Kornimate/medical-research-clean huggingface dataset:
a trial of equine f (ab')2 antivenom for treatment of scorpion envenomation in morocco

Conditions: Poisoning by Scorpion Sting

Summary: this study has the objective to demonstrate the effectiveness of alacramyn namo in the treatment of north africa and middle east scorpions envenomation by reducing the severity of envenomation. the primary endpoint is make a comparison between antivenom and placebo groups, at 4 hours after study drug, of the number of cases showing improvement in class of envenomation.

in an effort to shorten hospital stay and to further decrease mortality, a new antivenom has been developed. this antivenom is a third generation f(ab')2 "fabotherapeutic" agent.it is administered intravenously which should lead to rapid neutralization of circulating venom. this study will demonstrate whether or not use of the new antivenom in children receiving standardized supportive care leads to resolution of the syndrome within 4 hours of treatment.the onset of clinical symptoms following a scorpion envenomation is usually within 5 to 30 minutes following the sting. established a classification of the patient status to differentiate a simple scorpion sting from a severe envenomation. a simple sting (class i) is characterized by signs that are local only: pain at the inoculation point, redness, edema, and numbness. a class ii envenomation is characterized by the presence of some systemic signs: hypothermia, hyperthermia, chills, nausea, abdominal pain and diarrhea. being 15 years old or younger or the presence of priapism, vomiting, sweating, or a body temperature greater than 39°c are factors predictive of severity. a severe envenomation (class iii) is characterized by cardiovascular failure, often leading to death; respiratory failure related to the cardiac failure; and neurologic failure due to hypoxia.

Eligibility criteria:
inclusion criteria: * male or female 6 months to 15 years * class ii b or iii scorpion envenomation * presenting within 5 hours of sting * informed consent read and signed by parent or legal guardian exclusion criteria: * unable to provide informed consent * prior use of antivenom for this envenomation * allergy to horse serum * pregnant or breast-feeding * patients with underlying condition mimicking symptoms of scorpion envenomation (congenital heart disease, chronic oxygen therapy, etcetera)

Keywords: effectiveness new antivenom north africa and middle east scorpio envenomation
allergy immunotherapy for the reduction of asthma

Conditions: Wheezing; Asthma; Allergy

Summary: in this clinical study we aim to determine the effect of allergy immunotherapy in decreasing asthma and allergy related disease in children who had multiple episodes of wheezing and who are at high risk for developing persisting asthma. these risks include a history of asthma in the parents, allergies to environmental allergens (such as dust mite, cockroach or mouse) and other allergic diseases such as eczema or food allergies. allergy immunotherapy is not new and has been practiced for many years to treat asthma and environmental allergies in older children and adults, but has not yet been systematically studied in young children.


Eligibility criteria:
inclusion criteria: * children between 18 months through 3 years who had at least 2 episodes of wheezing prior to enrolment. * positive skin tests or specific immunoglobulin e (ige) antibody titers to at least one of common airborne allergens: dust mite, cat, cockroach, mouse, dog, pollen (all allergy testing can be done at the screening visit at the study site). * the child must also fulfill the criteria for high risk of developing persistent asthma by meeting at least one of the following major conditions or 2 of the following minor conditions: * major criteria: history of atopic dermatitis and/or parental history of asthma. * minor criteria: md-diagnosed allergic rhinitis, wheezing unrelated to colds, blood eosinophils above 4%. exclusion criteria: * the child has a severe systemic condition (other than allergy or asthma) including (but not limited to) seizures, major congenital anomalies, physical and intellectual delay, cerebral palsy, chest surgery, tuberculosis, primary or secondary immunodeficiency or cardiac disorder (except a hemodynamically insignificant atrial or ventricular septum defect or heart murmur). * the child was born following 35 or less weeks of gestation. * parental report that the child received oxygen for more than 5 days in the neonatal period, or required mechanical ventilation at any time since birth. * the child fails to thrive, defined as crossing of two major growth percentile lines during the last year. * the child has chronic lung disease of prematurity (cldp), cystic fibrosis or any other chronic lung disease. * the child ever received immunotherapy. * the child ever received i.v. gammaglobulins or immunosuppressants (other than corticosteroids for asthma). * history of a life-threatening asthma exacerbation which required intubation and mechanical ventilation.

Keywords: wheezing asthma allergy immunotherapy
a study of zevalin and simultaneous application of beam high-dose chemotherapy followed by autologous stem cell transplantation in refractory and relapsed aggressive non-hodgkin lymphomas

Conditions: Primary Non-Hodgkin-Lymphoma; Refractory Non-Hodgkin-Lymphoma; CD20+ Aggressive Non-Hodgkin's Lymphoma

Summary: phase ii study concomitant high-dose radio-immuno- and chemotherapy with simultaneous application of zevalin and beam followed by autologous peripheral stem cell transplantation in relapsed and refractory cd 20+ non-hodgkin's lymphoma


Eligibility criteria:
inclusion criteria: * age: 18 - 65 years * risk group: 1) progression on primary therapy 2) initial or subsequent relapse * histology: diagnosis of relapsed aggressive non-hodgkin lymphoma, whenever possible confirmed by an excision biopsy of a lymph node or by a sufficiently large biopsy of an extranodal site if no lymph node lesion is present. the expression of the cd20 antigen must be demonstrated in the primary lesion or in the relapse. specifically, the following entities can be treated in this study: b-nhl: grade iii b follicular lymphoma diffuse b-cell lymphoma centroblastic immunoblastic plasmoblastic anaplastic-large-cell t-cell rich b-cell lymphoma primary effusion lymphoma intravascular b-cell lymphoma primary mediastinal b-cell lymphoma mantle cell lymphoma, blastoid variants of burkitt's lymphoma aggressive marginal zone lymphoma (monocytoid) * general condition: general condition ecog 0-3 (karnofsky: 40 - 100 %); for definition see annex 14.10 * presence of declaration of participation of the center and the patient's written consent form exclusion criteria: * prior mediastinal or extensive abdominal irradiation * prior high-dose therapy and autologous stem cell transplantation * impairment of renal function (creatinine \> 2.5 mg/dl, creatinine clearance \< 20 ml/min) * impairment of hepatic function (bilirubin \> 2.0 mg/dl, cholinesterase \[che\] \< 2000 u/l) * impairment of pulmonary function (transfer lung factor for co \[tlco\] \< 50 %, forced expiratory volume in 1 sec \[fev1\] \< 60 %, vital capacity \[vc\] \< 60 %) * relevant deterioration of the above organ functions on salvage therapy * failure of stem cell mobilization * active viral hepatitis * hiv infection * other active or not conclusively curatively treated malignoma * severe concomitant psychiatric illness or suspected lack of patient compliance * pregnancy or unreliable contraception * highly dynamic progress of lymphoma (lactate dehydrogenase \[ldh\] \> 1.5 x upper limit of normal \[uln\]) after salvage therapy immediately prior to radioimmunotherapy

Keywords: high-dose radio-immuno- and chemotherapy stem cell transplantation 90y-ibritumomab-tiuxetan
a myth orthopaedic implant pain in cold weather

Conditions: Pain; Cold Temperature

Summary: in daily practice, the investigators frequently hear patients with orthopaedic implants complaining of implant pain and coldness in the implant area in cold weather in outpatient clinics. however, when the literature is examined, there is only one study examining the effect of cold weather on the implant and only the pain in cold weather was questioned in this study. in this study, the investigators aimed to obtain clearer information by comparing the effect of cold air on orthopaedic implants with hot air with many parameters.

fractures and degenerative joint diseases are common medical problems that many people experience throughout their lives. orthopaedic implants are widely manufactured and used worldwide to replace a degenerated joint or to reduce a fractured bone and promote healing (1). in a 1988 incidence study, it was estimated that 4.9 million people in the usa had fixation material (2). today, this rate is thought to increase much more due to increasing population, developing and increasing number of motorised vehicles and increasing surgical indications. although the removal of these implants is a very controversial issue in the literature, most surgeons do not recommend routine removal of implants unless there are complications (3). in a study, it was reported that the reasons for implant removal were osteomyelitis and persistent pain in only 28% of patients, but the reason for removal was 'patient request' in 72% of patients who had implants removed (4). in daily practice, the investigators frequently hear patients with orthopaedic implants complaining of implant pain and coldness in the implant area in cold weather in outpatient clinics. however, when the literature was examined, there was only one study examining the effect of cold weather on the implant and only the pain in cold weather was questioned in this study. in this study, the investigators aimed to obtain clearer information by comparing the effect of cold air on orthopaedic implants with hot air with many parameters.

Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years with orthopaedic implants due to orthopaedic trauma. exclusion criteria: * patients \<18 years of age * patients with incomplete fracture union * patients with joint prosthesis (knee, hip, shoulder prosthesis, etc.) * patients with complications in the operated extremity (implant infection, implant failure, etc.) * acute or chronic infection (bacterial or viral infection) of any body site * patients diagnosed with neuropathy (diabetic, alcoholism, autoimmune, nutritional deficiency, infectious)

Keywords: pain implant cold weather
effects of desoximetasone spray 0.25% in patients with moderate to severe plaque psoriasis

Conditions: Psoriasis

Summary: the objective of this study is to demonstrate that desoximetasone 0.25% topical spray is effective for the treatment of patients with moderate to severe plaque psoriasis.


Eligibility criteria:
inclusion criteria: * male or non-pregnant, non-lactating female 18 years of age or older. * have a definite clinical diagnosis of stable plaque psoriasis involving ≥ 10% of the body surface area (bsa). * have a combined total lesion severity score (tlss) of ≥ 7 for the target lesion. * have a plaque elevation score ≥ 3 of (moderate) for the target lesion. * the target lesion must have an area of at least 5 cm². * have a physicians global assessment (pga) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity. exclusion criteria: * patient has current diagnosis of other types of psoriasis other than stable plaque psoriasis (i.e. acute, guttate, erythrodermic, exfoliative or pustular psoriasis) or has psoriasis of any kind of the face or scalp that will require active treatment during the study. nonprescription antipsoriatic shampoos will be allowed during the study when applied solely to the scalp. * patient has a history of psoriasis that has been unresponsive to topical corticosteroid therapy. * in the investigator's opinion, the patient has other dermatological conditions, such as atopic or contact dermatitis, that may interfere with the clinical assessments of the signs and symptoms of psoriasis. * patient has a history of allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance which, in the opinion of the investigator, would compromise the safety of the patient or the results of the study. * patient has been treated within 12 weeks (or five half lives, whichever is less) prior to the first dose of study drug with any biological therapies for psoriasis. * patient has received any systemic steroids within 4 weeks of the first dose of the study drug. the use of inhaled or intranasal corticosteroids is acceptable as long as usage has been stable for at least 2 weeks prior to the first dose of study drug and will be continued during the study. * patients who have used any topical antipsoriatic agents of any kind or any topical corticosteroids for any reason within 2 weeks prior to first use of study drug. nonprescription antipsoriatic shampoos used only on the scalp will be allowed during the study. * receipt of any drug as part of a research study within 30 days prior to first dosing.
pilot study to evaluate daily protein's intake following bariatric surgery by using the software protein assistant

Conditions: Obesity

Summary: the aim of this study is to evaluate the effect of the use of protein assistant on the daily protein intake in obese patients who underwent a bariatric surgery (in the 3 months following surgery).

after a bariatric surgery, food intake is reduced. patients should favor proteins to avoid loss of muscles. the guidelines recommend a minimal protein's intake of 60g per day. but this goal is achieved only for 55 to 60 % patients 4 months after surgery and 50 à 65 % patients at one year. protein assistant is a software which can calculate the amount of proteins eaten per day and can propose solutions if the intake is insufficient. the main objective of this study is to evaluate the effect of the use of protein assistant on the daily protein intake in obese patients who underwent a bariatric surgery (in the 3 months following surgery). protein assistant is suggested 1 month after bariatric surgery on a digital tablet. the patient is educated to use protein assistant. the patient has to complete a dietary record every 2 weeks during 2 months. the aim is to intake 60g per day. if the aim is not reached, protein assistant suggests qualitative and/or quantitative solutions.

Eligibility criteria:
inclusion criteria: * patients who underwent a bariatric surgery a month +/- one week ago * able to use a digital tablet * with internet access at home * accepting modalities of formation and of digital tablet lending * when the average of protein intake is under 60g/j on a 3 days dietary record, one month after bariatric surgery exclusion criteria: * lack of understanding of the use of a digital tablet * under the protection of justice * person participating to another trial * pregnant or breast-feeding women

Keywords: bariatric surgery
traumatic brain injury biological diagnosis via high definition tractography asymmetry screening

Conditions: Traumatic Brain Injury

Summary: the primary purpose of this study is to validate the high definition fiber tracking (hdft/hdftas) technology, so that faster, more reliable diagnosis can be implemented in traumatic brain injury (tbi). this study will involve traumatic brain injury patients and normal controls, in addition to 30 pilot participants who will be undergoing mri in order to develop a statistically sound range for the metrics derived from hdft.

this descriptive study sponsored by the united states department of defense involves the examination of tbi participants and normal control participants through mri (without contrast) scanning. normal controls are essential to develop a statistically sound range for the metrics derived from high definition fiber tracking (hdft). tbi subjects will undergo 1 mri scan and normal controls will be asked to undergo 1 mri scan. the study will involve blinded evaluations of results to determine the ability of hdft imaging methods to evaluate tbi. in addition to the tbi and normal controls evaluated in this research study, investigators will be running 30 pilot participants. these participants will be undergoing mri in order to streamline our pulse sequence and calibrate the mris. this is part of the technical development for the project and will occur before the recruitment of tbi subjects and normal controls for comparison. data from the pilot subjects will not serve as control data for the tbi subjects.

Eligibility criteria:
inclusion criteria tbi subjects: * documented history of tbi (for chronic). * no mri contraindications such as implanted ferrous metal, pacemakers, body weight above 125 kg, (might not fit in the scanner), or concerns about claustrophobia. exclusion criteria tbi subjects: * inability or unwillingness of subject to provide written informed consent. * history of penetrating gunshot wound. inclusion criteria control subjects: * no prior history of concussion, tbi, blast exposure, stroke, or other major neurological disorder. * no mri contraindications such as implanted ferrous metal, pacemakers, body weight above 125 kg, (might not fit in the scanner), or concerns about claustrophobia. exclusion criteria tbi subjects: * inability or unwillingness of subject to provide written informed consent. * history of concussions, stroke, or penetrating gunshot wound. inclusion criteria sequence development subjects: * no mri contraindications such as implanted ferrous metal, pacemakers, body weight above 125 kg, (might not fit in the scanner), or concerns about claustrophobia. exclusion criteria sequence development subjects: * inability or unwillingness of subject to provide written informed consent * contra-indication to mr imaging, such as ferrous metal, pacemakers, body weight above 125 kg or concerns
to investigate the effect of far-infrared radiation on lower extremity acupoints on the blood circulation of lower extremities in patients with hemodialysis

Conditions: Peripheral Arterial Disease

Summary: this study intends to irradiate the acupoints of both lower extremities of hemodialysis patients with far-infrared therapeutic apparatus to explore its effect on foot blood circulation, peripheral artery occlusion disease (paod) symptoms and ankle-brachial index (ankle-brachial index, abi) value.

after irradiating the lower extremity acupoints of hemodialysis patients with far-infrared rays, it is expected to improve the blood circulation of the lower extremities of hemodialysis patients, thereby improving the symptoms of indirect claudication and raising the ankle-brachial index to the normal range, and reducing the incidence of peripheral arterial disease in hemodialysis patients. the results of this study can provide an empirical reference for future clinical care.

Eligibility criteria:
inclusion criteria: * 1.patients diagnosed with chronic renal failure in a hemodialysis unit and receiving hemodialysis for at least three months 2. willing to participate in interventional treatment with far-infrared radiation 3. willingness to cooperate with intervention measures and inspection time 4. receive hemodialysis treatment three times a week exclusion criteria: 1. there are contraindications for abi examination (such as breast cancer lymph node dissection in the past), bilateral upper limb arteriovenous access, etc.), and a double- lumen dialysis venous catheter is placed in the groin 2. bedridden or unable to walk 3. history of distal amputation, dvt, cabg s/p due to trauma, ischemia or infection 4. consciously unclear and unable to cooperate 5. patients with wounds from calf to instep

Keywords: hemodialysis peripheral arterial occlusion disease far-infrared radiation lower extremity acupoints ankle-brachial index edinburgh claudication questionnair
tsh receptor mutations among a consanguineous community

Conditions: Hypothyroidism

Summary: resistance to thyrotropin (rtsh) is a condition of impaired responsiveness of the thyroid gland to tsh, characterized by elevated tsh, low or normal thyroid hormone levels, and hypoplastic or normal-sized thyroid gland. the aim of the present study was to evaluate the clinical course over time,the genotype-phenotype association and the frequency of two different tsh-receptor (tshr) mutations in a highly consanguineous population of the town of um-el-fahem.

resistance to thyrotropin (rtsh) is a syndrome involving reduced sensitivity to tsh. it is characterized by elevated tsh, absence of goiter (normal or hypoplastic thyroid gland) and normal to very low levels of thyroid hormones. the tsh-receptor (tshr) gene is located on chromosome 14q31 and it consists of extracellular, trans-membrane and intracellular domains. mutation in the tshr may cause either gain or loss of function of the receptor. loss-of-function mutations are autosomal-recessively inherited and lead to a spectrum of phenotypes, ranging from mild euthyroid hyperthyrotropinemia to severe congenital hypothyroidism (ch). insensitivity to tsh depends on both the severity and location of the tshr mutations. since the first report of familial euthyroid hyperthyrotropinemia caused by a tshr mutation, several cases of loss-of-function mutations of the tshr have been reported however only a few reports on the outcome of patients affected with tshr mutations. whether the condition of euthyroid hyperthyrotropinemia leads to clinical hypothyroidism, remains stable or normalizes over time has yet to be elucidated. we recently described a unique novel tshr-inactivating mutation located at the third extracellular loop that preferentially affected the inositol phosphate (ip) pathway in three sisters of arab-muslim decent that presented with euthyroid hyperthyrotropinemia. further analysis of the extended family revealed additional members with tshr syndrome phenotype carrying two different tshr mutations. all the affected subjects live in the same town. the aim of the present study was to evaluate the clinical course over time, the genotype-phenotype association and the frequency of these two different tshr mutations among the highly consanguineous population of the town of um el fahem.

Eligibility criteria:
inclusion criteria: * subjects belonging to extended family of the index case exclusion criteria:

Keywords: tsh receptor, resistance tsh, hyperthyrortropinemia
a study to estimate the effects of food on drug fesoterodine fumarate and the pharmacokinetics of 5-hydroxymethyl tolterodine (5-hmt) in healthy volunteers

Conditions: Urinary Bladder, Overactive

Summary: this is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 2-cohort, 3-period study to characterize the pharmacokinetics (process by which drug fesoterodine is absorbed, distributed, metabolized, and eliminated by the body) and the effects of food on the pharmacokinetics of the drug. this study will take place over approximately 8 weeks and will consist of a screening visit to determine eligibility for the study, and 2- or 3-period treatment phase for each cohort.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between 21 and 55 years of age(inclusive). exclusion criteria: * evidence or history of clinically significant disease. * evidence or history of urologic disease (benign prostate hyperplasia, recurrent urinary tract infections, urinary retention, etc.).

Keywords: food effect bioavailability pharmacokinetics fesoterodine 5-hydroxymethyl tolterodine treatment of overactive bladder