Kornimate/medical-research-clean huggingface dataset:
food allergy challenge diagnostic study

Conditions: Food Hypersensitivity

Summary: the objective of this study is to correlate various diagnostic measurements taken during an escalating dose oral food challenge to the subject's response. this study will investigate whether non invasive objective biomarkers can indicate a positive response to an escalating dose ofc before a systemic reaction occurs.

patients often discover their food allergies after consuming a given food and experiencing a subsequent allergic reaction. the majority of patients (75%) will then consult a food allergist for formal diagnosis and treatment information. with respect to patient quality of life, there is tremendous benefit in having a confirmed diagnosis of food allergy as often patients are unsure of the source of their reaction outside the office. allergists will conduct a skin prick test (spt) and assess serum specific ige levels to screen for specific food protein sensitivities. however, a positive response in spt and specific ige will confirm only sensitivity, and in more than 70% of cases patients that respond positively to spt and specific ige testing will not manifest an allergic response to food consumption. to address this issue, most food allergists will recommend an oral food challenge in a controlled setting to confirm the allergic response from consuming the suspected foods. the oral food challenge (ofc) consists of consuming escalating levels of the suspect food, (usually mixed in applesauce or controlled baked goods), until either a reaction manifests or until the challenge is complete with no reaction. the food challenge process poses significant risk to the patient. in 5% of cases, the patient experiences a severe allergic response which requires the use of epinephrine. these responses typically consist of severe reactions in gi or respiratory and arise from challenging patients with higher doses of food allergen then is necessary to prove a mild allergic response, which is directly linked to variability in diagnosis of a positive response, within subjects and within investigators. the investigators hypothesize that measurements taken using minimally-invasive diagnostic tests during the course of an escalating-dose oral food challenge will be able to detect a positive response before a systemic reaction occurs in the patient and may be able to screen with individuals predisposed to eoe.

Eligibility criteria:
inclusion criteria: * male or female of any race, aged 5 - 35 years with planned clinical oral food challenge; * have provided verbal and written informed consent. if under the age of 18, a parent/guardian must provide verbal and written informed consent; * be willing and able to follow instructions, including participation in study assessments, and can be present for the required study visits for the duration of the study; exclusion criteria: * be unable to comply with all study parameters and procedures

Keywords: food hypersensitivity oral food challenge skin prick test food biomarkers
local changes of skin characteristics after an application of a topical product with a warming or cooling effect

Conditions: Healthy

Summary: the use of topical over-the-counter (otc) products with a warming or cooling effect is widespread in the fields of sport, physiotherapy and in private households. advertisements for such products promise pain relief when suffering from musculoskeletal disorders such as muscle tension, rheumatism or acute injuries, e.g. sprains. in literature, there are only little information about the efficacy and the physiological mechanisms of topical warming or cooling products. therefore, the aim of this study is to investigate the local skin characteristics during and after an application of a topical product with a warming or cooling effect.

the use of topical products for local pain relief in chronic or acute musculoskeletal disorders is widely used. despite the widespread use of these products, there is missing information on the physiological mechanisms and efficacy of topical warming and cooling ointments. most of the existing literature is about the efficacy of topical non-steroidal anti-inflammatory drug (nsaid)-products on chronic pain in osteoarthritis. furthermore, one study tested the cooling effect of gels with different menthol concentrations. they found that, regardless of the concentration, the skin temperature was reduced up to one hour post application in the area of application. the aim of our study is to evaluate the change of skin characteristics after a single application of a warming or cooling topical product on healthy subjects. outcome parameters include skin perfusion, temperature, skin redness and subjective thermal sensation. we only selected products in form of alcohol based ointments, menthol or wintergreen oil. sprays and patches were excluded. the application area is the unilateral lumbar back region, whereas the contralateral side serves as control area. after an acclimatization period, baseline measurements are performed, followed by standardized application of the topical product. the local skin responses are measured in 10 mins time increments up to one hour.

Eligibility criteria:
inclusion criteria: * no existing musculoskeletal disorders in the region of interest * no surgery in the region of interest in the last year * healthy skin conditions in the region of interest exclusion criteria: * fear of treatment * regular intake of drugs, excluding contraceptives * metal implants in the region between c7 and sacrum, including hip joints * lack of epicritic and protopathic skin sensitivity * renal insufficiency * bronchial asthma * pregnancy/lactation * type 1 or 2 diabetes mellitus * polyneuropathy

Keywords: local skin responses hyperemia thermal sensation topical warming ointments topical cooling ointments skin perfusion subjective thermal sensation muscle tissue oxygenation skin temperature skin redness erythema
sun protection for florida's children

Conditions: Skin Cancer

Summary: purpose of the project is to develop a school-based intervention aimed at increasing hat use when children are outside at home and at school. the intervention is targeted to fourth grade children in hillsborough county, florida and is based on theory of reasoned action and planned behavior. it is structured to accomplish the following goals: (a) increase sun protection knowledge of children in regards to hat use,(b) foster more positive attitudes in regard to wearing hats,(c) change the subjective norms of wearing hats (d) target persons that children perceive as controlling their behavior of wearing hats(parents,teachers) and increase the use of hats when children are outdoors at school(primary outcome) and when outdoors at times other than school(secondary outcome).

intervention is aimed at encouraging students to use a wide brim hat when participating in outdoor activities. to accomplish this goal our approach will be multifaceted and will include: 1. individual sessions with school principals to facilitate a school policy that encourages hat use when children are outdoors. 2. sessions with fourth grade teachers that explains the importance of sun protection and hat use, and that addresses potential concerns by teachers. 3. classroom sessions with fourth grade children that improves sun protection knowledge, fosters more positive attitudes about hat use. and that changes the subjective norm of wearing hats when at school. 4. follow-up sessions in which children are provided free hats with a customized design that represents their school. 5. sun protection educational materials that are mailed to the parents of targeted children.

Eligibility criteria:
inclusion criteria: * one fourth/one fifth grade class. * 20 students minimum. * 25% of students are caucasian. * principle/teachers agree to participate. * majority of parents agree to participate. * majority of 4th grade students provide written assent. * one outdoor session lasting 20 minutes once per week where children are directly exposed to the sun. * outdoor session in an area observable by data monitors. * school can accommodate intervention components of study. * school environment stable over the intervention period. * randomized control school delay sun protection initiatives until project is completed. exclusion criteria: -

Keywords: children's behavior towards hat use
a safety and efficacy study of bimatoprost in men with androgenic alopecia (aga)

Conditions: Alopecia; Alopecia, Androgenetic; Baldness

Summary: this is a safety and efficacy study of bimatoprost in male subjects with androgenic alopecia (aga).


Eligibility criteria:
inclusion criteria: * mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year * willingness to maintain same hair style, length and hair color during study * willingness to have micro-dot-tattoo applied to scalp (stage 2 only) exclusion criteria: * drug or alcohol abuse within 12 months * hiv positive * received hair transplants or had scalp reductions * use of hair weaves, hair extensions or wigs within 3 months * use of minoxidil (oral or topical) and/or low level light treatment "combs" for hair growth within the last 6 months, or expected use during the study * application of topical steroids or nonsteroidal anti-inflammatory drugs (nsaids) to scalp within 4 weeks
a study of mirikizumab (ly3074828) in participants with moderately to severely active ulcerative colitis

Conditions: Ulcerative Colitis; Ulcerative Colitis Chronic

Summary: a study to investigate bowel urgency in adults with moderately to severely active ulcerative colitis (uc) treated with mirikizumab. the study will have 4 periods and will last for 36 weeks.


Eligibility criteria:
inclusion criteria: * have an established diagnosis of uc for ≥3 months * have confirmed diagnosis of moderately for severely active uc * have current bowel urgency * have demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic/janus kinase (jak) inhibitor/sphingosine-1-phosphate (s1p) receptor modulator therapy for uc. exclusion criteria: * have crohn's disease (cd) * have inflammatory bowel disease-unclassified, formerly known as indeterminate colitis, or * have ulcerative proctitis, disease limited to the rectum, that is, distal to the recto-sigmoid junction, which lies approximately 10 to 15 centimeter (cm) from anal verge. * have an inherited immunodeficiency syndrome or a monogenic cause of uc-like colonic inflammation * have any history or current evidence of cancer of the gastrointestinal tract * have active tuberculosis * have hiv infection.
effectiveness of pilates exercises in the treatment of dysmenorrhea: a randomized controlled trial

Conditions: Dysmenorrhea

Summary: the aim of this study is to investigate the effectiveness of pilates exercises in the treatment of dysmenorrhea and to contribute to the literature and information on this subject.

the study was planned as a randomized controlled study. the study will be conducted at the fizyorapt physiotherapy and exercise consultancy center. it will be divided into 2 main groups as those between the ages of 18-50, those with a menstrual period of 3-9 days, those with menstrual pain complaints, and those who cooperate in completing the assessment scales. participants will be asked to continue the given exercises for 6 weeks, 2 days a week and 45 minutes. people with psychological and physical disabilities will not be included in regular exercise. a personal information form will be prepared by the researcher in order to collect data on the sociodemographic characteristics of the participants. visual analog scale (vas) will be used to measure pain intensity and pain relief, beck depression scale to determine depression symptoms, and menstruation symptom scale to evaluate menstrual pain and symptoms. these surveys will be repeated before and at the end of the study. the data to be obtained will be evaluated using the spss24 package program.

Eligibility criteria:
inclusion criteria: * female individuals between the ages of 18-50 * those with a menstrual period of 3-9 days * having menstrual pain complaints in most of their menstrual cycles * cooperating in completing the assessment scales exclusion criteria: * having a history of abdominal surgery * having an active infection * having knee pain -. using medication * participants with any pathology that prevents exercise will not be included in the study
the effects of acupuncture on the natural pregnancy in patients with recurrent abortion

Conditions: Acupuncture; Recurrent Spontaneous Abortion; Ultrasound Therapy; Coagulation

Summary: recurrent spontaneous abortion (rsa) is a common pregnancy complication in women of reproductive age and the cause of rsa remains largely unclear. acupuncture is widely used in clinical practice to treat infertility and abortion. the role of acupuncture in the treatment of infertility is still unclear. the investigators conducted a randomized, prospective, controlled clinical trial to investigate its potential impact on pregnancy outcome. herein, the investigators not only evaluated the changes in patients' psychological stress before and after treatment but also followed up on pregnancy outcomes. in addition, changes in uterine artery blood flow were observed by ultrasound. changes in coagulation-related indicators were also detected.

to better illustrate the effectiveness and mechanism of acupuncture in infertility, especially in rsa patients, the investigators conducted a randomized, prospective, controlled clinical trial to investigate its potential impact on pregnancy outcome. herein, the investigators not only evaluated the changes in patients' psychological stress before and after treatment but also followed up on pregnancy outcomes. in addition, changes in uterine artery blood flow were observed by ultrasound. changes in coagulation-related indicators were also detected. the investigators hypothesized that acupuncture could promote and improve pregnancy by improving uterine artery blood flow and relieving patients' anxiety symptoms. to our knowledge, it has never been reported before.

Eligibility criteria:
inclusion criteria: * had a previous rsa history; * had a normal body mass index (bmi) of 18-25 kg/m2; * had no acute infection of the abdomen and low back skin; * had no history of liver or kidney disease. exclusion criteria: * acute infection in the abdomen or lower back * planning assisted reproductive technologies (art) in the next 3 months
prevalence of segmental colitis associated with colic diverticulosis (scad)

Conditions: Diverticular Disease of Colon; Diverticulosis, Colonic

Summary: colonic diverticula are common in western countries, affecting up to 60% of subjects over 70 years of age. in about 80% of patients, colonic diverticula remain asymptomatic (diverticulosis), while approximately 20% of patients may develop abdominal symptoms (symptomatic uncomplicated diverticular disease, sudd) and, eventually, complications such as bouts of diverticulitis or bleeding. a small proportion of patients with colonic diverticulosis may develop segmental colitis associated with diverticulosis (scad). scad is separate clinical disease with specific macroscopic (erythema, friability and ulcerations) and microscopic features characterized by chronic, mucosal inflammation involving the inter-diverticular mucosa (usually sigmoid colon) sparing the proximal colon and rectum colon. the most common symptoms of scad are rectal bleeding, diarrhoea and abdominal pain. to achieve scad diagnosis a correct biopsies sampling is mandatory. it is necessary to take biopsies on the borders of the diverticula and in the apparently normal adjacent mucosa as well as biopsies in both the colon proximal to the diverticular area and the rectum in order to exclude chronic inflammatory bowel disease. the spectrum of histological lesions associated with scad is variable, including mild non-specific inflammation and inflammatory bowel disease (ibd)-like changes. currently, data regarding prevalence of scad are scarce. it has been estimated that in patients with diverticulosis, scad prevalence ranged from 0.3-1.3%. the aim of the present study is to assess prospectively the prevalence of segmental colitis associated with colon diverticulosis (scad), in consecutive patients with colic diverticulosis, in a tertiary university centre.


Eligibility criteria:
inclusion criteria: * endoscopic finding of colonic diverticulosis associated with macroscopic signs of inflammation (erythema, friability and ulcerations) of the interdiverticular mucosa exclusion criteria: * inability to sign informed consent; * impossibility to perform biopsies during colonoscopy (e.g. anticoagulant therapy/ conditions predisposing to high risk of bleeding); * diagnosis of chronic inflammatory bowel disease.

Keywords: segmental colitis associated with colic diverticulosis
a study to investigate the long-term safety and efficacy of tolvaptan in patients with autosomal dominant polycystic kidney disease (adpkd) [extension of trial 156-04-251 in japan]

Conditions: Autosomal Dominant Polycystic Kidney Disease （ADPKD)

Summary: adpkd patients who enrolled in trial 156-04-251 will receive repeated oral administration of tolvaptan twice daily (morning and evening: 45mg/15mg, 60mg/30mg, or 90mg/30mg).


Eligibility criteria:
inclusion criteria: * patients who participated in trial 156-04-251 in japan and for whom crf collection has been completed. * patients who completed 3-year repeated administration and who completed the second follow-up visit or patients whose treatment with the trial drug was interupted due to pregnancy and who completed out the second follow-up visit in trial 156-04-251. * patients in whom any adverse events occurring in trial 156-04-251 were resolved orstabilized and require no further follow-up. exclusion criteria: * patients with egfr of less than 15 ml/min/1.73 m2 * pregnant, breast-feeding, or possibly pregnant women or women who are planning to become pregnant * patients who received any investigational drug other than tolvaptan within 30 days prior to commencement of administration of tolvaptan * any patients who, in the opinion of the principle investigator or subinvestigators, should not participate in the study
evaluation of the effect of adding corticosteroid to viscosupplementation

Conditions: Osteoarthritis

Summary: the purpose of this study is to evaluate if the investigators can achieve better early outcomes adding triamcinolone to the viscosupplementation procedure.

so far there is no convincing evidence that any treatment can be really effective in slowing or preventing the development of oa. the viscosupplementation by intraarticular injection of hyaluronate-derived products has gained popularity as a treatment modality of gonarthrosis. today there are various papers on the treatment of gonarthrosis by intraarticular injection. several methods have shown good results. there isn't, however, a consensus on the best method. the investigators know that in the treatment of osteoarthritis, with the viscosupplementation hylan is superior in the long term, than the infiltration with cortisone. the good short term results achieved by infiltration of cortisone make us think about the combination of these drugs. the investigators will be assessing 104 patients with osteoarthritis of the knee, divided into two groups. patients in group 1 will be subjected to infiltration procedure 6ml of hylan. patients in group 2 will undergo the procedure of infiltration with 6ml of hylan and 1ml (20mg) of hexacetonide triamcinolone. the researcher will apply the informed consent term, the pain visual analog scale (vas), womac and lequesne questionnaires. the questionnaires will be answered before infiltration (week zero), one week after the puncture (week 1), four weeks after (week 4) and 12 weeks after (week 12) and 24 weeks after (week 24).

Eligibility criteria:
inclusion criteria: * age between 45 and 80 years * osteoarthritis diagnosis with radiographic evidence * absence of previous intraarticular knee fracture * absence of allergy to synvisc or triancil exclusion criteria: * development of pioarthritis * failure to attend to the consultations

Keywords: viscosupplementation intra-articular injection hyaluronic acid osteoarthritis knee
liposomal bupivacaine with bupivacaine in ankle fracture open reduction internal fixation (orif)

Conditions: Ankle Fracture

Summary: this study is a randomized controlled trial assessing pain control in ankle fractures repaired with open reduction and internal fixation. patients are consented and enrolled pre-operatively, and randomized to either control or liposomal bupivacaine with bupivacaine administered intra-operatively.

this study is a prospective, randomized controlled trial assessing pain control in ankle fractures repaired with open reduction and internal fixation. patients are consented and enrolled pre-operatively, and randomized to either control or liposomal bupivacaine with bupivacaine administered intra-operatively. patients are to remain blinded to the treatment arm. the surgeon is non-blinded and administers the bupivacaine solution locally, intra-operatively. patients pain scores and pain medication usage is documented. a trained research coordinator contacts each patient at 24, 48, and 72 hours post-operatively to assess pain levels on a visual analog scale (vas) and pain medications taken. patients return for followup at standard intervals of 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post-operatively to assess healing and functional outcomes. patients are queried as to satisfaction with pain control at 2 weeks post-operatively. the study will compare outcomes including pain levels, pain medications taken, operating room (or) and post-anesthesia care unit (pacu) times, length of stay (los), satisfaction with pain control, clinical outcomes, and complication rates.

Eligibility criteria:
inclusion criteria: 1. patients at least 18 years old. 2. male or female 3. all racial and ethnic groups 4. fractures and fracture/dislocations of the ankle 5. patients who opt for surgical treatment of their fractures. 6. patients who consent to be randomized. 7. patients who are willing to follow-up for a minimum of 52 weeks. exclusion criteria: 1. patients younger than 18 years old 2. patients who are on chronic opioids 3. patients who abuse opioids 4. patients who are unwilling to follow-up for a minimum of 52 weeks 5. neurologic condition that could interfere with pain sensation
characterization of interferon beta -1b-induced tolerizing effect in dendritic cells

Conditions: Multiple Sclerosis

Summary: determine the in-vivo mechanism of action of inf-b-1b as it's mechanisms of action are not completely understood. we propose that high dose exogenous recombinant ifn-b-1b induces tolerizing effect on dc-dependent t-cell differentiation in patients with ms by inducing the expression of socs3 in dcs.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of ms * age 18-60 years, inclusive * expanded disability status of 0-6.5 * give written informed consent prior to any testing under this protocol