient with other conditions determined by the investigator to be inappropriate for this clinical study

Keywords: autism aripiprazole abilify
long-term supervised treatment interruption in hiv-infected patients

Conditions: HIV Infections

Summary: this trial is aimed at studying the safety of long term supervised treatment interruption in hiv infected patients with cd4 over 350/mm3 and plasma hiv rna under 50 000/ml. another aim of this study is to assess the immunological and virological factors associated with the duration of treatment interruption.

the limitations of the drugs used against hiv include their toxicity, their tolerability, their propensity to induce resistance when not taken with absolute regularity and their cost. treatment interruption in patients receiving antiretroviral treatment in the setting of chronic infection are associated with viral rebound and rapid cd4 t cell decrease conducting to antiretroviral therapy restart. in patients with high cd4+ cell counts (patients receiving treatment of chronic infection with controlled viremia and patients who are receiving haart now in whom treatment would not have been started based on current guidelines), we evaluated the safety of long term supervised treatment interruption. another aim of this study was to assess the immunological and virological factors associated with the duration of treatment interruption (proviral hiv dna at baseline and during follow-up, plasma hiv rna at baseline and during follow-up, cd4 t cell and cd8 t cell hiv specific responses at baseline and after 12 months).

Eligibility criteria:
inclusion criteria: * males and non pregnant females * 18 years of age and older * who have confirmed laboratory diagnosis of hiv infection * started on first line antiretroviral treatment with cd4 over 350/mm3 and plasma hiv rna below 50 000/ml * ongoing antiretroviral therapy at inclusion with cd4 over 450/mm3 and plasma hiv rna below 5000/ml exclusion criteria: * hbv-hiv co-infection receiving lamivudine therapy * ongoing immunotherapy including il2, interferon or hiv specific vaccine * pregnancy or project of pregnancy

Keywords: hiv infections
a study of epacadostat (incb024360) in combination with durvalumab (medi4736) in subjects with selected advanced solid tumors (echo-203)

Conditions: Solid Tumors; Head and Neck Cancer; Lung Cancer; UC (Urothelial Cancer)

Summary: the purpose of this study is to explore the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of incb024360 administered in combination with medi4736 in subjects with selected advanced solid tumors.


Eligibility criteria:
inclusion criteria: * male or female subjects, age 18 years or older * histologically or cytologically confirmed diagnosis of selected locally advanced or metastatic solid tumors * must have failed at least 1 prior treatment regimen for locally advanced or metastatic disease or be intolerant to treatment or refuse standard treatment exclusion criteria: * laboratory and medical history parameters not within protocol-defined range * participation in any other study in which receipt of an investigational study drug occurred within 28 days or 5 half-lives (whichever is longer) prior to first dose * prior treatment with immune checkpoint inhibitors (eg, anti-ctla-4, anti-pd-1, anti-pd-l1, and any other antibody or drug specifically targeting t-cell co-stimulation) or an ido inhibitor (exception is tumor types in which a pd-1 pathway targeted agent is approved, e.g. melanoma, non-small cell lung cancer.) * receipt of any anticancer medication in the 21 days prior to receiving the first dose of study medication * has an active or inactive autoimmune process * evidence of interstitial lung disease or active, non-infectious pneumonitis * prior radiotherapy within 2 weeks of initiating treatment; must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis * untreated central nervous system (cns) metastases or cns metastases that have progressed * currently pregnant or breastfeeding
oxycodone in treatment of early labour pain efficacy and safety

Conditions: Labor Pain

Summary: oxycodone is used to treat early labour pain instead of meperidine. however, the efficacy and effects of oxycodone to the newborn has not been studied. in the present study, patient who has received oxycodone is asked about pain relief and after labour single venous blood sample from the parturient and umbilical cord are taken for the analysis of oxycodone.


Eligibility criteria:
inclusion criteria: * oxycodone for pain relief * age 18 years or more * given informed consent exclusion criteria: * no oxycodone * age less than 18 years * no informed consent

Keywords: labor pain oxycodone
social feedback and dysfunctional risk taking in nssi adolescents

Conditions: Nonsuicidal Self Injury; Risk-Taking

Summary: nonsuicidal self-injury (nssi) is defined as direct, intentional physical injury without suicidal intention. problematic interpersonal relationships and decision-making have been demonstrated to play crucial roles in this maladaptive behavior, especially for adolescents. accumulating evidence suggests that decision processes and risk-taking are strongly influenced by the affective state of the individual. however, whether these interactions are disrupted in nssi adolescents has not been systematically examined. in the current study, the investigators modified one of the most widely used paradigms for measuring an individual's risk decision-making, the balloon analogue risk task (bart). the investigators combine social reward (green balloon), punishment (red balloon), and control feedback (yellow balloon), to investigate whether the nssi adolescents have dysfunctional risk-taking behavior while facing different social outcomes. the investigators recruit one group of nssi adolescents (n = 40) and one health control (hc) group (n = 40), to compare their risk-related decisions during the emotional bart. the investigators hypothesize that compared to hc, nssi adolescents will show altered effects of social reward and punishment on risk-related decision-making, in particular higher risk avoidance in the context of social punishment.


Eligibility criteria:
inclusion criteria: * 15-18 years * right-handed * normal or corrected normal visual acuity * meet the proposed dsm-5 frequency criteria (e.g., ≥5 days of nssi behaviors in the past year) exclusion criteria: * diagnosis of borderline personality disorder, major depressive disorder, other * psychiatric disorders, etc. * high suicidal risk * recent use of medications that can affect neural activity * have received or are receiving dialectical behavior therapy (dbt) other treatment for emotional problems within the past 6 months * have a contraindication to mri scanning (e.g., metal implants, claustrophobia or other conditions that make them inappropriate for mri scanning)
bioavailability of flucanazole

Conditions: Candidiasis

Summary: the objective of this study was an open-label, randomized, 2-way crossover to compare the single-dose relative bioavailability of flucanazole 40mgm/ml 35 ml suspension and pfizer (diflucan®) 40 mg/ml 35 ml fluconazole suspension under fed condition

the study is to be conducted as an open-label, randomized, single-dose, 2-way crossover, relative bio availability study performed on 200 healthy adult volunteers. a total 200 subjects will be assessed for auc for 72 hours after administration of flucanazole suspension

Eligibility criteria:
inclusion criteria male and females between the ages of 18 and 35 years * healthy individual * able to swallow exclusion criteria: * history or presence of significant: * cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease. in addition, history or presence of: alcoholism or drug abuse within the past year; hypersensitivity or idiosyncratic reaction to fluconazole or other azoles. subjects who have used any drugs or other substances known to be strong inhibitors of cyp (cytochrome p450) enzymes within 10 days prior to first dose. subjects who have used any drugs or other substances known to be strong inducers of cyp (cytochrome p450) enzymes within 30 days prior to first dose. subjects who have been anormal diet during the 30 days prior to the first dosing.
safety of allogeneic hematopoietic cell transplantation (hct) for patients with classical hodgkin lymphoma (chl) treated with nivolumab

Conditions: Lymphoma

Summary: an observational database analysis, using existing data of patients diagnosed with classical hodgkin lymphoma.

this study will include a retrospective and prospective observational database analysis.

Eligibility criteria:
inclusion criteria: * age greater than or equal to18 years; * first allogeneic hct for chl; * patients with prior autologous hct for chl; * any conditioning regimen, graft source or donor type. * for the primary analysis additional criterion includes prior exposure to nivolumab for treatment of chl immediately prior to the allogeneic hct, as defined as nivolumab used alone or in combination with other agents and used as the last line of therapy prior to an allogeneic hct with the interval between the last dose of nivolumab and start of the conditioning regimen no longer than 12 months. exclusion criteria: * patients with nodular lymphocyte-predominant hl * previous chimeric antigen receptor t-cell therapy or other genetically modified cellular product