Kornimate/medical-research-clean huggingface dataset:
iyengar yoga for prolonged grief disorder

Conditions: Prolonged Grief Disorder

Summary: experiencing the death of a loved one is inevitable for older adults. before the coronavirus disease 2019 (covid-19) pandemic, over 2.5 million people died annually in the united states, including 52,000 in wisconsin alone, and covid-19 has added to this toll. each person who dies leaves an average of five grieving people behind. most grieving older adults are resilient and recover their pre-loss functioning within one year. however, in about 10%, acute grief becomes protracted and debilitating, leading to the development of prolonged grief disorder (pgd), a clinically diagnosable mental health condition. pgd in older adults increases the risk for poorer medical, mental health, and cognitive outcomes; lower quality of life; disability; premature mortality; and suicide. despite the magnitude of this problem, the neurobiology of pgd in older adults is poorly understood. by using iyengar yoga (iy) as a probe for pgd neurobiology, this pilot project aims to address this critical gap.

our goal is to conduct a pilot study to examine in pgd the modulating effects of 10-week iy on circulating endocannabinoid and emotion processing brain circuit, and the associations between biological changes and clinical response.

Eligibility criteria:
inclusion criteria: * male or female greater than or equal to 40 years of age * bereavement \>6 months * score greater than or equal to 25 on the inventory of complicated grief (icg) * presence of pgd (subsyndromal and syndromal) * adequate visual and auditory acuity exclusion criteria: * delirium/unstable medical conditions * lifetime history of neurological illnesses: seizures, stroke, dementia of any etiology, severe head injury, brain tumor or surgery * serious back, joint or neck injuries within the past 3 months * currently practicing yoga * gross structural abnormalities on t1-weighted images * lifetime history of the following psychiatric disorders: bipolar or psychotic disorders, including psychotic depression * current alcohol/drug abuse or dependence * magnetic resonance imaging (mri) contraindications * acute suicidality
a multicenter phase 2 study of ci-1040 in patients with advanced nonsmall-cell lung, breast, colon and pancreatic cancer

Conditions: Colorectal Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Pancreatic Neoplasms

Summary: ci-1040 is an experimental drug that is being tested in patients who have advanced colorectal and lung cancer who failed no more than one prior chemotherapy regimen, breast cancer who have failed no more than 2 prior regimens and in patients with pancreatic cancer who have received no prior chemotherapy. ci-1040 is taken orally twice daily with meals. patients are required to have blood tests periodically while receiving treatment and will be monitored closely throughout the trial for possible side effects and for response.


Eligibility criteria:
inclusion criteria: * patients who are at least 18 years or older who have pathological or hiostological confirmation of colorectal, nonsmall cell lung cancer, breast, or pancreas cancer. * no more than 1 prior chemo for lung or colon cancer, no more than 2 for breast no prior chemotherapy for pancreas cancer. * original or recent tumor tissue must be available. * patients must have been off prior chemoptherapy for 4 weeks and radiation for 3 weeks. * patients must have adequate renal, liver, and bone marrow function, not have serious infection or life-threatening illness (unrelated to tumor). * must be able to swallow capsules and not have gastrointestinal disorders that may affect absorption of the drug. exclusion criteria: * unstable medical condition * prior chemotherapy within 4 week of screening * series infection * other tumor types * ecog performance status of 3 or 4.
extension to the study of efficacy of cdz173 in patients with apds/pasli

Conditions: Activated PI3Kdelta Syndrome (APDS); PASLI Disease

Summary: this study is designed to provide long-term cdz173 treatment, a selective pi3kδ inhibitor, to the patients with genetically activated pi3kδ, i.e., patients with apds/pasli who participated in the ccdz173x2201 study or who were treated previously with pi3kδ inhibitors other than cdz173. the study is open-label designed to establish the long-term safety, tolerability, efficay and pharmacokinetics of cdz173 in the target population.


Eligibility criteria:
inclusion criteria: * written informed consent must be obtained before any assessment is performed. * paients must have participated in the study ccdz173x2201 or were treated previously with pi3kδ inhibitors other than cdz173. * patients who are deemed by the investigator to benefit from pi3kδ inhibitor therapy. * patients or their legal representatives (for patients under the age of 18 years) must be able to communicate well with the investigator, to understand and comply with the requirements of the study. * documented apds/pasli-associated genetic pi3k delta mutation. exclusion criteria: - any medically significant disease or condition that is unrelated to apds/pasli other protocol-defined inclusion/exclusion criteria may apply.

Keywords: apds; pasli; pi3kdelta; p110delta-activating mutation causing senescent t cells, lymphadenopathy and immunodeficiency; activated pi3kdelta syndrome;
cryoablation combined with tislelizumab and chemotherapy as neoadjuvant and adjuvant therapy in resectable stage ii-iiib nsclc

Conditions: NSCLC (Non-small Cell Lung Cancer)

Summary: this is a phase ii single-arm study designed to evaluate the efficacy and safety of cryoablation combined with tislelizumab and platinum-based doublet chemotherapy as neoadjuvant therapy, followed by adjuvant tislelizumab therapy in patients with resectable stage ii-iiib non-small cell lung cancer (nsclc). the study consists of a screening phase, a treatment phase (including the neoadjuvant stage, surgery, and adjuvant stage), a safety follow-up period, and a survival follow-up period.


Eligibility criteria:
inclusion criteria: * aged ≥18 years at informed consent signing. * ecog performance status of 0 or 1. * histologically confirmed stage ii-iiib nsclc (ajcc 9th edition). * tumor size ≤5 cm. * deemed suitable for r0 resection by a thoracic surgeon for radical treatment. * adequate cardiopulmonary function for radical surgical resection. * eligible for cryoablation and platinum-based doublet chemotherapy. * adequate blood and organ function, as per laboratory tests within 14 days before enrollment. exclusion criteria: * prior treatment for current lung cancer, including chemotherapy or radiotherapy. * lcnec diagnosis. * known egfr mutations or alk translocations. for non-squamous nsclc, egfr mutation status must be confirmed locally or centrally if unknown. for squamous nsclc, egfr testing is not required if status is unknown. alk translocation testing is not required if status is unknown. * locally advanced, unresectable disease, regardless of stage or metastasis (stage iv). patients with mediastinal lymph node involvement on ct must undergo sampling for clinical staging to exclude stage iiib/c. * history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled pulmonary fibrosis. * severe chronic or active infections requiring systemic antimicrobials, including tuberculosis. * hospitalization for severe infections within 4 weeks before enrollment. systemic antibiotic treatment within 2 weeks before enrollment. * active autoimmune disease or history of recurrent autoimmune disease. * exceptions: well-controlled type 1 diabetes, hypothyroidism on hormone replacement, celiac disease, skin conditions not requiring systemic therapy, or diseases unlikely to recur without provocation. * severe infections requiring systemic treatment within the past 4 weeks. * corticosteroid or immunosuppressive use within 14 days before enrollment, except for specific local, topical, or short-term uses.

Keywords: ii-iii nsclc neoadjuvant adjuvant pathological complete response
effect of child preference for parental selection during induction

Conditions: Anxiety State; Child Behavior

Summary: induction of anesthesia can be distressing both for children and their parents. nonpharmacological behavioral interventions can reduce the anxiety of children without significant adverse effects as seen with sedative drugs. has not been documented. the aim of this study will be to evaluate the effect of children's preference on parental selection during the induction of anesthesia on children and parental anxiety during the perioperative period.

anesthetic induction can be one of the most stressful experiences for the child during the perioperative period, with almost 50% of the children showing significant anxiety. . to minimize the effect of anxiety, several methods have been adopted, such as the introduction of day-case surgery, parental presence at the induction of anesthesia, distractions and the use of pharmacological agents like midazolam to reduce anxiety. although the effect of parental presence on the anxiety of children and parents was studied in various studies. whether the children's choice of parental selection affects anxiety is not studied yet. in this study, we will evaluate the anxiety of children by using mypas .

Eligibility criteria:
inclusion criteria: * 80 children of both sex, aged 4-15 years with asa physical status i-ii will be enrolled exclusion criteria: 1. mentally challenged 2. deaf child 3. cerebral palsy 4. premedicated child 5. language problem 6. unco-operative 7. previous surgery or anesthesia history

Keywords: day- case surgery anxiety children
a research study looking into blood levels of the medicine nnc0487-0111 in the body and how well it is tolerated in participants with reduced kidney function and normal kidney function

Conditions: Diabetes Mellitus, Type 2; Obesity; Overweight

Summary: novo nordisk is developing the study medicine nnc0487-0111 to treat people living with type 2 diabetes and/or people living with overweight or obesity. the aim of this study is to see if blood levels of nnc0487-0111 are the same in people living with various degrees of reduced kidney function as for people with normal kidney function. participants will be given one single injection by the study staff in a skinfold in their stomach using a pen device (novopen®4).


Eligibility criteria:
inclusion criteria: * male or female, aged 18-80 years (both inclusive) at the time of signing the informed consent * body mass index (bmi) between 20.0 and 39.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening. * meeting the pre-defined egfr values based on the chronic kidney disease epidemiology collaboration (ckd-epi) creatinine equation (2021) adjusted for the estimated individual body surface area (bsa); * normal renal function - greater than or equal to 90 ml/min * mild renal impairment - 60 - 89 (ml/min) * moderate renal impairment - 30 - 59 (ml/min) * severe renal impairment - less than 30 (ml/min) not requiring dialysis * end-stage renal disease (esrd) - requiring dialysis treatment * for esrd: participants requiring dialysis treatment should be on current treatment with haemodialysis. exclusion criteria: * any disorder, unwillingness, or inability which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol. * use of drugs known to affect creatinine clearance including cephalosporin and aminoglycoside, antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim, cibenzoline, and nitrofurantoin within 14 days or 5 half-lives, whichever is greater, before dosing the investigational medicinal product (imp). * presence or history of any clinically relevant respiratory, metabolic, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions(except conditions associated with renal impairment or esrd).
sonovue guided prostate biopsy

Conditions: Prostate Cancer

Summary: this is a phase iii european multicenter, open label, prospective study to assess the diagnostic accuracy of the use of sonovue contrast agent to guide prostate biopsies in comparison with the current practice of ultrasound guided systematic biopsy. the trial will involve 15-20 european centers.


Eligibility criteria:
inclusion criteria: * male patient, age ≥ 40 years old * optimization part only: diagnosis of prostate cancer * main part: suspected prostate cancer scheduled for first biopsy and tpsa ≤ 10 ng/ml or already submitted to one systematic bioptic procedure with negative results currently under follow up procedure due to a persistent indication. * written informed consent and willing to comply with protocol requirements exclusion criteria: * documented acute prostatitis or urinary tract infections * known allergy to sulphur hexafluoride micro bubbles * any clinically unstable cardiac condition within 7 days prior to sonovue® administration such as: * evolving or ongoing myocardial infarction * typical angina at rest within the previous 7 days * significant worsening of cardiac symptoms within the previous 7 days * recent coronary artery intervention or other factors suggesting clinical instability (e.g., recent deterioration of ecg, laboratory or clinical findings) * acute cardiac failure, class iii/iv cardiac failure * severe cardiac rhythm disorders * right-to-left shunts * severe pulmonary hypertension or uncontrolled systemic hypertension or respiratory distress syndrome * bioptic procedure within 30 days before admission into this study (this exclusion criterion is only for the main part of the study) * determined by the investigator that the patient is clinically unsuitable for the study * participation in a concurrent clinical trial or in another trial within the past 30 days * repeated participation in this trial (the patient should not be enrolled twice in the present study)

Keywords: prostate cancer biopsy guided contrast enhanced sonovue suspicion of prostate cancer
fecal microbiota transplantation as a potential treatment for parkinson's disease

Conditions: Parkinson Disease

Summary: this pilot study aims to further explore the potential usage of fecal microbiota transplantation in treating constipation and possibly also motor symptoms in parkinson's disease (pd) patients, and to increase understanding of the potential relationship between the identities of intestinal microbial communities and pd.

fecal microbiota transplantation (fmt) is a technique in which intestinal microbiota are transferred from a healthy donor to the patient, with as primary goal to introduce - or restore - a stable and 'healthy' microbial community in the gut. parkinson's disease (pd) is a neurodegenerative disorder characterized by motor symptoms and gastrointestinal dysfunction, in particular constipation, affects up to 80% of pd patients and may precede the onset of motor symptoms by years. this study include one group of pd patients that will receive fmt. two other groups will serve as controls: 1. pd patients that will not receive fmt 2. healthy people who live with pd patients in the same house and share similar surrounding

Eligibility criteria:
inclusion criteria: * subjects aged \> 50 years, diagnosed as suffering from pd and under follow up of the movement disorders clinic in soroka university medical center. * subjects complaining of constipation . * subjects who did not perform a screening colonoscopy for colon cancer. * subjects who are clinically undertreated according to last movement disorders specialist's impression at the clinic visit. exclusion criteria: * subjects who do not complain of constipation or seem clinically stable properly treated pharmacologically. * subjects who already underwent a screening colonoscopy for colon cancer. * subjects who suffer from a cognitive decline and could not give their consent, or patients who refuse to undergo a colonoscopy.
detection of the prevalence of silent atherosclerosis across adult life

Conditions: Atheroslerosis

Summary: atherosclerosis is preventable, yet it continues to significantly contribute to global morbidity and mortality. atherosclerosis may occur early in life and may present in all vascular territories. the detect study's main aim is to determine the prevalence of asymptomatic atherosclerosis (silent) in an adult population of a wide age range of european ancestry through vascular ultrasound (vus) of peripheral arteries (carotid and femoral territories), as well as establishing the relationship between atherosclerosis in peripheral arteries, coronary arteries, and other vascular territories assessed by computed tomography angiography (cta). the detect study also aims to identify risk factors for development of subclinical atherosclerosis that can hopefully improve the detection of the risk for development of atherosclerotic cardiovascular disease (ascvd) with far higher precision than currently. in future research, the findings in this descriptive study may eventually be used as part of an age-adapted imaging-based screening for subclinical atherosclerosis. the investigators hypothesize that a precision medicine-based approach to identify candidates likely to benefit from primary prevention against atherosclerosis, may improve medical decision making, by combining traditional risk factors, including lifestyle and psychological factors, phenotypic findings and findings on vascular imaging, and patterns of circulating biomarkers to identify risk of atherosclerosis especially in young individuals and at earlier disease stages (the ultimate population target of react project, phase ii), maximizing the potential for prevention long before overt disease occurs. an essential aspect of this approach is to pinpoint the specific risk factors in each individual that primarily drive atherosclerosis throughout their life and could serve as therapeutic targets. thus, the overall purpose of this study is to establish the necessary knowledge, including extensive characterisation of atherosclerosis across life and thus add to the rational foundation for future development of a far more efficient and precise prophylaxis against ascvd as compared with the presently applied methods.


Eligibility criteria:
inclusion criteria: * the study will include adults ≥18 to ≤70 years of age (1:1 sex ratio in each 10 years age strata). * have not been diagnosed with ascvd prior to inclusion into the study (participants with other cardiovascular diseases or predisposing factors are not excluded). * the participants will be recruited from sites in denmark (n \~ 8,000) (and spain (n \~ 8,000)). * participants need to be capable and be able to read and understand danish, english, spanish or arabic. exclusion criteria: * the participants will be excluded from the cta with contrast if they have severe renal disease (egfr \<30 ml), contrast allergies, pregnancy or other conditions excluding the performance of a ct-scan.
extensive small cell lung cancer treatment using an investigational drug plus chemotherapy in chemotherapy-naive adults

Conditions: Small Cell Lung Cancer

Summary: this study will gather and compare data about the effectiveness and safety of two different treatments for extensive small cell lung cancer (sclc) in patients who have not received previous chemotherapy. one treatment will use an investigational drug in combination with an fda approved chemotherapy. the other treatment will use a combination of two fda approved chemotherapy drugs.


Eligibility criteria:
inclusion criteria: * written informed consent (patient's written understanding of and agreement to participate in this study). * patients with confirmed extensive small cell lung cancer (sclc). * no prior chemotherapy within 5 years of the diagnosis of sclc. * presence of either measurable or non-measurable sclc by x-ray or physical examination. * at least 3 weeks since last major surgery (a lesser period is acceptable if decided to be in the best interest of the patient). * at least 24 hours since prior radiotherapy. patients who have received radiotherapy must have recovered from any reversible side effects, such as nausea and vomiting. * laboratory criteria: patients must have adequate bone marrow reserve and adequate kidney and liver function. exclusion criteria: * symptoms of spreading of the disease to the brain that requires treatment with drugs called steroids. * any active infection. * severe medical problems other than the diagnosis of sclc, that would limit the ability of the patient to follow study guidelines or that would expose the patient to extreme risk. * ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of sclc. * use of an investigational drug within 30 days before the first dose of study medication. * women who are pregnant or lactating. * patients of child-bearing potential who refuse to practice an adequate form of birth control. * patients with clinical evidence of any stomach or intestinal (gi) condition. * patients requiring treatment with the drug cyclosporin a.

Keywords: chemotherapy-naive small cell lung cancer sclc extensive disease ed topotecan hycamtin oral
efficacy of a whitening dentifrice on tooth discoloration

Conditions: Tooth Discoloration

Summary: the purpose of this study was to compare the whitening effect of a toothpaste containing blue pigment with a conventional toothpaste and with at-home tooth bleaching; evaluate the subject's perception about tooth color improvement and; and evaluate the safety and acceptability of these products.

the study was approved by local ethical committee under protocol number caae: 035541412.7.0000.5188, and each volunteer signed an informed consent form prior to enrollment in the study. the sample size calculation was carried out based on a previous study. to detect the bleaching effect with a power of 80% and a one-tailed alpha error of 5%, a sample size of 20 subjects in each treatment group was necessary to detect a 20% difference between groups in shade change. a 20% addiction in subjects' number, taking into consideration potential loss or refusal, gave a total sample size of 75 subjects (25 in each group). the individuals were invited to participate in this clinical trial through advertisement exposed at the federal university of paraíba, brazil. basing on eligibility criteria, 75 volunteers were selected to the trial and randomized to one of the three groups of treatment: g1- brushing teeth with a conventional toothpaste; g2- brushing teeth with a silica whitening dentifrice containing blue pigment; and g3 - at-home tooth bleaching with 10% carbamide peroxide. the treatments will be detailed in another section. it was used a simple randomization to allocate the subjects, and a randomization table was prepared in the excel program by a member, not directly involved with the clinical part of the study. to mask the products used in the treatment groups, each toothpaste type was enveloped with an adhesive tape of a different color and the seal of the bleaching gel syringe was removed. the same examiner responsible for subject allocation did this procedure. thus, testing with the toothpastes was double-blinded, where both evaluator and subject did not know which toothpaste was being used. the outcomes evaluated were: tooth shade, subjects' perception about tooth color appearance, and safety and acceptability of products tested, which were measured at baseline, 2-weeks, 3-weeks and 4-weeks of the beginning of treatments. for statistical analysis, data were checked for normal distribution using the kolmogorov smirnov test, and then it was applied the appropriated parametric or non-parametric tests. differences were considered statistically significant when p \< 0.05.

Eligibility criteria:
inclusion criteria: * to have six maxillary anterior teeth with a mean shade of c1 or darker (vitapan classical, vita zahnfabrik, bad sackingen, germany), exclusion criteria: * with active caries or periodontal disease, * presenting non-vital anterior teeth, * previous hypersensitivity, * under orthodontic treatment, * with structural defect in the enamel, * who had used tooth whiteners within the previous 3 years, * smokers, * pregnant or lactating

Keywords: tooth discoloration toothpaste tooth bleaching clinical trial