Kornimate/medical-research-clean huggingface dataset:
symptom clusters in children with leukemia

Conditions: Childhood Leukemia

Summary: the purpose of this study is to examine the phenotypic and genotypic characteristics and their associations with symptom clusters experienced during treatment for childhood leukemia.

a repeated measures research design will evaluate phenotypic and genotypic treatment-related symptom associations experienced by children and adolescents 3-17 years of age with a diagnosis of leukemia.

Eligibility criteria:
inclusion criteria: * phenotypic and genotypic treatment-related symptom associations will be evaluated in children and adolescents 3-18 years of age with a diagnosis of leukemia. exclusion criteria: * children without a definite diagnosis of leukemia will be excluded. * children must be able to understand and answer the questions on the questionnaires. * children with have a cognitive impairment (e.g. down syndrome) will not be able to complete the questionnaires and will not be eligible for the study.
anterior shoulder instability treated with a semitendinosus subscapular sling procedure

Conditions: Anterior Shoulder Dislocation; Joint Instability

Summary: the arthroscopic subscapular sling procedure is a new technique for shoulder stabilization, which has been developed in human cadaveric studies by klungsøyr et al, but has yet to be tested clinically. the procedure stabilizes the shoulder by using a semitendinosus graft that makes a new labrum and a sling around the subscapular tendon. extensive biomechanical robotic testing of the procedure shows significant less translation and thus better stability of the humeral head with the sling compared to a normal bankart repair. the investigators consider the biomechanical results after robotic testing sufficient to advocate a planned pilot study in humans. in this pilot study the clinical and radiological results of the sling will be investigated in a small number of cases. the safety of the subscapular sling procedure will be assessed. this studies results are expected to be a further step towards implementation of the sling procedure as a surgical option for shoulder instability.


Eligibility criteria:
inclusion criteria: * clinical anterior instability of the shoulder and/or previous failed bankart repair or arthroscopic findings concluding with too weak anterior structures to perform capsulolabral or labrum repair * be able to understand oral and written norwegian /english exclusion criteria: * cuff injury or previous cuff repair * surgical fracture treatment of the glenoid or humeral head * other instability procedures in the shoulder except bankart repair and anterior capsular plications * previous infections in the shoulder * mri detectable fatty infiltration of the subscapularis or partial/total tendon rupture * severe glenohumeral arthrosis * multidirectional or posterior instability * not able to comply fully with the protocol due to psychosocial and physical conditions

Keywords: shoulder joint orthopedics arthroscopy
a trial of bile acid supplementation in patients with multiple sclerosis

Conditions: Progressive Multiple Sclerosis

Summary: this study aims to identify the safety and tolerability of bile acid supplementation in patients with progressive multiple sclerosis (ms). participants will also be assessed for an impact of the bile acid on their immune system and gut microbiome. half of the participants will receive the bile acid tauroursodeoxycholic acid (tudca) and half will receive placebo. the investigators believe participants who take tudca will have normalization of blood bile acid levels, a normalization of abnormal immune response and a normalization of the gut microbiome.


Eligibility criteria:
inclusion criteria: * diagnosis of progressive ms based on lublin criteria * low bile acid levels identified using targeted metabolomics analysis * on the same therapy for the past 6 months and not expected to switch therapy in the next 6 months * no relapse in the past 3 months exclusion criteria: * no previous history of liver disease or cholecystectomy * no stage iv/v chronic kidney disease or other severe metabolic derangements (e.g. poorly controlled thyroid disease or diabetes) * bmi \ 40 kg/m2 * female patients who are pregnant or nursing, or not willing to use contraception * chronic antibiotic use * corticosteroid treatment within the past 30 days * known history of other neuroinflammatory, neurodegenerative or systemic autoimmune disease
rehabilitation after intensive care

Conditions: Rehabilitation of Muscle Strength

Summary: patients with critical illness loose bodymass, mainly muscle. the purpose of the present study is to evaluate wheather tailored physical training and/or a sip drink (proteinrich) have effect on the six minutes walking test (6mwt), muscle strength, body weight, body composition and quality of life after intensive care. this is a single center randomised controled study comprising patients ≥45 years of age staying 5 days or more in the intensive care unit (icu). the design is factorial. inclusion takes place when the patient is leaving the icu.


Eligibility criteria:
inclusion criteria: * icu patients ≥45 years with los ≥ 5days exclusion criteria: * patients \< 45 years, cerebral function that make cooperation impossible, fractures in the spine, pelvis and/or lower extremities, unable to perform the intervention los \< 5 days

Keywords: sip drink protein muscle strength 6 minutes walking test
study of ibi318 in patients with advanced cutaneous squamous cell carcinoma

Conditions: Advanced Cutaneous Squamous Cell Carcinoma

Summary: the purpose of this study is to evaluate the safety and efficacy of ibi318 (anti-pd-1/pd-l1) in adult participants with metastatic (nodal or distant) cutaneous squamous cell carcinoma (cscc), or unresectable locally advanced cscc that is not amenable to surgery and/or radiation.


Eligibility criteria:
inclusion criteria: 1. able to understand and willing to sign the icf. 2. adults 18 years of age or older. 3. eastern cooperative oncology group (ecog) performance status of 0 or 1. 4. life expectancy at least 12 weeks. 5. adequate organ and bone marrow function. 6. histologically confirmed diagnosis of invasive cscc. . exclusion criteria: 1. prior treatment with an agent that blocks the pd-1/pd-l1 pathway. 2. any investigational drugs received within 4 weeks prior to the first study treatment. 3. receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy. 4. history of autoimmune disease , present active autoimmune disease or inflammatory diseases 5. pregnant or nursing females.
transpyloric feeding in severe bronchopulmonary dysplasia

Conditions: Bronchopulmonary Dysplasia

Summary: bronchopulmonary dysplasia (bpd) is the most common complication of extreme preterm birth. it impacts 10,000-15,000 infants in the us annually, including approximately 50% of infants with birth weight \< 1000g. bpd is associated with multiple long-term adverse outcomes including chronic cardiopulmonary and neurodevelopmental impairments. infants with severe bpd, defined as a need for ≥ 30% inspired oxygen and/or mechanical respiratory support at 36 weeks postmenstrual age (pma), suffer the greatest burden of these chronic sequelae. recurrent episodes of hypoxemia and prolonged exposure to supplemental oxygen are linked to the development of these impairments. gastroesophageal reflux (ger) contributes to these mechanisms by exacerbating pulmonary inflammation and inducing bronchospasm. unfortunately, clinically available methods to diagnose ger in infants are unreliable. moreover, acid suppressive agents are both ineffective and carry high risk of serious life-threatening morbidity. simple transpyloric feeding has promise, but has not been evaluated in bpd. this study will pilot n-of-1 trials to assess whether transpyloric feeds reduce airway complications of ger and and whether this methodology can aid in identifying individual infants with severe bpd who are likely to benefit from prolonged use of transpyloric feeds. aim 1. to determine for each enrolled infant with severe bpd whether transpyloric compared to gastric feeds reduce the number of daily intermittent hypoxemic events (primary outcome) and improve a validated bpd severity score (secondary outcome). the investigators hypothesize that 80% percent of enrolled infants will have significantly fewer daily intermittent hypoxemic events with transpyloric compared to gastric feeds and will have this feeding method formally recommended. aim 2. to pool results from multiple n-of-1 trials to determine whether transpyloric compared to gastric feeds reduce airway complications of ger in infants with severe bpd. the investigators hypothesize that transpyloric compared to gastric feeds will be associated overall with a 15% reduction in number of daily intermittent hypoxemic events.


Eligibility criteria:
inclusion criteria: * gestational age ≤ 32 weeks * severe bpd (fio2 ≥ 30% and/or mechanical ventilation or non-invasive positive pressure respiratory support at the time of enrollment) * post menstrual age of 36-45 6/7 weeks at enrollment * parent and/or guardian permission (informed consent) exclusion criteria: * prior intolerance to transpyloric feeds * history of surgical anti-reflux procedure * congenital heart disease (not including patent ductus arterioles and hemodynamically insignificant ventricular septal defect or atrial septal defect) * structural abnormalities of the upper airway, lungs, or chest wall * other congenital malformations or syndromes that adversely affect life expectancy or cardio-pulmonary development * parent, guardian, or subject who, in the opinion of the investigators, are unlikely to participate for the duration of the study
using snapshotnir with provocative leg maneuver for pad assessment

Conditions: Peripheral Arterial Disease

Summary: the objective of this trial is to determine if near-infrared spectroscopy (nirs) can accurately evaluate the degree of peripheral arterial disease (pad) during a provocative elevation maneuver of the lower extremity (pemle) test, as compared to routine clinical assessments.

this study is designed as a prospective observational study to assess the effectiveness of nirs to accurately evaluate the degree of pad, as compared to routine clinical assessment, during the pemle test protocol. this will be a single visit study where subjects will be screened and enrolled during a regular clinic visit.

Eligibility criteria:
inclusion criteria: * 35-99 years of age * subject has at least 1 intact forefoot * can achieve leg positions to complete the study exclusion criteria: * the subject is unwilling or unable to comply with the protocol or scheduled appointments. * the subject has had transmetatarsal amputation or higher on both limbs. * vascular intervention within the past year * subjects who have had a previous distal bypass procedure * pregnant or plans to become pregnant * deemed by the pi to be unsuitable for the study

Keywords: ankle-brachial index tissue oxygen saturation near infrared spectroscopy nir peripheral arterial disease pad cli provocative leg maneuver pad screening
trial comparing sedation for endoscopy with propofol versus midazolam in cirrhotics

Conditions: Hepatic Encephalopathy

Summary: to compare effects of sedation for upper gastrointestinal endoscopy with propofol and midazolam on psychometric tests and critical flicker frequency (cff) in cirrhotics

upper gi endoscopy is routinely performed in patients with chronic liver disease to screen for complications related to portal hypertension such as esophageal and gastric varices and portal gastropathy. sedation is frequently administered to facilitate patient tolerance.patients with hepatic dysfunction who undergo endoscopy are at increased risk for complications related to sedation.propofol has a favorable pharmacokinetic profile in comparison with benzodiazepines and opioids, which makes it especially appropriate for sedation in endoscopy.in previous studies cognitive functions were assessed by various paper and pencil tests. however learning affects the paper and pencil tests if repeated at short interval of time.cff analysis was found to be sensitive and objective in the quantification of low-grade he, and there is a significant correlation between cff and the portosystemic encephalopathy syndrome (phes) battery.considering this, we designed a prospective randomized controlled study with cirrhotic outpatients to compare effects of sedation for upper gastrointestinal endoscopy with propofol versus midazolam on psychometric tests and critical flicker frequency in cirrhotics

Eligibility criteria:
inclusion criteria: * known chronic liver disease (child-pugh class a , b or c ) who presented for upper gi endoscopy for routine variceal screening. * the diagnosis of liver disease will be based on available past history, serological testing, radiological imaging, and liver histology when available. * staging of cirrhosis will be determined by meld score and by child-pugh score . all patients will complete a standard preprocedure history and physical examination to establish current degree of encephalopathy and ascites. exclusion criteria: * active gi bleeding * overt encephalopathy * active alcohol intake during the past 6 weeks * significant co morbid illness such as heart, respiratory, or renal failure and any neurologic diseases such as alzheimer's disease, parkinson's disease and nonhepatic metabolic encephalopathies. * patients with known allergy to sedative * hepatocellular carcinoma * previous tips or shunt surgery, * patients on psychoactive drugs, such as antidepressants or sedatives * patients with an american society of anesthesiology (asa) physical status of class iv or v * patients with visual or mental impairment who will unable to complete the psychometric testing or cff
study of eye bank pre-cut donor grafts for endothelial keratoplasty

Conditions: Fuchs Endothelial Dystrophy; Corneal Edema

Summary: descemet's stripping with endothelial keratoplasty (dsek) is a cornea-sparing transplant technique that replaces only the diseased endothelial cell layer of the patient's cornea. the dsek technique requires lamellar dissection of the donor tissue prior to implantation in the patient's eye. the surgeon usually dissects the donor cornea with a microkeratome at the time of surgery. recently some eye banks have begun to pre-cut the donor graft as an added service. the purpose of this study was to compare outcomes with eye bank pre-cut and surgeon-dissected donor grafts for dsek.


Eligibility criteria:
inclusion criteria: * candidate for descemet's stripping with endothelial keratoplasty * at least 21 years old * willing and able to return for scheduled follow-up visits * reads and signs informed consent document exclusion criteria: * visual acuity of less than 20/400 in fellow eye * known sensitivity to planned study concomitant medications
a phase 3 study to evaluate the efficacy and safety of tnx-102 sl in patients with fibromyalgia

Conditions: Fibromyalgia

Summary: this is a phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of tnx-102 sl 5.6 mg (2 x 2.8 mg tablets) taken daily at bedtime for the treatment of fibromyalgia.


Eligibility criteria:
inclusion criteria: * the patient is male or female 18 to 65 years of age, inclusive. * the patient has a diagnosis of primary fm as defined by the 2016 revisions to the 2010/2011 fibromyalgia diagnostic criteria (american college of rheumatology preliminary diagnostic criteria) * the in clinic 7-day recall nrs average daily pain intensity score at screening visit within protocol defined range. exclusion criteria: - history of or evidence for a diagnosis of borderline personality disorder (bpd).

Keywords: pain sleep fibromyalgia fm
improving sickle cell disease (scd) care using web-based guidelines

Conditions: Sickle Cell Disease

Summary: the overall goal of this proposed project is to 1) increase co-management between sickle cell specialists and primary care providers (pcp's); 2) increase the use of hydroxyurea (hu) which prevents vaso-occlusive episode (voe), eds and subsequent hospitalizations, and death; 3) identify and link patients not receiving primary or scd specialty care to care, and 4) shift healthcare use from eds and hospitalizations to primary and specialty co-management. many persons with scd experience a poor quality of life, serious medical complications and frequent painful events that require treatment from scd specialty care, primary care and emergency department (ed) providers. there are two dominating models of care in the united states; neither are ideal. many people with scd have all of their healthcare needs addressed by sickle cell specialists who do not typically provide primary care and are often geographically distant from the patients' home. other sickle cell patients receive all of their care in eds. both models are inadequate and result in an alarmingly high number of ed visits for many patients. current care models are neither cost efficient nor promoting optimal patient outcomes. to improve outcomes, the investigators will implement a new model of care for scd using nurse care managers, web based-interactive algorithms, and test if additional patient provided coaching can improve outcomes.

to inform the model, the investigators will conduct an initial in-depth multi-level assessment of the barriers to care and implementation of the nhlbi "evidence-based management of sickle cell disease". with barriers and facilitators identified at the patient, provider, healthcare organization and community levels, the investigators will develop another study evaluation interventions that may improve the barriers.

Eligibility criteria:
inclusion criteria: - scd patients in the 31 geographic counties surrounding duke with genotypes hemoglobin ss, sc, sβ° or, sβ+. and -parents of 15-20 year old scd patients in the 31 geographic counties surrounding duke with genotypes hemoglobin ss, sc, sβ° or sβ+. and -healthcare providers of sickle cell patients in the 31 geographic counties surrounding duke exclusion criteria: * non-english speaking

Keywords: sickle cell disease needs assessment barriers to care access to care primary care
artichoke and bergamot phytosome

Conditions: Hypercholesterolemia

Summary: according to who data, about 50% of deaths each year are caused by cardiovascular disease. one of the strategies for prevention of cardiovascular diseases, in addition to a correct lifestyle, is to implement therapies that reduce the level of cholesterol in the blood and at the same time control the glycemic levels, which are closely related in the maintenance of metabolic homeostasis. the aim of this clinical study is to confirm the potential broader activity as hypocholesterolemic agent in bergamot poor-responders subjects with mild hypercholesterolemia. the study was a 8-week randomized double-blind placebo-controlled trial. participants were randomized to either the supplement based on dry extract from artichoke leaf and bergamot phospholipid (31) or placebo arm (29).


Eligibility criteria:
inclusion criteria: * mild hypercholesterolemia (220 - 280 mg/dl) * subjects were not taking any medication likely to affect lipid metabolism (such as statins) * subjects were bergamot poor-responders exclusion criteria: * liver, renal and thyroid diseases * history of cardiovascular disease (cvd)

Keywords: bergamot cynara cardunculus
effect of hydrocortisone phonophoresis versus iontophoresis in patients with subacromial impingement syndrome

Conditions: Impingement Syndrome; Subacromial Impingement Syndrome

Summary: the purpose of this study will be to compare the efficacy of adding hydrocortisone phonophoresis or iontophoresis on pain, function, range of motion and shoulder external rotation isometric strength in patients with subacromial impingement syndrome.

routine physiotherapy has been advocated was an effective treatment for sis. however, there is lack of best exercise treatment and lots of studies are under consideration. according to published data focused on management of shoulder pain, it looks like that therapeutic exercise is not sufficient to treat sis and it is compulsory to combine with other remedies to get the best results

Eligibility criteria:
inclusion criteria: 1. all patients were diagnosed as unilateral sis with stage ii neer classification \> 3 months. 2. positive impingement sign (neer's test or hawkins-kennedy test), / painful arc during active arm elevation, pain or weakness with resisted isometric external rotation or resisted scapular plane abduction with the humeral internal rotation (empty can test) 3. the age of patients ranged from 18 - 60 years old. 4. both genders will be involved. 5. shoulder pain scores more than 5 on a numeric rate scale for pain of 0- 10. 6. failure to respond to conservative nsaid. exclusion criteria: 1. frozen shoulders. 2. arthritis of the shoulder. 3. shoulder instability. 4. pregnant women. 5. a pacemaker. 6. previous shoulder surgery. 7. history of dislocation of the shoulder. 8. internal metallic fixation. 9. malignancy. 10. previous corticosteroid injection. 11. rheumatoid arthritis 12. partial or full thickness tear of the rotator cuff. 13. cervical radiculopathy. 14. physiotherapeutic shoulder treatment within the last 3 months. 15. the patients will randomly be assigned into 3 equal groups, 20 patients for each group.
european phase iii study of apd421 in ponv

Conditions: PONV

Summary: a comparison of the efficacy of apd421 and placebo in the prevention of ponv in patients at moderate-to-high risk of ponv.


Eligibility criteria:
inclusion criteria: * male or female patients ≥ 18 years of age * patients undergoing elective surgery (open or laparoscopic technique) under general anaesthesia, expected to last at least one hour from induction of anaesthesia to wound closure and expected to require at least one overnight stay in hospital exclusion criteria: * patients scheduled for outpatient/day case surgery * patients scheduled to undergo intra-thoracic, transplant or central nervous system surgery * patients scheduled to receive only a local anaesthetic/regional neuraxial (intrathecal or epidural) block * patients who are expected to remain ventilated for a period after surgery * patients who are expected to need a naso- or orogastric tube in situ after surgery is completed