Kornimate/medical-research-clean huggingface dataset:
non-pharmacological treatment of insomnia in nursing homes.

Conditions: Insomnia

Summary: the study wants to examine the feasibility of a non-pharmacological approach for insomnia in nursing homes provided by trained nurses/paramedics and physicians.


Eligibility criteria:
inclusion criteria: * male and female nursing home residents of age 55+ with insomnia, defined as difficulty in getting to sleep, difficulty in staying asleep, early wakening, or non-restorative sleep exclusion criteria: * insufficient cognitive ability for self-reflection * dementia * insomnia caused by a medical disorder (hyperthyroidism, congestive heart failure, peripheral arterial disease, gord, copd/asthma, angina pectoris, benign prostatic hyperplasia, arthritis, other * insomnia caused by medication * substance misuse * other sleep disorder: restless legs syndrome, periodic limb movement disorder, sleep apnoea, narcolepsy * psychiatric disorder: psychotic or bipolar disorder in anamnesis, major depression present or more than 2 episodes in anamnesis * short stay

Keywords: insomnia
study of talazoparib, a parp inhibitor, in patients with advanced or recurrent solid tumors

Conditions: Advanced or Recurrent Solid Tumors; Breast Neoplasms; Ovarian Cancer, Epithelial; Ewing Sarcoma; Small Cell Lung Carcinoma; Prostate Cancer; Pancreas Cancer

Summary: this is a single-arm, open-label study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of talazoparib in patients with advanced tumors with dna-repair pathway deficiencies. there will be 2 parts to the study: a dose escalation phase in which the maximum tolerated dose will be defined, and a dose expansion phase.


Eligibility criteria:
inclusion criteria: * histologically or cytologically documented, unresectable, locally advanced or metastatic solid tumor * must have available archived tumor tissue (formalin-fixed paraffin-embedded) \[ffpe\]. * 18 years of age or older. * have measurable disease by response evaluation criteria in solid tumors (recist, v1.1) or increased ca-125 (ovarian cancer) or psa (prostate cancer) and/or ca 19-9 (pancreatic cancer). * eastern cooperative oncology group (ecog) performance status ≤ 1. * have adequate organ function * able to take oral medications. * willing and able to provide informed consent. * sexually active patients must be willing to use an acceptable method of contraception. * females of childbearing potential must have a negative serum pregnancy test at screening. * willing and able to comply with all study procedures. part 2 dose expansion tumor types: * breast and ovarian cancer patients with deleterious or pathogenic brca mutations who have received no more than 4 prior regimens for metastatic disease. * prostate or pancreatic cancer patients with deleterious or pathogenic brca mutations who have received no more than 2 prior regimens for metastatic disease. * small cell lung cancer (sclc) patients who have received no more than one prior regimen for sclc. * ewing's sarcoma patients who have received no more than 3 prior regimens for metastatic disease. exclusion criteria: * part 2 expansion: prior treatment with a parp inhibitor. * has history of central nervous system (cns) metastasis. \* exception: in patients with sclc, history of adequately treated brain metastasis who do not require corticosteroids for management of cns symptoms. * has had major surgery within 28 days before cycle 1, day 1. * has active peptic ulcer disease. * active gastrointestinal tract disease with malabsorption syndrome. * pregnant or breastfeeding at screening or planning to become pregnant (in each case, either oneself or one's partner) at any time during the study.

Keywords: brca1 protein brca2 protein
virtual peer-to-peer (vp2p) support mentoring for chronic pain: a pilot rct

Conditions: Chronic Pain

Summary: study hypothesis: a virtual peer-to-peer support intervention will improve health outcomes and quality of life in adolescents with chronic pain.

the aim of this project is to develop and examine the impact of a virtual peer support program on health outcomes and quality of life of adolescents with chronic pain using a waitlist randomized controlled trial. in addition to standard medical care, adolescents in the experimental group will receive a manualized peer mentorship program that will provide modeling and reinforcement by trained young adults aged 16-25 years who have learned to function successfully with their pain. mentoring sessions consist of 10 sessions of 30-45 minute skype calls over 8 weeks. feasibility of the program will be measured in addition to quality of life, physical and emotional symptoms, pain coping, self-efficacy, social support, and self-management skills.

Eligibility criteria:
inclusion criteria: * males and females 12-18 years old * diagnosed chronic pain condition (e.g., neuropathic pain, complex regional pain syndrome, chronic musculoskeletal pain, chronic daily headache, chronic widespread pain) * able to speak and read english * access to internet connection, computer capable of using free skype software * willing and able to complete online measures. exclusion criteria: * significant cognitive impairments * major co-morbid illnesses (i.e., psychiatric conditions) likely to influence hrql assessment * participating in peer support or self-management interventions (e.g., webmap).

Keywords: adolescent skype peer mentorship internet self-management
electrical optimization of cardiac resynchronization therapy in non-responder patients

Conditions: Heart Failure; Cardiac Resynchronization Therapy

Summary: cardiac resynchronization therapy (crt) is an established treatment for patients with systolic heart failure and bundle branch block, improving functional capacity, quality of life and reducing morbi-mortality. however, one-third of patients are non-responders. among factors associated with non-response, suboptimal electrical settings of the device, i.e. inadequate pacing vector selection and atrioventricular (av) delay, is an important cause. the aim of the study is to investigate whether the optimization of crt settings (pacing vector and av delay) results in improved clinical and echocardiographic outcomes in a non-responder crt population after 6 months of therapy.

this study is non-randomized, prospective, interventional, multicentric study. patients who have been implanted with a crt device between 6 and 18 months prior to inclusion and are considered non-responders are eligible for this study. crt non-response can be clinical (lack of functional improvement or hospitalization for heart failure) and/or echocardiographic (insufficient improvement of lvef and/or reduction of lvesv). among exclusion criteria, permanent atrial fibrillation is of note. recruited patients will be submitted to an optimization procedure of their crt device settings. this will be performed with a non-invasive method using the finapress nova device, which records blood pressure with a digital cuff. the peak of blood pressure will correspond to the optimal device settings. the first step will be to chose the best pacing vector. the second step will be to chose the best av delay. the best setting, i.e. associated with the highest blood pressure, will be programmed at the end of the optimization protocol. the patients will be followed at 6 months with clinical evaluation and echocardiography to assess the conversion rate of non-responders to responders.

Eligibility criteria:
inclusion criteria: * patient older than 18 * patient implanted with a crt (crt-p or crt-d) more than 6 months but less than 18 months before inclusion * non-responder patients: clinical criteria (packer classification): lack of improvement of nyha functional class and/or hospitalization for heart failure echocardiographic criteria: lack of improvement of lvef \> 5points and/or reduction of lvesv \< 15% * patient who had signed an informed consent and is willing to comply with study requirements * patient covered by french national healthcare insurance exclusion criteria: * permanent/persistant atrial fibrillation/ supra-ventricular tachycardia * scheduled hospitalization for major cardiac intervention or cardiac surgery in the 6 coming months * life-expectancy of less than 6 months * pregnant or breastfeeding women * adults under legal protection

Keywords: cardiac resynchronization therapy non-responders pacing vector optimization atrioventricular delay optimization non invasive hemodynamic optimization heart failure
paracervical block during office hysteroscopy

Conditions: Paracervical Block

Summary: the purpose of this study is to determine the effectiveness of paracervical block for pain relief in office hysteroscopy - particularly with the placement of the essure device. subjects will be randomized to receive either paracervical block or saline, and will have pain assessments performed throughout the procedure. subjects and physicians will be blinded to group assignments.


Eligibility criteria:
inclusion criteria: * women eligible and scheduled for office hysteroscopic placement of essure devices exclusion criteria: * planned secondary procedures * lidocaine allergy * repeat procedures

Keywords: hysteroscopy pain medication lidocaine office procedures
safety study of a vaccine against meningitis in infants (2,4 & 6 months age) after a birth dose of hepatitis b.

Conditions: Hepatitis B; Diphtheria; Whole Cell Pertussis; Tetanus; Haemophilus Influenzae Type b

Summary: the purpose of this study is to compare the reactogenicity \& safety of tritanrix™-hepb/hib-menac vaccine to the international standard of care, tritanrix™-hepb/hiberix™.

randomized study with four groups to receive one of the following vaccination regimens after a dose of hepatitis b vaccine given at birth: * one of the 3 lots of gsk biologicals' hib-menac mixed with gsk biologicals' tritanrix™-hepb (3 different groups) * gsk biologicals' tritanrix™-hepb/hiberix™

Eligibility criteria:
inclusion criteria: • healthy infants 56-83 days of age at the time of the first vaccine dose, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks \& has received a birth dose of hepatitis b vaccine within the first 3 days of life. exclusion criteria: * any confirmed immunodeficient condition, based on medical history and physical examination. * planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period with the exception of oral polio vaccine (opv). * use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. * bacille calmette-guérin (bcg) vaccine received after the first 2 weeks of life. * previous vaccination against diphtheria, tetanus, pertussis, haemophilus influenzae type b, and/or meningococcal disease. * history of diphtheria, tetanus, pertussis, hepatitis b, haemophilus influenzae type b and/or meningococcal disease or known exposure to these diseases since birth. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
a study of family-integrated care for reducing uncertainty

Conditions: Premature Infant

Summary: to explore the intervention effect of family participatory nursing on the uncertainty of illness of parents of hospitalized premature infants, and to evaluate the uncertainty level of parents of premature infants in different stages. the study will be described the feeling of parents of premature infants after family participation nursing through interview. we will provide support for families of premature infants, and then to provide support for growth and development of premature infants.

most of the current management mode of restricting or forbidding visiting in neonatology, parents can not establish the perception of premature infants and lack of communication with medical staff, which will lead to negative emotions represented by uncertainty of disease.the research on uncertainty of disease started late in china, mostly used in tumor, epilepsy and congenital heart disease. the research on parents of nicu children mostly focused on the analysis of influencing factors of uncertainty of disease, lacking intervention research, and the measures were only the information support mode based on health education. we want to explore the intervention effect of family participatory nursing on the uncertainty of illness of parents of hospitalized premature infants, and to evaluate the uncertainty level of parents of premature infants in different stages. describe the feeling of parents of premature infants after family participation nursing through interview. we will provide support for families of premature infants, and then to provide support for growth and development of premature infants.

Eligibility criteria:
inclusion criteria: children: * 32 weeks \< gestational age \< 37 weeks * birth weight ≤ 2500g * apgar score \> 7 * transferred to our hospital within 8 hours after birth parents: * have normal communication ability and understanding ability * agreed to participate in this study exclusion criteria: children: -with serious life-threatening diseases, the neonatal critical cases score (discussion draft) was rated as "extremely critical" parents: -there are serious diseases or major negative events in the family (such as traffic accidents, natural disasters, etc.)
residual or recurrent obstruction after septal myectomy

Conditions: Hypertrophic Obstructive Cardiomyopathy

Summary: the goal of this observational study is to report the outcomes after septal myectomy in young children and infants and identify the mechanisms of residual or recurrent obstruction after surgery. in the main question\[s\] it aims to answer are: * what is the early and mid-term results of septal myectomy in young children and infants with severe and extensive obstructive hypertrophic cardiomyopathy (hcm)? * what are the mechanisms of residual or recurrent obstruction? echocardiography and clinical course of children and infants under the age of 14 who underwent septal myectomy for hypertrophic obstructive cardiomyopathy from january 2013 to december 2020 will be followed up.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of hypertrophic obstructive cardiomyopathy (hocm) * age young than 14 years * patients who have undergone septal myectomy exclusion criteria: * older than 14 years old; * secondary left ventricular hypertrophy (lvh) related to subaortic stenosis or aortic stenosis.

Keywords: septal myectomy residual or recurrent obstruction children and infants hypertrophic obstructive cardiomyopathy
study of recombinant human-mouse chimeric anti-cd20 monoclonal antibody to treat non-hodgkin's lymphoma

Conditions: Diffuse Large B Cell Lymphoma

Summary: cd20, the protein which is expressed on the surface of all mature b cells, is active in many b-cell lymphomas that express this molecule such as diffuse large b cell lymphoma (dlbcl), the most frequently occurring subtype of non-hodgkin lymphomas. in clinical practice, cyclophosphamide, doxorubicin, vincristine, and prednisone combination chemotherapy (chop) is still considered one of the standard treatment to dlbcl. cmab304(retuxira), the chimeric monoclonal antibody is designed to targeted against cd20 for treatment of lymphoma diseases. this trial aimed to observe the safety and efficacy of cmab304, by added cmab304 to chop chemotherapy regimen compared with chop chemotherapy alone.

rituximab, a chimeric anti-cd20 monoclonal antibody, has been proved valuable treatment for cd20-positive dlbcl. the combination of rituximab with chop has been shown to increase both survival and response rate, in comparison to chop alone. cmab304(retuxira), a biosimilar of rituximab, was developed by shanghai cp guojian pharmaceutical co.,ltd. previous phase i study showed that cmab304 was well tolerated as monotherapy and the pharmacokinetic data exhibited a non-linear profile over the dose range of 250 to 500 mg/m2. in this study, efficacy and safety of cmab304 were evaluated in dlbcl patients.

Eligibility criteria:
inclusion criteria: 1. age from 18 to 70 year, male or female 2. previously untreated 3. dlbcl patients with cd20-positive 4. lymphoma lesions can be measured and evaluated; spiral ct or mr evaluation of the lesion must be ≥ 1cm; measured by clinical examination or others must be ≥ 2cm 5. normal blood test, adequate liver and renal function; 6. ecog score 0\~2 7. life expectancy of greater than 3 months 8. no other malignancy treatment history, except cured carcinoma in situ of the cervix or squamous cell or basal cell skin cancer 9. signed icf exclusion criteria: 1. dlbcl transformed from other low-grade nhl types 2. primary central nervous system lymphoma, or primary gastrointestinal dlbcl 3. history of foreign protein allergies 4. abnormal liver and/or renal function 5. suspected or diagnosed central nervous system violation 6. serious infection or organic diseases 7. heart disease, heart failure, heart block above second degree, myocardial infarction occurred within six months 8. breastfeeding or pregnant 9. leukemia crisis or bone marrow metastases

Keywords: untreated, cd20-positive
testing the effectiveness of celecoxib in patients with painful sore throat

Conditions: Pharyngitis

Summary: we are proposing a study in which we utilize and augment the sore throat pain model to assess the analgesic effectiveness of celecoxib compared to placebo in patients with painful pharyngitis under randomized, double-blind, placebo-controlled conditions.


Eligibility criteria:
inclusion criteria: * the patient must have a diagnosis of pharyngitis with objective findings of tonsillo-pharyngitis. * the patient is willing to take "nothing by mouth" including inhaled treatments except trial medication during the two hours while at the site and following trial drug administration (e.g. not smoking, food, drink, candy, lozenges, chewing gum). the patient will be allowed food and drink between hours 2 and 24, but no other oral or inhaled treatments such as smoking, lozenges, chewing gum. after the two hour assessment, the patients will be allowed food and drink within one half-hour following any hourly evaluations sore throat. exclusion criteria: * the patient has used any analgesic/antipyretic within 1 dosing interval preceding administration of the first dose of trial medication. * the patient anticipates using any inhaled therapy including beta-agonists (e.g., ventolin) during the 24 hour trial period and, if used, has only used inhaled therapy on an intermittent basis in the week prior to the screening visit.

Keywords: sore throat acute pain
pharmacokinetics of insulin detemir in healthy volunteers from taiwan

Conditions: Diabetes; Healthy

Summary: this trial is conducted in asia. the aim of this trial is to investigate pharmacokinetics of insulin detemir in healthy taiwanese subjects.


Eligibility criteria:
inclusion criteria: * considered generally healthy upon completion of medical history and physical examination as judged by the investigator * body mass index (bmi) between 18 and 27 kg/m\^2, inclusive * fasting plasma glucose maximum 6.1 mmol/l * non-smoker or smoking maximum 5 cigarettes per day or the equivalent exclusion criteria: * participation in any other clinical trial involving other investigational products within the last 3 months * subject with a history of alcohol or drug dependence * subject with a first-degree relative with diabetes mellitus
safety, tolerability and pharmacokinetics of lnk01004 ointment in adults with atopic dermatitis.

Conditions: Atopic Dermatitis

Summary: the purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of lnk01004 ointment (0.3%, 1.0%, and 1.5%) vs vehicle twice daily (bid) in adults patients with atopic dermatitis.

this is a multicenter, randomized, double-blind, vehicle-controlled, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of lnk01004 ointment twice daily (bid) in participants with mild to moderate atopic dermatitis as compared with vehicle cream bid.

Eligibility criteria:
inclusion criteria: * participants were diagnosed with atopic dermatitis (ad) for at least 6 months. * participants with an investigator's global assessment (iga) score of 2 to 3 at screening and baseline. * participants with body surface area (bsa) of ad involvement, excluding the scalp, face, and intertriginous areas, of 3% to 20% at screening and baseline. * bmi of 18.0-30.0 kg/m2, with body weight ≥ 50 kg for man and ≥ 40 kg for woman. * be willing to comply with the study lifestyle restraints, e.g., no washing of the administered area within 6 hours of study drug administration, no sweaty exercise. exclusion criteria: * participants with a physical condition which, in the investigator´s opinion, might interfere with the assessment of atopic dermatitis or expose the patient to an unacceptable risk by study participation. * participants with current evidence of any acute skin infection with a history of recurrent or chronic severe skin infection. * participants with known allergies to components or excipients of the test drug. * participants who are pregnant, nursing, or planning a pregnancy during the study period. * systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable corticosteroids, mycophenolate mofetil, pde4 inhibitor) used for atopic dermatitis within 4 weeks or 5 half-lives of baseline (whichever is longer). * participants with the following hematologic abnormities at screening: * leukocytes \< 3.0 × 10\^9/l. * neutrophils \< lower limit of normal. * hemoglobin \< 10 g/dl. * lymphocytes \< 0.8 × 10\^9/l * platelets \< 100 × 10\^9/l. * alanine aminotransferase (alt) or aspartate aminotransferase (ast) ≥ 1.5 × upper limit of normal. * tbil ≥ 1.5 × uln, or uln \< tbil \< 1.5 × uln but judged by the investigator to be abnormal clinically significant;