Kornimate/medical-research-clean huggingface dataset:
indirect approach of c0-1 and c2-3 segments in flexion-rotation test

Conditions: Neck Pain; Cervical Spine Disease; Rotation

Summary: restrictions on upper cervical spine are associated with cervical pain. the vast majority of upper cervical spine rotation occurs at the c1-2 segment. flexion-rotation test is a valid measure that predominantly measures rotation in c1-2 segment, however upper cervical spine rotation also implies c0-1 and c2-3 due to ligament anatomy. restriction in flexion-rotation may be due to direct restriction in c1-2, but also to a premature tightening of the alar ligament as a result of lack of movement in c0-1 or c2-3. the objective is to compare the effect of a 20-minutes single cervical exercise session with or without manual therapy of c0-1 and c2-3 segment in flexion-rotation test in patients with chronic neck pain and positive flexion-rotation test. to carry out the objective, the following will be designed a randomized controlled assessor-blind clinical trial with primary healthcare patients. this population will be patients with chronic neck pain and positive flexion-rotation test. these patients will be assigned in manual therapy + exercise group or in exercise group. exercise will be focused on deep anterior cervical muscles. manual therapy will combine techniques in c0-1 and c2-3 with this exercise. flexion-rotation test, neck pain intensity, pain intensity during the flexion-rotation test and cervical range of motion will be measured before and after the intervention.


Eligibility criteria:
inclusion criteria: * a medical diagnosis of chronic neck pain with more than 3 months of evolution. * a positive result in the flexion-rotation test (less than 33º or a difference of 10º or more between the two rotations). * being over 18 years old. * having signed the informed consent. exclusion criteria: * contraindications for manual therapy or exercise. * having participated in exercise or manual therapy programs in the last three months. * presenting warning signs or having suffered a relevant neck trauma. * an inability to maintain supine position. * the use of pacemakers (the magnets in the crom device could alter their signal) * an inability to perform flexion-rotation test * language difficulties. * pending litigation or lawsuits.

Keywords: manual therapy neck pain exercise restriction
is there an allergy to pure metallic gold microparticles?

Conditions: Allergic Reaction

Summary: the investigators hypothesize gold is inert and thereby there is no pure-gold allergy. the primary aim of this study is to measure the prevalence of allergy to metallic pure gold microparticles and allergy to gsts.

true test panel which includes gold sodium thiosulphate (gsts), 1 % w/v in petrolatum, and gold microparticles, 20-micron diameter, 1 % w/v in petrolatum, will be added added to the baseline series. it will be applied to the upper back of healthy adults in aluminum finn chamber for 48 hours. clinical evaluation will be performed 24 hours after removal the test according to standard procedures for evaluation of epi-cutaneous challenging (johansen 2015).

Eligibility criteria:
inclusion criteria: * patients with chronic dermatitis exclusion criteria: * age \< 18
alternate chemotherapy regimens for the clearance of w.bancrofti infection

Conditions: Filarial; Infestation

Summary: diethylcarbamazine (dec) essentially a micro-filaricidal drug is given for 12 days as standard treatment for the clearance of w. bancrofti infection. it takes about one year for the individuals to completely clear the microfilaria from the blood. it takes another two to four years to clear the antigen. the aim of the present study is to shorten the time taken for clearing the mf and antigen from the blood either by co-administration or sequential administration of a macrofilaricidal drug, albendazole or doxycycline. this study is a randomized, double blind, controlled clinical trial to study the efficacy of these drug combinations in complete clearance the mf and antigen from the blood in shorter span of 180 days and 365 days respectively.

purpose: lymphatic dwelling parasite w. bancrofti is the most common cause of secondary lymphoedema. till today, there is no effective treatment protocol for the complete clearance of w. bancrofti infection, in a short duration of time. methods: the investigators conducted a double blind rct under field conditions recruiting 146 asymptomatic w. bancrofti infected individuals. participants were randomly assigned one of the four regimens for 12 days, dec 300 mg + doxycycline 100 mg co-administration or dec 300 mg + albendazole 400 mg co-administration or dec 300 mg + albendazole 400 mg sequential administration or control regimen dec 300 mg. participants were followed up at 13, 26 and 52 weeks post-treatment for the clearance of infection.

Eligibility criteria:
inclusion criteria: * residing in or around pondicherry and adjoining tamilnadu areas * night blood microfilaria counts \> 10 mf/ml by membrane filtration * no history of treatment for filarial infection for the last two years at least * willing for home visits by the staff of the center * willing to give written informed consent exclusion criteria: * body weight less than 30 kg * hepatic or renal disease as evidenced by clinical or biochemical abnormalities. - concurrent illness like hypertension, diabetes mellitus, cardiac conditions and epilepsy requiring chronic medication * psychiatric illness * patients under tetracycline or doxycycline therapy * history of de-worming by albendazole or other anti-helminthic during last one year * pregnancy or lactation

Keywords: lymphatic filariasis w. bancrofti dec albendazole doxycycline
mézières therapy in the ucam's athletes with low back pain

Conditions: Low Back Pain; Postural; Strain

Summary: the purpose of this research study focuses on the re-harmonization of the kinetic chains and posture based on spinal muscular atrophy and global stretching while trying to test the effectiveness of mézières therapy on sports subjects with low back pain.

the experimental study was conducted on 139 young athletes of national rhythmic gymnastics of murcia, ucam murcia cf and ucam murcia cb/eba during a six months period in the city of murcia. precisely, the mézières therapy was conducted in an experimental group of 69 athletes and in a control group with other 70 athletes with low back pain. this study is developed through a cycle of global stretching decompensate interventions on the athletes with postural alterations and vertebral pain at 95% confidence level. the statistical analysis was handled by using the univariate general linear model with the support of spss statistics.

Eligibility criteria:
inclusion criteria: * between 15 - 39 years * athletes with low back pain lasting more than 1 month * scoliosis * kyphosis exclusion criteria: * presence of tumors or spinal metastases * vertebral fractures * osteoporosis * infection or inflammation in acute diseases with involvement of the central nervous system * herniated discs

Keywords: low back pain mézières method postural treatment athletes
superficial vein thrombosis (svt) treated with rivaroxaban versus fondaparinux

Conditions: Superficial Vein Thrombosis

Summary: the purpose of this study is to evaluate the efficacy and safety of rivaroxaban versus fondaparinux in the treatment of superficial vein thrombosis (svt).

evaluation of efficacy and safety of 45 days of rivaroxaban 10 mg vs. fondaparinux 2.5 mg in the treatment of superficial vein thrombosis of risk patients for major vte complications to prove non-inferiority of oral rivaroxaban treatment

Eligibility criteria:
inclusion criteria: * acute symptomatic supragenual superficial vein thrombosis of the leg * at least one of the following major risk factor for vte: * age \> 65 years or * male sex or * history of dvt/pe/svt or * history of cancer or active cancer or * autoimmune disease or * svt of a non-varicose vein * thrombus extension of at least 5 cm * proximal thrombus end with more than 3 cm distance to the saphenofemoral junction (sfj) * age \> 18 years * written informed consent exclusion criteria: * other indication for therapeutic anticoagulation such as acute deep vein thrombosis, acute pulmonary embolism, atrial fibrillation with indication for anticoagulant therapy * any pe or dvt within last 6 months before inclusion * clinical signs of pe without objective exclusion (ct or vq scan, angiography) * svt without signs of thrombotic/inflammatory activity (activity signs: diameter \> 4 mm, pain, redness, elevated local or systemic temperature) * svt after sclerotherapy * duration of symptoms \> 3 weeks * pretreatment of more than 72 h with therapeutic dosages of oral or parenteral anticoagulants * pretreatment of more than 5 days with subtherapeutic oral or parenteral anticoagulants * indication for escalated antiplatelet therapy (monotherapy with aspirin \> 325 g/d and any dual antiplatelet therapy) * svt closer than 3 cm to saphenofemoral junction (svj) * anticipated superficial vein surgery within 90 days * anticipated thrombolytic therapy within 90 days * manifest clinically relevant bleeding * clinically relevant bleeding in the last 30 days before study inclusion * major surgery within last 30 days before inclusion * ophthalmic, spinal or cerebral surgery within last 90 days * severe head trauma within last 90 days * hemorrhagic stroke within last 12 months * hereditary or acquired severe hemorrhagic diathesis * gastrointestinal bleeding within last 90 days requiring endoscopy * uncontrolled arterial hypertension (systolic \> 180 mm hg, diastolic \> 110 mm hg) * acute endocarditis * low platelet count (\< 100 x 109/l) * prothrombin time \< 50 % * calculated creatinine clearance \< 30 ml/min * significant liver disease such as acute hepatitis, chronic active hepatitis, cirrhosis * life expectancy \< 3 months * any contraindications listed for rivaroxaban or fondaparinux * women of child bearing potential without safe contraception method * pregnant or breastfeeding women * participation in another trial with pharmacological intervention

Keywords: superficial vein thrombosis thrombosis svt
department of defense ptsd adaptive platform trial - intervention a - fluoxetine

Conditions: Post Traumatic Stress Disorder

Summary: this is a phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for ptsd utilizing an adaptive platform trial design. intervention a - fluoxetine will assess the safety and efficacy of fluoxetine in participants with ptsd. please see nct05422612 for information on the s-21-02 master protocol.

the general structure of this adaptive platform trial (apt) consists of a 30-day screening period, a 12-week platform treatment period, and a 4-week safety follow-up. the s-21-02 platform trial will evaluate the safety and efficacy of multiple investigational products for the treatment of ptsd (see nct05422612 for master protocol information). participants are randomized among the multiple cohorts in the study and the resulting randomization enables sharing/pooling of control subjects, where all interventions may be compared to a common control (placebo). this record only includes information relevant to the fluoxetine cohort. once a participant meets all eligibility criteria for the master protocol, eligibility for each currently enrolling intervention cohort is assessed. eligible participants will be randomized with equal probability into a cohort. participants randomized to the fluoxetine cohort are then randomly assigned to receive either fluoxetine or placebo (in a ratio of 5:3; intervention:placebo), for the duration of the 12-week treatment period. parties interested in having their intervention considered for testing within the m-pact should complete a request for information form using this webpage https://citeline.qualtrics.com/jfe/form/sv_8etqkw6tnug4z42..

Eligibility criteria:
inclusion criteria: no additional inclusion criteria beyond the inclusion criteria specified in the master protocol (nct05422612). exclusion criteria: the following exclusion criteria are in addition to the exclusion criteria specified in the master protocol (nct05422612). 1. recent history of treatment for ptsd with fluoxetine at doses of 20 mg daily, for at least 4 weeks. a remote history of treatment with fluoxetine for non-ptsd symptoms will be discussed on a case-by-case basis with the contract research organization (cro) medical monitor.
ex vivo expansion of circulating tumor cells as a model for cancer predictive pharmacology

Conditions: Melanoma; Circulating Tumor Cell

Summary: several studies conducted over the past decade have shown that circulating tumor cells (ctcs) can be used as a marker for predicting disease progression and survival in patients with early or metastatic cancer. a high number of ctcs correlate with aggressive disease, increased metastasis and decreased survival rates. knowledge of metastasis mechanisms was mainly obtained from mouse models with ctcs after orthotopic transplants. the only possibility to study the patient's ctc subpopulations is to carry out ex-vivo expansion and develop an animal model with ctc xenograft. because circulating blood collection is simple and non-invasive, ctcs can be used as a marker to track disease progression and survival in real time. ctcs could also guide therapeutic choice.


Eligibility criteria:
cohort 1 inclusion criteria: * histologically confirmed cutaneous or mucosal melanoma (per american joint committee on cancer (ajcc) staging system) that is unresectable or metastatic * no prior systemic anticancer therapy for unresectable/metastatic melanoma or clinical/radiological disease progression (recist1.1) if previously treated and before new treatment * no prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as cutaneous carcinoma or cervix) * followed in saint louis hospital * tumor tissue available in saint louis hospital * subjects must have signed and approved written informed consent form * no pregnancy * any positive test for hepatitis a virus, hepatitis b virus or hepatitis c virus indicating acute or chronic infection, and/or detectable virus exclusion criteria: * none cohort 2 : inclusion criteria : * histologically confirmed cutaneous or mucosal melanoma * candidates for sentinel lymph node analysis and surgical recovery (this examination is in practice reserved for melanomas \>1mm thick or ulcerated) * no prior adjuvant anticancer therapy * followed in saint louis hospital * tumor tissue available in saint louis hospital * subjects must have signed and approved written informed consent form * no pregnancy * any positive test for hepatitis a virus, hepatitis b virus or hepatitis c virus indicating acute or chronic infection, and/or detectable virus exclusion criteria: * none
improving the nutritional status of the malnourished chronic hemodialysis patients in the state of tennessee

Conditions: End Stage Renal Disease

Summary: we propose to identify malnourished chronic kidney dialysis patients through a statewide effort and subsequently treat them based on a protocol (provision of oral nutritional supplementation) over a period of six (6) months.


Eligibility criteria:
inclusion criteria: * on chd dialysis for more than 6 months * adequately dialyzed (kt/v \> 1.0) with a biocompatible hemodialysis membrane. patients with kt/v \> 1.0 but \< 1.4 will be evaluated for etiologies of lower than optimal dialysis dose and every effort will be made to increase the dialysis dose to 1.4 or above. patients with all access types will be recruited to the study. * suboptimal nutritional status identified by one of the following criteria: 1. protein catabolic rate less than 1.0 g/kg/d calculated by three-point urea kinetic modeling on at least 2 occasions over the past 3 months 2. progressive unintentional weight loss more than 2.5% of the initial or ideal body weight and/or patients who are less than 90% of ideal body weight. 3. biochemical parameters of malnutrition defined by one of the following measurements over the consecutive two months prior to inclusion: 1. serum albumin less than 4.0 g/dl 2. serum transferrin concentration less than 250 mg/dl 3. serum prealbumin concentration less than 32 mg/dl 4. subjective global assessment score less than 5. exclusion criteria: * intolerance to nutritional supplementation (unable to tolerate any of the nutritional supplements available) * refusal to sign a consent form * on nutritional supplementation (idpn or po) within 2 weeks of the study initiation.
mystroke in chronic stroke

Conditions: Stroke

Summary: this is a single-center randomized control trial assessing the impact of a personalized video-based educational platform on patients satisfaction and stroke knowledge in the context of chronic stroke.


Eligibility criteria:
inclusion criteria: 1. history of ischemic stroke between 1 and 10 years prior to enrollment 2. receiving outpatient stroke care at the hospital of the university of pennsylvania 3. at least 18 years old 4. access to a smart phone, tablet, or computer 5. willingness to complete 2 follow-up surveys (7 days and 90 day post-enrollment) exclusion criteria: 1. unwilling or unable to access the customized app with a smartphone, tablet, or computer 2. complete dependence on caregiver for all activities of daily living 3. stroke occurred less than 1 year or greater than 10 years prior to screening/enrollment 4. patient has severe aphasia (score of greater than or equal to 2 on national institutes of health stroke scale item 9)
boost study 31380 (mhealth)

Conditions: Addiction

Summary: the purpose of this research is to examine the potential for a new software-based behavioral support approach, for individuals with opioid use disorder, as an addition to usual care.

the purpose of this study is to examine the potential for a novel computer-based approach to mitigate the symptoms of opioid use disorder as part of a comprehensive treatment program. the study is designed as a single-arm field-test of cognitive training for individuals under supervised medical treatment for opioid use disorder. a custom and proprietary smartphone package (mhealth platform) comprises the intervention available to enrolled subjects for interaction over the study period. commercial mobile devices serve as information presentation and data recording instruments. additional outcome measures incorporate subject-reported data.

Eligibility criteria:
inclusion criteria: * age 18-65 years * diagnosis of opioid use disorder * experiencing symptoms multiple times per week * familiar with smartphone usage exclusion criteria: - none specified
pharmacokinetics in patients with newly diagnosed high-grade glioma receiving temozolomide and radiation therapy

Conditions: Brain and Central Nervous System Tumors; Thrombocytopenia

Summary: rationale: studying samples of blood in the laboratory from patients receiving temozolomide may help doctors learn how temozolomide works in the body. it may also help doctors learn more about how a patient's genes may affect the risk of developing thrombocytopenia. purpose: this clinical trial is studying the pharmacokinetics in patients with newly diagnosed high-grade glioma receiving temozolomide and radiation therapy.

objectives: * compare the pharmacokinetic (pk) profiles of temozolomide (tmz) in patients who develop severe thrombocytopenia vs pk profiles in patients who do not develop severe thrombocytopenia while receiving standard first-line therapy for management of newly diagnosed high-grade gliomas. * determine if patients who develop thrombocytopenia have any single nucleotide polymorphisms in the o6-methylguanine-dna methyltransferase gene. outline: this is a pilot, prospective, multicenter study. patients receive oral temozolomide once daily on days 1-42. patients also undergo cranial radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity. blood samples are collected periodically for pharmacokinetic and pharmacogenomic analysis, genotype analysis, plasma temozolomide levels, and mgmt repair gene polymorphism analysis. after completion of study treatment, patients are followed for 1 month. projected accrual: a total of 150 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed high-grade glioma (who grade iii or iv) * must be scheduled to receive standard first-line therapy (cranial radiotherapy and temozolomide) patient characteristics: * anc ≥ 1,500/mm³ * platelet count ≥ 100,000/mm³ * creatinine ≤ 1.7 mg/dl * bilirubin ≤ 1.5 mg/dl * transaminases ≤ 4 times upper limit of normal * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell carcinoma of the skin prior concurrent therapy: * no prior hormonal therapy for brain tumor * no prior biological agents (including immunotoxins, immunoconjugates, antisense agents, peptide receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocytes, lymphokine-activated killer cells, or gene therapy) * no prior immunotherapy * no prior chemotherapy * no prior radiotherapy, including cranial radiotherapy * concurrent glucocorticoid therapy allowed * no concurrent carbamazepine * no other concurrent experimental therapy * no other concurrent cytotoxic therapy

Keywords: thrombocytopenia adult anaplastic oligodendroglioma adult brain stem glioma adult mixed glioma adult giant cell glioblastoma adult gliosarcoma adult glioblastoma adult anaplastic astrocytoma adult anaplastic ependymoma adult pineal gland astrocytoma
naltrexone augmentation of nicotine patch therapy - 1

Conditions: Tobacco Use Disorder

Summary: naltrexone augmentation of nicotine patch therapy

this double blind placebo controlled study is designed to determine whether naltrexone can be used to help reduce cigarette use and craving for cigarettes. eligible participants will receive 21mg transdermal nicotine as an outpatient. in addition, participants will receive one of three doses of naltrexone (25,50 or 100mg) or a placebo and brief counseling over the course of six weeks with follow-up appointments three, six, and twelve months after the beginning of treatment.

Eligibility criteria:
inclusion criteria: 1. age 18 and older 2. willingness and ability to give written consent 3. smoking 20 cigarettes per day for at least 1 year 4. at least one prior attempt to stop smoking 5. baseline expired carbon-monoxide level of at least 10 ppm 6. weigh at least 100 lbs. 7. english speaking 8. one person per household exclusion criteria: 1. pregnant or nursing women or women who do not use a reliable form of birth control 2. unstable cardiac disease 3. history of dermatoses 4. current alcohol dependence 5. current use of opiates 6. a urine drug screen that is positive for opiates 7. serious current neurologic, psychiatric or medical illness 8. chronic pain conditions necessitating opioid treatment 9. evidence of significant hepatocellular injury as evidence by sgot or sgpt \>3 x normal or elevated bilirubin 10. current use of smokeless tobacco, pipes, cigars, nicotine gum or nicotine patch 11. patients requiring concomitant therapy with any psychotropic drug or on any drug with a psychotropic component

Keywords: nicotine dependence