Kornimate/medical-research-clean huggingface dataset:
tofacitinib for reduction of spinal inflammation in patients with psoriatic arthritis presenting with axial involvement

Conditions: Psoriatic Arthritis; Spondylitis; Sacroilitis

Summary: to evaluate the efficacy of tofacitinib in reducing inflammation in the sacroiliac joints and spine on magnetic resonance imaging (mri) in patients with active psoriatic arthritis (psa) with axial involvement (basdai \[bath ankylosing spondylitis disease activity index\] ≥ 4 and total backpain ≥ 4 despite treatment with nsaids plus evidence of active inflammation in the sacroiliac joints or spine on mri).

this study is a prospective, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy of tofacitinib in reducing inflammation in the sacroiliac joints and in the spine on mri in patients with active axial psa. eligible patients (n=80) will be randomized 1:1 to receive either tofacitinib 5mg orally twice daily or placebo for a 12-week period. after week 12, all patients will receive tofacitinib 5mg orally twice daily for another 12 weeks. the study duration will include a 6-week screening period, a 24-week treatment period and a safety follow-up period of 4 weeks. patients will be closely monitored throughout the study on a total of 11 visits. safety data will be collected in the form of adverse events, vital parameters, physical examinations, and laboratory parameters throughout the study. the baseline mri of the whole spine and sacroiliac (si) joints will be performed within the 6-week screening period to confirm the presence of active inflammation (bone marrow edema) compatible with spondyloarthritis (will be assessed by a central reader), at week 12 to evaluate the primary study endpoint, and at week 24 to evaluate the secondary endpoint. the primary study endpoint will be an improvement of the total berlin mri score for sacroiliac joints and spine at week 12 as compared to baseline.

Eligibility criteria:
inclusion criteria: * psoriatic arthritis fulfilling classification for psoriatic arthritis (caspar) criteria * chronic back pain \> 3 months * basdai value ≥ 4 and backpain ≥ 4 / 10 vas * presence of active inflammation in screening mri of sacroiliac joints and / or spine (central reading) * history of inadequate response to ≥ 2 nsaids or intolerance / contraindications exclusion criteria: * active current infection, severe infections in the last 3 months * history of recurrent herpes zoster or disseminated herpes simplex * immunodeficiency * chronic hepatitis b, c or hiv infection * women: pregnant or lactating (have to practice reliable method of contraception) * other severe diseases conflicting with a clinical study, contraindications for mri

Keywords: psoriatic arthritis sacroiliitis spondylitis mri
oral ketorolac for pain relief during iud insertion

Conditions: Contraception

Summary: ketorolac is a non-steroidal anti-inflammatory drug (nsaid), similar to ibuprofen but it is used to treat more severe pain. ketorolac (trade name: toradol) is typically used after surgical procedures. when taken orally, it should not cause sedation. the purpose of this study is to determine if oral ketorolac is effective at reducing pain during iud placement versus a placebo tablet.

in the united states, 10% of women choose an intrauterine device (iud) for contraception. with typical use, unintended pregnancy rates in the first year of iud contraception are 0.8% (copper t) and 0.2% (lng). it is known that long-acting, reversible contraception methods reduce the long-term cost of unintended pregnancies. a common deterrent to intrauterine contraception is the fear of pain during placement. methods of pain relief during iud insertion must be fast-acting but have minimal sedation. there have been many attempts to find effective pain relief during iud placement. neither ibuprofen nor naproxen have been shown to be effective in reducing pain. misoprostol has been used to increase cervical ripening; however, pain was not decreased, and side effects of nausea and vomiting were increased. ketorolac is a nonsteroidal anti-inflammatory drug (nsaid) that works by reversibly inhibiting cyclooxygenase-1 and 2.time to peak plasma concentration ketorolac in the oral form is 44 minutes. studies have shown that one dose of ketorolac can be as potent as morphine. ketorolac is also well established for pain control in the immediate post-operative period. a recent study showed that intramuscular ketorolac wais effective in reducing pain after iud insertion, but 20% of the participants reported that after the procedure, the injection site was as painful as the iud placement. the current study was designed to evaluate if there is reduced pain during iud placement using oral ketorolac 40-60 minutes before the procedure compared to a placebo.

Eligibility criteria:
inclusion criteria: * non-pregnant * english speaking women * 18 years of age or older desiring an iud for contraception exclusion criteria: * enrollment in another study * pre-medication with any type of analgesic medication * contraindication to an iud * weight under 50 kg * allergy to non-steroidal anti-inflammatory medications * past medical history of liver disease, renal disease, peptic ulcer disease or recent gastrointestinal bleed, * daily narcotic pain use * positive cultures for gonorrhea or chlamydia.

Keywords: intrauterine device
cse for labour analgesia: a comparison of two intrathecal regimens

Conditions: Labor Pain

Summary: analgesia in labour is not readily available in many parts of sub-saharan africa. the overall cost of epidural services in terms of human personnel and financial implication makes this inaccessible to many women in labour. thus, a cheaper, less technically demanding and easier option that can produce as much satisfaction for the parturient and would allow her participate in the second stage of labour by being able to bare down is being studied. the single shot spinal (sss) would provide pain relief in these women however its draw back is its time limitation as the option of a top up is not available. two regimen of drug options would be considered using opioids. these would be compared to see how well they are able to provide analgesia in women who hitherto have had vaginal birth. their onset, duration of action and possible side effects would be compared. null hypothesis: single shot spinal with bupivacaine fentanyl (bf) cannot provide a statistically significant difference in labour analgesia in comparison with bupivacaine fentanyl morphine (bfm) alternate hypothesis: single shot spinal with bf can provide a statistically significant difference in labour in comparison with bfm

a double blinded randomized study comparing 2 intrathecal mixtures for labour analgesia. 94 multiparous parturients in active labour who have given informed consent would be recruited into the study. they would be randomly allocated into 2 groups using simple random sampling. an assistant would know the code and prepare the intrathecal solutions. baseline vitals would be taken and patient's pain score noted. due protocol would be followed and a combined spinal epidural sited but with the epidural not activated until the effect of the spinal wears off. routine monitoring would be done and various parameters and indices noted. where the effect of the spinal lasts the duration of labour thus no need to activate the epidural, this would also be noted. data would be analysed using statistical package of social sciences (spss) version 20.

Eligibility criteria:
inclusion criteria: * parturients in active labour \>4cm dilatation * american society of anesthesiologists (asa) classification i and ii exclusion criteria: * significant co-morbidities like uncontrolled hypertension or diabetes * maternal hemorrhage with hypotension * significant bleeding/clotting disorders

Keywords: single shot spinal intrathecal narcotics morphine fentanyl labour analgesia
to compare treatment with doxorubicin or capecitabine for metastatic breast cancer in women 60 years and older

Conditions: Metastatic Breast Cancer

Summary: the main purpose of this study is to compare treatment with either pegylated liposomal doxorubicin or capecitabine as first line chemotherapy for metastatic breast cancer in women 60 years and older.

this is an open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), multicenter study comparing with pegylated liposomal doxorubicin (pld) with capecitabine as first line chemotherapy of metastatic breast cancer in women 60 years and older. the study consists of a screening phase (up to 14 days prior to treatment), treatment phase (up to 1 year), and post-treatment follow-up phase. the planned duration of treatment was 1 year in the absence of disease progression or unacceptable toxicity. approximately 300 patients will be enrolled and randomly assigned to receive 1 of 2 treatment groups (pld or capecitabine). safety evaluations will consist of vital sign examination, physical examination, incidence and severity of adverse events, and laboratory tests findings and will be followed throughout the study.

Eligibility criteria:
inclusion criteria: * clinically or pathologically proven metastatic breast cancer * eastern cooperative oncology group performance status between 0-2 * adequate bone marrow, renal and liver functions within normal limits * left ventricular ejection fractions more than 45% measured by multiple gated acquisition scan or echocardiogram within 6 weeks of randomization exclusion criteria: * prior chemotherapy for metastatic disease (hormonal or chemotherapy in adjuvant setting and hormonal therapy in metastatic setting is allowed) * prior treatment with capecitabine or pegylated liposomal doxorubicin in the adjuvant setting (prior anthracyclines up to certain dose limit is allowed) * evidence of brain metastases unless previously treated and asymptomatic for 3 months or greater * history of cardiac disease with new york heart association class ii or greater or clinical evidence of congestive heart failure * anthracycline resistant disease (locally recurrent or metastatic disease while on adjuvant anthracycline therapy or relapse less than 18 months after therapy completion)

Keywords: metastatic breast cancer breast cancer pegylated liposomal doxorubicin capecitabine doxil xeloda
early procalcitonin kinetics during empirical antibiotic therapy in critically ill patients

Conditions: Bacterial Infections

Summary: to investigate the value of procalcitonin (pct) kinetics between 0-8-16-24 hours after starting empirical antibiotic therapy in critically ill patients, to predict appropriate or inappropriate antibiotic treatment.


Eligibility criteria:
inclusion criteria: * clinical signs of infection * suspected or proven acute infection requiring empiric antibiotic therapy as decided by the attending icu physician * suspected site of infection has to be present and documented * microbiological sample sent for staining * inflammatory markers available at the start of the therapy exclusion criteria: * patients younger than 18 years * who received prophylactic or empiric antibiotic therapy 48 hours before inclusion * whose receiving acute renal replacement therapy in the first 24 hours following antibiotic treatment * following cardiopulmonary resuscitation * end stage diseases with a "do not resuscitate" order * immunocompromised patients (human immunodeficiency virus infection, bone marrow transplantation, malignant haematological disorders and chemotherapy) * post cardiac surgery patients

Keywords: empiric antibiotic therapy
exploration of glutamatergic system with pet radiotracer in gilles de la tourette patients: pilot study (glutatour)

Conditions: Tourette Syndrome

Summary: gilles de la tourette syndrome is a neuropsychiatric disorder characterized by motor and vocal tics often associated with psychiatric comorbidities (obsessive compulsive disorder, anxiety and depressive syndrome, impulsivity). the pathophysiology of gilles de la tourette syndrome remains unclear.

gilles de la tourette syndrome is a neuropsychiatric disorder characterized by motor and vocal tics often associated with psychiatric comorbidities (obsessive compulsive disorder, anxiety and depressive syndrome, impulsivity). the pathophysiology of gilles de la tourette syndrome remains unclear. it would involve an alteration of striatal-cortico-thalamic cortical circuits resulting in dopaminergic dysfunction. but glutamatergic hypothesis is also discussed from pharmacological, biochemical and genetic arguments. exploration of glutamatergic system can be done in humans in vivo using a new radiotracer: the \[18f\] fnm (fluoroethylnormemantine), a derivative of memantine. in the present study, aim of the study 1) to show the glutamatergic system "in vivo" in patients with tourette's syndrome and 2) to perform correlations between various motor and behavioral symptoms and the pattern of brain fixation for this radiotracer. to do that, a pilot study will be conducted in 12 patients with tourette's who will be evaluated in terms of motor (tics) and behavioral (ocd, anxiety, depression, impulsivity) symptoms. each patient will have a pet-scan exam and a brain mri exam. data analysis will be carried out from two different approaches: first by region of interest, and secondly, without topographic a priori with the statistical parametric mapping (spm) software.

Eligibility criteria:
inclusion criteria: * gilles de la tourette syndrome according to the american psychiatric association criteria (5 th ed, american psychiatric association (apa), 2013) * aged 18 and over * patients treated with 2nd-generation neuroleptics for at least 3months * signed consent form exclusion criteria: * contraindications for mri exam * claustrophobia * person under exclusive period for another study * pregnant women * patients under non-authorized treatment (1rst generation neuroleptics) or non-treated by neuroleptics

Keywords: tourette syndrome the glutamatergic system pet-scan physiopathology
expanded access protocol for subjects with relapsed or refractory advanced solid tumors receiving tj210001

Conditions: Solid Tumor Metastatic Cancer Advanced Cancer

Summary: this eap was designed to provide tj210001 to the remaining subjects with relapsed or refractory solid tumors who were enrolled on the parent study, tj210001stm101 (nct04678921), and plan to continue with treatment.


Eligibility criteria:
inclusion criteria: 1. males or females, of any race, age ≥ 18 years; 2. participation in the parent tj210001stm101 study and thought to have potential to derive clinical benefit from continued treatment in the opinion of the parent study investigator from uninterrupted dosing of tj210001; 3. willingness and ability to comply study treatment and standard of care testing and procedures; 4. women of childbearing potential (wocbp) must: 1. agree to use at least 2 effective contraceptive methods (1 highly effective method in combination with a barrier method; oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner), one of which must be barrier, from signing the icf, throughout the study, and for up to 12 weeks following the last dose of tj210001; 2. avoid conceiving for 12 weeks after the last dose of tj210001; 3. avoid donation of ova until 12 weeks after the last dose of tj210001; 4. agree to ongoing urine pregnancy testing, if clinically indicated, during the course of the study. 5. males must agree to use a condom (a latex condom is recommended) during sexual contact with a pregnant female or a female of childbearing potential and will avoid donation of sperm or having a female partner conceive from the time of signing the icf, while participating in the study, during dose interruptions, and for at least 12 weeks after the last dose of study treatment, even if he has undergone a successful vasectomy; 6. patient or patient's health care proxy is able and willing to provide written informed consent and able to follow study instructions. exclusion criteria: * any unresolved ongoing toxicity or clinical event that would make continued treatment with tj210001 inappropriate; 2. current treatment on another therapeutic clinical trial; 3. currently pregnant; 4. current evidence of any condition (including medical, psychiatric or substance abuse disorder), therapy, or laboratory abnormality that might interfere with the patient's participation or is not in the best interest of the patient to participate, in the opinion of the treating investigator

Keywords: monoclonal antibody anti-c2ar
long-term treatment with the ketogenic diet in epilepsy

Conditions: Epilepsy; GLUT1DS1; PDH Deficiency

Summary: this study will provide a comprehensive assessment of long-term treatment with the ketogenic diet, a medical diet with high fat and low carbohydrate intake, focusing on safety and cardiovascular implications. we will assess patients with epilepsy or one of two rare metabolic diseases; glucose transporter type 1 deficiency syndrome (glut1 ds) or pyruvate dehydrogenase complex deficiency (pdhd).


Eligibility criteria:
inclusion criteria: * treatment with the ketogenic diet at the national centre for epilepsy (sse) for 5 years or more * able to travel from the national centre for epilepsy - sse (sandvika) to rikshospitalet (gaustad) to perform procedures to investigate cardiovascular risk factors * willing to draw extra blood for research purposes * willing to sign informed consent and participate in the study in accordance with the study protocol * willing to sign informed consent for blood samples to be included in research biobank at the department of neurology, oslo university hospital exclusion criteria: * non-compliance with the dietary treatment for 6 months or longer or more than once per month * not possible to communicate with parents in norwegian or english without interpreter * patient not able to cooperate and lie still for about ten minutes during the carotid ultrasound examination * psychiatric/mental illness, alcohol or drug abuse or other factors making it impossible to pursue the study protocol

Keywords: ketogenic dieting
a north-american eight-week study to evaluate the efficacy and safety of saredutant in patients with generalized anxiety disorder

Conditions: Anxiety

Summary: the primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to placebo in patients with generalized anxiety disorder. the secondary objectives are to evaluate the efficacy of saredutant on disability and quality of life in patients with generalized anxiety disorder, and to evaluate blood levels of saredutant.


Eligibility criteria:
inclusion criteria: * diagnosis of generalized anxiety disorder as defined by diagnostic and statistical manual of mental disorders (dsm-iv-tr) criteria and confirmed by the mini international neuropsychiatric interview (mini) plus generalized anxiety disorder module. exclusion criteria: * total score of less than 22 on the ham-a. * montgomery-asberg depression rating scale (madrs) total score greater than 18. * patients with a current history (within 6 months) of major depressive disorder or history or presence of bipolar disorders or psychotic disorders. * patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence. * patients who have used the following prior to entry into acute phase: antipsychotics within 3 months, antidepressants including monoamine oxidase inhibitors (maois) within 1 month, anxiolytics within 2 weeks, mood-stabilizer (lithium, anticonvulsants) within 1 month, and/or high dose or prolonged benzodiazepine (continuous use for 3 months prior to admission) use. the investigator will evaluate whether there are other reasons why a patient may not participate.

Keywords: anxiety clinical trials
enhancing exercise and psychotherapy to treat pain and addiction in opioid use disorders ("expo" pilot trial)

Conditions: Opioid-use Disorder; Pain

Summary: the purpose of this pilot trial is to determine the feasibility of integrating exercise and psychotherapy that is specifically targeted to reducing and managing pain into residential drug treatment programs. the investigators will evaluate the feasibility (adherence) of integrating 'assisted' rate cycling, voluntary rate cycling and psychotherapy for pain (i-stop) in participants with an opioid use disorder (oud) and pain enrolled in residential drug treatment programs. the investigators will also explore the potential effects of 'assisted' rate cycling, voluntary rate cycling and i-stop on pain, cravings, depression, anxiety, weight and sleep.


Eligibility criteria:
inclusion criteria: * 18 to 65 years old * must be enrolled in a residential drug treatment program at a collaborating drug treatment center * must be diagnosed with an opioid use disorder (oud; icd-10 f11.20) or a poly-substance drug use that includes an opioid component (icd-10,f19.xx) and self-reported pain or a pain condition describing a non-cancer related chronic pain disorder * must be approved to exercise in the study by the drug treatment center medical director, physician or other relevant clinical staff or primary care physician (pcp) exclusion criteria: * any substantive contraindications to exercise

Keywords: exercise psychotherapy residential drug treatment oud chronic pain
prevalence of myofascial pain syndrome in adolescent idiopathic scoliosis

Conditions: Scoliosis; Adolescence; Myofascial Pain Syndrome; Trigger Point Pain, Myofascial; Physical Medicine and Rehabilitation

Summary: this is an observational and cross-sectional prevalence study. 10-18 years aged participants with adolescent idiopathic scoliosis were recruited in the study. myofascial pain syndrome will be questioned to the participants. additionally, all participants will be evaluated using their findings for scoliosis and myofascial pain syndrome diagnostic criteria. cobb angle, coronal balance, shoulder and pelvis asymmetry, sagittal spino-pelvic parameters of the spine (cervical lordosis, thoracic kyphosis, lumbar lordosis angles and sagittal vertical axis, sacral slop angle and pelvic incidence) will be measured.

this is an observational and cross-sectional prevalence study. patients diagnosed with adolescent idiopathic scoliosis who applied to the physical medicine and rehabilitation clinic of kanuni sultan süleyman training and research hospital will be included in our study. these participants will be aged between 10-18 years. these patients will be evaluated using their findings for scoliosis and myofascial pain syndrome diagnostic criteria. cobb angle, coronal balance, shoulder and pelvis asymmetry, sagittal spino-pelvic parameters of the spine (cervical lordosis, thoracic kyphosis, lumbar lordosis angles and sagittal vertical axis, sacral slop angle and pelvic incidence) will be measured. diagnostic criteria of myofascial pain syndrome; as the major criteria; 1. regional pain complaint 2. pain or sensory change reflected from trigger points to a specific area 3. palpable taut band in accessible muscles 4. extreme tenderness at one point along the taut band 5. decreased range of motion that can be measured as for the minor criteria; 1. complaint of clinical pain and/or sensory change on pressurized palpation of the trigger point 2. local twitch response of the tender point on the taut band with palpation and needling 3. reduction of pain by injection of the tender point or stretching of the muscle five major and at least 1 minor criteria are required for the clinical diagnosis of myofascial pain syndrome. patients with a previous history of surgery for scoliosis and neuromuscular scoliosis were excluded from the study.

Eligibility criteria:
inclusion criteria: * aged between 10-18 years * diagnosed as adolescent idiopathic scoliosis * agreed to participate in the study exclusion criteria: * neuromuscular or any other type of scoliosis * any surgical treatment for scoliosis or spine.

Keywords: scoliosis sagittal alignment cobb angle myofascial pain