Kornimate/medical-research-clean huggingface dataset:
chiropractic spinal manipulation for headache

Conditions: Cervicogenic Headache; Tension-Type Headache

Summary: this is a pilot and feasibility randomized controlled trial to assess the efficacy of chiropractic spinal manipulative therapy in patients with tension-type and cervicogenic headache.

this study is a pilot and feasibility randomized controlled trial that aims to assess the efficacy of 8 treatment sessions of chiropractic spinal manipulative therapy compared to the same number of sham manipulative therapy or placebo interventions for chronic cervicogenic and tension-type headache. the hypothesis proposed is that chiropractic care will reduce the intensity and frequency of both cervicogenic and tension-type headache episodes, when compared to placebo. a sample of 20 participants suffering from cervicogenic or tension-type headache for at least 3 months, aged 18 to 67 will be randomized to receive either 8 sessions of spinal manipulative treatment (2 times per week for a total of 4 weeks) or 8 sessions of a validated sham spinal manipulation. outcomes will be assessed at baseline, after 4 treatments and at the end of the treatment period.

Eligibility criteria:
inclusion criteria: * at least 2 episodes per month of cervicogenic or tension-type headache for at least 3 months. diagnoses will be determined by case history and physical examination according to the international headache society criteria (3rd edition) exclusion criteria: * not fulfilling the inclusion criteria * having received chiropractic treatment in the previous 12 months * diagnosis or frequent symptoms of migraine headaches (symptoms present at least once a month) without an overlapping presentation of cervicogenic or tension-type headache. * patients with pathologies affecting the nervous system (ms, tumors, past history of stroke...) * contraindications to manual therapy, particularly spinal manipulative therapy (cancer, uncontrolled high blood-pressure, severe cardiovascular conditions) * past history of cervical spine surgery * pregnancy * having being diagnosed with a psychiatric conditions, with the exception of depression and anxiety
effects of insoles in patients with rheumatoid arthritis: randomized controlled trial.

Conditions: Rheumatoid Arthritis

Summary: deformity and foot pain is nearly omnipresent (90%) in rheumatoid arthritis (ra), due to the interaction between inflammation and abnormal biomechanical. these cause instability in the hindfoot, which cause deformity of the forefoot, and they cause more pressure on the plantar forefoot and more pain during daily activities. non-pharmacological interventions (insole, footwear) have an important role, reducing pain and disability, increasing the effectiveness and improving daily activities.

randomized double-blind clinical trial. two samples of patients will be taken: the control group, which will consist of patients with rheumatoid arthritis and standardized insoles, and other group, which will consist of patients with rheumatoid arthritis and insoles made with direct adaptation technique (tad) and patients with rheumatoid arthritis and insoles made with an scanner (cad-cam). the variables that the investigators will measure are: age, sex, study level, current occupation, rheumatoid arthritis evolution time, quality of life and physical function, pain and health level and general function of the foot. the investigators will use: an accelerometer, and questionnaires: foot and ankle ability measures (faam), manchester foot pain and disability index (mfpdi), medical outcomes study short form-36 (sf-36) y foot function index (ffi). this study will analyze patients in the universities of malaga and salford for 6 months.

Eligibility criteria:
inclusion criteria: * more than 18 years of age * early ra * to meet the criteria of american college of rheumatology * history of bilateral subtalar and/or ankle and/or talonavicular pain * informed consent * normal range of motions at the ankle, subtalar, and midtarsal joints. exclusion criteria: * concomitant musculoskeletal disease * central or peripheral nervous system disease * endocrine disorders, especially diabetes mellitus with a level of insufficient foot sensitivity * patients with a history of orthopedic foot surgery * those currently using foot orthoses. * patients with foot trauma in the last 6 months previous to the study * vascular diseases affecting the foot, active synovitis and edema. * normal daily walking aids will be not permitted.

Keywords: rheumatoid arthritis foot insoles quality of life physical activity
biomarkers to detect mesothelioma early in patients exposed to asbestos or vermiculite

Conditions: Malignant Mesothelioma; Pulmonary Complications

Summary: rationale: studying samples of body fluid and blood from patients who have been exposed to asbestos or vermiculite in the laboratory may help doctors learn more about changes that may occur in dna and identify biomarkers related to cancer. purpose: this laboratory study is looking for biomarkers to detect mesothelioma early in patients exposed to asbestos or vermiculite.

objectives: * identify patients with known asbestos exposure at early stages of disease development (i.e., indolent premalignant pleural plaques and fibrosis vs malignant pleural mesothelioma). * determine the expression levels of tumor-associated proteins in these patients. * analyze samples of serum and pleural effusions obtained from these patients. * determine the proteomic profile of samples obtained from these patients. * determine the molecular mechanisms associated with the regulation of the extracellular matrix microenvironment proteins (e.g., osteonectin, intelectin, or matrix metalloproteins) involved in disease onset and progression. outline: this is a multicenter study. patients undergo collection of body cavity fluid, including pleural effusion, and blood. specimens, including fresh frozen malignant pleural mesothelioma tumor tissue, if available, are analyzed for proteomic profile, gene expression profile, and tumor-associated protein expression levels. projected accrual: a total of 200 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * exposure to vermiculite or asbestos insulation * symptomatic or nonsymptomatic exposure-related disease * seen at a clinic in libby, montana (card clinic) or michigan (coem) patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: malignant mesothelioma pulmonary complications
phaco-ucp versus phaco alone for oag and cataract

Conditions: Cataract; Glaucoma, Open-Angle

Summary: this study was carried out to evaluate the safety and efficacy of combined phacoemulsification and ultrasound ciliary plasty (phaco-ucp) as a first-line surgical treatment of coexisting cataract and op /en angle glaucoma compared to phacoemulsification alone. to our knowledge, this is the first report of results of combined phaco-ucp

the study involved 61 eyes of 61 patients with coexisting cataract and open angle glaucoma, 31 eyes were managed with phaco-ucp and 30 eyes of age and sex matched patients were managed with phacoemulsification alone. patients were randomized for either combined phacoemulsification and ultrasound ciliary plasty (phaco-ucp) (the study group) or phacoemulsification alone (the control group). all surgeries were performed by one experienced surgeon (y ez). preoperative evaluation included manifest refraction, bcva measurement, slit-lamp biomicroscopy, gonioscopy, indirect ophthalmoscopy, measurement of iop with goldmann applanation tonometry (average of 3 readings taken). corneal diameter (white-to-white) and axial length measurement were done using iol master 500 (carl zeiss meditec ag., germany). ultrasound pachymetry with tomey sp-100 (tomey corp. nagoya, japan) and visual fields using humphrey field analyzer (24-2, sita, standard program carl zeiss meditec ag., germany) were also performed.

Eligibility criteria:
inclusion criteria: * patients diagnosed with poag or pseudoexfoliation glaucoma with coexisting visually significant cataract that required phacoemulsification exclusion criteria: * patients with any other type of glaucoma, including narrow angle glaucoma, neovascular, uveitic or angle recession glaucoma, patients with advanced glaucoma characterized by advanced optic disc cupping or visual field damage, history of glaucoma or intraocular surgery and other ocular diseases that would affect safety or interfere with the procedure. we also excluded patients with incomplete follow-up or missing data
five fraction sabr dose escalation for early stage squamous cell carcinoma of the lung

Conditions: Lung Cancer

Summary: the purpose of this study is to test whether 5 fraction stereotactic ablative body radiation (sabr) is safe and improves local control for early state squamous cell carcinoma of the lung. while three fraction sabr is effective for the treatment of early stage non small cell lung carcinoma (nsclc) of all histologies, it is not safe for many patients. while four and five fraction sabr is safe, recently published data and our institutional data suggests that local control for early stage squamous cell carcinoma of the lung using the current four or five fraction sabr is suboptimal.

1. primary objectives during phase i study - determine the safety and maximum tolerated radiation dose for five fraction sabr for squamous cell cancer of the lung. during phase ii study - determine 2 year local control of dose escalated five fraction sabr vs. institutional historical control standard dose sabr in squamous cell cancer of the lung. 2. phase ii secondary objectives * determine overall survival, progression free survival and patterns of failure after sabr. * determine tolerability of dose escalated sabr.

Eligibility criteria:
inclusion criteria 1. age ≥ 18 at time of consent. 2. ability to provide written informed consent and hipaa authorization. 3. pathological diagnosis of squamous cell carcinoma of the lung. 4. staging pet/ct (invasive mediastinal staging strongly encouraged but not required). 5. tumors \< 7cm 6. any location eligible for sbrt (including, but not limited to, peripheral, chest wall abutting and central tumors) 7. n0 m0 disease 8. plan to undergo four or five fraction sabr 9. baseline pfts available within 6 months of treatment start or will be obtained prior to treatment start (no finding will exclude patient from enrollment in trial) exclusion criteria 1. previous radiation therapy to the lung per investigator discretion. 2. inability to comply with treatment per investigator discretion. 3. inability to follow standard of care follow up recommendations per investigator discretion. 4. kps\<40
antagonistic interaction cb1-paracetamol

Conditions: Pain

Summary: evaluation of an possible inhibiting effect of rimonabant on the analgesic effect of paracetamol in healthy volunteers

double blind, cross-over, randomized and controlled versus placebo, study in healthy volunteers.

Eligibility criteria:
inclusion criteria: * healthy volunteers * between 18 and 40 years old * written consent given exclusion criteria: * rimonabant or paracetamol hypersensibility * excessive consumption of alcohol, tobacco, coffee, tea or toxicomania * concomitant medication * chronical diseases

Keywords: pain, analgesia healthy volunteers
ketamine and midazolam infusions for crps: feasibility study

Conditions: Complex Regional Pain Syndromes

Summary: this study will assess the feasibility of administering ketamine plus midazolam or midazolam alone, when infused over 5 days in an outpatient setting, to adults with complex regional pain syndrome (crps).

subanesthetic ketamine infusions are a potentially impactful treatment for chronic refractory pain, but the acute psychoactive effects of ketamine complicate successful masking in randomized trials. multi-day ketamine infusions have produced long-lasting, but not permanent, remission of symptoms in complex regional pain syndrome (crps), a chronic and often debilitating neuropathic pain condition that can affect one or more limbs. in this feasibility study, 4 adults with crps will be randomized to receive either ketamine and midazolam or midazolam-only, infused over 5 days in an outpatient setting. the objectives of this feasibility study are: 1. assess whether the recruitment and retention rate observed in this feasibility study can support a larger clinical trial. 2. evaluate whether participants can adhere to study procedures. 3. determine whether midazolam, when given alone as an intravenous (iv) infusion, can be used as an active placebo that is well-tolerated, practical, and believable compared to a ketamine plus midazolam infusion. 4. gather preliminary data on clinically-relevant outcomes for crps.

Eligibility criteria:
* age 18 to 65 years * meets the international association for the study of pain (iasp) diagnostic criteria for complex regional pain syndrome (crps) * primary complaint of crps-attributable pain for ≥3 months * average pain intensity of ≥3/10 over the last month * can read and comprehend english-language questionnaires * can receive text messages by phone * can identify a responsible adult who can provide transportation to and from infusion site for 5 consecutive days (mon-fri)

Keywords: feasibility study ketamine midazolam complex regional pain syndrome active placebo analgesics dissociative anesthetics chronic pain neuropathic pain
prevent it 2.0/gpp -icbt to reduce the risk of committing child sexual abuse

Conditions: Pedophilia

Summary: child sexual abuse is a large-scale global problem, and with the internet and communication technologies enabling new ways to sexually abuse children, the problem is drastically increasing. prevent it is a free, anonymous, internet-delivered, therapist assisted, cognitive behavioral therapy (cbt) intervention for individuals concerned about their sexual urges or behaviors involving children. the treatment program is based on many years of clinical experience from working with this patient group, results from several previous research projects. using the scientifically rigorous design of a randomized controlled trial with waitlist control, we want to evaluate prevent it 2.0 - an updated cognitive behavioral therapy treatment for individuals who are concerned about their sexual urges regarding children. the study design is an academically initiated randomized controlled clinical trial where prevent it 2.0 is compared with waitlist control. participants in the waitlist control will wait thirteen weeks before starting active treatment. while on the waitlist, participants will respond to questions about ongoing problematic sexual behavior. recruitment will be carried out through multiple channels, and takes place on both "darknet" and "clearnet". all contact with participants, the treatment, evaluations, and termination of the contact, is conducted via the online treatment platform iterapi, designed specifically for clinical trials of internet-mediated cbt. the treatment contains nine modules over thirteen weeks and the content of the therapy is classic cbt.


Eligibility criteria:
inclusion criteria: * concern about sexual urges regarding children * informed consent to participate exclusion criteria: * participants with a severe psychiatric illness (such as high acute suicide risk or severe substance abuse) * participants that are judged to have a limited understanding of the languages that the treatment is delivered in (english) * lack serious intention to participate (assessed by the researcher/therapist during the intake interview, which lasts approximately one hour)

Keywords: child sexual abuse pedophilic disorder preventive psychiatry internet based intervention cognitive behavioral therapy waitlist
romiplostim in thoracic transplantation

Conditions: Thrombocytopenia

Summary: the investigators developed a platelet transfusion saving strategy based on thrombopoietin administration in heart or lung transplantation (hlt) patients or assist device implantation in bridge-to-transplantation (btt) or bridge to-decision (btd). this strategy was applied from may 2014 to october 2015 in patients whose platelet counts were below 100 giga per liter (g/l). as part of a health care quality improvement project, the investigators evaluated this strategy in a before/after design. january 2010 to december 2013 constituted the before period.

in may 2014, after heart or lung transplantation or assist device implantation, the investigators decided to off-label administered romiplostim in patients with thrombocytopenia below 100 giga per liter. the purpose was to reduce platelets transfusion side effects. romiplostim was used off treatment algorithm was based on previously published data in idiopathic, thrombocytopenia, cirrhotic and hematological patients. the first subcutaneous injection of 1.5 to 2 μg/kg of romiplostim was administered in the postoperative periods. an algorithm based on patient weight and platelet count evolution was established to determine romiplostim doses to administered weekly. romiplostim posology was adjusted between 2 and 5μg/kg according to platelet count with a maximum of 4 administrations in the icu. if platelets remained below 50 giga per liter after 2 injections, bone marrow analysis after hematologist referral was discussed. platelet count until day 15 after the last injection was monitored to detect thrombocytosis. in january 2016, the investigators decided to retrospectively assess romiplostim implementation in the standard of care in the icu through a healthcare quality improvement project in a before/after design.

Eligibility criteria:
inclusion criteria: * patients admitted in icu after hlt, btt or btd assist device implantation with platelet counts below 100g/l at least once in the post-operative period exclusion criteria: * age under 18 or over 65, combined heart and lung transplantation, multiple organ dysfunction syndrome (mods), pericardial effusion, active surgical bleeding, assist device dysfunction or suspected/diagnosed heparin-induced thrombocytopenia. we also excluded patients with myelodysplastic or myeloproliferative syndrome, hematological malignancy, severe liver cirrhosis with a child-pugh score superior to 6, receiving antiplatelet therapy, aplasia diagnosed on bone marrow analyses, pregnancy, thrombophilia, prior pulmonary embolism or stroke in the previous 6 months. thrombophilia was defined as factor v leyden mutation, activated protein c resistance, protein s deficiency, protein c deficiency, prothrombin gene mutation, factor viii excess, atiii deficiency or antiphospholipid syndrome. for the assistance population, the protocol also excluded destination-therapy devices or patients with transplantation contraindications

Keywords: transfusion saving strategy heart or lung transplantation assist device extra corporal life support (ecls) left ventricular assist device (lvad ) total artificial heart
dabigatran etexilate in patients with mechanical heart valves

Conditions: Heart Valve Diseases

Summary: to validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.


Eligibility criteria:
inclusion criteria: 1. patients aged 18-75 2. patients who have received a bileaflet mechanical heart valve exclusion criteria: 1. prior valve surgery 2. uncontrolled hypertension 3. severe renal impairment 4. active liver disease 5. increased risk of bleeding
pain free laceration repairs using intra-nasal ketamine

Conditions: Laceration

Summary: lacerations are one of most common trauma in children presenting to the emergency department (ed). currently, there are wide variations regarding sedation and analgesia practices when suture are required. even though topical anesthesia is very useful to reduce pain, it does not obviate the use of pharmacologic agents to decrease stress in anxious children undergoing laceration repairs in the ed. there is a growing interest in the intranasal (in) route of administration in the pediatric population. it bypasses the first hepatic passage and thus provides medications direct access to the systemic circulation leading to higher and faster serum concentrations than would the oral route. also, intravenous (iv) cannulation can be avoided reducing the pain associated with it and the need for nursing time and procedure delay. in fentanyl and midazolam are two agents that can be combined for this procedure, but respiratory depression is a feared adverse effects. ketamine is the most commonly used iv agent for procedural sedation, and can offer potent analgesia and sedation while maintaining respiratory drive and protective airway reflexes. few studies have evaluated in ketamine for procedural sedation. there is a wide range of dosing reported from 3 to 9 mg/kg. this raises the question as what is the lowest possible dosage that can be used to successfully repairs laceration in children with minimal restrain and no adverse events, as described by the pediatric emergency research canada (perc)/ pediatric emergency care applied research network (pecarn) consensus.


Eligibility criteria:
inclusion criteria: 1. children aged 1 to 12 years; 2. weight between 10 and 30 kg 3. any laceration requiring sutures repair; 4. need for procedural sedation according to the emergency physician assessment for the suture repair exclusion criteria: 1. american society of anesthesiologists (asa) physical status class iii and more; 2. previous administration of iv, in or oral analgesics or opioid other than acetaminophen and ibuprofen; 3. allergy or previous adverse reaction to ketamine; 4. aberrant nasal anatomy or nasal trauma; 5. presence of multiple trauma or eye rupture suspicion 6. head injury with loss of consciousness, decreased glasgow coma scale (gcs) or intracranial bleeding; 7. cognitive impairment; 8. known glaucoma; 9. pregnancy 10. language barrier 11. known schizophrenia or psychotic event; 12. uncontrolled hypertension; 13. airway instability (tracheal surgery, tracheal stenosis, tracheomalacia, and laryngomalacia) 14. active pulmonary infections (including upper respiratory infections) 15. known or suspected cardiac disease 16. known or suspected kidney disease

Keywords: intranasal ketamine pain management