Kornimate/medical-research-clean huggingface dataset:
a trial of the safety of escalating doses of pro131921 in patients with relapsed or refractory chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia

Summary: this is an open-label, multicenter, phase i/ii study of the safety of escalating doses of single-agent pro131921 in patients with chronic lymphocytic leukemia (cll) who have relapsed after or were refractory to treatment with a purine nucleoside analogue-containing regimen. the trial will enroll in two phases: a phase i dose-escalation portion and a phase ii expanded treatment cohort, with enrollment of additional patients in order to expand safety experience and collect preliminary anti-leukemia activity data.


Eligibility criteria:
inclusion criteria: * documented history of histologically confirmed b-cell cll * relapsed or refractory cll with history of prior treatment with purine nucleoside analogue-containing regimen * eligible for treatment of their cll based on criteria adapted from the national cancer institute-working group (nci-wg) response criteria for cll * for patients of reproductive potential (males and females), use of a reliable means of contraception * for females of childbearing potential, a negative serum pregnancy test exclusion criteria: * prior use of anti-cd20 monoclonal antibody therapy (other than rituximab) * prior use of any non-cd20 targeted monoclonal antibody therapy within 6 months of enrollment * current or recent cll treatment * history of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies * evidence of acute/active autoimmune hemolytic anemia or other autoimmune complications of cll * use of hematopoietic growth factors or rbc and/or platelet transfusions * evidence of significant uncontrolled concomitant diseases, such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders * evidence of myelodysplasia or myelodysplastic changes on bone marrow examination * history of cancer other than cll) * known active bacterial, viral, fungal, mycobacterial, or other infection or any major episode of infection requiring hospitalization or treatment with iv antibiotics or oral antibiotics * a major episode of infection requiring hospitalization or treatment with iv antimicrobials within 4 weeks of screening or oral antimicrobials within 2 weeks of screening * positive hepatitis b or c serology * positive human immunodeficiency virus (hiv) serology * active cytomegalovirus (cmv) disease by antigen or polymerase chain reaction testing * pregnancy or lactation * cns leukemia * recent major surgery, other than diagnostic surgery

Keywords: cll leukemia lymph
the covid-19 back-to-normal study: analysis of multiple outcomes

Conditions: COVID-19 Vaccines

Summary: during the study, members of different online and offline communities will be followed post covid-19 vaccination. injection-site (local) and systemic reaction data will be assessed on vaccination day and afterwards using either web surveys or personal communication, depending on study participant preference. hypothesis to be tested: the safety profile and the magnitude and durability of immune responses to the covid-19 vaccines as well as adverse reactions depend on health conditions, metabolism and microbiomes.

the outbreak of severe acute respiratory syndrome coronavirus 2 (sars-cov-2) was declared a public health emergency of international concern in january 2020 and upgraded to pandemic in march 2020. first vaccines to prevent covid-19 were authorized for emergency use in the us in december 2020, but a number of unknowns still remains. one of these unknowns is the relationship of the microbiota, gut dysbiosis and impaired metabolism with active immunity to pathogens and vaccines and tolerance to antigens. study groups will be based on age, metabolism, donated diagnostic test results and self-reported symptoms. data will be collected continuously via surveys and investigator-participant interactions, as needed. statistical methods used will be the ones with the greatest power.

Eligibility criteria:
inclusion criteria: * individuals 18 or older at the time of consent * intention to vaccinate and of being available for entire study period exclusion criteria: * any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint.

Keywords: drug-related side effects and adverse reactions long-term adverse effects immunogenicity, vaccine covid-19
pilot study to evaluate the somnotouch device to quantify spontaneous baroreflex sensitivity

Conditions: Healthy; Heart Failure

Summary: to measure the spontaneous baroreflex sensitivity in ambulatory patient, a device made for measuring blood pressure beat by beat and continuously, the somnotouch system, could be a useful tool. the somnotouch system has never been used to assess the sensitivity of the baroreflex. a good correlation for measuring the baroreflex sensitivity between the system "somnotouch" and digital photoplethysmography as a reference method is expected but should be evaluated. the main purpuse is to evaluate the somnotouch system to quantify the spontaneous baroreflex sensitivity in healthy young subjects, in elderly healthy subjects and in subjects with heart failure. we will also evaluate the feasibility of measuring the baroreflex sensitivity in ambulatory conditions for 24 hours, the variations in sensitivity of the baroreflex sensitivity between day and night, the reproducibility of orthostatic tolerance test.


Eligibility criteria:
for healthy volunteers inclusion criteria: * good health * normal ecg * cardiac ejection fraction \> 50% exclusion criteria: * with chronic disease or treatment * under law protection * not affiliated to the national health insurance for patients with heart failure inclusion criteria: * clinically sable * with sinusal heart rhythm * without sign of neuropathy * cardiac ejection fraction \< 50% exclusion criteria: * with pace maker * under law protection * not affiliated to the national health insurance * skin lesion or severe allergia

Keywords: volunteers
a study to determine the epidemiology and evaluate the burden of disease in respiratory syncytial virus/human metapneumovirus and influenza a infected hospitalized participants (adults and children)

Conditions: Respiratory Tract Infections

Summary: the purpose of this study is to describe the clinical and economic burden in adults and infants/children less than or equal to 5 years of age by type of respiratory pathogen (respiratory syncytial virus \[rsv\], influenza a, and human metapneumovirus \[hmpv\] in adults; rsv and hmpv in infants/children) based on medical resource utilization; rate and type of complications during and after hospitalization; mortality; rate and reasons of re-hospitalization related to index hospitalization; post-discharge care information and international classification of diseases 9th/10th revision (icd-9/10)/diagnostic-related group (drg) codes used (distribution).


Eligibility criteria:
inclusion criteria: * adult greater than or equal to (\>=) 18 years of age or infant/child less than or equal to (=\<) 5 years of age * participants hospitalized must have documentation of a confirmed diagnosis by pcr during the prespecified recent past season(s): rsv, influenza a, or hmpv infection in adults rsv or hmpv in infants/children (the first hospitalization in the season of data collection with confirmed diagnosis by pcr is considered the index hospitalization) * participants may include those hospitalized in the season of data collection with or without symptoms of a respiratory viral infection (including those of nosocomial origin), and/or to treat complications of viral infections, including patients admitted to the intensive care unit (icu) * hospitalized greater than (\>) 24 hours
building community capacity for disability prevention for minority elders (positive minds - strong bodies)

Conditions: Depression; Anxiety; Physical Disability

Summary: the primary intervention offered through this study is a manualized and culturally adapted cbt intervention combined with an exercise intervention, administered by trained community health workers and exercise trainers to ethnic minority elders with moderate to severe mood symptoms and at risk of disability. in addition to the intervention implementation, the study examines how to successfully build collaborative research for the provision of evidence-based mental health and disability prevention treatments for ethnic minority elders in community-based settings. thus, the study will evaluate the three components necessary for a successful intervention: efficacy, since the intervention must work, acceptability among clients and partnering agencies, and feasibility and sustainability within the organization.

the researchers have partnered with 5 community-based organizations and 2 clinics, each of whom will recruit 60 elder participants to be randomized into either the intervention (cbt+exercise) or control (enhanced usual care) groups. each participant randomized into the intervention group will receive 10 sessions of individual cbt for depression and anxiety (positive minds), using a translated and culturally adapted manual, and administered by a trained community health worker. in addition, each participant will engage in three exercise groups per week for 12 weeks, using the increased velocity specific to task (strong bodies; invest) protocol. both intervention and control groups will be assessed biweekly for symptoms of depression, anxiety, and suicidality, and both groups will participate in a thorough assessment at baseline, and 2, 6, and 12 months after baseline.

Eligibility criteria:
inclusion criteria: * age 60+ * fluency in english, spanish, mandarin or cantonese * score above threshold on phq-9, gad-7, or geriatric depression scale (gds-short form) * score within threshold of sppb exclusion criteria: * participants will be excluded if there is evidence of: * current substance use disorders * current or last 3 months of specialty mental health treatment * evidence that patient the participant lacks capacity to consent assessed using the ucsd brief assessment of capacity to consent. * suicidal risk (score of 4 or 5 on the paykel suicide questionnaire), whereby participant will be referred for immediate treatment to specialty care * if the participant's physician advises against strenuous physical exercise. * exclusion from the disability component will also happen if the participant is home-bound, has an acute or an exacerbated chronic disease, or has neuro-musculoskeletal impairment that prevents them from participating in the exercises

Keywords: depression anxiety disability ethnic minority elders
hemodynamic parameters in people with atherosclerotic vascular disease referred to a secondary prevention and cardiovascular rehabilitation program

Conditions: Peripheral Artery Disease (PAD); Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)); Cerebrovascular Atherosclerosis

Summary: the main purpose of this study is to evaluate the hemodynamic changes in the forefoot of patients with coronary, cerebrovascular or peripheral atherosclerotic disease referred a 12-week cardiovascular rehabilitation program (prev program). also, this study will describe the characteristics of patients admitted to the prev program and their evolutions in terms of favorable, unfavorable outcomes and complications and up to one year after completion of the program.


Eligibility criteria:
inclusion criteria: * any individual aged 18 years and older who has been diagnosed with peripheral artery disease, coronary artery disease, angina, ischemic heart failure, transient ischemic attack or ischemic stroke (non-cardioembolic, non-hemorrhagic); * have been admitted to the prev program; exclusion criteria: * being not able to give written informed consent;

Keywords: cardiovascular rehabilitation supervised exercise therapy secondary prevention cardiovascular secondary prevention cardiovascular rehabilitation program hemodynamics of lower limbs toe pressure measurement
post-concussion syndrome in professional athletes: a multidisciplinary study

Conditions: Chronic Traumatic Encephalopathy

Summary: to examine the relationship between repeated concussions and late decline of brain function. in addition, all participants agreeing to participate in the study will be asked to will their brains to the krembil neuroscience centre concussion project at the toronto western hospital with the consent and full knowledge of their families and doctors. however, it is possible to participate in the research without agreeing to a brain donation. the project team is specifically attempting a clinical-mri-brain tissue research analysis to determine the exact mechanism of the damage to brain tissue following repeated concussions. this condition is known as chronic traumatic encephalopathy (cte), and shows an abnormal protein in the brain called tau-protein.

we hypothesize that repeated concussions in retired professional athletes will be associated with abnormalities in neurological, neuropsychological, biofluids and neuroimaging assessments. the primary objectives of the study are: 1. to determine the effects of repeated concussions on neurological, neuropsychological and psychosocial functioning. 2. to determine the relationship between repeated concussions and neuroanatomical abnormalities in brain gray and white matter subserving cognitive and motor functions using structural mri assessment. 3. to determine the relationship between repeated concussions and changes in the cerebrospinal fluid composition. 4. to (i) establish the infrastructure to conduct ongoing pathological examination of donated brains. 5. in order to investigate whether the effects of repeated concussions on brain function and brain structure are progressive and related to the condition known as chronic traumatic encephalopathy, prospective, longitudinal, follow-up data will be collected

Eligibility criteria:
inclusion criteria: fluent in english, and a history of multiple concussions , low exposures , or no concussions (control group ). determination of concussion exposure will be determined as follows: previous concussion will be based on the player's recall of injury and defined as "an injury resulting from a blow to the head that caused an alteration in mental status and one or more of the following symptoms: headache, nausea, vomiting, dizziness/balance problems, fatigue, trouble sleeping, drowsiness, sensitivity to light or noise, blurred vision, difficulty remembering, and difficulty concentrating. exclusion criteria: neurological disorders prior to concussions (e.g.: seizure disorder); systemic illnesses known to affect the brain (e.g., diabetes and lupus); a history of psychotic disorder; known developmental disorders (e.g., attention deficit disorder, dyslexia); history of migraines; and, active engagement in litigation.
effect of salpingectomy during conservative hysterectomy

Conditions: Genital Diseases, Female; Hysterotomy; Affecting Fetus; Leiomyomata Uteri; Adenomyosis, Endometriosis; Dysfunctional Uterine Bleeding; Cervical Dysplasia; Uterine Prolapse

Summary: the study compares the effect of bilateral salpingectomy associated with conservative hysterectomy on ovarian function to the standard hysterectomy with conservation of both ovaries and tubes in terms of hormone assays, ovarian ultrasound evaluation, complications, quality of life.

hysterectomy is one of the most common gynecologic procedures performed in clinical practice. in this study we focused on non menopausal patients under 52 years having hysterectomies for benign disease : uterine leiomyomas, adenomyosis, endometriosis, dysfunctional uterine bleeding, genital prolapse, cervical dysplasia... with failure of conservative treatment. the standard procedure during hysterectomy with conservation of the ovaries has been the preservation of fallopian tubes with the clamps placed as close to the uterine corpus as possible. this is suggested to decrease interference with the vascular structures in the mesosalpinx and mesovarium. however it is unclear whether tubal conservation at the time of hysterectomy has any influence on ovarian blood flow or ovarian reserve. another point to be considered is the occurrence of post-hysterectomy carcinoma in the preserved fallopian tube, theoretically, these cases could be prevented if tubal excision is performed during hysterectomy the study compares the effect of bilateral salpingectomy associated with conservative hysterectomy on ovarian function to the standard hysterectomy with conservation of both ovaries and tubes in terms of hormone assays, ovarian ultrasound evaluation, complications, quality of life. impact of treatments on ovarian reserve are tested by measuring amh at baseline and 3 days, 6 weeks and 6, 12 months after surgeries. quality of life is also assessed at these time points, with a questionnaire (women health questionnaire whq).

Eligibility criteria:
inclusion criteria: * age ≥ 18 years and less than 52 years * indication of a conservative hysterectomy for benign disease * signed informed consent * non menopausal women (amh \>0,21 ng/ml) exclusion criteria: * pregnancy * desire of future pregnancy * menopausal status * patient unable to give informed consent * any physical or psychiatric condition that could impair with patient's ability to cooperate with post operative data collection * previous salpingo and /or oophorectomy (unilateral or bilateral) * genital cancer disease or atypical endometrial hyperplasia * hyperandrogenia * any ovarian mass that needs surgical exploration * any immunotherapy that could interfere with immunological tests
pregnancy and fibrinogen disorders

Conditions: Hypofibrinogenemia, Congenital; Afibrinogenemia, Congenital; Dysfibrinogenemia, Congenital

Summary: the aim of this observational study is to evaluate the prevalence of uncomplicated pregnancies in women suffering from congenital fibrinogen disorders (i.e, hypofibrinogenemia, dysfibrinogenemia, hypodysfibrinogenemia) as well as to describe pregnancies outcomes in such diseases.

women with quantitative or qualitative fibrinogen disorders are often more prone to obstetrical complications, from bleeding to recurrent miscarriages or thrombosis. data on fibrinogen levels variations throughout the pregnancy and on the delivery management are lacking. in this observational study will be include adult women with pas obstetrical history. a general questionnaire on demographics and clinical data will be filled out by the patient's physician. a detailed questionnaire on obstetrical data will also be completed contacting the patient in case of lacking data.

Eligibility criteria:
inclusion criteria: * inherited fibrinogen disorders (hypofibrinogenemia, dysfibrinogenemia, hypodysfibrinogenemia) * at lest one past pregnancy * adult exclusion criteria: * no past pregnancy * not confirmed fibrinogen disorder

Keywords: pregnancy obstetric miscarriage haemorrhage fibrinogen
alemtuzumab and cyclosporine for the prevention of graft vs host disease after stem cell transplants

Conditions: Graft Versus Host Disease; Bone Marrow Transplantation

Summary: graft versus host disease (gvhd) is one of the common complications after stem cell transplant. this is a complication, which happens when the new stem cells from the donor attack other cells in the body of the transplant recipient. recently, an antibody (protein) called alemtuzumab or campath has been found to be effective in the prevention of graft vs. host disease. previous studies have shown a low risk of gvhd with alemtuzumab, however the risk of disease recurrence was high. previous studies have used a high dose of alemtuzumab. the purpose of this study is: * to find if by lowering the dose of alemtuzumab, can serious gvhd be prevented without increasing the risk of relapse (your condition getting worse). * to find whether low dose of alemtuzumab in combination with cyclosporine can prevent gvhd more effectively when compared to current standard of care and does not increase the risk of recurrence.


Eligibility criteria:
inclusion criteria: * diagnosis of a hematological malignancy * peripheral blood as source of stem cells * able to give informed consent * availability of 6/6 matched sibling donor * fit for transplant using a conventional or reduced intensity approach exclusion criteria: * ast/alt \>3 x iuln at the time of transplant * serum creatinine \> 1.5 x iuln at the time of transplant * prior allogeneic transplant * syngeneic donor * active uncontrolled infection * hiv positive * pregnancy at the time of bmt

Keywords: graft versus host disease alemtuzumab campath bone marrow transplants
multimodal imaging in pre-surgical evaluation of epilepsy

Conditions: Partial Epilepsy

Summary: epilepsy is the most common chronic neurological disorder in the world, affecting more than 50 million people worldwide. approximately 35% of patients with epilepsy are refractory to all available antiepileptic drugs. drug-resistant epilepsies are often partial or focal. patients with drug-resistant focal epilepsy suffer from an increased risk of death, primarily due to seizure-related fatalities, in comparison with the general population. the only therapeutic option for this form of epilepsy is the surgical removal of the region of the brain responsible for seizures, called the epileptogenic zone (ez). this requires the precise localization of the ez based on a comprehensive pre-surgical evaluation of patients. today the gold standard for localizing the ez and validating a non-invasive technique for localization of the ez remains intracerebral stereo-eeg (stereo-electroencephalography or seeg) recordings of spontaneous seizures. the implementation strategy of the intracerebral depth electrodes is guided by clinical and neuroimaging data, including anatomical magnetic resonance imaging (mri), positron emission tomography (pet) with fdg (fluoro-deoxy-glucose) and magnetoencephalography (meg). although the contribution of each technique in the pre-surgical localization of the ez has already been shown, no wide-scale study has examined the cumulative contribution of these three techniques.

the purpose of this study is (i) to evaluate rigorously the diagnostic value of multimodal imaging for non-invasive localization of the ez and (ii) to better target the indications for intracerebral recordings (seeg).

Eligibility criteria:
inclusion criteria: * patient with drug-resistant focal epilepsy * candidates for pre-surgical evaluation including fdg pet, mri, meg and seeg recordings. * age 18-65 years * eeg-confirmed focal epilepsy for \>2 years * signed informed consent form. exclusion criteria: * age \ 65 years * contraindication to the mri * pregnant woman * head size incompatible with meg recordings * adult subject to legal protection measure.

Keywords: focal epilepsy pre-surgical evaluation multimodal imaging seeg