Kornimate/medical-research-clean huggingface dataset:
couple hopes (helping overcome ptsd and enhance satisfaction)

Conditions: Posttraumatic Stress Disorder

Summary: posttraumatic stress disorder (ptsd) will be a severe problem in canada in the wake of covid-19, especially for military members, veterans, first responders, and healthcare workers (mvfh). however, gold standard face-to-face ptsd treatments do not meet current mvfh needs, which requires virtual interventions and minimal healthcare resources. recognizing the need for a virtual, low-resource ptsd intervention for mvfh with ptsd and their loved ones, the investigators developed couple hopes (helping overcome ptsd and enhance satisfaction). couple hopes is a secure, online self-help intervention for those with ptsd and their partners (www.couplehopes.com). however, mvfh are now particularly likely to be exposed to traumas related to covid-19. it is essential to identify if couple hopes is safe and helpful for couples involving mvfh with covid-19-related ptsd specifically. this project will therefore test the efficacy of couple hopes compared to a delayed waitlist control in 70 couples wherein one member is a mvfh with covid-19-related ptsd. the investigators will examine if couple hopes is helpful in improving ptsd symptoms and relationship satisfaction for such couples, and if it is more or less helpful to this end for these couples compared to those with other forms of trauma exposure. 70 couples including a mvfh with covid-19-related ptsd, will be randomly assigned to receive couple hopes or to a waitlist. ptsd symptoms and relationship satisfaction will be measured \~weekly during the intervention and one month after it. related problems (e.g., depression, anxiety, healthcare use) will be measured before, in the middle of, after, and one month after, the intervention.


Eligibility criteria:
inclusion criteria: * individual who is a canadian military member, veteran, first responder or healthcare worker with clinically significant levels of ptsd symptoms related to covid-19 * individual who is an american healthcare worker with clinically significant levels of ptsd symptoms related to covid-19 * must be willing to be audio-recorded for coaching sessions * intimate partner willing to participant and complete intervention modules together * access to high speed internet exclusion criteria: * elevated suicide risk * severe physical aggression between partners in the past year * clinically significant ptsd symptoms in both members of the dyad

Keywords: self-help internet-delivered intervention couple satisfaction covid-19 coronavirus
effect of cervical discharge removal during et on pregnancy rate

Conditions: Infertility

Summary: pregnancy rate may be affected by multiple factors such as embryo transfer techniques. even small differences in embryo transfer methods may affect pregnancy rates. there is an inconsistency about the effect of the removal of cervical discharge on embryo transfer outcomes. some studies showed that cervical mucus removal before embryo transfer can increase pregnancy rate, however the others could not find any significant effect about the removal of cervical mucus on pregnancy or live birth rates. given to the conflicting evidences, our study aimed to determine whether the cervical discharge removal has positive effect on pregnancy rate.

492 infertile women who were candidate for fresh embryo transfer during ivf/icsi cycles were eligible for this study if they had two or more good quality embryos. all categories of female or male factors infertility except uterine factor infertility were eligible for participation in the study. immediately prior to embryo transfer, women were randomly allocated to either treatment (cleaning the cervical canal) or control groups. in treatment group, excess mucus and debris were cleared from the cervical canal using a sterile cotton swabs. the cervical discharge was scored as mucosal, bloody, combination of mucosal and bloody, or infected. control group had no cervical cleaning before embryo transfer. then, the embryos were loaded into the transfer catheter by the embryologist and were deposited into the uterine cavity by one experience physician. the primary endpoint was clinical pregnancy. fertilization, implantation, abortion, and live birth rates were the other outcomes of interest or secondary outcomes.

Eligibility criteria:
inclusion criteria: * women who were candidate for fresh embryo transfer during ivf/icsi cycles were eligible for this study if they had two or more good quality embryos and age fewer than 40 exclusion criteria: * the patients with frozen-thawed embryo transfer cycle * those with oocyte donation cycle * the women with uterine abnormality * the women with submucosal and intramural myoma * who does not have good-quality embryos appropriate

Keywords: cervical mucus, embryo transfer, icsi cycle, pregnancy rate
e-health care process support for diabetes type ii patients

Conditions: Diabetes Mellitus Type II,

Summary: the purpose of the study is to clinically evaluate a new approach to treatment of patients with diabetes mellitus type ii by using specially developed mobile-internet software solution. the effect of information and communication technologies (ict) to improve the integrated care of people with diabetes will be identified, developed, introduced and clinically evaluated. the investigators expect that usage of an e-health application in health care of patients with diabetes mellitus type ii could improve the following healthcare outcomes: results of the laboratory tests (with emphasis on hba1c value), regular medication usage, blood pressure values, body mass index (bmi) values, diet, regular exercise and quality of life.

diabetes mellitus (dm) is defined as a "group of common metabolic disorders that share the phenotype of hyperglycemia". it is generally agreed that in caucasian populations the prevalence rate is between 2% and 6%. prevalence rate of dm in slovenia is about 5%. type 2 dm accounts for 90% to 95% of all diabetes cases. results of many clinical studies demonstrated the great potential of information and communication technology (ict) applications to improve health care of patients with chronic diseases including diabetes mellitus. in this study an ict mobile environment to improve the process of an integrated care of people with diabetes mellitus will be identified, developed, introduced and clinically evaluated. the study will include 140 patients diagnosed with diabetes mellitus type ii who are managed in primary care. the study will use and evaluation questionnaire that will cover issues regarding the patient quality of life. subjects with a blood pressure meter and a scale, will be able to enter the value of the systolic and diastolic blood pressure and the body weight. subjects will be motivated to regularly enter data about their blood pressure, body weight, dietary misconducts and to complete available questioners. in addition to this, users can enter values about their physical activity (type, duration, intensity).

Eligibility criteria:
inclusion criteria: * type 2 diabetes, treated with non-pharmacological interventions or/and tablets (non-insulin-dependent diabetes mellitus) * internet connection and personal computer /lap-top computer * mobile phone * sufficient level of internet and e-mail usage - checked by short questionnaire * age \>18 or \<75 years exclusion criteria: * significant co-morbidity * type 1 diabetes * insulin-dependent type 2 diabetes

Keywords: diabetes mellitus tip ii ehealth solution health information technology quality of life family medicine satisfaction with e-health care primary care
internet-delivered cognitive behavioral therapy following myocardial infarction

Conditions: Myocardial Infarction; Cardiac Anxiety; CBT; Exposure

Summary: myocardial infarction (mi) is one of the leading cause s of health loss globally, representing a large proportion of general disability. anxiety and depression occur in 20-30 percent of patients following mi and have been identified as risk factors for recurrent adverse cardiac event. the purpose of our this study is to develop and evaluate a disease specific cognitive behavioral therapy (c bt) protocol to reduce cardia anxiety, depression, increase physical inactivity and quality of life (q ol) in patients following mi

the study will include 30 patients. the mi-specific cbt lasts for 8 weeks and is therapist guided and delivered via internet via a secure digital platform by licensed psychologists expertise in cbt for cardiac disease or final year psychologist under supervision. during treatment, the psychologists will have direct access to a cardiologist assigned to the project and treatments are conducted in close interdisciplinary collaboration to ensure patient safety

Eligibility criteria:
inclusion criteria: ( - )mi ≥ 6 months before assessment ( - )age 18-75 years endorsed cardiac anxiety that leads to significant distress or interferes with daily life (cardiac anxiety questionnaire (caq); score ≥20) ( - ) on optimal medical treatment ( - )able to read and write in swedish. exclusion criteria: ( - ) heart failure with severe systolic dysfunction (ejection fraction ≤ 35%) ( - ) significant valvular disease ( - ) planned coronary artery bypass surgery or other invasive therapy ( - ) other severe medical illness ( - )any medical restriction to physical exercise ( - )severe psychiatric disorder, severe depression, or risk of suicide ( - )alcohol dependency
early kangaroo mother care in gambian hospitalised unstable neonates

Conditions: Preterm Infant; Hypothermia, Newborn; Death; Kangaroo Mother Care; Infection, Bacterial

Summary: the mortality effect of kangaroo mother care in stable newborns \<2000g is well established but mortality effect in unstable newborns is not conclusively known. this pragmatic clinical trial aims to investigate the mortality and clinical effects of early continuous kangaroo mother care (kmc) compared to standard care in mild-moderately unstable neonates \<2000g in a resource limited hospital setting.

this individually randomised controlled trial will compare 2 parallel groups of hospitalised mild-moderately unstable neonates \ 24h of admission and when stable. the intervention will be un-blinded to participants and researchers with blinding of outcomes where possible. if participants clinically deteriorate and meet "stopping criteria" they will be temporarily withdrawn from the intervention arm and re-start kmc when clinically stable, as per the control arm. intention to treat analysis will be used. duration of time spent in kmc will be documented and compared between arms. all other hospital management will be provided as per a standardised preterm management protocol, based on current standard care at the study site and compliance to this protocol will be monitored in both arms. underlying protective mechanisms for early kmc will also be explored, focusing on causal pathways such as thermal control, cardio-respiratory stability, infection prevention control and gastro-intestinal stability pathways.

Eligibility criteria:
inclusion criteria: * new admission to study site during study period * admission weight \<2000g * age 1 - 24h at start of screening * alive at enrolment * availability of study bed * written informed consent from parent or caregiver * parent or caregiver available and willing to provide intervention, if necessary exclusion criteria: * congenital malformation incompatible with life or needing immediate surgical correction * severe jaundice needing immediate management * seizures * clinically stable as assessed over pre-defined period of cardio-respiratory monitoring * severely unstable as assessed over pre-defined period of cardio-respiratory monitoring * completed triplet admission * mother and/or neonate enrolled in another research study at time of hospital admission
a study to investigate the antiviral effect, safety, tolerability and pharmacokinetics of vh3739937 in in treatment-naive adults living with hiv-1

Conditions: HIV Infections

Summary: the primary purpose of this study is to assess the antiviral activity of vh3739937 in human immunodeficiency virus type-1 (hiv-1) infected treatment naive (tn) participants during monotherapy.


Eligibility criteria:
inclusion criteria: * participants who are overtly healthy (other than hiv infection) as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring * positive hiv antibody test * treatment-naïve: no antiretrovirals (arvs) (in combination or monotherapy) received after the diagnosis of hiv-1 infection * body weight ≥50.0 kilogram (kg) (110 pounds \[lbs\]) for men and ≥45.0 kg (99 lbs) for women and bmi for all participants within the range 18.5-35.0 kilogram per meter square (kg/m\^2). * capable of giving signed informed consent * participant must be willing and able to start combination antiretrovial therapy (cart) as selected with the investigator on study day 8 (except in the case of early termination, clinically relevant ae/sae, lab abnormality, the withdrawal of consent, lost to follow-up, etc., where circumstances could dictate otherwise). exclusion criteria: * current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of gilbert's syndrome or asymptomatic gallstones) * participants with primary hiv infection, evidenced by acute retroviral syndrome (e.g., fever, malaise, fatigue, etc) and/or evidence of recent (within 3 months) documented viremia without antibody production and/or evidence of recent (within 3 months) documented seroconversion * myocardial infarction, acute coronary syndrome, unstable angina, stroke, transient ischemic attack, or intermittent claudication in the past 3 months * the participant has received an investigational hiv vaccine (immunotherapeutic or immunomodulatory) * regular use of drugs of abuse * sensitivity to heparin or heparin-induced thrombocytopenia

Keywords: vh3739937 treatment naïve hiv-1
acellular dermal matrix in breast reconstruction

Conditions: Breast Cancer

Summary: allogenic acellular dermal matrix has been used in burn injuries or abdominal walls reconstructions. however, it is solely used in breast reconstructions after breast carcinoma amputation. the efficacy of such allogenic dermal matrix can be advantageous when compared to current treatment options, however, this has to be proved.

this is a prospective study, where patients undergoing breast reconstruction surgery using acellular dermal matrix (adm) with expander use in first phase of reconstruction will be included. the permanent breast implants will be implanted approximately half year during second surgery. acellular dermal matrix is a soft tissue graft that is formed by decellularization, however with intact extracellular dermal matrix. such structure is able to re-create adequate skeleton for host cells with subsequent incorporation and revascularization. the safety and appropriateness of such adm in breast reconstruction surgery will be analyzed.

Eligibility criteria:
inclusion criteria: * signed informed consent * total one-side mastectomy due to breast cancer * age between 18-60 years exclusion criteria: * failure to obtain signed informed consent

Keywords: breast implants acellular dermal matrix
resin infiltration vs self-assembling peptide (p11-4) in treating white spot lesions

Conditions: White Spot Lesion

Summary: clinical assessment of the effectiveness of two treatment modalities (self-assembling peptide (p11-4) (alone or combined with fluoride) and resin infiltration) for treating white spot lesions

patient/population: patients that range from 7-14 years of age with with at least one non-cavitated wsl located on smooth surfaces of maxillary or mandibular permanent teeth and comparable in size, opacity, and whitish appearance. intervention: i1: self-assembling peptide (p11-4) i2: self-assembling peptide (p11-4) with fluoride varnish comparator resin infiltration outcome: primary outcome * esthetic improvement of white spot lesion outcome measure: photographic analysis outcome measuring device: image analysis to calculate change in area ratio of wsl to the labial surface using photoshop software. outcome measuring unit: change in percentage • tooth remineralization 1. outcome measure: international caries detection and assessment system (icdas) score. outcome measuring device: visual and clinical examination by operator outcome measuring unit : numerical score from 0-6 2. outcome measure: quantitative light fluorescence score from wsl outcome measuring device: diagnodent pen outcome measuring unit: numerical score from 0-99 secondary outcome outcome measure: patient satisfaction outcome measuring device likert 5-point faces scale ranging from very sad to very happy outcome measuring unit :numerical score from 1-5 study design: randomized clinical trial time: 6 months

Eligibility criteria:
inclusion criteria: * age (a range from 7-14 years of age was determined) * good general health (absence of disease/no handicaps, to ensure oral care at home) * preserved pulp vitality of the teeth. * consolidated oral care daily. * agreement by patient and parents (or guardians) to participate in the study exclusion criteria: * patients with periodontal diseases (periodontal pockets or dental mobility) or radiologically identified pathologies (periapical radiolucency). * teeth revealing any restorations were excluded from the current study. * any previous or planned wsl treatment.

Keywords: resin infilteration , white spot lesions , self assembling peptide, remineralization
improving ultrasound images in brain tumour surgery with the use of an acoustic coupling fluid mimicking brain tissue.

Conditions: Brain Neoplasms; Glioma

Summary: tools for improving brain tumor surgery, in particular for gliomas, are increasing. there seems to be an agreement that achieving extensive resections, when done safely without jeopardizing neurological function, improves survival. ultrasound is currently used as a tool for providing 2d or 3d images for tumor localization and resection control. for the use in resection control the resection cavity is filled with saline to provide acoustic coupling between the ultrasound transducer and tissue. however, attenuation of acoustic waves is very low in saline compared to the brain and this difference in attenuation is the cause of artifacts that may severely degrade the ultrasound images. such artifacts are seen as high-intensity signal at the resection cavity wall and beyond. the artificial signal enhancement can potentially mask small tumor remnants and is generally making the interpretation of images more difficult. this research group has developed an acoustic coupling fluid intended for use in the resection cavity instead of saline. tests in laboratory measurements have shown that the fluid reduces artifacts and has the potential to enhance ultrasound image quality in brain tumor surgery. three different concentrations of the acoustic coupling fluid have been tested in a phase 1 study that included 15 patients with glioblastoma. the concentration that provided the optimal ultrasound images, from qualitative and quantitative inspection, is used in the current phase ii study. this study is a randomized controlled trial aiming to include 82 patients with glial brain tumours. its purpose is to test the fluid during surgery of glial brain tumours to further investigate safety and efficacy.


Eligibility criteria:
inclusion criteria: * a diffuse glial tumour (high-grade (stage 1), low-grade or high-grade (stage 2)) is suspected from the diagnostic magnetic resonance images (mri). * in cases where histopathology is not known from previous biopsy or resection (i.e. diagnosis is suspected based on mri findings and not from previous surgery) a tissue sample for frozen section is necessary to confirm the diagnosis. * karnofsky performance status \>=70 exclusion criteria: * not able to consent (e.g. severe cognitive impairment) * intended biopsy only (meaning: cases not suitable for resection) * hypersensitivity to egg protein * hypersensitivity to soya or peanut protein * hypersensitivity to glycerol * pregnancy of breast-feeding * intention to become pregnant during the time of the study

Keywords: ultrasonography ultrasonics brain surgery
guided meditation to decrease perioperative anxiety and increase patient intraoperative compliance in vascular surgery

Conditions: Peripheral Vascular Disease

Summary: the primary purpose of this clinical trial is to test the feasibility of implementing a perioperative guided meditation program for patients undergoing peripheral vascular interventions that are performed under procedural sedation and analgesia.

this is a prospective, randomized, controlled study involving 30 adult patients undergoing peripheral vascular interventions. patients will be randomized to two arms: an intervention arm where patients will participate in perioperative guided meditation, and a control arm where patients will receive standard of care without any meditation intervention.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * undergoing an endovascular procedure for peripheral vascular disease * anesthesia plan for procedural sedation and analgesia exclusion criteria: * pre-existing psychiatric disorder such as anxiety, panic disorder, depression, psychosis, or bipolar disorder * non-english speaking * prior history of ipsilateral lower extremity amputation * urgent or emergent surgery * anesthesia plan for general anesthesia * undergoing a hybrid procedure (simultaneous endovascular and open surgery)
autologous cytokine-induced killer cell adoptive immunotherapy for acute myeloid leukemia and myelodysplastic syndrome

Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndrome, High Grade

Summary: a phase i/ii study to explore the feasibility and efficacy of autologous cik cells in patients with acute myeloid leukemia (aml)/ high grade myelodysplastic syndrome (mds) 1. group 1: as adjuvant therapy in minimal residual disease state after autologous pbsct. 2. group 2: as an adoptive immunotherapy in untreated disease state when conventional therapy with curative intent is not applicable

this is a phase i /ii study on the feasibility / efficacy of adoptive immunotherapy with autologous cik cells for the following 2 groups of patients who have aml or high grade mds : 1. group 1 patients in minimal residual disease state post autologous peripheral blood stem cell transplant ( pbsct ), and 2. group 2 patients with untreated high grade mds or aml, who are not fit for standard curative intent chemotherapy. the cik cells will be generated by leukapheresis from patients and cultured in gmp facilities. four repeated infusions will be given for a target dose of 1x10e10 t cell per infusion. efficacy will be assessed by 1. disease free survival compared to historical control in group 1 given cik cells post autologous pbsct as adjuvant immunotherapy (n=20 over 3 years), and 2. effect on the peripheral or marrow leukemia cell load in group 2 patients given cik cells as alternative therapy in place of chemotherapy (n=10).

Eligibility criteria:
inclusion criteria: 1. for group 1: aml or mds post autologous peripheral blood or marrow stem cell transplant. 2. for group 2: high grade mds ( raeb or raebit ) or aml, whom the haematologist in charge has assessed and deemed unfit for chemotherapy with curative intent.patients must have fairly stable white cell count requiring only low dose or no myelosuppressive medication 3. patients must understand the trial nature of this treatment and accept the possible absence of benefit. exclusion criteria: 1. uncontrolled infection 2. life expectancy less than 6 weeks. 3. contraindication to undergo one session of leukapheresis for pbmnc harvesting

Keywords: acute myeloid leukemia myelodysplastic syndrome autologous cik cells autologous peripheral blood stem cell transplant