Kornimate/medical-research-clean huggingface dataset:
t-20 with anti-hiv combination therapy for patients with prior anti-hiv drug treatment and/or drug resistance to each of the three classes of approved anti-hiv drugs

Conditions: HIV Infections

Summary: the purpose of this study is to compare the change in viral load (amount of hiv in the blood) of patients who receive t-20 with selected anti-hiv drugs to that of patients who receive only selected anti-hiv drugs.

eligible patients remain on their pre-study regimen until baseline. an ob regimen is chosen by the physician and patient based on the patient's prior treatment history, prior and current laboratory abnormalities, the screening gt/pt antiretroviral resistance testing, and any prior gt/pt antiretroviral resistance (if available). the drugs in the ob regimen are chosen from among the currently approved antiretrovirals and permitted newly approved/investigational antiretrovirals available in the countries where the study is implemented, and must consist of 3 to 5 drugs, including no more than 1 newly approved/investigational agent. patients are stratified with respect to viral load and use (versus non-use) of any of the allowed newly approved/investigational antiretrovirals. patients are randomized to receive 1 of the following 2 treatments for 48 weeks: ob or ob plus t-20. patients are followed to assess viral load, safety, antiretroviral resistance, t-20 pharmacokinetics, and quality of life. at the end of 48 weeks of treatment patients are allowed to (a) roll over and receive ob plus t-20 (for patients receiving ob regimen alone) or (b) continue taking ob plus t-20 (for patients already receiving ob plus t-20), for an additional 48 weeks (plus 4 weeks safety follow-up period), or until 12 weeks after commercial availability of t-20 in the country in which they are treated, whichever comes first. all patients are followed in this study for a maximum of 100 weeks from their initial baseline visit date.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are hiv-infected. * are at least 16 years old (have consent of parent or guardian if under 18). * have a viral load (level of hiv in the blood) of 5,000 copies/ml or more. * have received anti-hiv drugs for at least 6 months and/or have shown resistance to each of the 3 types of anti-hiv drugs as follows: nucleoside reverse transcriptase inhibitors (resistant to 1 or more); nonnucleoside reverse transcriptase inhibitors (resistant to 1 or more); and protease inhibitors (resistant to 2 or more, taken either together or 1 after the other for at least 6 months total).

Keywords: hiv-1 drug therapy, combination drug resistance, microbial rna, viral membrane fusion anti-hiv agents viral load
staccato prochlorperazine in migraine (in clinic)

Conditions: Migraine Headache, With or Without Aura

Summary: development of staccato prochlorperazine for the treatment of migraine headache.


Eligibility criteria:
inclusion criteria: * subjects who have migraine headache with or without aura (diagnosis according to international headache society guidelines) for at least 6 months, who have been pain free for at least 48 hours since the end of their last migraine attack, who have a pain rating of moderate or severe prior to dosing. exclusion criteria: * subjects who have taken any other migraine or pain medication within 48 hours of randomization, with a history of allergy or intolerance to phenothiazines and related drugs, or are considered by the investigator, for any reason, to be an unsuitable candidate for receiving prochlorperazine, or unable to use the inhalation device, must be excluded.

Keywords: migraine, staccato prochlorperazine migraine headache with or without aura.
study of metabolic homeostasis in chinese

Conditions: Healthy; Metabolic Syndrome

Summary: in this open-label, acute intervention study, we will recruit 120 sex-matched participants aged 20-70 years (100 normal or overweight/obese subjects and 20 mets subjects). they will be assigned to one of the six groups according to age, bmi and with and without mets and have a standardized mixed macronutrient tolerance test (mmtt) by orally administered a 400-ml beverage (75g glucose, 60g lipid, and 20g protein). fasting and postprandial blood, and urine and fecal samples will be collected. the primary aim is to establish a more comprehensive system to quantify different aspects of metabolic health based on fasting and postprandial data. the study protocol has been approved by the ethics committee of shanghai institutes for biological sciences.

the recruited 120 subjects (60 men and 60 women aged 20-70 years) will be recruited according to the followings: 1) individuals aged 20-29 years with normal weight (18.5 kg/m2 ≤ bmi \< 24 kg/m2); 2) individuals aged 30-49 years with normal weight; 3) individuals aged 30-49 years with overweight/obesity (bmi ≥ 24 kg/m2); 4) individuals aged 50-70 years with normal weight; 5) individuals aged 50-70 years with overweight/obesity; and 6) individuals aged 30-70 years with mets. a standard questionnaire will be use to collect information like lifestyle factors, nighttime sleep duration; anthropometric measurements will be performed. blood samples will be collected via a catheter at fasting state (t = 0 min) and 5 successive time points post-mmtt (t = 30, 60, 120, 180 and 240 min). at t = 0 ,1 and 2 h, the fingertip blood will be collected as well. body composition will be measured by dual energy x-ray absorptiometry (dxa). all these samples will be used to the assessment of blood chemistry, metabolomics, single nucleotide polymorphism (snp), gut microbiota etc.

Eligibility criteria:
inclusion criteria: * healthy subjects: age 20-70 bmi ≥ 18.5 kg/m2 * mets subjects: age 30-70 bmi ≥ 18.5 kg/m2 and at least meet three of the following criterions(ncep-atpiii, for asian americans) 1. waist circumference ≥ 90 cm (men), ≥ 80 cm (women). 2. total triglyceride ≥ 1.7 mmol/l. 3. hdl-c \<1.03 mmol/l in men, \<1.3 mmol/l in women. 4. systolic blood pressure ≥ 130 mmhg or diastolic blood pressure ≥ 85 mmhg. 5. fasting plasma glucose ≥ 5.6 mmol/l. exclusion criteria: 1. clinically diagnosed diabetes or use of anti-diabetic medications; 2. clinically diagnosed cardiovascular, kidney, liver, pituitary, alimentary tract, and thyroid diseases, cancer(s), or mental illnesses; 3. pregnancy or lactation; 4. having gastrointestinal surgery within 1 year, excepting appendicitis or hernia; 5. current use of antidepressant(s); 6. alcohol consumption \> 40 g/d or other substance abuse; 7. severe diarrhea (watery stools ≥ 3 times/day ≥ 3 days or longer) in previous 3 months; 8. participating any other studies within previous 3 months.

Keywords: metabolic health mmtt resilience
a multicenter extension study of taliglucerase alfa in pediatric subjects with gaucher disease

Conditions: Gaucher Disease

Summary: a protocol to extend the assessment of the safety and efficacy of taliglucerase alfa in pediatric subjects (2 to \<18 years old) with symptoms and clinical manifestations of gaucher disease who completed treatment in protocols pb-06-002 (switchover study from imiglucerase) or pb-06-005 (naïve treatment with taliglucerase alfa).


Eligibility criteria:
inclusion criteria: * successful completion of protocol pb-06-002 or pb-06-005 * the subject, parent(s) or legal guardian(s) signs an informed consent and/or assent exclusion criteria: * currently taking another investigational drug for any condition. * presence of neurological signs and symptoms characteristic of gaucher disease with complex neuronopathic features other than longstanding oculomotor gaze palsy. * presence of any medical, emotional, behavioral or psychological condition that in the judgment of the investigator would interfere with the subject's compliance with the requirements of the study.

Keywords: gaucher disease pediatrics
awake nasal fiber-optic intubation of severely obese patients in lateral position

Conditions: Anesthesia; Intubation;Difficult; Intubation; Difficult or Failed; Anesthesia Intubation Complication

Summary: airway management in severely obese patients remains a challenging issue for anesthetists and may lead to life-threatening situations. awake fiber-optic bronchoscopy intubation (fobi) technique is considered as the gold standard when a difficult airway is anticipated to secure the airway and to facilitate the surgery. fobi is usually done in supine position, while (in conscious patients) lateral position is the most recommended position to keep the upper airway patent. this prospective clinical trial study will test whether awake fobi in lateral position will provide a safe profile or a significant advantage over fobi in supine position, in morbidly obese patients undergoing elective bariatric surgery.

airway management in severely obese patients remains a challenging issue for anesthetists and may lead to life-threatening situations. awake fiber-optic bronchoscopy intubation (fobi) technique is considered as the gold standard when a difficult airway is anticipated to secure the airway and to facilitate the surgery. fobi is usually done in supine position, while (in conscious patients) lateral position is the most recommended position to keep the upper airway patent. this prospective clinical trial study will test whether awake fobi in lateral position will provide a safe profile or a significant advantage over fobi in supine position, in morbidly obese patients undergoing elective bariatric surgery. the main outcome is success rate and duration of the procedure. secondary outcomes are oxygenation maintenance, hemodynamic stability, airway complication, sedation score, and postoperative airway morbidity in 6 hours after surgery.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical status classification two and three. * patients scheduled for elective bariatric surgeries under general anesthesia. exclusion criteria: * refusal of fiberoptic intubation. * allergy to local anesthetics. * coagulopathy. * raised intracranial or intraocular pressure.

Keywords: anesthesia intubation obesity fiberoptic
trial of tomotherapy in breast cancer

Conditions: Breast Neoplasms

Summary: tomotherapy is a new radiation therapy system that uses an integrated ct scanner during delivery of radiation treatment to improve the accuracy of the treatment. furthermore the irradiation is delivered helicoidally allowing highly conformal shaping of dose distribution. however the magnitude of the clinical advantage of using the system in breast cancer is unknown. the purpose of the present study is to investigate whether or not the tomotherapy can substantially reduce pulmonary and cardiac toxicities, as compared with conventional radiotherapy.

prior to surgery: histological confirmation; medical imaging. localizing markers are placed in case of breast conserving surgery. after surgery, patients are randomized to one of two treatment arms: * arm i: radiotherapy using tangential chest fields, and supraclavicular field in case of nodal involvement, according to our hospital's standard procedure (voordeckers m et al, radiother oncol 2003;68:227 and 2004;70:225). dose-fractionation: 50 gy in 25 fractions over 5 weeks, 2 gy/fraction. additional boost 16 gy in 8 fractions over 2 weeks if breast conserving surgery (verify marker/clip localization) and age \<= 70 years. * arm ii: radiotherapy using the tomotherapy system. target area (breast, thorax wall, nodal areas) delimited according to pre-operative imaging and pathological description. dose-fractionation (adapted from whelan t et al, jnci 2002;94:1143): 42 gy in 15 fractions over 3 weeks, 2.8 gy/fraction. simultaneous boost 0.6 gy/fraction if breast conserving surgery. physics quality control is integrated during treatment in both arms. radiotherapy begins within 6 weeks after the last breast surgery. concurrent or sequential adjuvant systemic treatments are allowed. in case of sequential adjuvant treatment with chemotherapy first, radiotherapy begins within 6 weeks after completion of the adjuvant chemotherapy. quality of life, arm mobility and edema, pulmonary and heart function are assessed prior to radiotherapy, at 1-3 months after completion of radiotherapy, then yearly.

Eligibility criteria:
inclusion criteria: * informed consent * histologically proven breast carcinoma * stage i or ii (t1-3n0 or t1-2n1 m0, ajcc/tnm 6th edition) * surgery with clear margins * pre-operative medical imaging (at least ct, mri, and/or pet-scan) exclusion criteria: * prior breast or thoracic radiotherapy * pregnancy or lactation * fertile patients without effective contraception * psychiatric or addictive disorders

Keywords: early breast cancer post-operative radiation treatment
vocal demands among classroom teachers

Conditions: Voice Disorders

Summary: the purpose of the study "a comparison of vocal demands with vocal performance among classroom teachers" is to gather information about the voice production of teachers using three separate strategies: (a) measures of voice assessed with the computerized speech lab (csl) and the phonatory aerodynamic system (pas) instruments in the siuc voice lab.

(a) measures of voice assessed with the computerized speech lab (csl) and the phonatory aerodynamic system (pas) instruments in the siuc voice lab

Eligibility criteria:
inclusion criteria: * enrollment in teaching education programs; active teachers. exclusion criteria: * current diagnosed with voice disorder.

Keywords: voice aerodynamics acoustics
near infrared spectroscopy in aortic valve replacement

Conditions: Aortic Valve Stenosis; Transcatheter Aortic Valve Implantation; Eligibility for Both Anaesthetic Methods

Summary: transcatheter aortic valve implantation (tavi) is an alternative for patients, that are considered to be too sick for conventional aortic valve replacement. there is no conclusive opinion about the best anesthesiologic management of these patients. sedation and general anaesthesia are both adequate and the current literature shows no benefit towards one of these methods. this study wants to investigate the influence of these two anesthesiologic managements on the cerebral oxygen saturation during the "rapid pacing"-period during valvuloplasty. the patients are randomised allocated to one of these two anaesthesiological managements. the investigators use the near-infrared spectroscopy (nirs) to measure the cerebral oxygen saturation. parallel there will be a measurement of cerebral biomarkers to monitor cerebral hypoxia.


Eligibility criteria:
inclusion criteria: * informed consent * transcatheter aortic valve implantation exclusion criteria: * denial by patient * denial by screening anaesthesist * active neurodegenerative disease
immediate skeletal and dento-alveolar effects of two and four mini-screw supported hyrax for maxillary expansion in non-growing patients

Conditions: Transverse Maxillary Deficiency; Posterior Crossbite, Upper Airway

Summary: transverse malocclusion is very common in adult ,using conventional hyrax expander has many limitations and side effects, therefore ,recently a minis crews assisted rapid expansion is recently introduced to overcome hence complications

transverse malocclusion is very common in adult ,using conventional hyrax expander has many limitations and side effects such as buccal tipping, marginal bone loss, dento aloveolar expansion. in such cases , surgically assisted rapid palatal expansion used to be the option of choice ,due to the invasiveness of the procedure and co-morbidity associated with it ,minis crews assisted rapid expansion is recently introduced to overcome the complications of both convectional and surgically assisted rapid palatal expansion

Eligibility criteria:
inclusion criteria: * adults male or female aged from 18-30 years with skeletal maxillary constriction * unilateral or bilateral dental posterior cross-bite * mid-palatal suture maturation (grade c, d) according to f angileri classification * good oral hygiene exclusion criteria: * no functional crossbite due to premature contacts * no previous orthodontic treatment * no buccal crossbite * no craniofacial anomalies or syndromes.
continuous glucose monitoring in new mothers with type 1 diabetes

Conditions: Hypoglycemia; Breastfeeding

Summary: with appropriate day-time carbohydrate intake and insulin dose, the 24 hour glucose levels and prevalence of night-time hypoglycaemia are comparable in breastfeeding new mothers and formula feeding new mothers with type 1 diabetes at the second after delivery diabetes control compared with the first after delivery diabetes control at steno diabetes center.


Eligibility criteria:
inclusion criteria: * age between 18 and 45 years. * delivery of a single infant. * proficiency in danish to read and understand the patient information sheet, questionnaires and to converse with the diabetes caregivers. exclusion criteria: * a diagnosis with severe mental or psychiatric barriers or a concurrent disease on the decision of the principal investigator
the im able study: a study of warriors & veterans following neuromusculoskeletal injury of the lower limb

Conditions: Limb Salvage; Braces; Lower Extremity

Summary: the purpose of the im able(injuries managed with advanced bracing for lower extremities) study is to determine if advanced (adv) ankle foot orthoses (afos) will enable users to achieve greater levels of physical and self-reported function compared with conventional (conv) afos for those ambulating at or above the independent community level of ambulation.

there were approximately 20,000 extremity trauma cases associated with the wars in iraq and afghanistan. many of these individuals have experienced multiple limb-sparing surgeries and orthotic utilization. many continue functioning with use of their orthosis while others may seek delayed amputation. it is unclear if limb salvage or amputation is more advantageous functionally or preferred following lower extremity(le) trauma. the ideo (intrepid dynamic exoskeletal orthosis) was developed to assist in maintaining high functional performance in patients who have experienced high energy lower extremity trauma (helet) and limb salvage surgeries primarily effecting the le below the level of the knee joint. the ideo represents one "advanced" orthotic option for a traumatized and surgically spared limb however there are other "advanced" orthotic options. problematically, few studies have reported outcomes associated with these devices. in the few studies available, sample sizes are small which greatly reduces generalizability of study findings. the purpose of the im able study is to determine if advanced (adv) ankle foot orthoses (afos) will enable users to achieve greater levels of physical and self-reported function compared with conventional (conv) afos for those ambulating at or above the independent community level of ambulation.

Eligibility criteria:
inclusion criteria: 1. lower extremity injury of any etiology requiring use of an afo 2. male or female, of any ethnicity 3. 18-65 yrs of age 4. 100-275 lbs 5. ≥ 1 yr. of orthotic experience exclusion criteria: 1. body weight \ 275 lbs 2. does not speak english or spanish 3. known cognitive impairment (i.e. diagnoses such as traumatic brain injury, dementia)

Keywords: orthotics high-energy lower extremity trauma physical therapy bracing functional performance performance assessment
ginkgo biloba vs desmopressin in treatment of children with monosymptomatic nocturnal enuresis

Conditions: Nocturnal Enuresis in Children; Desmopressin; Monosymptomatic Nocturnal Enuresis

Summary: the efficacy of ginkgo biloba versus desmopressin in treatment of children with monosymptomatic nocturnal enuresis

bedwetting among children is a common disorder, affecting 30% at age 4, 10% at age 6, 3% at age 12, and 1% at age. untreated, the spontaneous cure rate is about 15% a year. treatment is dominated by two approaches, enuresis alarm and drugs. treatment with drugs has largely been focused on tricyclic antidepressants especially imipramine or, more recently, antidiuretic agents such as desmopressin. for imipramine the proportion of total remission is 10-50% during treatment and a long term cure in 5-40%. however, numerous reports of side effects, some lethal, have led to a decline in its use. one of theory of nocturnal enuresis is deep sleep in children, this the main cornerstone in using alarm as line of management. on the other hand drugs used in re-habitation of sleep rhythm seems to be with great benefits in management as ginkgo biloba. ginkgo biloba leave extract is among the most widely sold herbal dietary supplements in the united states. its purported biological effects include: scavenging free radical; lowering oxidative stress; reducing neural damages, reducing platelets aggregation; anti-inflammation; anti-tumor activities; anti-aging, and improve night sleep rhythm. the aim of this study is to evaluate the effect of ginkgo biloba versus desmopressin in treatment of children with monosymptomatic nocturnal enuresis.

Eligibility criteria:
inclusion criteria: * all children with monosymptomatic nocturnal enuresis. exclusion criteria: * children with day and night wetting.

Keywords: monosymptomatic nocturnal enuresis nocturnal enuresis desmopressin ginkgo biloba
a retrospective study of the natural history of patients with severe perinatal and infantile hypophosphatasia (hpp)

Conditions: Hypophosphatasia (HPP)

Summary: this study aims to characterize the natural history of patients with severe perinatal or infantile onset hpp.

hypophosphatasia (hpp) is a life-threatening, genetic, and ultra-rare metabolic disease characterized by defective bone mineralization and impaired phosphate and calcium regulation that can lead to progressive damage to multiple vital organs, including destruction and deformity of bones, profound muscle weakness, seizures, impaired renal function, and respiratory failure. there are no approved disease-modifying treatments for patients with this disease. there is also limited data available on the natural course of this disease over time, particularly in patients with the juvenile-onset form.

Eligibility criteria:
inclusion criteria: * parent(s) or legal guardian(s) must provide written informed consent prior to data abstraction, unless all of the following apply: * the patient is deceased; and * the responsible irb/iec/reb does not require informed consent per a review of their documented local policies for collecting retrospective data on patients who are deceased; and * written confirmation is received from the responsible irb/iec/reb confirming that the abstracted data can be analyzed and used to support regulatory filings by the sponsor * patient must have a documented diagnosis of hpp as indicated by 1 or more of the following: * documented alpl gene mutation(s) * serum alkaline phosphatase (alp) below the age-adjusted normal range and either plasma pyridoxal 5'-phosphate (plp) or urinary phosphoethanolamine (pea) above the upper limit of normal * serum alp below the age-adjusted normal range and hpp-related radiographic abnormalities on x-ray * patient must have onset of signs of hpp prior to 6 months of age and have documentation of 1 or more of the following characteristics of perinatal and infantile hpp: * respiratory compromise (up to and including respiratory failure) requiring institution of respiratory support measure(s), requiring medication(s) for management of symptom(s), and/or associated with other respiratory complications (e.g., pneumonia(s), respiratory tract infection(s)) * pyridoxine (vitamin b6)-responsive seizures * rachitic chest deformity exclusion criteria: patients will be excluded from study participation if they have 1 or more of the following exclusion criteria: * patient received treatment with asfotase alfa at any time prior to data abstraction * patient has clinically significant other disease both living and deceased patients will be considered for study participation

Keywords: hypophosphatasia hpp bone disease soft bones low alkaline phosphatase genetic metabolic disorder alkaline phosphatase tissue non-specific alkaline phosphatase rickets osteomalacia