Kornimate/medical-research-clean huggingface dataset:
stereotactic body radiotherapy combined with pd-1 blockers for locally advanced or locally recurrent pancreatic cancer

Conditions: Stereotactic Body Radiotherapy; PD-1 Inhibitors; Pancreatic Cancer

Summary: the goal of this observational study is to investigate the efficacy and safety of stereotactic body radiotherapy combined with pd-1 blockers for lapc and lrpc. the patients, diagnosed with locally advanced pancreatic cancer (lapc) or locally recurrent pancreatic cancer (lrpc). lrpc or lapc, undergoing sabt and pd-1 blockers in our hospital from december 2020 to april 2023 were reviewed consecutively. all patients provided written informed consent before treatment. the study was conducted in accordance with the declaration of helsinki, and it was approved by the institutional ethics committee of peking university third hospital.

the goal of this observational study is to investigate the efficacy and safety of stereotactic body radiotherapy (sbrt) combined with pd-1 blockers for lapc and lrpc. the patients, diagnosed with locally advanced pancreatic cancer (lapc) or locally recurrent pancreatic cancer (lrpc). lrpc or lapc, undergoing sbrt and pd-1 blockers in our hospital from december 2020 to april 2023 were reviewed consecutively. the schedule of sbrt is 25 to 50 gy in 5 fractions and the pd-1 blockers are monoclonal antibodies targeted to pd-1 molecules on the t lymphocytes. all patients provided written informed consent before treatment. the study was conducted in accordance with the declaration of helsinki, and it was approved by the institutional ethics committee of peking university third hospital.

Eligibility criteria:
inclusion criteria: 1. lrpc confirmed by pathologic or imaging diagnosis and lapc confirmed by pathology; 2. disease size ≥1 cm; 3. kps≥70; 4. adequate hematological reserves, hepatic function, renal function and heart function; 5. expected survival \> 3 months. exclusion criteria: 1. unconfirmed mass; 2. the upper abdomen was previously treated with radiotherapy; 3. the patients previously underwent immunotherapy of pd-1 or pd-l1 monoclonal antibody; 4. a history of immunodeficiency, including hiv positive or other acquired, congenital immunodeficiency or other immune-related conditions requiring long-term oral hormone therapy; 5. patients with active infectious disease, trauma and severe wounds; 6. patients with any mental disorder; 7. patients with other somatic comorbidities of clinical concern; 8. pregnancy and lactation.
feasibility of using telepractice to provide modified interaction guidance.

Conditions: Autism Spectrum Disorder

Summary: the purpose of this study is to determine the feasibility of using telepractice to provide modified interaction guidance (mig) to caregivers and their child with autism. mig as an intervention to improve attachment for children with autism and their primary caregiver.

the process objectives target focus on1) recruitment, 2) retention, 3) engagement with tools, 4) time demand on dyads, and 5) eligibility criteria. the resource assessment objectives include: 1) equipment and internet accessibility 2) communication methods, and 3) timelines. the management assessment objectives address: 1) ethical standards, 2) researcher qualifications and 3) data storage and collection. finally, when looking at the scientific assessment, the objectives relate to: 1) is use of a concurrent multiple baseline single-subject design feasible with this population? 2)capturing dyad needs, 3) burden levels, and 4) safety protocols. this study will evaluate the above listed dimensions of feasibility using a embedded mixed methods approach that incorporates both a single-subject design and qualitative data gathered throughout the research process and post intervention individual interviews.

Eligibility criteria:
inclusion criteria: 1. diagnosis of autism spectrum disorder 2. child between the ages of 24-60 months 3. first born child 4. no physical or medical conditions that affect the child's ability to participate in the activities that are part of the intervention process 5. ability to follow simple verbal directions in english 6. no current plan to initiate any treatment alternatives during the study period 7. willingness to participate in a -week intervention with a frequency of once a week 8. adults are primary caregiver 9. under age of 35 10. speak english 11. minimum grade 5 schooling 12. access to a computer and broadband wired or wireless (3g or 4g/lte) internet connection? exclusion criteria: * participants (both child and adult) will be excluded from the present study if they were deemed low functioning * child is not the first-born child * child already receiving aba treatment * parents have a history of mental illness

Keywords: modified interaction guidance
the effects of vitamin d supplementation on patients with type 2 diabetes and vitamin d deficiency

Conditions: Diabetes Mellitus; Vitamin D Deficiency

Summary: vitamin d plays a key role in keeping normal mineral balance and maintaining bone health. there is accumulating evidence linking deficient vitamin d status with both type 1 and type 2 diabetes. the purpose of this study is to evaluate the effect of high dose vitamin d supplementation (120000 units per month)for 6 months on glucose homeostasis and glycemic control,in vitamin d deficient patients with non-optimally controlled type 2 diabetes mellitus.

this is a randomized, double blind, parallel group, clinical trial for 6 months duration. the study group participants will receive vitamin d supplementation (120,000 iu per month) versus the placebo group for 6 months. glycemic control indexes will be measured in t2dm diagnosed study subjects. patient will be randomized 1:1 to one of two treatment groups. vitamin d group vs placebo group. randomization kits will include either vitamin d or vitamin d placebo. blood screens will be taken prior, after 3 months from randomization and after 6 months from randomization. anthropometric measurements will be drawn as well, at the same time points. determination of sample size in order to find a 0.5 mean difference in hga1c between the two treatment arms (standard deviation 1.2) a 184 sample size will be required to achieve 80% power, 5% alpha (two sided test). administrative and legal obligations: individual patient's medical information obtained as result of this study is considered confidential and disclosure to third parties. the investigator should maintain a list of appropriately qualified people to whom trail duties are delegated. source and study documents will be locked under the supervision of the pi- principle investigator for 15 years. study documentations and storage the investigator should maintain a list of appropriately qualified people to whom trail duties are delegated. all persons authorized to make entries and/or correction on crf will be included on the investigators team list delegation log. study printout and electronic crf's, icf's and other study documents will be stored in the at haemek medical center under the supervision of the pi. all identifying details will be completely erased. the investigator and staff are responsible for maintaining a comprehensive and centralized filing system of all study- related documentation, suitable for inspection at any time.

Eligibility criteria:
inclusion criteria: * written inform consent must be obtained from the patient before any assessment is performed. * male or female patient, 18 years or older. * diabetes mellitus patients. * hga1c levels on randomization above 7.5% in the last 6 months. * low 25(oh) vitamin d levels : under 50nmol/l exclusion criteria: * patient who are unable consume food orally. * life expectancy under 7 month. * unable to sign inform consent. * patient unwilling or unable to comply with study procedure.

Keywords: diabetes mellitus hga1c 25(oh) vitamin d hga1c levels above 7.5%
women's perception of respectful maternity care, birth experiences and perception of traumatic birth

Conditions: Maternity; Birth, First; Traumatic Birth; Intrapartum Fetal Distress

Summary: the effect of the ıntrapartum care model given in line with the world health organization (who) recommendations on women's perception of respectful maternity care, birth experiences and perception of traumatic birth

the research is a randomized controlled trial. the research will conducted with 124 primiparous pregnant women (intervention group n=62, control group n=62) who were hospitalized in the delivery unit of aksaray training and research hospital between september 2023 and january 2024. the pregnant women in the intervention group will given the intrapartum care model in line with who recommendations after cervical dilation reached 5 cm. the control group will received only the standard intrapartum care in the hospital. data will be collected using the personal information form, birth follow-up form, respectful maternal care scale, birth experience scale, and traumatic birth perception scale.

Eligibility criteria:
inclusion criteria: * those who are 18 years of age or older, * those who are in term pregnancy (38-41 weeks), * those who are primiparous, * those who have a single, healthy, vertex positioned fetus, * those who have cervical dilatation of 5 cm or more, * those who can speak and understand turkish, * those who voluntarily agree to participate in the research. exclusion criteria: * those with chronic diseases (hypertension, diabetes, etc.), * those with a diagnosed mental illness (depression, anxiety or other psychotic disorder, etc.), * those with maternal and fetal complications (oligohydramnios and polyhydramnios, placenta previa, preeclampsia, premature membrane rupture, presentation anomalies, intrauterine growth retardation, fetal anomalies, intrauterine death, macrosomic baby, cord prolapse, etc.), * those with any complications that prevent vaginal birth (cephalopelvic disproportion, etc.), * elective cesarean section, * those who became pregnant with assisted reproductive techniques, * those who received childbirth preparation training.

Keywords: respectful maternity care scale birth experience scale traumatic birth perception scale who intrapartum care recommendations
treating chronic knee pain with noninvasive peripheral nerve stimulation using novel interferential radiofrequencies

Conditions: Chronic Knee Pain; Chronic Knee Osteoarthritis; Post Surgical Neuropathic Pain

Summary: first, the subject will undergo screening and provide informed consent. baseline measurements are then taken. the subject remains seated with back support throughout the session. the technician verifies and marks the knee for treatment and wraps an antenna applicator strap around the lower leg near the knee. the device is turned on in test mode to confirm the therapy location, with the subject identifying when they feel a sensation over their pain area. the power threshold for this sensation is recorded. the therapy, which lasts 15 minutes, is delivered at 90% of this threshold to ensure the subject does not feel it. after therapy, post-treatment measurements are taken.

1. subject will perform screening and informed consent 2. baseline measurements will be taken 3. subject will sit in chair with back support throughout duration of the session 4. knee for treatment will be verified and marked 5. technician will wrap antenna applicator strap around the lower leg, at the knee 6. device is turned on and set to test mode to verify therapy location. subject will verify when they feel a sensation covering their existing chronic knee pain. the power threshold for sensation is recorded. 7. therapy begins and lasts for 15 minutes, power threshold is set to 90% so that the subject does not feel the therapy 8. at the end of 15 minutes, post-therapy measurements are recorded

Eligibility criteria:
inclusion criteria: * pain greater than mid-range using standardized pain inventory (spi). * no medication for pain both over-the-counter and by prescription for 24 hours prior to treatment. * body mass index (bmi) to be calculated for all participants with limitation for any bmi that is lower than normal. (target is normal, overweight or obese). * age greater than 18. exclusion criteria: * existing peripheral nerve stimulator implant in the lower extremities

Keywords: rfpns hypersound neuroharmonix noninvasive pns
medtronic closed-loop spinal cord stimulation system

Conditions: Low Back Pain; Leg Pain; Upper Limb Pain

Summary: the purpose of the study is to further understand the closed-loop feature in chronically implanted patients by characterizing the efficacy of the next generation, spinal cord stimulator.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * candidate is undergoing medtronic scs device trial for chronic, intractable pain of the trunk and/or limbs * if being treated for low-back and/or leg pain, * the baseline overall\^ visual analog scale is ≥ 60 mm and * baseline back and/or leg pain visual analog scale is ≥60 mm. \^average overall pain in the back and/or leg in the 72 hours prior to the baseline visit, measured using visual analog scale. * if being treated for upper limb pain - baseline visual analog scale is ≥ 60 mm for upper limb pain * on stable (no change in dose, route, or frequency) prescribed pain medications being used for back and leg pain or upper limb pain, as determined by the investigator, for at least 28 days prior to device trial * willing and able to provide signed and dated informed consent * willing and able to comply with all study procedures and visits exclusion criteria: * indicated for an scs device to treat stable intractable angina pectoris or peripheral vascular disease of fontaine stage iii or higher * previously trialed or implanted with spinal cord stimulator, peripheral or vagus nerve stimulator, deep brain stimulator or an implantable intrathecal drug delivery system * currently participating, or plans to participate, in another investigational study unless written approval is provided by the medtronic study team * major psychiatric comorbidity or other progressive diseases that may confound study results, as determined by the investigator * serious drug-related behavioral issues (e.g. alcohol dependency, illegal substance abuse), as determined by the investigator * pregnant or planning on becoming pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal) * be involved in an injury claim or under current litigation
teriparatide on maxillary sinus floor osseointegration

Conditions: Bone Regeneration

Summary: the aim of this triple blind randomized controlled trial will be to analyze the effect of a dose of teriparatide combined with a xenograft on bone augmentation of the maxillary sinus, to observe the microarchitecture of the newly formed bone and the primary and late stability of implants placed on these grafts. the sample is composed of 42 participants who have a clinical indication for maxillary sinus floor augmentation with bone grafting due to residual bone height less than or equal to 5mm for the installation of dental implants. each side will be grafted with bio-oss® or bio-oss® combined with 1 dose (20 µg) of teriparatide (forteo®). three months after grafting, at the time of placement of dental implants, bone biopsies will be obtained using a short 2mm trephine bur. these bone cores will be submitted to histological and histomorphometric analysis. the stability of the implants will be measured, at the time of their installation, through the insertion torque, and through the use of resonance frequency equipment (ostell®) in three moments: immediately and at 3 and 6 months after the installation of the dental implants.


Eligibility criteria:
inclusion criteria: * pneumatization of a maxillary sinus with a residual ridge ≤ 5 mm in height (according to baseline conebeam tomograph). * must sign an informed consent to participate in this study. exclusion criteria: * residual ridges less than 4 mm in height. * uncontrolled systemic disease (asa 3, 4, 5, and 6) * presenting with osteoporosis or any disease of bone metabolism. * having received radiotherapy. * cancer. * any systemic condition that affects calcium absorption. * kidney disease. * coagulation disorders. * history of sinusitis. * maxillary sinus pathology. * heavy smoking (\> 1 pack per day). * drug or alcohol users. * pregnancy. * treatment with drugs that affect bone metabolism. * treatment with immunosuppressants. * allergies. * uncontrolled periodontal pathology. * tooth extractions in the last three months.

Keywords: teriparatide bio-oss® bone graft dental implants maxillary sinus augmentation bone regeneration
aerosol inhalation treatment for dyspnea - patients

Conditions: Dyspnea

Summary: the purpose of this protocol is to develop and test aerosol furosemide, as a treatment that has the potential to significantly improve symptom management and enhance the quality of care for patients with intractable dyspnea.

this is the second study in a series of studies investigating the treatment effect of aerosolized furosemide on hospitalized patients and outpatients with intractable dyspnea. the study will focus on patients who experience intractable dyspnea at rest or with minimal activity, e.g., dressing, bathing, cooking, or walking stairs or short distances. there are two parts to this study: study 2a is a pilot study on 5-10 patients. these trials are not blinded or placebo controlled; the investigators will use them to discover practical problems, and take the information back to the laboratory to develop solutions. we enrolled 7 subjects for study 2a. study 2b will a randomized, placebo - controlled, double- blind study on 25 - 40 patients. the two planned treatments will be aerosolized furosemide and aerosolized saline, and will be given to each patient on two separate days. we failed to reach our enrollment goal, and ultimately enrolled 17 subjects for participation in study 2b.

Eligibility criteria:
inclusion criteria: * intractable dyspnea at rest or with minimal activity exclusion criteria: * chronic congestive heart failure * liver or kidney disease * systemic lupus erythematosis (sle) * receiving potassium supplementation or other indication of hypokalemia * major psychiatric disorders * furosemide hypersensitivity * not mentally competent and/or alert (unable to grant informed consent) * under 18 years old * not fluent in english * inadequate birth control

Keywords: dyspnea hospitalized patients ambulatory outpatients shortness of breath chronic obstructive pulmonary disease pulmonary disease
does propranolol, a beta blocker, attenuate stress-induced drinking?

Conditions: Alcohol Drinking

Summary: for this protocol, the investigators plan to conduct a pilot study evaluating the effect of propranolol on alcohol consumption. using a parallel design, the investigators plan to randomize 20 non-treatment seeking adults with alcohol use disorders (dsm-5) to propranolol extended release (160mg/day or placebo; n=10 per cell) to evaluate whether propranolol reduces alcohol self-administered in the laboratory. importantly, the investigators will evaluate whether propranolol counteracts stress-induced effects on alcohol self-administration. following titration to steady state medication levels over a 2-week period, each subject will complete two laboratory sessions consisting of a well validated method for inducing stress or neutral/relaxing state (order counterbalanced), followed by a 2-hour alcohol self-administration paradigm known to be sensitive to medication effects.


Eligibility criteria:
inclusion criteria: 1. age 21-65 2. able to read and write english 3. meets diagnostic and statistical manual of mental disorders (dsm-5) criteria for current (past 6 months) alcohol use disorders 4. able to take oral medications and willing to adhere to medication regimen exclusion criteria: 1. participants with any significant current medical conditions. 2. women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or partner is surgically sterile or she is postmenopausal (hormone contraceptives \[oral, implant, injection, patch, or ring\], contraceptive sponge, double barrier \[diaphragm or condom plus spermicide\], or iud) 3. suicidal, homicidal or evidence of current (past 6-month) mental illness. 4. specific exclusions for administration of propranolol not already specified. 5. subjects likely to exhibit clinically significant alcohol withdrawal during the study.
nutrition and oral health in orthopaedic surgery

Conditions: Orthopedic Disorder; Metabolism and Nutrition Disorder

Summary: this prospective observational study evaluates the relationship between the objective oral health status and the patient reported diet in 64 adult patients undergoing elective major orthopaedic surgery (hip, knee, or spine surgery).


Eligibility criteria:
inclusion criteria: * age ≥55 * male and female gender * major elective orthopedic surgery (hip, knee, spinal) * signature of the informed consent exclusion criteria: * inability to follow the study protocol * neuropsychiatric disease, developmental disorders
the efficacy of diclofenac gel for breakthrough pain and the neuropathic components of pain in knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the purpose of this proposed study is to conduct a trial with knee osteoarthritis (oa) patients using the diclofenac gel.

the purpose of this proposed study is to conduct a trial with knee oa patients using the diclofenac gel. the effectiveness of diclofenac gel in managing breakthrough pain or the neuropathic components of pain (e.g., the burning, soft tissue joint sensitivity, or allodynic components) in knee oa is unknown. it is likely that patients will use the gel in a as needed (prn) fashion, on top of other analgesics prescribed for their pain. the neuropathic components of a generally nociceptive or inflammatory condition, such as knee oa, are underappreciated, and typically not tracked in oa analgesic studies. yet, evidence across a variety of chronic painful conditions suggests that these components are quite disabling. the results of this study would show whether diclofenac gel as a prn medication is beneficial to patients suffering from knee oa pain.

Eligibility criteria:
inclusion criteria: * ages 20-75 * unilateral or bilateral knee osteoarthritis (oa), confirmed radiographically. * patients taking oral non-steroidal anti-inflammatory drugs (nsaids) in the amount and schedule prior to the breakthrough period will be permitted. exclusion criteria: * patients with clinical history of anterior cruciate ligament (acl) involvement. * patients on tricyclic antidepressants or anticonvulsants (neuropathic medications) * history of ulcers or gastrointestinal (gi) bleeding * coagulation disorders * hypersensitivity to aspirin or nsaids * congestive heart failure and edema * advanced renal disease * aspirin triad * pregnant women

Keywords: knee osteoarthritis