Kornimate/medical-research-clean huggingface dataset:
an evaluation of the effect of vitamin d supplementation on depressive symptoms among chinese adolescents

Conditions: Depressive Symptoms

Summary: the goal of this randomized controlled clinical trial is to investigate the effects of vitamin d3 supplementation on depression in chinese adolescents with elevated depressive symptoms and vitamin d deficiency. the main question it aims to answer whether vitamin d3 supplementation can reduce depressive symptoms. participants in the intervention group will receive vitamin d3 capsules and mental health education. the control group will receive vitamin d3 placebo and mental health education. researchers will compare the change in depressive symptoms from baseline to post-intervention at 12 weeks between the intervention and control groups.

investigators will conduct a randomized controlled trial to examine whether vitamin d3 supplementation can improve depressive symptoms. a total of 310 participants will be recruited from two middle schools. inclusion criteria are grades 7th and 8th students whose caregivers signed informed consents, self-reported mild and moderate depressive symptoms with scores of bdi-ii\>13, and serum 25(oh)d concentration of 12-20 ng/ml. exclusion criteria are the use of anti-psychotic treatments or interventions in the past 3 months; serious health conditions (e.g., major psychiatric disorders, serious infectious diseases, chronic gastrointestinal diseases, and hepatic or renal diseases); the use of vitamin d supplements in the past 3 months; self-reported suicidal plans/attempts in the past 3 months; intellectual disability. participants will be randomly assigned into a supplementation or placebo group. supplementation arm will receive oral dose 2000 iu vitamin d3 per day for 6 weeks and followed by 800 iu per day for 6 weeks; placebo arm will receive placebo every day for 12 weeks. both of these two groups will receive additional mental health education. for the first 6 weeks, vitamin d or placebo will be administrated every two weeks. for the next 6 weeks, vitamin d or placebo will be administrated every three weeks. the primary outcome of this study is to compare the change of depressive symptoms between supplementation or placebo group from pre- to post-intervention at 12 weeks.

Eligibility criteria:
inclusion criteria: 1. students whose caregivers signed informed consents; 2. students with serum 25(oh)d concentrations below 20 ng/ml; 3. students with self-reported depressive symptoms (bdi-ii score of 14 or higher) exclusion criteria: 1. students who are currently receiving or have used anti-psychotic treatments or interventions (including drugs and non-drugs) in the past 3 months; 2. students who have serious health conditions (e.g., major psychiatric disorders, serious infectious diseases, chronic gastrointestinal diseases, and hepatic or renal diseases); 3. students who are currently taking or have taken vitamin d supplements in the past 3 months; 4. students with self-reported serious suicidal ideation, suicidal plans and attempts in the past 3 months; 5. students with intellectual disability.

Keywords: depressive symptoms vitamin d
mass vaccine and drug administration, bangladesh

Conditions: Plasmodium Falciparum Malaria

Summary: this is an open i.e. not blinded, cluster-randomised, controlled intervention study. the study will use a factorial design to estimate the protective effectiveness of mass drug administrations, mass vaccinations, combined mass vaccinations and drug administrations versus the current standard of care.

trial activities: the investigators are most interested in the combined effect of mass administration of vaccines and drugs on malaria transmission. can mvda reduce the parasite prevalence in intervention villages compared to control villages which did not receive the intervention? the entire village population will be enrolled at study start and followed for two years after d0, the first day of the interventions in the intervention villages. the village population is a dynamic cohort with new members entering the cohort by birth or immigration and other members leaving the cohort due to emigration or death. newcomers entering villages will receive mvda as soon as feasible and as appropriate (dependent on age). secondly, the investigators want to know how effective the individual components of the intervention, mass vaccinations and mass drug administrations are in relation to mvda?

Eligibility criteria:
inclusion criteria: * current residence in a study village irrespective of permanence * age 6 months and above (no upper age limit) * written informed consent provided by participants (or a parent/guardian in case the participant is under 18 years old) exclusion criteria: * pregnancy, plan to get pregnant, or breastfeeding. * acute illness requiring intervention * a history of an adverse reaction to study drugs/vaccine and prior receipt of any other malaria vaccine or enrolment in another intervention trial.

Keywords: plasmodium falciparum malaria malaria vaccine malaria drug administrations
immediate effect of energy alignment and mantra on stress related pain in adolescents

Conditions: Stress Related Disorder; Musculoskeletal Pain; Headache

Summary: psychiatrists have expressed concern at the emergence of education as a serious source of stress for school-going children - causing high incidence of deaths by suicide. many adolescents in india are referred to hospital psychiatric units for school-related distress - exhibiting symptoms of depression, high anxiety, frequent school refusal, phobia, physical complaints, irritability, weeping spells, and decreased interest in school work. previous studies have found significant anxiety, distress, depression, worn outs and severe impact of psychological factors on the performances of dental, engineering and medical student. but students preparing for competitive exams have not been studied yet. current study reports the scientific evidence of immediate effect of yoga based techniques combined with music and vedic chants on adolescents preparing for competitive exams.


Eligibility criteria:
inclusion criteria: * all adolescents enrolled at the participating centers and that agree to sign informed consent. exclusion criteria: * not agreement to sign the informed consent
benefits of mild body exercises in parkinson's disease

Conditions: Parkinson Disease

Summary: the purpose of this study is to learn the effects of two mild body exercises on quality of life, non-motor symptoms, anxiety, depression, fatigue, sleep quality, cognition, and executive function on people with parkinson's disease (pd).


Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic pd * currently taking levodopa with some improvement in motor symptoms, and on a stable dose for a minimum of 4 weeks prior to starting the study * hoehn \& yahr stage i to iii (mild to moderate pd) exclusion criteria: * mini mental state examination (mmse) score \< 24 * central neurological diseases other than pd or prior major head trauma with loss of consciousness, including other forms of parkinsonism, uncontrolled or significant cardiovascular diseases, orthopedic or medical problems that would interfere with gait * being primarily wheelchair bound * deep brain stimulation * expected change in pd medications over the course of the study * subjects with mri contraindications such as pacemaker, aneurysm clips, artificial heart valves, metal fragments, foreign objects or claustrophobia.
studies in porphyria iv: gonadotropin-releasing hormone (gnrh) analogues for prevention of cyclic attacks

Conditions: Porphyria

Summary: objectives: assess whether chronic administration of gonadotropin-releasing hormone analogues is safe and effective for the prevention of cyclic attacks of acute porphyria in women.

protocol outline: all patients receive a gonadotropin-releasing hormone (gnrh) analogue. treatment begins on days 1 to 3 of a menstrual cycle. low-dose estrogen begins at approximately 3 months. all patients must have a daily calcium intake of at least 1 gram; supplements are allowed. patients are followed for at least 1 year.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- acute porphyria, i.e.: acute intermittent porphyria hereditary coproporphyria variegate porphyria definite cyclic attacks with severe abdominal pain and other porphyria symptoms during luteal phase of menstrual cycle only attacks resolve completely within 5 days of onset of menses, i.e., no symptoms between attacks at least 4 to 6 attacks during the 6 months prior to entry more than half of these attacks must meet the following criteria: readily distinguishable from menstrual cramps and premenstrual syndrome required hospitalization for narcotic analgesics, phenothiazines, hematin, intravenous fluids, or other treatment luteal attacks not requiring hospitalization must be similar in symptoms and differ only in severity no life-threatening porphyria attacks no cyclic abdominal pain unless caused by porphyria --prior/concurrent therapy-- at least 6 months since ovulation suppression --patient characteristics-- reproductive: menstrual cycle 25-35 days for at least 6 months prior to entry pelvic exam normal within 60 days prior to entry pap smear normal, i.e., no dysplasia no amenorrhea no other menstrual abnormality no other gynecologic abnormality negative pregnancy test medically approved contraception required for 2 months prior to entry and throughout study or at least 1 menstrual cycle following tubal ligation other: no allergy to gonadotropin-releasing hormone analogues no clinically significant abnormal laboratory test results no medical contraindication to protocol treatment

Keywords: inborn errors of metabolism porphyria rare disease
the use of 2d and 3d imaging modalities and its influence on diagnosis and treatment planning in orthodontics

Conditions: Orthodontics; Malocclusion; Impacted Tooth; Cephalometry; Cone-Beam Computed Tomography; Panoramic Radiography

Summary: research questions: 1. will the panoramic images derived from cone beam ct data give better diagnostic ability than conventional panoramic radiographs? 2. will 3d cephalometric analysis offer the orthodontists and surgeons better information for treatment planning? 3. will the 3d cephalometric analysis give more accurate treatment plan and better treatment outcome? general hypothesis and special aims overall aims: * to compare 2d versus 3d cephalometric analysis: treatment planning and therapeutic outcome. * to determine the accuracy and diagnostic ability and usability of the 3d cephalometric analysis. * to evaluate the diagnostic ability and usability of the panoramic image derived from cone beam ct data as compared to 2d panoramic images. * to evaluate the value of the cone beam ct data in cephalometric analysing process for orthodontic and maxillofacial surgery treatment. hypotheses: 1. the availability of the 3d cephalometric analysis influences the orthodontic and maxillofacial treatment plan and decision, and might change the treatment outcome. 2. panoramic images derived from cone beam ct data may provide equal information for diagnosis as conventional panoramic images. 3. cone beam ct will be able to replace "classic orthodontic imaging" being more time and dose efficient and having a beneficial effect on treatment outcome.


Eligibility criteria:
inclusion criteria: * age 12-25 years old * patients with malocclusions * patients with jaw relation defect both with or without the need of orthognathic surgery * patients with maxillofacial defects: tumors and trauma * patients with eruption problems: embedded or impacted teeth which have to be removed exclusion criteria: * patients with congenital deformities * patients with systemic diseases that may effect the growth formation: growth factor defect and thyroid hormone defect.
b cell repertoires in chronic lymphocytic leukemia and aging

Conditions: Chronic Lymphocytic Leukemia

Summary: b-cll is the most prevalent leukemia in the western hemisphere, accounting for \~25% of all leukemia's (1). this disease occurs virtually exclusively in the aging population, with the median age of diagnosis ranging between the mid 60s and the early 70s. indeed, its occurrence before the age of 50 is quite unusual. this increase in occurrence with age is not unique to b-cll; rather, it is characteristic several b cell lymphoproliferative disorders (e.g., non-hodgkin's lymphoma, multiple myeloma). gender and race also influence the development of b-cll. thus, the ratio of men: women is \~2:1 and the prevalence is increased in caucasians. the rate of occurrence of b-cll among asians is significantly lower than for caucasians and this does not increase with immigration to the west. dna sequence analyses performed in our laboratory and in those of others indicate that b-cll cells from unrelated patients share ig v gene characteristics. these include the use of selected genes, the association of these genes with certain d and jh gene segments that code for unique cdr3 motifs, and the occasional occurrence of highly similar vhdjh + vljl pairs. in \~50% cases, these rearranged genes are mutated, whereas in the others mutations are infrequent; this difference is related to the vh gene family used by the b-cll cell.


Eligibility criteria:
inclusion criteria: * 18 years of age patients must be willing to be contacted in the future exclusion criteria: * patients who are known to be anemic, with a hemoglobin \<8 patients who are known to be infected with hiv

Keywords: chronic lymphocytic leukemia
microbial community composition and dynamics in lungs of cystic fibrosis sibling pairs

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to identify all the bacterial species present in the respiratory tracts of patients with cystic fibrosis (cf), and to connect them with clinical information. traditional culture methods of throat swab and sputum samples can only identify the most prevalent bacteria in samples, those of which there are over about 5 million bacteria per teaspoon. a recently developed method has been found to be more sensitive and can detect up to several hundred bacterial species in throat swab or sputum sample of individual cf patients.

this study does not include testing of any investigational drugs and this is a noninvasive study requiring only a sputum/swab sample paired with information contained in the routine clinic letters and laboratory results your cf physicians obtain at your regular clinic visits.

Eligibility criteria:
inclusion criteria: * between the ages of 1-16 upon enrollment * diagnosis of cystic fibrosis exclusion criteria: * none
a pilot study of intraoperative gamma camera imaging during sentinel node biopsy for melanoma

Conditions: Melanoma

Summary: this is a single-institution pilot study seeking preliminary evidence of the usefulness of mobile gamma cameras in patients undergoing sentinel node biopsy for melanoma.


Eligibility criteria:
inclusion criteria: * 18 years of age or older, and * plan to go to the operating room for sentinel node biopsy using technicium-99 labeled colloid. exclusion criteria: * under 18 years of age, * unable to give informed consent, or * not planned to go to operating room for sentinel node biopsy using technicium-99 labeled colloid.

Keywords: melanoma imaging sentinel node biopsy
treatment with apixaban versus warfarin in patients with left ventricular thrombus after acute myocardial infarction

Conditions: Left Ventricular Thrombus; Acute Myocardial Infarction

Summary: the optimal anticoagulant for the treatment of left ventricular (lv) thrombus following acute myocardial infarction (ami) is unclear. the aim of this multicenter randomized study is to evaluate the efficacy of apixaban versus warfarin with respect to thrombus resolution in patients with lv thrombus after ami.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years at the time of signing the informed consent * lv thrombus confirmed on tte\* day 1-28 after the ami * signed informed consent * criteria applicable only for female subjects: women of childbearing potential must provide a negative pregnancy test not be breastfeeding and be willing and able to use highly effective contraception. women of non-childbearing potential must be 1 year post-menopausal. exclusion criteria: * ongoing\* treatment with anticoagulant therapy due to mechanical heart valve prosthesis atrial fibrillation with or without significant mitral valve stenosis venous thromboembolism requiring anticoagulant therapy thrombophilia requiring anticoagulant therapy preexisting lv thrombus already treated with anticoagulant therapy other reasons for anticoagulant therapy * high bleeding risk active non-trivial bleeding known chronic bleeding disorder severe anemia defined as hemoglobin \< 80g/l thrombocytopenia defined as platelet count \< 80 x 10\^9 * known significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or known hepatic insufficiency classified as child-pugh c or d at randomization * known allergy, intolerance or hypersensitivity to either of the study interventions * any contraindication for the use of an anticoagulant or listed in the local labelling for apixaban or warfarin. * participation in other study investigating effects and safety of anticoagulant treatment. * known current alcohol or drug abuse * any other condition, as judged by the investigator, that would make the participant unsafe or unsuitable for the study or life expectancy \< 6 months

Keywords: apixaban warfarin
the efficacy of steroid therapy in vestibular neuritis

Conditions: Vestibular Neuritis

Summary: the purpose of this study was to compare the treatment effectiveness of steroid therapy for vestibular neuritis by using video head impulse test.

this study was a prospective, randomized controlled study. the enrolled vestibular neuritis patients were randomized to conservative treatment or steroid treatment when they are diagnosed with caloric test. after initial vestibular work-up including caloric, video head impulse tests, and a questinnaire (dhi), the patient was examined with the same tests again at 6 months later. the efficacy of steroid for the patients with vestibular neuritis would be determined by the comparison of the data of each group.

Eligibility criteria:
inclusion criteria: * ages over 18 years * acute vertigo that occurred within 7 days * the spontaneous nystagmus should be detected * caloric weakness over 20% exclusion criteria: * suspicious or verified a central nervous system lesion * if the patient has denied. * other otologic disease (acute/chronic otitis media, otosclerosis, etc) * the patient with history of otologic surgery * the patient with history of brain surgery

Keywords: vestibular neuritis vertigo head impulse test steroid
parent nurse controlled analgesic in pediatric patients with developmental delay

Conditions: Post Operative Pain

Summary: the purpose of this study is to compare, the safety, efficacy and level of parent and nurse satisfaction with three methods of opioid administration post-operatively in children (4-18 years of age) with developmental delay.

children with developmental delay are at higher risk for inadequate pain assessment and management. patient controlled analgesia (pca) allows patients to administer opioids by pushing a pca button when needed. this eliminates the delay of waiting for a nurse to obtain and administer pain medication. pca has been shown to be safe, effective, and superior to intramuscular, intermittent opioid dosing for pain management in children. often, children with developmental delays cannot operate a pca independently, can not self report their pain and are often given pain medication "as needed" through an iv. parent/nurse controlled analgesia (pnca) allows parents and nurses to push the pca button for patients who are not able to do so themselves. this way of giving pain medicine has not been thoroughly studied. some healthcare professionals use pnca for these children, others do not. this study is being done to compare pnca \& intermittent opioid administration. participants will be randomized into one of the three study groups: 1. parent/nurse controlled analgesia (pnca) with a continuous intravenous (iv)infusion of pain medicine. 2. pnca without continuous iv infusion of pain medicine. 3. pain medicine given through iv administered on an "as needed" basis(prn) by the nurse. the acute pain service will follow all three groups of patients throughout the study. this team specializes in the management of children's pain. pain team is also available 24 hours a day, 7 days a week. the study will continue until child can tolerate pain medication in his/her stomach. data will be collected regarding safety, efficacy, parent \& nurse satisfaction.

Eligibility criteria:
inclusion criteria: * children with developmental delay between 4 and 18 years of age who are unable to operate pca due to developmental delay. * children scheduled for surgery anticipated to require \>24hour stay with anticipation of iv narcotics will be required. * children whose parents are able to verbalize an understanding of pnca. * parents with fluency in english(both speaking and writing). exclusion criteria: * patients who do not meet inclusion criteria * patients whose parents do not give informed consent * patients allergic to both morphine and hydromorphone * patients with severe physiologically altering obstructive sleep apnea * patients who are or are expected to remain on a ventilator * patients receiving an epidural -

Keywords: developmental delay cognitive impairment pain control post operative pain opioid pain assessment parent nurse controlled analgesic patient controlled analgesic children pain analgesic safety parent satisfaction nurse satisfaction pediatric
the effect of three different fluids(albumin 5%, normal saline, hydroxyethyl starch 130 kd) on microcirculation in severe sepsis/septic shock patients

Conditions: Severe Sepsis; Septic Shock; Microcirculation

Summary: major microvascular blood flow alterations have been documented in patients with severe sepsis. it was also demonstrated that the microcirculation improved in survivors of septic shock but failed to do so in patients dying from acute circulatory failure or with multiple organ failure after shock resolution. early, effective fluid resuscitation is a key component in the management of patients with severe sepsis and septic shock with the goal of improving tissue perfusion. the best fluid in this early resuscitation phase has been and still is under debate. the aim of this study is to evaluate the effect of three different fluids(albumin 5%, normal saline, hes 130 kd) on microcirculation in severe sepsis/septic shock patients using sidestream dark field (sdf) microscopy and near-infrared spectroscopy (nirs) analysis.


Eligibility criteria:
inclusion criteria: * adult patients will be enrolled within 24 hrs of onset of severe sepsis/septic shock with an indication for fluid bolus administration. exclusion criteria: * liver cirrhosis * shock from other causes * oral injuries (precluding sdf imaging) * severe peripheral vascular disease, dialysis fistula, or mastectomies precluding safe forearm occlusion * age \< 18 years

Keywords: sepsis microcirculation saline crystalloid colloid albumin hydroxyethyl starch