Kornimate/medical-research-clean huggingface dataset:
walk with me (wwm) for perinatal grief

Conditions: Grief; Post Traumatic Stress Disorder; Suicidal Ideation; Miscarriage; Stillbirth; Infant Death

Summary: the goal of this clinical trial is to learn if the along with me web-based intervention works to decrease posttraumatic stress symptoms and suicidal ideation among bereaved parents following pregnancy and early infant loss. it will also learn whether peer guides provide additional improvements on these outcomes. the main questions it aims to answer are: • do people who receive along with me or along with me plus a peer guide compared to services as usual have lower posttraumatic stress symptoms and suicidal ideation than those who do not receive the intervention? researchers will compare along with me and along with me plus a peer guide to services as usual (referrals made in the hospital setting) to see if along with me works to prevent and address posttraumatic stress symptoms and suicidal ideation. participants will: * receive access to a mobile app with approximately 10 therapeutic modules about how to manage grief and other symptoms. * receive check-ins with a peer guide (in the peer guide condition only)

our clinical trial is a randomized, three-group controlled trial in which 300 bereaved parents who have experienced pregnancy or early infant loss will be randomly assigned to control (group 1: treatment as usual, n = 100), along with me only (group 2, n = 100), or the along with me plus peer guide (group 3, n = 100). participants will be recruited prior to randomization and assigned to condition after consent. bereaved parents in the treatment arms will receive access to the along with me app that provides psychoeducation on grief, and cognitive behavioral therapy (cbt) and mindfulness skills to manage grief and reduce the risk of posttraumatic stress following pregnancy loss. all participants will complete a baseline assessment that includes self-report of posttraumatic stress symptoms and suicidal ideation, and secondary measures pertaining to mental health symptoms, substance use, coping, grief self-efficacy, and for those in the treatment condition, acceptability and usability for the along with me app. additional assessments will occur at 3 months, 6 months, and 9 months.

Eligibility criteria:
inclusion criteria: * within the first month of pregnancy or early infant loss * reside in the united state * speak and read either english or spanish at a 6th grade reading level * 15 or older exclusion criteria: * not pregnant or has not experienced an early infant loss * does not reside in the united state * does not speak and read either english or spanish at a 6th grade reading level * 14 or younger
study of pharmacokinetics, efficacy, and safety of a recombinant and protein-free factor viii (rahf-pfm) in pediatric patients with hemophilia a

Conditions: Hemophilia A

Summary: the purpose of this study is to evaluate whether rahf-pfm is effective and safe in the treatment of children with hemophilia a. the study consists of 2 parts. part 1 of the study is a pharmacokinetic evaluation, and part 2 is an evaluation of efficacy and safety.


Eligibility criteria:
inclusion criteria: * subject is less than 6 years of age * severe or moderately-severe hemophilia a as defined by a baseline factor viii level \<= 2%, documented at screening or on the basis of historical data (e.g., at hemophilia diagnosis) * documented medical history of at least 50 exposure days for treatment with all other factor viii products * subject's parent or legally authorized representative has provided informed consent exclusion criteria: * detectable inhibitor to factor viii measured in the screening sample by the local or central hemostasis laboratory * history of inhibitor to factor viii at any time prior to screening * subject has any one of the following laboratory abnormalities at the time of screening: 1. platelet count \< 100,000/mm3 2. hemoglobin concentration \< 10 g/dl (100 g/l) 3. serum creatinine \> 1.5 times the uln for age 4. total bilirubin \> 2 times the uln for age * subject has an inherited or acquired hemostatic defect other than hemophilia a (e.g., platelet dysfunction secondary to uremia, liver failure, von willebrand's disease) * subject has known hypersensitivity to recombinate rahf * subject is currently participating in another investigational drug study or has participated in any clinical study involving an investigational drug within 30 days of study entry * subject is identified by the investigator as being unable or unwilling to cooperate with study procedures

Keywords: factor viii deficiency
developing a mobile method to measure thc-induced impairment

Conditions: Measuring THC-induced Cognitive Impairment Using a Mobile Application

Summary: marijuana use, for both recreational and therapeutic purposes, is becoming increasingly common as states remove restrictions on use. the increased use raises new concern about the safety of this drug, including its ability to impair basic cognitive and psychomotor tasks, and whether the users are aware of their impairment. we propose to design a simple performance test that users can use in the field, using a cell phone, to assess their level of impairment relative to their own drug-free state. in this preliminary study, we will compare participants' simple task performance after a known dose of delta-9-tetrahydrocannabinol (thc), or placebo, administered under double-blind conditions. in our app the participants will be asked to gauge their own perceived level of impairment (as determined by self-ratings and judgments of impairment) as well as their actual impairment (as gauged by the app), providing important feedback and training about their ability to detect impairment.


Eligibility criteria:
inclusion criteria: 1. 18-35 years old, males and females (n=44; 36 completers; 18 men, 18 women) 2. bmi 19-26 3. high school education, fluent in english 4. experienced non-daily marijuana users exclusion criteria: 5. current drug/alcohol abuse or dependence 6. past year drug/alcohol dependence 7. diagnosis with drug treatment for psychosis/bipolar/schizophrenia 8. past year major depression 9. panic/anxiety attacks in past 2 months 10. post traumatic stress disorder 11. attention deficit hyperactivity disorder 12. cardiovascular illness, high blood pressure, abnormal ekg 13. current medications 14. pregnant or planning to become pregnant
a comparison of atovaquone and pentamidine in the prevention of pneumocystis carinii pneumonia in hiv-infected patients who cannot take tmp/smx

Conditions: Pneumonia, Pneumocystis Carinii; HIV Infections

Summary: to assess whether high dose or low dose atovaquone suspension is more effective than aerosolized pentamidine as prophylaxis against pneumocystis carinii pneumonia (pcp) in high-risk hiv-infected patients. to compare the safety of chronic administration of the three regimens in patients with advanced hiv disease. to determine the relationship between steady state atovaquone plasma concentrations and prophylactic efficacy against pcp.

patients are randomized to receive oral atovaquone at 1 of 2 doses once daily or aerosolized pentamidine once every 4 weeks. treatment continues until 18 months after the last patient is enrolled. patients are stratified into primary or secondary prophylaxis strata based on prior occurrence of a pcp episode.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * antimicrobial agents not specifically prohibited. concurrent treatment: allowed: * transfusion. patients must have: * hiv positivity. * prior pcp (histologically confirmed) or documented cd4 count \ 100 f) for 2 or more weeks. * no current or suspected active pcp, and no signs of active pcp on chest x-ray. * prior intolerance to tmp/smx or other trimethoprim or sulfa-containing regimens. * life-expectancy of at least 6 months. note: * pregnant women are eligible at the discretion of the investigator. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * significant psychosis or emotional disorder that would preclude study compliance. * severe chronic diarrhea (e.g., \> five stools/day) that may negatively affect absorption of oral medication. * unable to take oral medication or unable or unwilling to take medication with food. concurrent medication: excluded: * rifampin. * other investigational agents except for drugs available through treatment inds or expanded access programs. * medications likely to have anti-pneumocystis effect (e.g., dapsone, trimethoprim, pyrimethamine, trimetrexate, other dhfr inhibitors, sulfadiazine, sulfamethoxazole, other sulfonamides, primaquine, clindamycin, and sulfonylureas. * corticosteroids in greater than physiologic replacement doses for more than 21 consecutive days. * systemic therapy for cns toxoplasmosis, kaposi's sarcoma, lymphoma, other active malignancies, or other disease that may decrease life expectancy or confound assessment. patients with the following prior conditions are excluded: * history of severe or intractable intolerance to atovaquone or aerosolized pentamidine. * prior hypoglycemia, pancreatitis, arrhythmias, or severe hypotension associated with any form of pentamidine. * prior enrollment in this protocol. active substance abuse that would preclude study compliance.

Keywords: pneumonia, pneumocystis carinii pentamidine antifungal agents acquired immunodeficiency syndrome aids-related complex atovaquone
immunogenicity and safety study of scb-2023 vaccine as a booster in adults

Conditions: COVID-19

Summary: the purpose of this study is to assess the immunogenicity and safety of scb-2023 trivalent vaccine compared to the prototype scb-2019 monovalent vaccine in participants previously vaccinated with 3 doses of inactivated covid-19 vaccine ≥6 months prior to enrollment.


Eligibility criteria:
inclusion criteria: * male or female ≥18 years of age. * individuals willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests and other study procedures. * individuals willing and able to give an informed consent, prior to screening. * healthy participants or participants with pre-existing medical conditions who are in a stable medical condition. * individuals who received three doses of inactivated covid-19 vaccine. exclusion criteria: * body temperature \>37.8°c (axillary), or any acute illness at baseline. * confirmed sars-cov-2 infectionor with known history of covid-19. * individuals who have received an investigational or licensed covid-19 vaccine prior to day 1 (except for inactivated covid-19 vaccine). * any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy. * any progressive unstable or uncontrolled clinical conditions. * individuals who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or during the study period. * history of severe adverse reaction associated with a vaccine or severe allergic reaction. * history of malignancy within 1 year before screening. * individuals who have received any other investigational product. * individuals who have received any other licensed vaccines within 14 days prior to enrollment. * treatment with rituximab or any other anti-cd20 monoclonal antibodies. * known bleeding disorder that would, in the opinion of the investigator, contraindicate i.m. injection. * administration of intravenous immunoglobulins and/or any blood products. * any condition that, in the opinion of the investigator, would interfere with the primary study objectives or pose additional risk to the participant.
s9709, laser surgery plus radiation therapy in treating patients with early stage cancer of the larynx

Conditions: Head and Neck Cancer

Summary: rationale: laser surgery for cancer of the larynx may have fewer side effects and improve recovery. radiation therapy uses high-energy x-rays to damage tumor cells. combining radiation therapy and laser surgery may kill more tumor cells. purpose: phase ii trial to study the effectiveness of laser surgery plus radiation therapy in treating patients with early stage cancer of the larynx.

objectives: i. assess the feasibility of treating untreated stage i, ii and selected stage iii squamous cell carcinoma of the supraglottic larynx with endoscopic surgery and irradiation. ii. estimate the 3 year progression free survival and describe the location of disease progression. outline: patients receive carbon dioxide laser laryngectomy within 28 days following protocol registration. patients with n1 disease may undergo an optional neck dissection ipsilateral to the neck mass. neck dissection includes complete removal of at least lymph node levels 2-4. radiation therapy begins 14 days following laser surgery. patients are followed every 3 months for the first year, every 6 months for the second year, and every 12 months thereafter until death. projected accrual: there will be 50 patients accrued into this study in 3 years with an estimated accrual rate of 20 patients per year.

Eligibility criteria:
disease characteristics: histologically proven, newly diagnosed, untreated stage i, ii, or selected stage iii (t1-t2, n1, m0) squamous cell carcinoma of the supraglottic larynx bidimensionally measurable disease no metastatic or stage iii t3 disease no immediate life-threatening complications of the disease patient characteristics: age: over 18 performance status: swog 0 or 1 life expectancy: not specified hematopoietic: wbc greater than 3,500/mm3 platelet count greater than 50,000/mm3 hemoglobin greater than 10.0 g/dl hepatic: not specified renal: not specified cardiovascular: at least 3 months since prior myocardial infarction no uncontrolled congestive heart failure no unstable or uncontrolled angina other: no prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer in situ cervical cancer other cancer for which the patient has been disease-free for at least five years no history of prior laryngeal cancer no history of primary tumors of any aerodigestive tract site except disease site all fertile patients must use an effective contraceptive method must be medically able to undergo general anesthesia no psychological, familial, sociological or geographical conditions that do not permit medical follow-up and compliance with study protocol no other unstable or pre-existing major medical condition prior concurrent therapy: no prior treatment for squamous cell carcinoma of the supraglottic larynx

Keywords: stage i squamous cell carcinoma of the larynx stage ii squamous cell carcinoma of the larynx stage iii squamous cell carcinoma of the larynx
filmarray® and management of ventilator associated pneumonia in covid-19 ards

Conditions: SARS-CoV2 Infection; Ventilator Associated Pneumonia; Ards; COVID-19

Summary: ventilator associated pneumonia (vaps) are a very common side effect in intensive care units. they are the leading causes of nosocomial infections and excess mortality in intensive care units: associated with a controversial death rate of around 13%. vaps complicate about 40-50% of covid-19 acute respiratory distress syndrome (ards) and the mortality would be twice higher. thus, in this context of the covid-19 pandemic, this represents a considerable rate of patients. unfortunately, the risk factors for vaps are poorly understood and the bacterial ecology varies around the world. also, facing a high prevalence of multi-resistant bacteria in this population, the choice of probabilistic antibiotic therapy is complex and represents a considerable impact for care. new microbiological rapid diagnostic techniques have appeared in recent years, among them the filmarray® seems to present interesting diagnostic performances with the ability to detects resistance to antibiotics. this technique has been studied in acute community pneumonia but has not been validated in vap and even less during the covid-19 period. investigators decide to conduct this study to investigate if the early identification of the pathogens and their mechanism of resistance using filmarray® would improve the relevance of the antibiotic treatment. the aim of this project is to evaluate the contribution of a rapid diagnostic technique to the management of ventilator associated pneumonia during covid-19 acute respiratory distress syndrome before an interventional study.


Eligibility criteria:
inclusion criteria: * age ≥ 18 yers * covid-19 acute respiratory distress syndrome hospitalization * affected ventilator associated pneumonia * having multiplex pcr analysis filmarray® exclusion criteria : patient opposition to participate to the study

Keywords: filmarray ards covid 19 ventilator associated pneumonia diagnostic
observation of patients with primary pulmonary hypertension receiving prescribed ventavis inhalation therapy regarding safety and efficacy for up to 4 years

Conditions: Hypertension, Pulmonary

Summary: this is an observational study to monitor the continued effectiveness of ventavis (inhaled iloprost) in the long-term. the study observes the effects and the safety of ventavis inhalation therapy over at least 2 years and up to 4 years. a total of 54 patients from around 30 study sites in europe will be included in the study. this observational study will collect information in patients receiving a medication that is already available on prescription in the participating countries. ventavis is used to treat moderate cases of primary pulmonary hypertension.


Eligibility criteria:
inclusion criteria: * the treating physician has chosen ventavis as a suitable long-term treatment for the patient * patient with primary pulmonary hypertension (i.e. idiopathic pulmonary arterial hypertension or familial pulmonary arterial hypertension) and classified as nyha functional class iii (nyha = new york heart association) * no prior treatment with ventavis or other active treatments for primary pulmonary hypertension within 6 weeks of date of study inclusion (unless otherwise advised by bayer schering pharma) exclusion criteria: * any condition that prevents participation in the study, including pregnancy and other contraindications for ventavis treatment (as listed in the current ventavis summary of product characteristics and patient package insert)

Keywords: primary pulmonary hypertension
impulsivity and time perception

Conditions: Cannabis Use

Summary: cannabis smokers having begun prematurely their consumption (before 16 years) present a persistent impulsivity much later after have stopped their consumptions. the literature highlights that the impulsivity promotes the passage towards a compulsive consumption, and the loss of control. to explain this phenomenon, some authors hypothesized that impulsivity would lead the subjects to overestimate the duration of events and to choose immediate rewards than preferred but delayed rewards. this hypothesis questions the role of the temporal anticipation in the impulsive choices. in a first hypothesis, the temporal impulsivity could be an endogenous deficit bound to the reward, and would be responsible for disorders of the temporal anticipation. in this case, the disorders should be observed especially when the subject anticipates a reward. alternately, a disorder of the temporal anticipation could provoke impulsivity, and in this case, would be present with or without reward. to separate these hypotheses, we propose to test the capacities of temporal anticipation of non-smokers and early smokers of cannabis by means of a behavioral task " hazard function task ", which allow to measure the capacity of a subject to anticipate the apparition of an event on the basis of a temporal cue. the neuronal correlates will be measured by a recording eeg of the wave ' cnv ' (fix a quota for denial of variation) which reflects the temporal accumulation and the processes of anticipation.


Eligibility criteria:
inclusion criteria: * healthy volunteers man or woman of age between 18 and 50 years-old * absence of consumption of cannabis and tobacco for 1 year and absence of substance use disorder in history * matching in age and sex to the group consumers of cannabis * early consumers of cannabis (at the beginning of the consumptions before 16 years) * man or woman of age between 18 and 50 years old * statement of more than three consumptions a day of cannabis for at least one year and consumption of cannabis having begun before the age of 16 years. * urinary analysis is positive for the presence of cannabis * positive auto-questionnaire cast: 2 positive answers to cast questionnaire * hospitalized or not exclusion criteria: * presence or history of a severe and invalidating somatic pathology (neurological, cardiovascular, lung, metabolic, renal, hepatic, gastro-intestinal) * history of cranial trauma with loss of consciousness. * substance use disorder except the substance tested in the protocol (cannabis). * invalidating sensory disorders in particular visual: glaucoma, any retinal pathology. visual acuteness 0.8 * history of general anesthesia in the previous 3 months the study * any evolutionary neurological or psychiatric pathology * subject under guardianship * pregnancy * feeding

Keywords: early onset of cannabis use addiction time perception
study of regn4018 administered alone or in combination with cemiplimab in adult patients with recurrent ovarian cancer or other recurrent mucin-16 expressing (muc16+) cancers

Conditions: Recurrent Ovarian Cancer; Recurrent Fallopian Tube Cancer; Recurrent Primary Peritoneal Cancer; Recurrent Endometrial Cancer

Summary: the main purpose of this study is to: * learn about the safety of regn4018 and to find out what dose of regn4018 can be given alone or with cemiplimab to patients with ovarian cancer or cancer of the uterus * the study will also look at the levels of regn4018 and/or cemiplimab in your body and measure how well your body can remove the study drug(s). this is called pharmacokinetics * the study will also look at any signs that regn4018 alone or with cemiplimab can treat recurrent advanced ovarian cancer or cancer of the uterus * to find out how safe and tolerable the sarilumab pretreatment is, in combination with regn4018 and cemiplimab


Eligibility criteria:
key inclusion criteria: 1. ovarian cancer cohorts only: patients with histologically or cytologically confirmed diagnosis of advanced, epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer who have all of the following: 1. serum ca-125 level ≥2 x upper limit of normal (uln) (in screening) 2. has received at least 1 line of platinum-containing therapy or must be platinum-intolerant (applicable for dose escalation and non-randomized dose expansion cohorts) 3. documented relapse or progression on or after the most recent line of therapy 4. no standard therapy options likely to convey clinical benefit 2. adequate organ and bone marrow function as defined in the protocol 3. life expectancy of at least 3 months 4. randomized phase 2 expansion cohort (ovarian cancer only): platinum-resistant ovarian cancer patients who have had 1 to 3 lines of platinum-based therapy as defined in the protocol. 5. endometrial cancer cohorts only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-programmed cell death ligand 1 (pd-1) therapy and platinum-based chemotherapy: 1. muc16 positivity of tumor cells ≥25% by immunohistochemistry (ihc) 2. 1-2 prior lines of systemic therapy key exclusion criteria: 1. prior treatment with anti-programmed cell death (pd-1)/pd-l1 therapy, as described in the protocol 2. ovarian cancer expansion cohorts only: more than 4 prior lines of cytotoxic chemotherapy 3. prior treatment with a muc16 - targeted therapy 4. untreated or active primary brain tumor, central nervous system (cns) metastases, or spinal cord compression, as described in the protocol 5. history and/or current cardiovascular disease, as defined in the protocol 6. severe and/or uncontrolled hypertension at screening. patients taking anti-hypertensive medication must be on a stable anti-hypertensive regimen note: other protocol inclusion/exclusion criteria apply