Kornimate/medical-research-clean huggingface dataset:
study examining parker-flex endotracheal tube for obese patients

Conditions: Obesity

Summary: a recent article examined the use of parker flex-tip tubes to standard etts for oral fiberoptic intubation and concluded that there was a significant benefit in terms of difficulty encountered when using the parker flex-tip. the parker flex-tip tracheal tube has a flexible, curved, and tapered tip design different from traditional endotracheal tubes. the design allows the tube to lie closely against the fiberoptic scope that is often used to facilitate intubation, resulting in a smaller gap between the ett and the fiberoptic scope. this may allow the ett to clear anatomic obstructions more easily. the patients they examined had an average body mass index (bmi) categorized as normal weight. to our knowledge, there have not been any studies that have investigated the use of the parker flex-tube for fiberoptic intubations in patients categorized as obese by bmi. our hypothesis is that the parker flex-tip ett results in easier passage of the ett over a fiberoptic scope during elective fiberoptic intubation of obese patients in comparison to a traditional ett.

this is a randomized, double-blinded study. neither the patient nor the anesthesia practitioner advancing the ett will know the group to which the patient has been assigned. on the day of surgery, participants will be randomized 1:1 to one of two groups. both groups will be electively intubated with a fiberoptic scope. one group will be intubated using a parker-flex endotracheal tube and the second group of will be intubated with a standard endotracheal tube. there will be an equal probability of being assigned to either group. no placebo or control group will be used. randomization will be computer-generated and assignments will be enclosed in sealed envelopes to provide allocation concealment. the anesthesiology technician involved in the case will open the envelope at the start of the case and will not be blinded to the study, due to the fact that the technician must prepare the endotracheal tube for the fiberoptic intubation.

Eligibility criteria:
inclusion criteria: * bmi of 30 or greater * american society of anesthesiologists (asa) physical status classification i- iii * patients scheduled for elective procedures requiring general anesthesia and endotracheal intubation. exclusion criteria: * predicted difficult airway based on physical exam and patient's history * rapid sequence intubation indicated (patients who require to be intubated as quickly as possible) * prior trauma or surgery in the oropharynx/larynx * known abnormal laryngeal structures (tumors) * infectious and toxic conditions * cervical spine instability * emergency surgery
duration of protection: gsk dtap vaccines

Conditions: Diphtheria; Acellular Pertussis; Tetanus

Summary: the purpose of this study is to assess duration of protection for gsk dtap vaccines in preventing pertussis.


Eligibility criteria:
inclusion criteria: * kaiser permanente northern california (kpnc) member who received 5 doses of acellular pertussis vaccines be-tween ages 1 month and 84 months at kpnc. * the 5th dose was given between the ages of 47 and 84 months. * all 5 dtap doses received were manufactured by gsk, depending on study objective (otherwise this criterion will not apply). * born in 1999 and later. inclusion criteria for cases: • all individuals meeting above inclusion criteria who tested pcr-positive for pertussis and negative for parapertussis during the study period. inclusion criteria for pcr-negative controls: • all individuals meeting above inclusion criteria who tested pcr-negative for both pertussis and parapertussis during the study period. inclusion criteria for kpnc-matched controls: * all individuals from the general kpnc population meeting above inclusion criteria who match a pcr-positive case on sex, age, race or ethnic group, and medical center. * kpnc members on the day their matched case under-went the pcr test (anchor date). exclusion criteria: * individuals whose pcr test date (or anchor date) is less than 2 weeks after receiving their 5th dtap dose. * individuals who were not kpnc members for greater than 3 months between their 5th dtap dose and pcr test date (or anchor date). * individuals who received reduced antigen content pertussis vaccine (tdap) or any pertussis-containing vaccine after their 5th dtap dose but before their pcr test date (or anchor date). exclusion criteria for controls: • individuals will be excluded from serving as a control once they test positive for pertussis.
evaluation of an integrated economic strengthening and hiv prevention program for vulnerable youth in south africa

Conditions: HIV; HIV Infections

Summary: this study evaluates whether the integration of an economic strengthening program with an hiv-prevention education program produce synergistic effects on economic and health outcomes for south african youth ages 14-17 years old.

in south africa, the overall hiv prevalence of 12.2% can be reviewed based on a number of factors: age, province, type of locality, race, economic household conditions, and marital status. those to be reached through the aspires intervention and evaluation are economically disadvantaged black african youth, male and female, located in urban localities in gauteng province, and are situated within a setting of high risk and vulnerability for hiv. the aspires project is providing technical assistance to provide economic strengthening (es) and hiv prevention education programming for adolescents. the aspires es intervention includes financial capability building through the provision of financial education in combination with access to appropriate youth-friendly savings mechanisms. the hiv prevention education intervention vhutshilo 2.2 will be used in this study. this study will assess whether the integration of an es intervention with an hiv-prevention education intervention improves economic and health outcomes beyond singular interventions, estimate the resources required at the program level to support the es and hiv-prevention education interventions; and describe whether the interventions were perceived as effective in addressing economic and health outcomes and to describe how and why the interventions were perceived as effective or not. this study will enroll up to 2000 youth ages 14-17 and randomly assign them to either 1) es intervention only, 2) hiv prevention intervention only, 3) combined es and hiv intervention, or 4) no intervention.

Eligibility criteria:
inclusion criteria: * beneficiary of future families in a study community * parent or guardian consent allowing adolescent to participate in the study * willing to sign or make their mark on an assent form * willing to provide contact information * only one adolescent is eligible per household

Keywords: aspires
assessment of a upper limb robotic device in stroke patients

Conditions: Stroke

Summary: the objectives of this phase ii clinical study are: evaluate the efficacy, safety, patient adeherence and clinical applicability of a new robotic device for patients with stroke at a physical rehabilitation institution (instituto de medicina física e reabilitação do hospital das clínicas da universidade de são paulo - imrea hcfmusp - rede de reabilitação lucy montoro, unidade vila mariana). methods: 10 patients with stroke diagnosis and fugl-meyer score ranging from 34 to 55 will be selected to be included in the study. after signing the informed consent form and being assessed by the baseline evaluations, they will undertake 18 sessions of robotic therapy, which in its turn will be prescribed three times a week. after this period, the patients will be evaluated for future comparison of both the pre-treatment and final assessments.


Eligibility criteria:
inlcusion criteria: 1. between 40 and 65 years. 2. both genders. 3. clinical and radiological diagnosis of ischemic stroke in the vascular territory of the middle cerebral artery or anterior cerebral artery. 4. clinical assessment of disability with diagnosis of right or left hemiparesis. 5. onset between 24 and 36 months. 6. clinical stability verified in medical evaluation. 7. spasticity less than or equal to 2 in modified ashworth scale. 8. moderate motor impairment in upper limb, according to fugl-meyer assessment upper limb score (34 to 55 points). 9. to remain seated in a backrest chair during the intervention period (about 55 minutes). 10. acceptance of informed consent form to participate in the study. exclusion criteria: 1. joint, muscle or tendinous lesions and/or pain that can occur during the intervention and make it difficult or impossible to perform robotic tasks. 2. progressive worsening of spasticity. 3. withdrawal of the informed consent form. 4. new episode of stroke. 5. comorbidities that may occur during interventions such as hypertension, seizures, diabetes, among other uncontrolled clinical issues.

Keywords: stroke rehabilitation upper limb motor activity robotic
a study to evaluate the safety and efficacy of hl231 solution for inhalation in patients with copd

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: to evaluate the efficacy and safety of hl231 solution for inhalation vs ultibro in chinese patients with moderate to very severe copd


Eligibility criteria:
inclusion criteria: 1. males and females of chinese ethnicity, at least 40 years of age. 2. patients with with a clinical diagnosis of moderate to severe copd confirmed by spirometry according to according to gold criteria 2023. 3. patients with a post-bronchodilator forced expiratory volume in one second (fev1) \&lt; 80% of the predicted normal value, and post-bronchodilator fev1/fvc (forced vital capacity) \&lt; 0.70 at visit 1. 4. modified medical research council (mmrc) grade of at least 2 at visit 1. exclusion criteria: 1. patients with any of the following diseases:α-1 antitrypsin deficiency, asthma, active pulmonary tuberculosis, lung cancer, pulmonary edema, cystic fibrosis, obliterated bronchiolitis, sarcoidosis, or other diseases that the investigator considers to be at risk of safety/efficacy for the patient, e.g lung fibrosis, pulmonary hypertension, interstitial lung disorder, active bronchiectasis. 2. patients with a history of serious cardiovascular disease; 3. patients with type i or uncontrolled type ii diabetes; 4. patients with paradoxical bronchospasm, narrow-angle glaucoma, symptomatic benign prostatic hyperplasia (benign prostatic hyperplasia patients who were stable on treatment could have been considered), bladder-neck obstruction, severe renal impairment, or urinary retention, or any other medical history, which, in the opinion of the investigator, would contraindicate the use of an anticholinergic agent; 5. patients who have had hospitalized due to copd or pneumonia within 8 weeks prior to screening (visit 1) or screening. 6. patients who have had an acute (viral or bacterial) upper or lower respiratory tract infection, sinusitis, pharyngitis or urinary tract infections within 4 weeks prior to screening (visit 1) or screening. 7. patients who have had a copd exacerbation that required treatment with systemic steroids, hospitalization or emergency treatment in the 8 weeks prior to screening (visit 1). 8. patients with conditions contraindicated for treatment with or having a history of allergy or hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof: anticholinergic/muscarinic receptor antagonist, long- or short-acting β2-agonists, sympathomimetic amines, lactose/milk proteins, or any of the other excipients of the delivery system. other protocol-defined inclusion/exclusion criteria may apply.
randomized, double-blind, placebo-controlled study to assess fatigue in patients with acd due to ra receiving procrit

Conditions: Anemia; Rheumatoid Arthritis

Summary: the purpose of this research study is to determine fatigue (tiredness) in subjects with chronic rheumatoid arthritis with chronic anemia. fatigue in subjects who get procrit will be compared to fatigue in subjects who get placebo (a medically inactive substance). the study will also evaluate hemoglobin levels (oxygen-carrying protein in red blood cells), safety, anemia related health concerns, vitality, arthritis related function and work productivity.

procrit is not approved for the treatment of anemia of chronic disease in rheumatoid arthritis patients. approximately 270 subjects will be participating in this trial, at approximately 25 centers in the united states. patients will be eligible to participate in this study if hemoglobin (hb) is \<=11.0 g/dl. the hypothesis is that procrit improves fatigue scores in rheumatoid arthritis patients with anemia of chronic disease. if a patient chooses to participate, he/she will be randomized to receive either procrit or placebo on a weekly basis starting at 20,000 units per injection (up to a maximum of 40,000 units).

Eligibility criteria:
inclusion criteria: * patients must have rheumatoid arthritis with chronic anemia. patients must have signed an informed consent * women must be postmenopausal for at least one year, surgically sterile, or practicing an effective method of birth control, or have a negative serum pregnancy test * women must not be breast feeding during this study period. exclusion criteria: * uncontrolled hypertension * elective surgery, including joint replacement, anticipated to require transfusion during the extension study period * thromboembolic event during the double-blind study including acute myocardial infarction, cerebrovascular accident and/or transient ischemic attack * deep vein thrombosis and/or pulmonary embolism * uncontrolled psychiatric disease * planning to be enrolled in any other clinical trial during the course of this study

Keywords: anemia rheumatoid arthritis hemoglobin level
natural history study for patients with nemaline myopathy in the uk

Conditions: Nemaline Myopathy

Summary: the goal of this study is to to learn more about what assessments would be useful to measure for nm and what normally happens during the lives of people with nm to support future clinical trial development.

current treatments for people living with nemaline myopathy are supportive only. several potential therapies are in development which may be available in the next 5-10 years. the barrier to these becoming available is that there is little data available on the natural progression (natural history) of nemaline myopathy. this means that it would be difficult to do a clinical trial of a treatment because it is not known which assessments would be useful to measure or what normally happens during the lives of people with nm.this study aims to better define the natural history and disease specific outcome measures and biomarkers. this study will comprehensively evaluate the natural clinical progression of the disease using medical data and examination findings, scales and questionnaires for the assessment of motor function, breathing, swallow function and quality of life and fatigue. in addition it will collect data on continuous movement and gait analysis using real world data and wearable sensors (syde and maiju), blood samples for future genetic and proteomic analysis and respiratory analysis using ventilatory and thoraco-abdominal pattern for paediatric participants.

Eligibility criteria:
inclusion criteria: * patient and/or parent or legal guardian must be willing and have the ability to provide written informed consent for participation in the study. * male or female * any age * diagnosis of nm which in most cases includes having a disease-causing variant/s in one of the known nm causative genes and a consistent clinical phenotype. exclusion criteria: * any confirmed chronic or acute condition or disease affecting any system(s), which could interfere with the results of the study and/or the compliance with the study procedures. this will be subject to the clinical judgement of the chief investigator (ci) and/or the principal investigator (pi). * clinically significant medical finding on the physical examination other than nm that, in the judgment of the investigator, will make the patient unsuitable for participation in, and/or completion of the study procedures. * participants of ongoing (interventional) clinical trials that assess the efficacy of potential treatments will be excluded as assessments need to be done on the basis that represent the natural progression of nm. * safety concerns. this includes anything that might put the participant and/or their parent(s) or guardian(s) at risk through participating in the study potentially including but not limited to: safeguarding concerns, social issues and health issues.
endometrial scratching in in vitro fertilization cycles with oocyte donation

Conditions: Subfertility

Summary: this study is designed to evaluate the potential benefit in pregnancy rates produced by an endometrial scratching made in an ivf cycle prior to embryo transfer in patients with donated oocytes.

this is a randomized, comparative, prospective, double blind study. the first stage of this study consists of revising the patients medical records to identify possible candidates. patients indicated are randomized into two groups: experimental and control. they are followed up to 12 week of pregnancy.

Eligibility criteria:
inclusion criteria: * do ivf cycle with donor eggs * will adjust to protocol for the study. * have signed informed consent exclusion criteria: * clinically significant systemic disease, hypothalamic or pituitary tumors * ovarian, uterine or breast cancer * hormonal abnormalities and / or medical , biochemistry, hematology pathology, which might interfere with gonadotropin treatment. * known positivity for human immunodeficiency virus (hiv), hepatitis c or b virus (hcv / hbv) of the candidate or her partner. * uterine factor(submucosal fibroids, intramural fibroids\> 4 cm) * hydrosalpinx * patients receiving immune treatment * positive diagnosis thrombophilia * preimplantation genetic diagnosis needed * in case of using marital sperm are excluded the following patients:altered male karyotype, altered meiosis in testicular biopsy, altered fish, sperm fragmentation\> 45% * pregnancy contraindication * known allergy to preparations containing estrogens or any of its excipients. * simultaneous participation in another clinical trial with medication. * do not want or can not adjust to study protocol.
zero-fluoroscopy approach versus fluoroscopic approach for the ablation of paroxysmal supraventricular tachycardia

Conditions: Paroxysmal Supraventricular Tachycardia

Summary: this study is aimed to compare the feasibility, safety and efficacy of a zero-fluoroscopic approach using ensite navx with conventional fluoroscopic approach using ensite navx plus fluoroscopy for the ablation of paroxysmal supraventricular tachycardia.

fluoroscopy is the imagine modality routinely used in catheter ablation of cardiac arrhythmias. as we all know,fluoroscopic radiation is harmful both to the patients and the operation staffs. recently,three-dimensional navigation systems have been developed and implemented in electrophysiological procedures for guiding catheters inside the heart chambers. among the three-dimensional navigation systems, ensite navx is a promising system used for zero-fluoroscopic approach for performing catheter ablation of paroxysmal supraventricular tachycardia. this study is aimed to compare the feasibility, safety and efficacy of a zero-fluoroscopic approach using ensite navx with conventional fluoroscopic approach using ensite navx plus fluoroscopy for the ablation of paroxysmal supraventricular tachycardia.

Eligibility criteria:
inclusion criteria: * atrioventricular nodal reentrant tachycardia * atrioventricular reentrant tachycardia exclusion criteria: * atrial tachycardia * organic supraventricular tachycardia

Keywords: fluoroscopy ablation three dimensional paroxysmal supraventricular tachycardia radiation
sonification embodied associations

Conditions: Multiple Sclerosis

Summary: the objective of this study to investigate, if learning and recall of a sequence of body movements (steps that realize a pattern on the ground) can be improved by self-produced music (having particular melodic-structures in relation to the pattern), compared to the same sound (a single tone) for each pattern in persons with multiple sclerosis compared to age and gender matched controls


Eligibility criteria:
inclusion criteria: * time up and go (tug) test: 8 sec -- \> 21 sec exclusion criteria: * cognitive impairment hindering the understanding and execution of the experimental procedures, * pregnancy, * hearing impairment, * amusia * beat deafness, * colour blindness.
open, non-comparative, multi-centre post marketing clinical follow-up investigation to evaluate performance and safety on diabetic foot ulcer, dfu when using fast gelling dressing as intended.

Conditions: Diabetic Foot Ulcers

Summary: the primary objective of this post market clinical follow-up (pmcf) investigation is to evaluate performance and safety of fast gelling dressing when used as intended in diabetic foot ulcer (dfu). the primary endpoint will be changes from baseline in the condition of the peri-wound skin measured by the following variables; maceration, redness/irritation, rash/eczema, blistering, dermatitis, skin stripping, trauma to wound edges and product degradation on the skin


Eligibility criteria:
inclusion criteria: 1. both gender ≥18 years old. 2. subjects with type 1 or 2 diabetes mellitus. 3. texas grade a1 or 2, c1 or 2 4. exuding diabetic foot ulcer 5. ulcer localisation; below the ankle 6. signed informed consent. exclusion criteria: 1. known allergy/hypersensitivity to the dressing. 2. hba1c ≥ 10% (86 mmol/mol) (most recent value within 3 months) 3. wound infection requiring systemic treatment 4. subjects who will have problems following the protocol. 5. subjects included in other ongoing clinical investigation at present or during the past 30 days. 6. toe pressure less than 70 mmhg 7. clinical suspicion of osteomyelitis (based on probe to bone/radiological changes) 8. dry wounds