Kornimate/medical-research-clean huggingface dataset:
using botox to treat patients with idiopathic clubfoot

Conditions: Clubfoot

Summary: the purpose of this study is to determine the effectiveness of treatment of idiopathic clubfoot utilizing botulinum toxin type a (botox). this is not a hypothesis-generating study as we are reporting on outcomes of patients who have been treated by this method of clubfoot treatment.

subjects with clubfoot will be assessed at the initial visit by dr. alvarez. during this visit, the first part of treatment, which is manipulation and casting of the clubfoot will be started. following this visit, there will be weekly visits for continued manipulation and casting until no further correction of the clubfoot is seen. at this point, (usually after four weeks of casting or when the subject is 6-8 weeks of age), botox® will be injected into the calf muscles of the affected foot or feet. before the injection, the patch of skin overlying the intended site(s) of injection will be covered with a local anaesthetic cream (emla). this will be applied 30 minutes prior to the injection. this helps numb the skin where the injection will take place. a dose of 10 iu/kg botox® will be used. following the botox injection another cast will be applied. this will be followed by at least 3 more weekly cast changes to maintain the correction. after the casting and once the child's foot (feet) are big enough and have achieved a minimum of 15 degrees of ankle dorsiflexion with the knee in flexion, the bracing period will begin. this involves use of boots and bars which are worn fulltime until the child begins to weight-bear (usually occurs between 4 to 6 months of age). until the child reaches skeletal maturity, there will always be a tendency for the foot to return to its clubbed position. therefore, continued vigilance is part of the care for clubfoot. the following is the appointment schedule, assuming that there are no recurrences: * weekly appointments for 3 - 5 weeks for initial manipulation and casting * botox® injection * weekly appointments for 3 - 4 weeks for casting post botox® injection or until the foot is big enough to fit in the brace * weekly appointments for 10 weeks (brace wear at this point) * monthly appointments for 9 months (brace wear at this point) * appointments every 6 months until your child reaches 8 years of age * yearly appointments thereafter until your child reaches 14 years or skeletal maturity if there is a recurrence of clubfoot malposition, manipulation and casting will be reinstated and a possible repeat of injection of botox® will be administered.

Eligibility criteria:
inclusion criteria: * idiopathic clubfoot or clubfoot that is not associated with any other neuromuscular disorders or syndromes

Keywords: idiopathic clubfoot botox injection idiopathic talipes equinovarus, also known as idiopathic clubfoot
multiple myeloma turkish prospective patient registry

Conditions: Multiple Myeloma; Relapse Multiple Myeloma

Summary: this is a non-interventional, national, multi center, prospective multiple myeloma registry in turkey

in this study, approximately from 40 centers 1000 patients will be recruited. all patients will be followed-up till the study end. all the laboratory results, treatment protocols and responses will be recorded and assessed with eortc multiple myeloma specific quality of life multiple myeloma specific (my-20) and eortc quality of life-c30 questionnaires.

Eligibility criteria:
inclusion criteria: * diagnosed as multiple myeloma * patients signed informed consent form * patients received no more then 2 lines of therapy exclusion criteria: * patients below 18 years old

Keywords: multiple myeloma mm registry turkey
higher order aberration and relationship with soft contact lens modulus

Conditions: Corneal Wavefront Aberration

Summary: higher order aberrations are imperfects in the eye that affect the quality of image projected onto the retina. soft contact lenses are made of different materials with different stiffness. this study looks to see if the soft contact lens material affects the amount of higher order aberrations in an eye.


Eligibility criteria:
inclusion criteria: * willing and able to provide informed consent * adults \> 18 years old regardless of gender, race, or ethnicity * habitual single vision soft cl wearer for at least 1 week in any modality. exclusion criteria: * multifocal soft cl wear * gp or ortho k wear in the last 3 months. * active eye infections and inflammations. * current use of ocular medication.

Keywords: contact lens higher order aberration modulus
long term study of solifenacin succinate and tamsulosin hydrochloride oral controlled absorption system (ocas) in males with lower urinary tract symptoms

Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia

Summary: clinical study to examine the safety, tolerability and efficacy of long-term combination therapy of tamsulosin and solifenacin in the treatment of males with lower urinary tract symptoms (luts) associated with benign prostatic hyperplasia (bph) with a substantial storage component.

this is an open-label extension study following the double blind 905-cl-055 study

Eligibility criteria:
inclusion criteria: * completion of 12 weeks double-blind treatment in study 905-cl-055 exclusion criteria: * any significant pvr volume (\>150 ml)

Keywords: vesomni solifenacin succinate ec905 tamsulosin hydrochloride ocas treatment lower urinary tract symptoms benign prostatic hyperplasia
tracheal rapid ultrasound exam (t.r.u.e) for confirming endotracheal tube placement in emergency intubation

Conditions: Intubation

Summary: reliable endotracheal tube (ett) insertion confirmation is essential for critically ill patients. incorrect placement causes a high rate of mortality and morbidity. therefore, early detection of accidental esophageal intubation must be a primary focus of emergency airway efforts in emergency department (ed). although many techniques have been suggested to verify the ett placement, there is currently no entirely reliable method. ultrasonography (us) is an indispensable and easily accessible tool in ed. several studies of ultrasonographic confirmation of ett position provided promising results in cadaver model or patient in a controlled operating room setting.in this study, the investigators have proposed a protocol called t.r.u.e, an acronym for tracheal rapid ultrasound exam, to confirm the ett position in emergency intubation. this method provided a fast, real-time examination to prevent esophageal or endotracheal intubation.

establishing a definite airway, endotracheal tube placement, is an important component for resuscitation. a high rate of morbidity and mortality was reported for unrecognized esophageal intubation. therefore, early detection of esophageal intubation is essential for emergency airway management. there are several methods being used for endotracheal tube confirmation, such as auscultation of breathing sound, chest x-ray and capnography.2 however, all of these methods had false-negative rates and not entirely reliable during resuscitation. ultrasound is an indispensable and easily accessible tool in emergency department. recent studies showed that ultrasound can be used to confirm endotracheal tube placement in cadaver model. in this prospective study, we investigate the sensitivity and specificity of ultrasound for endotracheal tube confirmation in emergency intubation the study is conducted in the emergency department at national taiwan university hospital and approved by the hospital institutional review board. during resuscitation, the duty emergency resuscitation team performs the intubation and confirms the endotracheal tube position by auscultation and end-tidal capnography. meanwhile, the researcher performs ultrasonography examinations for endotracheal tube position. a curvilinear ultrasonography transducer is used and placed transversely on the anterior neck just superior to the suprasternal notch and bilateral hemithorax. the result of ultrasonography will be compared with auscultation, capnography and chest x-ray. sensitivity and specificity of ultrasonography examination is computed to determine the accuracy and effectiveness of clinical use.

Eligibility criteria:
inclusion criteria: * patients required intubation exclusion criteria: * head and neck trauma * head and neck tumor * status post tracheostomy * status post neck surgery * children (\<18 years old)

Keywords: endotracheal tube ultrasonography
prospective assessment of tbdx feasibility

Conditions: Pulmonary Tuberculosis

Summary: the purpose of this study will be to determine the performance characteristics of tbdx with culture as a gold standard. in addition, the investigators will assess the laboratory technicians' appraisal and technical suitability of the tbdx system.

this will be a blinded, prospective study to determine the performance of the tbdx system for detection of pulmonary tb in comparison to led microscopy and culture as a gold standard. the study will involve recruitment of 300 tb suspects per site with a high workload and experienced technicians. participants will be recruited under the find tb reference materials project and leftover sputum samples used for the assessment of the tbdx.

Eligibility criteria:
inclusion criteria: * persistent cough (\>2 weeks) and at least one other typical symptom of pulmonary tb (fever, night sweats, malaise, recent weight loss, contact with active case, hemoptysis, chest pain, loss of appetite) * provision of informed consent (find tb reference materials) * provision of sputum for adequate testing exclusion criteria: * patients receiving any anti-tb medication, in the 60 days prior to testing. * patients with only extra-pulmonary disease

Keywords: diagnosis
postoperative analgesia using ganglion impar block after anal surgery

Conditions: Postoperative Pain

Summary: the aim of this study is to evaluate the ganglion impar block in the prevention of postoperative pain after anal surgery.

postoperative analgesia using ganglion impar block after anal surgery introduction ganglion impar block may be used for treatment of chronic perineal pain (1) aim the aim of this study is to evaluate the ganglion impar block in the prevention of postoperative pain after anal surgery. patients and methods after approval of local ethical committee and patient consent, this double blinded randomized study will be done on 60 patients undergoing hemorrhoidectomy surgery in alexandria university hospital. after standard general anesthesia with propofol 1-2mg/kg lma for airway management and maintenance with isoflurane 1%. the patient will be randomized into two groups. bupivacaine group; ganglion impar will be blocked using g25 quinqe spinal needle using bupivacaine 0.5% 10ml. saline group; ganglion impar will be blocked using g25 quinqe spinal needle using normal saline 10ml postoperative vas will be measured each 1 for the first 6 hours then at 9 and 12 hours postoperative. first request of pain medications will be measured. results results will be collected in tables and graphs. appropriate statistical analysis will be done. discussion results of the study will be discussed compared to other studies.

Eligibility criteria:
inclusion criteria: * patients undergoing hemorrhoidectomy surgery in alexandria university hospital. exclusion criteria: * coagulation effects * allergy to bupivacaine * previous anal surgery * patient refusal
study to investigate the pharmacokinetic comparability of dosing triferic avnu iv by continuous infusion and iv bolus.

Conditions: End Stage Renal Disease

Summary: this study will investigate the administration of triferic avnu intravenously by three different administration schedules compared to continuous infusion over 3 hours

an open-label, randomized, four period sequential study of triferic avnu administered intravenously by three different administration schedules compared to continuous infusion over 3 hours

Eligibility criteria:
inclusion criteria: * adult hemodialysis patients ≥18 years of age. * signed informed consent to participate in the study. * stable on hemodialysis prescription for ≥3 months. * able to sustain hemodialysis 3x/week for 3 to 4 hours. * hemoglobin concentration \>9.5 g/dl. * serum tsat ≥20%. * receiving hemodialysis via av fistula or graft. * able to receive hemodialysis for 4 hours at each session over the duration of the treatment periods. * able to receive intermittent heparin administration for anticoagulation of the dialysis circuit. * serum tibc ≥ 150 µg/dl. exclusion criteria: * active bleeding disorder (gi, skin, nasal...) * receiving hemodialysis via catheter. * receiving iv iron within 10 days of the first on-study hemodialysis treatment. * receiving oral iron within 10 days of the first on-study hemodialysis treatment. * any other condition, that in the opinion of the investigator would not allow completion of the 4 hemodialysis treatments in the study.

Keywords: pharmacokinetics
safety of gsk biologicals' infanrix-ipv+hibtm vaccine in healthy vietnamese toddlers

Conditions: Acellular Pertussis; Haemophilus Influenzae Type b; Tetanus; Poliomyelitis; Diphtheria; Diphtheria-Tetanus-aPertussis-Poliomyelitis-Haemophilus Influenzae Type b Vaccines

Summary: this study aims to evaluate the safety and reactogenicity of a booster dose of infanrix-ipv+hib™ when administered to healthy vietnamese toddlers at 12 to 24 months of age who were vaccinated previously against diphtheria, tetanus, and pertussis diseases within their first six months of lives.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that parent(s)/legally acceptable representative(s) \[lar(s)\] can and will comply with the requirements of the protocol. * a male or female between, and including, 12 and 24 months of age at the time of vaccination. * written informed consent obtained from the parent(s)/lar(s) of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. * subjects who were primed with three doses of a dtp and polio vaccine in the first 6 months of life, and who have received the last dose of the primary vaccination at least six months before the receipt of study vaccine. exclusion criteria: * child in care. * use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period. * administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * evidence of previous or intercurrent booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis and/or hib disease or vaccination. * history of any neurological disorders or seizures. * history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. * major congenital defects or serious chronic illness. * acute disease and/or fever at the time of enrolment. * administration of immunoglobulins and/or any blood products within the three months preceding vaccination or planned administration during the study period.

Keywords: booster infanrix-ipv+hibtm dtpa-ipv/hib vietnamese toddlers
bioavailability of three oral formulations for hormone replacement therapy in postmenopausal women

Conditions: Menopause; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to determine the extent of bioavailability of two low dose estradiol/norethisterone acetate (neta) preparations with a marketed estradiol/norethisterone acetate (neta) preparation.


Eligibility criteria:
inclusion criteria: * healthy * postmenopausal * caucasian race * smoking (up to 5 cig./per day) is allowed * good state of health: evidenced by medical history, physical examination including gynecological examination, results of laboratory examination exclusion criteria: * known or suspected allergy to trial products or related products * previous participation in this trial * previous estrogen and/or progestin hormone replacement therapy * known, suspected or history of breast cancer * systolic blood pressure (bp) at least 160 mm hg and/or diastolic bp at least 100 mm hg, currently treated or untreated * body mass index (bmi) above 35.0 kg/m\^2
injections of botulinic toxin in plantar lesions of localized epidermolysis bullosa simplex

Conditions: Epidermolysis Bullosa Simplex

Summary: the investigators hypothesize that palmar injections of botulinic toxin, via an inhibition of the sudation, would limit the occurrence of blisters in localized epidermolysis bullosa simplex (lebs).

epidermolysis bullosa is a group of rare genetic diseases characterized by the occurrence of blisters and erosions due to skin fragility. there are 4 different subgroups, based on the location of the skin cleavage area. the most frequent subgroup is the simplex form, consisting predominantly of the localized form (localized epidermolysis bullosa simplex: lebs). the incidence of lebs was estimated at between 1/318.000 and 1/35.000. the disease starts early in infancy by the occurrence of blisters and erosions located on soles, secondary to frictions during the walk. the phenomenon is worsened by heat and sudation. lebs is due to mutations in keratin genes. life expectancy in lebs is normal but the quality of life is significantly impaired due to permanent skin pain and limitation of everyday activities (walking, sports). there is no effective or curative treatment. patients must limit the frictions, protect the skin and use plasters in case of skin lesions. botulinic toxin has an agreement for the treatment of axillary hyperhidrosis and has been shown to be also effective on palms and soles. the efficacy of botulinic toxin in plantar lesions of lebs has been reported in the literature (one case report and a short retrospective series of 6 patients) but there is no proper study.

Eligibility criteria:
inclusion criteria: * diagnosis of lebs based on clinical symptoms and in some cases histological or molecular findings * palmar skin lesions: blisters and/or : erosions, edematous and erythematous lesions, crusts. 3 lesions per foot, as a minimum * similar clinical severity of skin lesions on both feet * patient with social security * written consent of the patient * patient able to understand the study's questionnaires exclusion criteria: * patients with only one leg and a different number of toes on each foot. * known hypersensitivity to botulinic toxin or its excipients * current treatment with aminosides * myasthenia * swallowing difficulties * respiratory disorders * past medical history of dysphagia or pneumopathy of inhalation * known allergy or contraindications to lidocaine, prilocaine, paracetamol or nitrous oxide * pregnancy (positive pregnancy test (β-hcg) for women of childbearing age, performed within the 2 days prior to the study. breastfeeding. * contraception during 6 months from inclusion * mental or physical or judicial incapacity to fill the questionnaires * guardianship patients * skin infection on the soles at the time of the inclusion * skin lesions located on the soles, not related to lebs (ie. post traumatic wound, wart) * patient suffering from dishydrosis * botulinic toxin injections in the previous 6 months * inclusion in another study in the previous 2 months

Keywords: dermatology rare skin diseases epidermolysis bullosa simplex botulinic toxin blisters
h5n1 vaccine study in japanese elderly population aged 65 years and older

Conditions: Influenza

Summary: the purpose of this study is to obtain immunogenicity and safety data of an h5n1 pandemic influenza vaccine in a japanese elderly population aged 65 years and older.


Eligibility criteria:
inclusion criteria: * participant is 65 years or older at the time of screening. * participant is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination. * participant is physically and mentally capable of participating in the study. * participant is willing and able to comply with the requirements of the protocol. exclusion criteria: * participant has a history of infection with h5n1 virus or a history of vaccination with an h5n1 influenza vaccine. * participant is at high risk of contracting h5n1 influenza infection (e.g., poultry workers). * participant currently has or has a history of a significant cardiovascular (including hypertension), respiratory (including asthma), metabolic, neurological (including guillain-barré syndrome and acute disseminated encephalomyelitis), hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder. * participant has any inherited or acquired immunodeficiency. * participant has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. such treatment includes, but is not limited to: systemic or inhaled corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs. * participant has a history of severe allergic reactions or anaphylaxis. * participant has a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating. * participant has received a blood transfusion or immunoglobulins within 90 days prior to study entry. * participant has donated blood or plasma within 30 days prior to study entry. * participant has received any influenza or any live vaccine within 4 weeks or any other inactivated vaccine within 2 weeks prior to vaccination in this study. * participant has a functional or surgical asplenia. * participant has a known or suspected problem with alcohol or drug abuse. * participant has been exposed to an investigational product (ip) within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an ip or investigational device during the course of this study. * participant is a family member or employee of the investigator. * participant has any other condition that disqualifies his/her participation in the study in the opinion of the investigator.