Kornimate/medical-research-clean huggingface dataset:
pet scan study to detect prostate cancer in patients with early psa recurrence

Conditions: Prostate Cancer (Post Prostatectomy)

Summary: flotufolastat f-18, sold under the brand name posluma, is a radioactive diagnostic agent for use with positron emission tomography (pet) imaging for prostate cancer. the research is being done to study the capability of 18f-rhpsma-7.3 (flotufolastat f-18) pet scan to detect prostate cancer when there are very low levels of prostate-specific antigen (psa) following previous radical prostatectomy surgery.

this is not an investigational study drug. flotufolastat pet scan is fda approved for positron emission tomography (pet) of prostate-specific membrane antigen (psma) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy and those with suspected recurrence based on elevated serum prostate-specific antigen (psa) level. in this research study, the flotufolastat-pet scan will be repeated if the initial scan does not show cancer and if psa further rises by greater than 0.1 ng/ml. other currently used scans for this purpose do not detect cancer in all patients with low levels of rising psa.

Eligibility criteria:
inclusion criteria: * history of localized adenocarcinoma of the prostate with prior curative intent radical prostatectomy. * an elevated psa test result that is greater than or equal to 0.1 ng/ml and less than 0.5 exclusion criteria: * patients who are planned to have an x-ray contrast agent or other pet radiotracer \& less than 24 hours prior to the flotufolastat f-18 psma-pet scan. * patients currently receiving androgen deprivation therapy (adt).

Keywords: rising psa following cancer prostatectomy surgery
use of whole body vibration in patients with fibromyalgia

Conditions: Fibromyalgia

Summary: the objective of this study is to evaluate the efficacy of a 3-month program consisted of the use of whole body vibration (wbv) in patients with fibromyalgia in order to determine whether this intervention would be effective to short and medium-term improvement of symptoms in these patients.

this was a single blind randomized controlled trial. forty patients of fm group were assigned randomly to 2 study groups: 20 patients will be part of the experimental group (eg) that will perform a neuromuscular treatment using the vertical whole body vibration platform and another 20 will constitute the control group (cg). all these subjects will sign the corresponding informed consent for their participation in the study, according to the ethical criteria established in the helsinki declaration. the study took place between january and juny 2019. two groups of variables were analyzed in the present study three times: before, after and follow-up after three months of the intervention.

Eligibility criteria:
inclusion criteria: * patients with fm were included in the study if they fulfilled the 1990 classification criteria of the american college of rheumatology for fibromyalgia. * pain-free volunteers were included if they did not present pain symptoms or some type of treatment in any part of the body during the previous 12 months. exclusion criteria: * participants were excluded from the study if they had not signed the informed consent or if they reported any other musculoskeletal disorder rather than patients with fm, any neurological disorder or had previous spinal fusion surgery or spinal cord stimulation.
oct angiography and nrai in dementia

Conditions: Alzheimer Disease; Dementia; Mild Cognitive Impairment

Summary: the primary goals of this study are to use optical coherence tomography (oct) angiography (blood vessel mapping) to: 1. detect retinal blood vessel and blood flow changes in participants with dementia. 2. detect amyloid protein deposits in the retinas of participants with dementia.


Eligibility criteria:
inclusion criteria for dementia subjects: * physician-confirmed diagnosis of probable alzheimer's disease * mild dementia, as defined by score of 20 or greater on the mini-mental state exam, or score of 15 or greater on the montreal cognitive assessment, or clinical dementia rating scale score of 1. * age older than 55 years. * able to comply with study procedures * corrected visual acuity at least 20/400 in either eye. * has a legally authorized representative who can sign study consent form and accompany the participant to the oct study visit. inclusion criteria for dementia-free controls: * age older than 55 years * able to comply with study procedures * able to maintain stable fixation for oct imaging * corrected visual acuity of at least 20/40 in either eye * dementia-free, as defined by score of 24 or greater on the mini-mental status exam, or a score of 18 or greater on the montreal cognitive assessment, or clinical dementia rating of \<1.0. exclusion criteria for both dementia and dementia-free subjects: * non-alzheimer's disease related primary neurologic disease affecting the central nervous system (i.e. multiple sclerosis, parkinson's disease) * evidence on ophthalmological exam within the last year of other ocular diseases or pathology that would confound the assessment of dementia (e.g. glaucoma, diabetic or hypertensive retinal disease, amblyopia, etc.) * media opacity such as cataract, corneal scar, or vitreous opacity that could interfere with retinal imaging. * previous intraocular surgery except for uncomplicated cataract extraction with posterior chamber intraocular lens implantation * inability to maintain stable fixation for oct imaging or provide informed consent * spherical equivalent refractive error greater than +3 or -7 diopters, or astigmatism magnitude of greater than 2 diopters. * diabetes for more than 10 years or hemoglobin a1c level of \> 10 within the 180 days prior to oct scanning. * uncontrolled hypertension. : sbp \> 170 or dbp \> 100 * arrhythmia: irregular pulse, or heart rate not between 50 and 110 beats per minute * pregnancy or breast feeding.

Keywords: mci oct angiography alzheimer's dementia
augmenting massed prolonged exposure with a stellate ganglion block to treat ptsd

Conditions: Stress Disorders, Post-Traumatic

Summary: this is a small, open-label treatment study that tests the potential safety and treatment effectiveness of a stellate ganglion block combined with massed prolonged exposure (pe). each of the 12 participants will receive ten 90-minute sessions of massed prolonged exposure and an injection of a stellate ganglion block between the first and second pe sessions.

massed pe will be conducted by doctoral-level therapists. participants will meet with their providers for individual, 90-minute sessions. they will then be asked to complete out-of-session treatment assignments throughout the rest of the day. between the individual therapy session and out-of-session treatment assignments, participants will engage in approximately four to six hours of treatment per day, monday through friday, for two weeks. the stellate ganglion block injection will be administered between the first and second massed pe session by qualified medical personnel as per standard operating procedure for the placement of a stellate ganglion block. a research nurse will be in attendance during the procedure and for an hour recovery period following the block administration. during pe treatment, participants will complete interim assessments of their ptsd symptoms, mood symptoms, trauma-related cognitions, and suicidal ideation proceeding sessions 6 and 10.

Eligibility criteria:
inclusion criteria: 1. active duty or retired military service member (age 18- 65 years) 2. ptsd diagnosis as assessed by clinician-administered posttraumatic stress scale (caps-5) 3. able to speak and read english (due to standardization of outcome measures) 4. defense enrollment eligibility reporting system (deers)-eligible to receive care at brooke army medical center for the stellate ganglion block. exclusion criteria: 1. classification as high risk for suicide 2. current serious mental health diagnosis (e.g., bipolar or psychosis) 3. symptoms of moderate to severe substance (to include alcohol) use within the last 30 days 4. pregnancy (i.e. positive pregnancy test at screening) or breastfeeding 5. current anticoagulant use 6. history of bleeding disorder 7. infection or mass at injection site 8. myocardial infarction within 6 months of procedure 9. pathologic bradycardia or irregularities of heart rate or rhythm; 10. symptomatic hypotension 11. phrenic or laryngeal nerve palsy 12. history of glaucoma 13. uncontrolled seizure disorder 14. history of allergy to local anesthetics
effectiveness of femaltiker in stimulation lactation among mothers of preterm infants

Conditions: Lactation Induced

Summary: femaltiker is a food for special medical purposes with a unique composition. because beer, but not ethanol, has been reported in a number of studies to stimulate prolactin levels and breastmilk production, polysaccharide from barley was chosen as a potential galactogogue. to verify our assumption, a randomized, double blinded research with placebo was performed. the study was conducted according to good clinical practice and 10% of output data was audited by the outside monitor. the research was conducted from 14 april 2014 to 7 october 2015 in two nicus with consent of the ethics committee on medical warsaw university.

the traget population consisted of volunteers women who delivered infants at \< 37 weeks gestation. criteria of exclusion were: hypothyroidism and diabetes type i or ii diagnosed and treated before pregnancy. the schedule of the study included three visits with in certain point time during two weeks postpartum. during the study patients had taken twice a day product or placebo, respectively. the protocol of the study included : * three consecutive blood collections for examination of prolactin level on every visit (10 min beforeblood examination of prolactin level in triplet on every visit (10 min before breastfeeding session, 10 min after beginning of breastfeeding and 10 min. after finishing of breastfeeding.) * filling pumping log to control variation in the milk yield and efficacy of lactation. * measurement of the volume of milk producing before blood examination (directly in case of pumping by the mother or indirectly based on weight of the baby before and after feeding) * interview with lactation consultant concerning patient's self-estimation of lactation efficacy data collection was done using the crf in the paper form which were then put tto the database in exceldocuments.

Eligibility criteria:
inclusion criteria: * mothers of preterm infants (born before 37 completed weeks of pregnancy) exclusion criteria: * hypothyroidism * diabetes type i or ii diagnosed and treated before pregnancy * participating in other study

Keywords: galactagogues, lactogenesis, preterm labor
clinical assessment study in crigler-najjar syndrome

Conditions: Crigler-Najjar Syndrome

Summary: this is a pre-phase 1 prospective, non-interventional clinical assessment study to evaluate crigler-najjar syndrome subjects requiring daily phototherapy, aged 1 year and older.


Eligibility criteria:
key inclusion criteria: * subject has a diagnosis of crigler-najjar syndrome resulting from a confirmed mutation in the ugt1a1 gene * subject is aged equal or greater than 1 year of age * subject receives daily phototherapy for a minimum of 6 hours within a 24-hour period (daily illumination time) exclusion criteria: * subject is currently participating in an interventional study or has received gene or cell therapy * subject has received a whole liver, partial liver, or hepatocyte transplant; or subject has a liver transplant scheduled within the planned participation period of this study * subject has significant cholestatic disease, in the opinion of the investigator * subject is receiving phenobarbital or other known inducer of ugt1a1 within 30 days of screening * subject has any clinically significant underlying liver disease (other than crigler-najjar syndrome), in the opinion of the investigator * subject has a history of, or currently has, a clinically important condition other than crigler-najjar syndrome, in the opinion of the investigator
cognitive functional therapy for treating individuals with chronic shoulder pain

Conditions: Chronic Shoulder Pain; Exercise Therapy; Psychosocial Rehabilitation

Summary: shoulder pain is a debilitating musculoskeletal condition with functional, physical, and psychological impacts. interventions for chronic shoulder pain should address the biopsychosocial model, with cognitive functional therapy emerging as a promising physiotherapy approach. cognitive functional therapy approaches the multidimensional nature of pain, integrating physical and cognitive aspects. the aim of this randomized controlled trial is to compare the effects of cognitive functional therapy with therapeutic exercise on biological aspects of pain (pain intensity, disability, function, perception of improvement/deterioration, and central pain processing), and psychosocial aspects of pain (sleep quality, self-efficacy, and biopsychosocial factors). the hypothesis of this study is that cft will lead to greater improvements in these outcomes compared to therapeutic exercise.

this will be a randomized controlled trial, single-blinded with two parallel groups. seventy-two individuals with chronic shoulder pain will be randomly assigned to one of two groups: cft or therapeutic exercises. the interventions will last eight weeks, with the cft group receiving therapy once a week and the therapeutic exercise group receiving sessions twice weekly. the primary outcomes will be pain intensity and disability, while the secondary outcomes will include function, self-efficacy, sleep quality, biopsychosocial factors, perception of improvement/deterioration, and central pain processing.

Eligibility criteria:
inclusion criteria: * men or women; * age between 18 and 60 years; * presence of shoulder pain for more than 3 months; * pain intensity of 4 points or more on the 11-point numeric pain rating scale. * high level of disability or moderate level of irritability. exclusion criteria: * history of fracture or surgery of the clavicle, scapula, and/or humerus, surgical stabilization or rotator cuff repair; * history of dislocation, instability (positive sulcus sign or apprehension test), and/or rotator cuff tear (positive drop arm test); * adhesive capsulitis verified by the presence of gradual onset pain associated with stiffness and reduced passive and active mobility; * ongoing pregnancy; * reproduction of shoulder pain radiating to the entire upper limb during cervical or thoracic spine tests (positive spurling test); * neurological or systemic diseases that may alter muscle strength and sensitivity such as rheumatoid arthritis, fibromyalgia, lupus, gout, and diabetes; * corticosteroid injection in the shoulder region in the last 3 months; * physiotherapy treatment in the last 6 months. * active treatment for cancer

Keywords: shoulder pain subacromial pain rotator cuff related shoulder pain shoulder impingement chronic pain psychosocial rehabilitation biopsychosocial
the tolerability and pharmacokinetics study of hec110114 tablets in healthy adult subjects

Conditions: Chronic Hepatitis C

Summary: a phase i, single center, randomized, double-blind, placebo-controlled, single \& multiple ascending dose study to access the tolerability and pharmacokinetics of hec110114 tablets in healthy adult subjects


Eligibility criteria:
inclusion criteria: * sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions * be able to complete the study according to the trail protocol * subjects (including partners) have no pregnancy plan within six months after the last dose of study drug and voluntarily take effective contraceptive measures * male subjects and must be 18 to 45 years of age inclusive * body weight ≥ 50 kg and body mass index（bmi）between 18 and 28 kg/m2, inclusive * physical examination and vital signs without clinically significant abnormalities. exclusion criteria: * use of \>5 cigarettes per day during the past 3 months * allergies constitution ( multiple drug and food allergies) * history of alcohol abuse (14 units of alcohol per week: 1 unit = 285 ml of beer, or 25 ml of spirits or 100 ml of wine) * donation or loss of blood over 450 ml within 3 months prior to screening * 12-lead ecg with clinically significant * positive for viral hepatitis (including hepatitis b and c), hiv and syphilis * subjects deemed unsuitable by the investigator for any other reason.
effectiveness of text messaging intervention to improve dietary behaviors among patients with type 2 diabetes mellitus in low resource area of sabah (dtext-sbh)

Conditions: Type 2 Diabetes Mellitus(T2DM)

Summary: the goal of this clinical trial is to learn if sending three (3) text messages per week over a six (6) months period to people with type 2 diabetes in areas with lack access to dietitian could help them stick to a healthier diet. the main questions it aims to answer are: * does a mobile phone text-message intervention improve dietary adherence among t2dm patients? * does a mobile phone text-message intervention improve hba1c and self-management among t2dm patients? researchers will compare dietary adherence, hba1c changes and self-management behaviors between the usual care group and intervention group. participants will: * be given three (3) text messages per week over a six (6) months period for the intervention group * both usual care and intervention group will be given standard medical nutrition therapy at baseline, 3rd and 6th months visits to the clinic


Eligibility criteria:
inclusion criteria: * have type 2 diabetes. * own a mobile phone. * able to use whatsapp. * able to read and speak bahasa malaysia. * have an hba1c level above 7.0%. * have not seen a dietitian in the previous 6 months. exclusion criteria: * individuals with type 1 diabetes mellitus and gestational diabetes mellitus. * patients with cognitive impairment affecting memory, attention, language, and problem-solving skills. * those with advanced diabetic complications, such as kidney failure and neuropathy. * individuals lacking regular access to a mobile phone or with poor network connectivity. * pregnant individuals or those planning to get pregnant in the next 6 months, as well as those currently nursing. * individuals with major illnesses like cancer or advanced heart disease. * those planning major surgery or gastric bypass in the next 6 months. * institutionalized individuals, such as those in nursing homes, old folks\&#39; homes, or imprisoned.

Keywords: type 2 diabetes mellitus lack access to dietitian ehealth dietary adherence low resource area
upper limb movement quality following stroke

Conditions: Stroke

Summary: the aim of this study is to monitor the daily upper limb movement of persons with stroke, and to relate these quantities to measures of recovery and impairment.

this study is part of the natural history of stroke recovery project. in this study the investigators plan to develop, test and validate an algorithm and software for using inertial measuring units (imus) to monitor upper limb daily movement. then, investigators plan to use this system to monitor such activity in stroke patients. investigators also plan to develop, test and validate an algorithm and software to test proprioception acuity based on muscle synergy during active and passive movement. muscle synergy will be determined based on muscles' electrical activity, as measured using surface electromyography (emg). investigators will then test the relation between daily movements of the upper limb in stroke patients, and their recovery/impairment levels, including proprioception acuity.

Eligibility criteria:
inclusion criteria: * \>18 years of age * independent in all activities of daily living before the stroke. * in- and out-patients at adi-negev nahalat-eran rehabilitation center. * medically stable * able to provide informed consent. exclusion criteria: * the presence of any degenerative neurological condition, neuropathy, myopathy or polio that are not secondary to stroke, excluding diabetic related changes. * traumatic brain injury and/or extra-cerebral hemorrhage. * significant psychiatric condition, including alcoholism and drug abuse. * any severe orthopedic condition (such as amputation or severe pain that limits activity) or chronic pain syndrome.
a randomized phase ii study of concurrent chemoradiation with every 3 week of cisplatin vs with weekly cisplatin in locally advanced nasopharyngeal carcinoma

Conditions: Nasophayngeal Carcinoma Between Stage II and IVb

Summary: the study try to show the weekly cisplatin based ccrt is not inferior to 3-weekly cisplabe based ccrt in terms of 3-yr progression free survival rate in advanced nasopharyngeal carcinoma


Eligibility criteria:
inclusion criteria: * histologically confirmed nasopharyngeal carcinoma age of 18 years or over stage ii \~ ivb no history of chemotherapy, radiotherapy, or immunotherapy for npc with measurable lesion based on recist 1.1 ecog ps 0 \~2 good organ function (liver, renal, hematologic) exclusion criteria: * active infectious disease requiring antibiotics uncontrolled heart disease pregnancy and on feeding state history of other malignancy within 5 years before enrollment, except for well treated non-melanomatous skin cancer, in situ cervical cancer, thyroid cancer
the effect of topical administration of common drugs on postoperative bleeding and pain

Conditions: Pain, Postoperative; Postoperative Hemorrhage

Summary: after surgical procedures, interventions to reduce postoperative pain and bleeding are of great importance. in this study, the effect will be investigated of smearing common drugs, which are designed for injection, directly onto the raw wound surface (topical application) created during surgery. topical application allows a small amount of drug to reach a large wound area, higher drug concentration in the exposed wound surface but very low concentration in the body, and no risk of injury from needles. although beneficial effects of such an easy and low-cost intervention would be expected, the investigators have found no previous reports on blinded and controlled studies.

the drugs to be studied on whether they reduce bleeding are adrenaline (constricts blood vessels) and tranexamic acid (txa) (prevents bloodclots from dissolving). the drug studied to what extent it reduces pain will be bupivacaine, a common local anaesthetic. patients undergoing bilateral symmetric breast surgery or single sided mastectomies are candidates for enrollment in the study. the bilateral patients will have two identical procedures and hence two identical wounds in the same patient. this enables the investigators to use one side as control and hence design our study arms as prospective and placebo-controlled. the patients undergoing a one-sided procedure will need to be compared to similar patients, but as wounds will be of different sizes and in different people, larger groups are needed to find significant differences between treatment and controls.

Eligibility criteria:
inclusion criteria: * patients undergoing unilateral simple mastectomy * patients undergoing bilateral symmetric breast surgery exclusion criteria: * pregnancy * a history of former thromboembolic events (to receive txa) * cardiovascular disease (to receive adrenaline)

Keywords: administration, topical tranexamic acid adrenaline bupivacaine surgery