Kornimate/medical-research-clean huggingface dataset:
a clinical utility study of prismra for rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: a clinical utility study for prismra testing therapeutic response in patients with rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * age ≥ 18 at time of consent * patient must meet the criteria for ra as defined by the 2010 acr/eular classification at visit 1 * patient has active, moderate to high, ra with a cdai of \>10 at visit 1 * patient has swollen and tender joint count of ≥ 2 each, as determined by cdai assessment at visit 1 using a 28-joint count * patient may participate in additional observational studies concurrently * patient is willing and able to complete the informed consent process and comply with study procedures and visit schedule exclusion criteria: * patients who are unable to understand the protocol and unable to provide informed consent * patients who are not indicated for prismra * patients who are receiving concurrent treatment with an investigational therapy or have used an investigational therapy less than 4 weeks prior to visit 1
outcome of failed and neglected terrible triad injury of the elbow

Conditions: Elbow Injury

Summary: the aim of the study is to evaluate the results of reconstruction of neglected and failed cases of terrible triad of the elbow

a terrible triad injury consists of posterior dislocation of the elbow associated with a radial head fracture and a coronoid fracture. this injury occurs during a fall onto an outstretched arm, and it presents a disruption of the bony and capsuloligamentous structures from the lateral side, which progresses anteriorly and medially.the primary goal of surgical treatment for terrible triad injury is to restore elbow function with. good stability. the current standard treatment involves internal fixation and reconstruction of the bony and ligamentous structures to allow early mobilization. fixation or replacement of radial head fractures and lateral ligament reconstruction represent the main operative procedures. a biomechanical and clinical study showed that restoration of the coronoid process and anterior capsule is an important step for a stable elbow. old "terrible triad" of elbow with no operative history is difficult to treat. the elbow's functions and stabilization can be recovered by thorough elbow release, repair of coronoid process and anterior capsule, radial head fixation or replacment reconstruction or repaire of, lateral collateral ligament and reinsertion of the common extensor tendon, combined with hinged external fixator although improved knowledge of this injury has yielded favourable clinical outcomes, complications continue to occur, including stiffness, recurrent subluxation or dislocation, heterotopic ossification, ulnar nerve neuropathy, and arthritis.the common causes of revision after terrible triad injury reconstruction are stiffness and recurrent instability, stiffness and instability, among all these complications, are indeed the most recurring. a stiff or unstable elbow is very poorly tolerated because of the lack of compensatory motion in adjacent joints, so it's very important to detect causes and risk factors that leading to fail terrible triad reconstruction.

Eligibility criteria:
inclusion criteria: * • age from 15 to 70 years' old * neglected cases more than 4 weeks * early failed cases whom had any intervention whether conservative treatment as cast or hinged elbow brace etc or operative and still complaining of instability of the elbow. in less than 6 weeks * late failed cases whom had any intervention whether conservative treatment as cast or hinged elbow brace etc or operative and still complaining of instability of the elbow after more than 6 weeks . exclusion criteria: * • older than 70 years old and younger than 15 years old * nerve injury * associated soft tissue loss * patients needs total elbow replacement or arthrodesis
ultrasound-guided intermediate cervical plexus block for carotid surgery

Conditions: Carotid Artery Stenosis

Summary: since stroke and myocardial ischemia are major causes of perioperative morbidity and mortality associated with carotid endarterectomy, monitoring the brain and ensuring the best hemodynamic stability are important goals of perioperative management. the investigators conducted a prospective observational study about efficacy and safety of the ultrasound-guided intermediate cervical plexus block (cpb), with early (immediate postoperative) and mid-term (day 30) outcomes in awake patients undergoing carotid endarterectomy.

from april 2011 to may 2013, all patients undergoing a carotid endarterectomy were informed of the study and prospectively included. the study was approved by our institutional ethical review board (cepar, institut mutualiste montsouris paris france). oral consent was obtained from patients. written informed consent of the patients to participate was not necessary according to the french law regarding observational study. the anesthesiologist in charge of the patient recorded all the parameters of the ultrasound-guided intermediate cervical plexus block: facility and duration of block performance, local anesthetic volume, quality of anesthesia and surgical dissection, and adverse effects of the intermediate cpb. . neurological status was assessed intraoperatively, in the postoperative setting and at one month after the procedure. perioperative hemodynamic stability (intraoperative non invasive blood pressure variations) and pulse oxymetry were recorded. as well as ecg and cardiac troponin i (ctni) measurments performed the day before surgery and each morning during the 3 first postoperative days. any clinical coronary or neurological event was recorded at one month. statistical analysis was performed on prism 6 for mac os x (version 6.0c, www.graphpad.com). data are presented as mean ± standard deviation (sd) for continuous data and number (percentage) for categorical data.

Eligibility criteria:
inclusion criteria: * patients undergoing carotid endarterectomy exclusion criteria: * none

Keywords: ultrasound-guided intermediate cervical plexus block
skeletal muscle dysfunction in heart failure

Conditions: Heart Failure, Congestive

Summary: patients suffering from congestive heart failure report reduced exercise capacity. this skeletal muscle dysfunction is also detectable when using small muscle groups which should not put any demand on the heart. we hypothesize that congestive heart failure has systemic effects that causes the skeletal muscle dysfunction.


Eligibility criteria:
inclusion criteria: * coronary heart failure * ejection fraction \<35% * nyha 2-3 * spirometry fev1 \> 80% exclusion criteria: * cardiomyopathy * transplantation candidate * active malignancy * restraining skeletal-muscular disease * claudication in legs * hospitalized last 30 days due to acute ischemic episode * intravenous inotrope or vasodilatating drugs last 14 days prior to inclusion * ami last 8 weeks prior to inclusion * organized training last 4 months * smoking on daily basis last 4 months * creatinin \< 150microliters/liter
early motion after volar fixation for distal radius fractures

Conditions: Radius Fracture

Summary: many surgeons pursue volar plating of the distal radius to allow earlier post-operative wrist motion. early motion is generally prescribed in the belief that it will result in greater final motion without compromising fixation. however, studies have failed to demonstrate clinically significant improvement in final wrist motion (\> 1 year follow up) compared to treatments requiring longer immobilization such as external fixation or bridge plating.

many surgeons pursue volar plating of the distal radius to allow earlier post-operative wrist motion. early motion is generally prescribed in the belief that it will result in greater final motion without compromising fixation. however, studies have failed to demonstrate clinically significant improvement in final wrist motion (\>1 year follow up) compared to treatments requiring longer immobilization such as external fixation or bridge plating (mcqueen 1996, handoll 2003, atroshi 2006, krishnan 2003, sommerkamp 1994, grewal 2005). only one study to date has attempted to define the early effects of wrist mobilization following volar plate fixation of the distal radius (lozano-calderon 2008). that study prospectively enrolled 60 patients and randomized them to begin wrist motion at 2 weeks (range 7 days - 13 days) or 6 weeks (range 42 to 49 days) postoperatively. this study found no significant difference in subjective or objective outcome measures at 3 or 6 months follow up. however, the investigation had several weaknesses. first, there was no attempt to confirm adherence to the immobilization protocols. those in the late motion group were not casted but remained in orthoplast splints which could be easily removed. secondly, this investigation collected data only at 3 and 6 months which prohibited them from commenting on the rate of improvement during the early weeks after mobilization. the authors acknowledged these limitations and further noted that no evaluation of patient cost was performed. finally, radiographic evaluations in this study did not include analysis of change in alignment from immediate postoperative films. thus, the literature to date suggests that early mobilization of the volarly plated distal radius is safe but does not improve final wrist motion. the benefits of mobilization in the early postoperative period though have not been clearly defined. this project proposes to fill this void in the literature and determine if early mobilization is an effective measure to hasten recovery of motion and function.

Eligibility criteria:
inclusion criteria: * adults over 18 years of age having volar internal fixation for distal radius fractures. exclusion criteria: * patients will be excluded if immobilization is required for distal radioulnar joint instability (whether operatively pinned or simply immobilized in supination) or an associated carpal injury. * patients with concurrent fracture of the ulna proximal to the base of the ulnar styloid will be excluded.

Keywords: wrist fracture motion surgery
cancer related fatigue in patients receiving chemotherapy

Conditions: Cancer; Fatigue

Summary: the purpose of this study is to examine the degree of fatigue in patients receiving chemotherapy. special interest goes out to the course of fatigue throughout five treatments and the actions taken by patients to reduce this fatigue.the correlation between fatigue and haemoglobin will also be subject of study.


Eligibility criteria:
inclusion criteria: * diagnosis of cancer requiring chemotherapy treatment exclusion criteria: * pregnancy * psychological illness * life expectancy less than three months * lack of basic proficiency in dutch

Keywords: chemotherapy
effect of padma 28 on endothelial function, autonomic nervous system and biomarkers in patients with coronary artery disease

Conditions: Coronary Artery Disease

Summary: this randomized, placebo-controlled, double-blinded trial investigates the effect of a 6 week intake of padma 28 on the endothelial function, biomarkers and the autonomic nervous systems in patients with coronary artery disease. the investigators hypothesize that padma 28 has a beneficial effect on endothelial function, arterial stiffness, the autonomic nervous systen and the blood inflammatory markers in patients with coronary artery disease compared to placebo treatment.

background this randomized, placebo-controlled, double-blinded trial investigates the effect of a 6 week intake of padma 28 on the endothelial function, biomarkers and the autonomic nervous systems in patients with coronary artery disease. padma 28 contains 20 herbs from tibet. the endothelial function will be measured by endopat 2000, the autonomic nervous system by an ambulatory electrocardiography during the orthostatic reaction and the biomarkers will be analyzed with taking a blood sample. the investigators hypothesize that padma 28 has a beneficial effect on endothelial function, arterial stiffness, the autonomic nervous systen and the blood inflammatory markers in patients with coronary artery disease compared to placebo treatment. objective to assess the effect of padma 28 on endothelial function, autonomic nervous system and biomarkers in patients with coronary artery disease. methods 80 patients with coronary artery disease will be recruited for the study. to measure endothelial function, the investigators use endopat 2000. the autonomic nervous system will be analysed with ambulatory electrocardiography.

Eligibility criteria:
inclusion criteria: * male patient with coronary artery disease * stable medication * physically stable * psychologically stable * written informed consent * willing and able to comply with all trial requirements * must have completed rehabilitation program since at least 6 months and no longer than 5 years prior to study begin exclusion criteria: * acute coronary syndrome within the last three months * abnormal high hepatic enzymes * renal insufficiency with compensated retention * intake of medication which may affect endothelial function * currently smoking * current malignant diseases, which may reduce the expectancy of life * chronic heart failure * insulin-dependent diabetes * known hypersensitivity against any ingredient of padma 28 * longterm intake of supplements * serious mental health issues * alcohol and/or drug abuse * simultaneous participation in another clinical trial

Keywords: endothelial function biomarkers autonomic nervous system coronary artery disease
cars: cannabis and alcohol reduction study

Conditions: Cannabis Use; Alcohol Use, Unspecified; Substance Use; Substance Use Disorders

Summary: the study will test a computerized treatment with subjects ages 13-17 years who are seeking treatment for alcohol and/or cannabis use. follow-up assessments will be conducted at one- and three-months following treatment.


Eligibility criteria:
inclusion criteria: * between the ages of 13 and 17 * be seeking treatment for either cannabis or alcohol use; * report co-occurring alcohol and cannabis use during the past three months (i.e., participants who report using both alcohol and cannabis during the three months prior to participation in the study, regardless of if the use was simultaneous) * have a caregiver willing to participate and provide consent.
the effects of expectation and knowledge on rizatriptan and placebo treatment of acute migraine headache

Conditions: Episodic Migraine

Summary: evidence-based medicine depends on distinguishing between pharmacological effects and placebo effects in randomized controlled trials (rct). this proposal seeks to rigorously investigate fundamental questions concerning pharmacological effects, placebo effects and their interactions. relief of symptoms of acute migraine will be the test condition for this scientific experiment because of migraine's evident clinical significance and the possibility of using participants as their own control during sequential acute migraine attacks. our overall goal is to elucidate how the pharmacological effects of 100 mg rizatriptan (an fda-proven effective medication for acute migraine) and the effects of placebo treatment can be modified by varied knowledge and/or expectation ("contextual") conditions. such knowledge has the possibility to suggest potentially more efficient methodologies to test new medications that can be used to augment and enhance the apparatus of the rct. general aim: to elucidate and clarify what is a pharmacological effect and what is a placebo effect, how such effects vary in different knowledge/expectations contexts, and mutually constitute one another and interact. general hypothesis: the measured pharmacological effect of an effective medication (rizatriptan) and the measured effect of placebo treatment are determined significantly by different knowledge/expectations contexts.


Eligibility criteria:
inclusion criteria: * patients will be considered for this study if they suffer from classical or common migraine for at least 3 years. * candidates will recruited from the clinical case load of dr. zahid bajwa and the headache and pain management center at bidmc. * only patients older than 18 years of age, * able to communicate clearly in english, * able to give an informed consent will be considered as candidates. * no limitation of gender or race is justified and thus, it is open to all patients fulfilling criteria for migraine type headache. * patients will be able to withdraw from the study at any time. * they will be included in the study if they meet the criteria for migraine with or without aura (headache-classification-committee-of-the-international-headache-society 1988), if they had \>4 migraine attacks each month for the previous year. exclusion criteria: * exclusion criteria will include cardiovascular or cerebrovascular disorders, * cardiac risk factors and liver disease, * uncontrolled hypertension, * peripheral and central nervous system disorders that affect sensory functions (such as sensory neuropathies and chronic pain), * the use of opiates or other analgesic drugs for any reason, and the use of other prophylactic anti-migraine drugs. * any patient with active hepatitis or elevated liver enzymes (based on their bidmc medical record) will be excluded as well. * employees who are under the direct supervision of the investigators will not participate in the study.
patient performed examination for patients with intra-articular hip pain

Conditions: Hip Pain Chronic; Hip Disease

Summary: the primary objective of this study is evaluate the diagnostic accuracy of a patient self-administered clinical examination of the hip compared with a traditional clinical examination (i.e. index test).


Eligibility criteria:
inclusion criteria: * age: 18-80 years * seeking care for hip related pain and/or clicking, catching, giving way or stiffness * able to sign or verbalize study consent * no other medical conditions (e.g. gynecological or urinary pathology) that may affect study results * english speaking exclusion criteria: * patients with primary lumbar spine, sacro-iliac or other non-hip related pain as determined with clinical examination * previous hip surgery * previous hip injury that would normally exclude from examination as standard practice * unable to sign or verbalize consent * other non-musculoskeletal pathology that may affect study results (e.g. gynecological or urinary pathology) * non-english speaking
bilateral occipital nerve field stimulation for the treatment of dtcch

Conditions: Chronic Cluster Headache

Summary: the purpose of this study is to assess the initial safety, tolerability, and effectiveness of the novel blistim occipital nerve field stimulation therapy for the prevention of chronic cluster headaches. this is a prospective, first in human study.


Eligibility criteria:
inclusion criteria: 1. ichd-3 criteria for chronic cluster headache 2. documented history of cch since at least 2 years 3. minimum mean attack frequency of 4 attacks per week 4. age range: 18-70 years 5. difficult-to-treat cch with documented previous complete failure, insufficient efficacy, intolerance, or contra-indications to most preventive ch treatments among which are oral steroids or suboccipital infiltrations, verapamil, lithium carbonate and topiramate. 6. no preventive ch treatment or stable preventive ch medication for ≥ 2 weeks before enrolment. subject agrees not to change existing treatment during the whole duration of the trial. 7. subject written informed consent provided before enrolment 8. subject willing and capable of subjective evaluation and to fill in an electronic ch diary, to understand questionnaires, and to read, understand and sign the written informed consent form. 9. subject willing and able to comply with study-related requirements, procedures, and visits. exclusion criteria: 1. other significant neurological, psychiatric, or disabling diseases which in the opinion of the investigator may interfere with the study. 2. history of epilepsy, current treatment of epilepsy 3. documented history of cerebrovascular accident (cva) 4. subjects suffering from a substance use disorder, as defined by diagnostic and statistical manual of mental disorders (dsm) criteria. recreational use of cannabis is allowed. 5. subjects at high risk of suicide/suicidal ideation in the past one year assessed with the c-ssrs 6. having another active implanted device such as a cardiac pacemaker, a spinal cord, peripheral nerve, sphenopalatine ganglion, or deep brain hypothalamic stimulator, and/or a drug delivery pump, etc. 7. cranial botulinum toxin injections in the past 3 months before enrolment. administration of the following treatments in the last month before enrolment: monoclonal antibodies blocking calcitonin gene-related peptide transmission, suboccipital infiltrations with steroids and/or local anaesthetics, oral steroids, radiofrequency procedure or infiltrations of the sphenopalatine ganglion, opioids who 3. 8. medication overuse headache (ichd 3 8.2) 9. inability to fill out an electronic diary. 10. previous surgery or trauma involving the cervical spine or the occipital bone 11. coagulopathy or required anticoagulant medications that cannot be safely discontinued in the perioperative period. 12. concurrent participation in another clinical study 13. planned pregnancy, pregnancy, or breastfeeding.

Keywords: cluster headaches
steps: an efficacy trial of a chronic pain self-management program for older adults

Conditions: Chronic Pain

Summary: the goal of this study is to determine whether community health workers (chws)-i.e., lay health workers with close ties to the communities they serve - can effectively teach cognitive-behavioral pain management strategies to older adults in a disadvantaged urban setting. specific aims are: to test, in a sample of 414 primarily african american older adults, whether the steps pain self-management intervention, delivered over 7 weeks through telephone sessions with a chw and mobile health tools, improves pain outcomes at 2 and 12 months compared to a usual care control group. we will also assess the mechanisms by which the intervention may bring about positive changes in pain outcomes. we will use mixed quantitative and qualitative methods to assess participant engagement and satisfaction, and factors affecting implementation.


Eligibility criteria:
inclusion criteria: * community-living * have a cell or landline phone * self-reported chronic musculoskeletal pain (pain in muscles or joints for \>= 3 months); \>=4 (0-10 scale) average pain level over last week; \>=1 day/previous 30 when pain made it difficult to do usual activities. * able to converse comfortably in english exclusion criteria: * serious acute illness or hospitalization in last month * planned major surgery in next three months that would interfere with program participation (e.g., knee or hip replacement); * severe cognitive impairment or other severe physical or psychiatric disorder judged by study team to pose significant barrier to participation