Kornimate/medical-research-clean huggingface dataset:
hydrogen water intervention with heart rate variability as an outcome biomarker in me/cfs

Conditions: Chronic Fatigue Syndrome

Summary: the goal of this clinical trial is to learn if the otc supplement, hydrogen water, works to treat the fatigue-related symptoms and functional limitations in adults with myalgic encephalomyelitis/chronic fatigue syndrome (me/cfs). it will also examine if heart rate variability (hrv) can be used to predict who will benefit from the hydrogen water treatment. the main questions it aims to answer are: does the otc supplement, hydrogen water, work to reduce the fatigue-related symptoms and improve functioning in participants who have me/cfs? can hrv be used to predict who will benefit from treatment with hydrogen water?

the purpose of this pilot study is to identify a biomarker for improvement in chronic fatigue syndrome. treatment of me/cfs starting on 10-day graduated dosing schedule followed by a standard daily dose of hydrogen water (a magnesium-based otc supplement) over 16 weeks is expected to yield two subgroups, improvers and non-improvers. these subgroups will be delineated by heart rate variability (hrv), a biological measure of health and well-being. higher hrv will predict improvement and lower hrv will predict non-improvement (no change or worsening). this would be the first biomarker of improvement found in me/cfs. if treatment is successful, subjects will experience a reduction in fatigue and an increase in physical function. thus, the study may advance potentially an effective intervention for individuals with me/cfs and further the understanding of the biology of favorable treatment outcomes, i.e., improved hrv status.

Eligibility criteria:
inclusion criteria: meets institute of medicine criteria for myalgic encephalomyelitis/chronic fatigue syndrome - exclusion criteria: medical illness that explains presenting fatigue; any psychosis. -

Keywords: chronic fatigue syndrome; heart rate variability; treatment; hydrogen water.
the effectiveness of acupuncture treatment for post-stroke depression and anxiety disorder.

Conditions: Post-stroke Depression; Anxiety Disorders

Summary: poststroke depression is seen with a frequency of up to 30%. drug options for depression and accompanying sleep problems are limited; in addition, effective doses cannot be increased depending on the comorbidities of the patients and the side effect profiles and drug interactions of the drugs used. acupuncture has been used in chinese traditional medicine for more than 2000 years and there are findings that it has positive effects in post-stroke depression and anxiety disorders. the aim of this study is to examine the effectiveness and reliability of acupuncture treatment in depression and anxiety disorders developing after stroke and to reduce the need for multiple drugs and / or high-dose medication in the treatment of these complications. the hypothesis of the study: acupuncture is an effective and reliable treatment method for depression and anxiety disorders in stroke patients.

patients who receive inpatient stroke rehabilitation at istanbul physical medicine rehabilitation training and research hospital, physical medicine and rehabilitation clinic, will be included in the study by the inclusion and exclusion criteria. their informed consent will be received. initially, clinical and demographic data of all patients will be noted. participants who volunteered for the study will be separated into the acupuncture treatment group and the control group by simple random sampling. both the acupuncture treatment group and the control group will be included in the conventional rehabilitation program 2 hours a day, 7 days a week, for 8 weeks. in addition the acupuncture treatment group will get acupuncture treatment which will be applied to baihui (du20), yintang (ex-hn3) points and bilateral tai chong (lr3), hegu (li4) points for 4 weeks, twice a week. during the application, the feeling of de qi will be taken and the application will take 20 minutes. measurements; hamilton depression rating scales, hamilton anxiety rating scales, pittsburg sleep quality index, barthel index, and change in psychiatric drug use will be assessed at baseline (week 0), 4th and 8th week post-treatment. the adverse events observed during the study will be noted and the compliance of patients in each application will be questioned by visual analog scale.

Eligibility criteria:
inclusion criteria: * minimum 2 months maximum 6 months after stroke * volunteering for study * mini-mental state examination \>17 * patients with hamilton depression rating scale\> 7 and/or hamilton anxiety rating scale\> 4 assessed by the psychiatrist exclusion criteria: * insomnia and depression before a stroke * aphasic patients * sleep apnea syndrome * psychiatric disorders (learning disabilities, mental disorder, autism) * decompensated cardiac, kidney, hepatic failure * infection on acupuncture points * pregnancy

Keywords: stroke acupuncture depression anxiety
physiotherapy for infants with bronchiolities

Conditions: Infant Conditions; Respiratory Insufficiency

Summary: children who are in a hospital with respiratory distress often have difficulty breathing, have thick mucus, and may find it hard to eat normally. sometimes physical therapy is used to treat these children, but it is not entirely known which methods help the children's condition. the aim of this study is to evaluate the most common physiotherapy treatment method that is currently in use in sweden for infants who are hospitalized with a lower respiratory infection.

all children under 2 years of age who are admitted to the hospital for a respiratory infection and who have previously been essentially healthy are asked to participate. the infants will be randomized to 3 groups, 1 control group and 2 intervention groups. the infants in the control group will receive the standard care at the clinic. in one intervention group the parents will receive instructions how to vary their child body position regularly, and in the other intervention group the child will receive physiotherapy regularly and the parents will carry out some treatment. further actions in the form of inhalations or stimulation of deep breathing, will be used when needed. the children will be observed following a structured observational protocol regularly throughout the hospital stay.

Eligibility criteria:
inclusion criteria: * infants hospitalized because of respiratory infections such as bronchiolitis, pneumonia or other airway obstructions. * age 0-24 months * born in gestation week 35 or later. * guardians understand written swedish, english, arabic or persian exclusion criteria: * previous cardiac or respiratory disease * hospitalized more than 24 hours on this occasion

Keywords: infant respiration
efficacy and safety of dalbavancin for the treatment of acute bacterial skin and skin structure infections

Conditions: Abscess; Wound Infection; Surgical Site Infection; Cellulitis

Summary: the primary object is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral linezolid) for the treatment of patients with a suspected or proven gram-positive bacterial skin or skin structure infection.


Eligibility criteria:
inclusion criteria: 1. male or female patients 18 - 85 years of age. 2. signed and dated informed consent document. 3. major abscess, surgical site infection, traumatic wound infection or cellulitis suspected or confirmed to be caused by gram-positive bacteria. 4. at least two (2) local signs and symptoms of absssi and at least one (1) systemic sign of infection. 5. requires a minimum of 3 days of iv therapy. 6. patient willing and able to comply with study procedures. exclusion criteria: patients presenting with any of the following: 1. a contra-indication to any required study drug. 2. pregnant or nursing females. 3. sustained shock. 4. participation in another study of an investigational drug or device within 30 days. 5. receipt of a systemically or topically administered antibiotic within 14 days prior to randomization, except receipt of a single dose of a short-acting antibacterial drug 3 or more days prior to randomization. 6. infection due to a dalbavancin or vancomycin-resistant organism. 7. evidence of meningitis, necrotizing fasciitis, gas gangrene, gangrene, septic arthritis, osteomyelitis, and/or endovascular infection. 8. exclusively gram-negative bacterial or a fungal absssi. 9. venous catheter infection. 10. infection of a diabetic foot ulcer or a decubitus ulcer. 11. device-related infections. 12. gram-negative bacteremia. 13. infected burns. 14. infected limb with critical ischemia. 15. superficial/simple skin and skin structure infections. 16. concomitant condition requiring non-study antibacterial therapy. 17. absssi requiring therapy for longer than 14 days. 18. adjunctive therapy with hyperbaric oxygen. 19. more than 2 surgical interventions for absssi anticipated. 20. chronic inflammatory condition precluding assessment of clinical response. 21. absolute neutrophil count \< 500 cells/mm3. 22. human immunodeficiency virus (hiv) infection with a cd4 cell count \< 200 cells/mm3. 23. recent bone marrow transplant, \> 20 mg prednisolone per day (or equivalent) or receiving immunosuppressant drugs after organ transplantation. 24. regular, chronic antipyretic use in patients unable to modify during the first three days of study drug therapy. 25. life expectancy less than 3 months. 26. conditions that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results. 27. prior participation in the study.
ultrasound guided posterior sacroiliac ligament corticosteroid injection in pregnancy-related pelvic girdle pain

Conditions: Pelvic Girdle Pain

Summary: the purpose of this study is to see if pelvic girdle pain can be more effectively treated with the use of injectable anti-inflammatory medication plus physical therapy compared with physical therapy and a saline injection.

pelvic girdle pain (pgp) in pregnancy is common with prevalence estimates of 45%.1 it is defined as pain experienced between the posterior iliac crest and the gluteal fold, particularly in the region of the sacroiliac joint.2 pain may radiate in the posterior thigh and can also occur in conjunction with/or separately in the symphysis. in pgp, the endurance capacity for standing, walking and sitting is diminished. the diagnosis of pgp can be reached after exclusion of lumbar causes and must be reproducible by specific clinical tests. while various pain mechanisms including mechanical, hormonal, inflammatory, and neural have been proposed in the development of pgp, the etiology and pathogenesis is poorly understood. it is possible that musculoskeletal changes influenced by hormonal (relaxin) elevation in pregnancy predispose pregnant women to acute musculoskeletal injury presenting clinically as pgp. an inflammatory response in other acute musculoskeletal injuries has been well described3 and may also occur in pregnancy related pgp particularly given the musculoskeletal vulnerability during this time. though pgp is common in pregnancy, no study to date has investigated the efficacy of anti-inflammatory treatment in pregnancy related pgp in order to better establish the contribution of inflammation in the etiology of pregnancy related pgp.

Eligibility criteria:
inclusion criteria: * women who are not doing other therapies for pain (physical therapy, chiropractic management, pool) * women between age 21 and 50 who plan to deliver at loyola or gottlieb * pain numeric rating scale (nrs) on average of greater than or equal to 5/10 at visit 1 * pain must be between the upper level of the iliac crests and the gluteal folds in conjunction with or separately from pain in the pubic symphysis and influenced by position and locomotion * 2/4 positive physical examination tests on the symptomatic side including the p4 test, the ldl test, pubic symphysis palpation and the acute straight leg rise (aslr) exclusion criteria: * women presenting with pgp in the first or third trimester (\ 28 weeks gestation) * women with pubic symphysis (anterior) pain alone * women who do not plan to deliver a baby at loyola or gottlieb * pain above the upper level of the iliac crest * history of lumbar or pelvic fracture, neoplasm, inflammatory disease, active urogenital infection or active gastrointestinal illness, current physical therapy or other therapies for pgp, or previous surgery of the lumbar spine, pelvic girdle, hip joint or femur * history or signs of radiculopathy or other systemic neurologic disease * women with diabetes or gestational diabetes

Keywords: sciatica pelvic girdle pain
central sensitization in chronic whiplash patients

Conditions: Chronic Pain

Summary: the purpose of this study is to determine whether the metabolite concentrations within the anterior cingulate cortex and periaqueductal gray matter predict the intensity and interference of neuropathic pain after the development of chronic whiplash syndrome.

persistent chronic pain is a common symptom of whiplash leading to reduced quality of life. little information is available regarding changes in brain processing areas and change in central sensitization to noxious input during the chronic phase of whiplash. metabolite concentrations in the anterior cingulate cortex and periaqueductal gray matter may be predictors of neuropathic pain and these changes may explain the development of central sensitization in people with chronic whiplash. until now, there is not any study that show this approach.

Eligibility criteria:
inclusion criteria: * whiplash syndrome * chronic pain * age between 18 to 65 years * 4 months to 2 years after the whiplash syndrome exclusion criteria: * neurological disease * claustrophobia

Keywords: metabolite central sensitization whiplash
seizure prevention in traumatic brain injury with levetiracetam and lacosamide

Conditions: Traumatic Brain Injury

Summary: the purpose of this study is to assess the incidence of early post-traumatic seizures. the study will also assess the benefit of lacosamide compared to levetiracetam in regards to agitation and behavioral adverse effects in patients with moderate to severe traumatic brain injury requiring seizure prophylaxis.

this is a prospective randomized controlled trial of patients with moderate to severe tbi requiring seizure prophylaxis to prevent early and late posttraumatic seizures. patients will be identified and randomized as soon as possible, within 24 hours, from injury and started on seizure prophylaxis if they meet the predefined inclusion and exclusion criteria. patients randomized to the levetiracetam group will receive levetiracetam 1000 mg intravenously or by mouth twice daily for a total of 7 days. patients randomized to the lacosamide group will receive lacosamide 200 mg intravenously or by mouth twice daily for a total of 7 days.

Eligibility criteria:
inclusion criteria: * 18 years and older * diagnosis of moderate to severe traumatic brain injury * seizure prophylaxis with one of the two study drugs within 24 hours of initial injury * patients admitted into the trauma team service exclusion criteria: * patients on anti-seizure or anti-epileptic medication * history of seizures, witnessed or activity of seizure before prophylaxis medication started * received anti-seizure medication before randomized into the study * patients with a history of alcohol withdrawal or experiencing alcohol withdrawal that require medication treatment * spinal cord injury, history of bradycardia or permanent pacemaker, end stage renal disease * transferred form an outside hospital \>24 hours from injury and/or given or unconfirmed anti-seizure medication at other hospital * death, withdrawal of life support or transfer to hospice within 24 hours of injury * special population (pregnant, incarcerated) * informed consent not obtained within 72 hours from injury

Keywords: brain injury post-traumatic seizures seizure medication
long-term efficacy and safety of asenapine using olanzapine as a positive control (41512)(completed)(p05784)

Conditions: Schizophrenia

Summary: schizophrenia is a brain disease. the primary features of schizophrenia are characterized by positive symptoms (symptoms that should not be there, inability to think clearly, to distinguish reality from fantasy i.e., hearing voices) and negative symptoms (a reduction or absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and relate to others). other symptoms include reduced ability to recall and learn new information, difficulty with problem solving, or maintaining productive employment. the symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other. the clinical development of asenapine, as described in the 2007 idb appears to have antipsychotic activity with superior symptomatic control compared to placebo and an improved safety profile compared to currently available neuroleptics. its fast dissolving formulation may further add to treatment compliance. while various titration schedules have been used in previous studies, dose increases at 5 mg bid up to 10 mg bid have been well tolerated. therefore, further exploration in a larger group of subjects with acute exacerbation of schizophrenia using an asenapine flexible dosing design ( 5 or 10 mg bid) will mimic actual clinical practice in a long-term 52-week extension trial.


Eligibility criteria:
inclusion criteria: * completed the short-term trial ( 041021 or 021022) * continued to meet all demographic and procedural inclusion criteria of the short-term trial upon entry into this long-term extension trial * sign a written informed consent for the 041512 trial. * demonstrated an acceptable degree of compliance with trial medication in the short-term trials in the opinion of the investigator exclusion criteria: * cgi-s score of greater or equal to 6 ( severely psychotic) * occurrence(s) of ae or other clinically significant findings that would prohibit their continuation * met any of exclusion criteria regarding medical/psychiatric status listed in the short-term trials ( 041021 or 041022) * met exclusion criteria for medication status in short-term trials except for antidepressants and mood stabilizers.
tailored therapy for helicobacter pylori in children

Conditions: Helicobacter Pylori Infection

Summary: this study is designed to compare the eradication rates，safety and compliance of tailored therapy to those of standard triple therapy in children with h. pylori infection. the primary purpose is to compare the eradication rates of children with h. pylori infection treated with tailored therapy to those treated with standard triple therapy. the secondary purpose is to evaluate the safety, compliance and factors that might affect eradication rates.

between march 2014 and march 2016, 200 children with upper gastrointestinal symptoms (4-18 years) and h. pylori infection will be recruited at beijing children hospital.after the informed consents are obtained from the guardians, the children will be randomly classified into the two group: 10 days standard triple therapy (omeprazole 0.8-1.0mg/kg.d,bid, amoxicillin 30-50mg/kg.d bid， clarithromycin 15-20mg/kg.d bid), or 10 days tailored therapy including one proton pump inhibitor ( rabeprazole 0.4-0.5mg/kg.d,bid. or esomeprazole 0.8-1.0mg/kg.d,bid) and two antibiotics (amoxicillin 30-50mg/kg.d bid, clarithromycin 15-20mg/kg.d bid, metronidazole15-20mg/kg.d bid) based on antibiotics susceptibility and cytochrome p450 isoenzyme 2c19 genotype. eradication status will be reassessed in four weeks after treatment.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of h. pylori infection. * presence of upper gastrointestinal symptoms. * referred for upper endoscopy at beijing children's hospital exclusion criteria: * presence of endoscopy contraindications * the administration of any drug that could influence the study results including proton pump inhibitors, h2-receptor blockers, bismuth salts and antibiotics within the previous four weeks; * gastrointestinal malignancy; * previous gastric or esophageal surgery; * severe concomitant diseases * history of allergy to any of the study drugs;

Keywords: helicobacter pylori therapy children
prison connect-sti/hiv prevention intervention for couples affected by incarceration

Conditions: Incarceration

Summary: the purpose of this study is to adapt an existing couples-level hiv prevention intervention for community populations (connect i/ii; pi: el-bassel) to enable implementation among couples affected by incarceration (prison connect) and pilot test its feasibility and acceptability among men incarcerated in the connecticut department of correction (ctdoc) and their community-dwelling committed female partners.

this pilot study will recruit male inmates in the connecticut department of correction and their community-dwelling female partner. using an adapted version of an efficacious couples-level hiv prevention intervention for community populations (connect; pi: el-bassel), this study will pilot test a single in-prison intervention session using face-to-face or teleconferencing modalities and a brief community follow-up session. feasibility and acceptability among the inmates and their partners will be assessed.

Eligibility criteria:
inclusion criteria: * eight hiv-positive and hiv-negative/unknown status male inmates and their partners (n=16 couples, 32 participants). male participants * at least 18 years of age * able to communicate in english, currently * incarcerated in the connecticut department of correction (ctdoc), due to be released within three months. * have a committed female partner who is not currently incarcerated and willing to participate in the study, and is * not concerned participation will cause violence in the relationship. female partners * be able to communicate in english * not currently incarcerated * confirm the committed partnership with the male inmate and willingness to participate in the study * not concerned participation in the study would cause violence in the relationship. exclusion criteria: * restricted to english-speaking participants due to language availability of staff and intervention materials.

Keywords: incarceration hiv
ct diagnoses in crohn"s disease activity

Conditions: Crohn's Disease

Summary: the study focused on the clinical value of ct in assessing the activity of crohn's disease.

"crohn's disease is an inflammatory disease with non-specific clinical manifestations. the lesions are more common in the ileocecal area and the end of the ileum, and also can affect the entire digestive tract. in recent years, the domestic incidence of crohn's disease has been increasing. at present, ct diagnosis still lacks the gold standard and requirescombination of clinical manifestations, endoscopic examination, imaging examination and laboratory examination results. ct has showed advantages of non-invasive inspection, fast imaging speed, high tissue density resolution, and strong patient acceptability. in addition, the examination can clearly show the internal and external tissue structure of the digestive tract, which has been widely used in the diagnosis and activity evaluation of crohn's disease. in order to clarify the clinical value of ct in assessing the activity of crohn's disease, this study mainly used retrospective analysis of the ct manifestations and clinical data of patients with crohn's disease to explore the clinical value of ct in assessing the activity of patients with crohn's disease."

Eligibility criteria:
inclusion criteria: * crohn's disease patients with confirmed endoscopic or pathological examination results * complete laboratory data such as crp, erythrocyte sedimentation rate, etc. exclusion criteria: * related inspection results are not complete * the interval between endoscopic and laboratory examination results exceeds 2 months