Kornimate/medical-research-clean huggingface dataset:
total facet arthroplasty system®(tfas®) clinical trial

Conditions: Spinal Stenosis; Low Back Pain; Spondylolisthesis; Lumbar Spinal Stenosis; Leg Pain; Spinal Diseases

Summary: the archus total facet arthroplasty system® (tfas®) is a non-fusion spinal implant indicated for treatment of patients with moderate to severe spinal stenosis. tfas® replaces the diseased facets following surgical removal. tfas® offers the surgeon new options for treating spinal stenosis patients, enabling a more comprehensive decompression via complete removal of the facets. tfas® also offers an alternative to rigid spinal fusion fixation enabling intervertebral motion. the clinical trial is intended to demonstrate restoration of stability and sagittal balance to the spine. tfas® also eliminates the need for painful bone graft harvest from the patient's hip which may be required with fusion procedures.


Eligibility criteria:
inclusion criteria: * degenerative spinal stenosis, central or lateral, at spinal levels l3-l4 or l4-l5 * skeletally mature male or female between the ages of 50 and 85 years of age inclusive * no greater than grade i degenerative spondylolisthesis at the index level * persistent leg symptoms,including pain, numbness, burning or tingling for a minimum duration of six months * operative candidates with no more than three levels of degenerative lumbar spinal stenosis requiring decompression * failed to respond to non-operative treatment modalities for a minimum duration of six months exclusion criteria: * male or female less than 50 or greater than 85 years old grade 2 or higher spondylolisthesis or any retrolisthesis at the index level * more than 3 vertebral levels of degenerative spinal stenosis requiring decompression * more than 1 vertebral level of degenerative spinal stenosis requiring instrumentation * not available for long term follow-up and interval visits * prior or concurrently planned lumbar fusion or disc replacement at any level of the lumbar spine * two or more previous surgeries to the lumbar spine at the same level to be implanted * is being treated with other devices for the same disorder (e.g. pain control devices) * active systemic infection or infection at the operating site * osteoporosis * known sensitivity to device materials * has an immunosuppressive disorder * has a medical condition that may interfere with clinical evaluations * is obese defined by a patient body mass index greater than 40 * has significant scoliosis (cobb \>25°) * is pregnant or planning to become pregnant within the proposed three year investigation

Keywords: spinal stenosis low back pain spondylolisthesis lumbar spinal stenosis leg pain spinal diseases
different retraining methods vs usual care on the prevention of peritonitis in peritoneal dialysis

Conditions: Peritonitis

Summary: to examine whether retraining via operation inspection or verbal education can reduce the risk for peritonitis in pd patients.

the design is prospective, randomized, controlled study. at baseline (during the first month), they will receive a standard training program on performing bag exchange and education on the prevention of peritonitis. then the participants will be randomized into three groups: retraining via operation inspection (g1), retraining via verbal education (g2) and usual care (g3). retraining will be performed every 2 months in g1 and g2 group. during the following 2 years or a longer period, all the participants will be followed up frequently with outcome events recorded.

Eligibility criteria:
inclusion criteria: * capd patients. * medically stable and receiving pd for\<1 week * age between 18 and 80 years * self-care or doing bag exchange by a fixed assistant exclusion criteria * followed up at least every 2 months * dialyzed with glucose lactate-buffered pd solutions produced by baxter corp, china exclusion criteria: * pregnancy; * undergoing apd therapy * intolerance to the study protocols; * severe and unstable condition, acute or chronic inflammation disease; * a high probability (assessed by the recruiting physician) of receiving a kidney transplant or transferring to hd or drop-out due to socioeconomic causes within 6 months; * suffering peritonitis before receiving the interventions * cognitive or psychological dysfunction; * communication barrier

Keywords: peritoneal dialysis retraining peritonitis
a study to compare safety and efficacy of upadacitinib to dupilumab in adult participants with moderate to severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this study will evaluate upadacitinib compared to dupilumab (dupixent®) in adults with moderate to severe atopic dermatitis (ad) who are candidates for systemic therapy.

the study is comprised of a 35-day screening period, a 24-week double-blinded treatment period, and a follow-up visit 12 weeks after the last dose. participants who complete week 24 have the option to enroll into an open-label study (study m19-850; nct04195698) of upadacitinib 30 mg once daily and receive treatment with upadacitinib for an additional 52 weeks. participants who meet eligibility criteria will be randomized in a 1:1 ratio to receive either upadacitinib or dupilumab. randomization will be stratified by baseline disease severity (validated investigator global assessment scale for atopic dermatitis \[viga-ad\] score of moderate \[3\] versus severe \[4\]) and age (\<40, ≥ 40 to \< 65, ≥ 65 years).

Eligibility criteria:
inclusion criteria: * participant has active moderate to severe atopic dermatitis (ad) defined by eczema area and severity index (easi) ≥ 16, investigator's global assessment (iga) ≥ 3, ≥ 10% body surface area (bsa) of ad involvement at the screening and baseline visits, and baseline weekly average of daily worst pruritus nrs ≥ 4. * participant is a candidate for systemic therapy or have recently required systemic therapy for ad. exclusion criteria: * participant has prior exposure to janus kinase (jak) inhibitor. * participant has prior exposure to dupilumab. * participant is unable or unwilling to discontinue current ad treatments prior to the study. * participant has requirement of prohibited medications during the study. * participant has other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of ad lesions. * female participant who is pregnant, breastfeeding, or considering pregnancy during the study.

Keywords: upadacitinib abt-494 dupilumab atopic dermatitis
influence of flat-knitted compression stockings class i and ii on venous malformations

Conditions: Vascular Malformations; Vascular Malformation Peripheral; Venous Malformation; Vascular Diseases

Summary: diseases with vascular malformations are rare and often congenital, affecting patients of all ages. depending on their extent and localization, they can cause discomfort and, especially if activity is restricted, lead to loss or reduced quality of life. the therapy is usually reserved for a few specialized centers and includes interventional sclerotherapy as well as conservative therapy by compression with appropriate compression stockings. however, there are currently no study-based recommendations for this approach. the aim of this study is to prove a therapeutic effect of compression therapy using flat-knitted compression stockings on venous malformations of the extremities and to derive from this a therapy recommendation in connection with an improvement in the health status and quality of life. for this purpose, patients with a confirmed venous malformation of the upper or lower extremity independent of previous therapy will be included. we will investigate patients with epi- and/or subfascial localization of the venous malformation independent of the local extent (cross-articular or not).


Eligibility criteria:
inclusion criteria: * patients with a confirmed venous malformation of the upper/lower extremity independent of previous therapy with epi- and/or subfascial localization of the venous malformation independent of the local extent (cross-articular or not) * compression stocking can be put on independently or by the parents * written declaration of consent present exclusion criteria: * lack of compliance, patient is not available for control appointments * additional drug therapy (anticoagulation) for extensive venous malformations with threatening thromboembolic complications * known allergic reaction/intolerance to components of flat-knitted compression stockings * pregnancy * rejection of the study participation by the patient * contraindications for the planned mri examination (pacemakers, implants not suitable for mri, claustrophobia) * occurrence of an emergency situation * severe heart failure as contraindication for compression therapy * peripheral arterial disease as contraindication for compression therapy

Keywords: compression therapy compression stockings class i compression stockings class ii short-form 12 (sf-12) quality of life wearing comfort magnetic resonance imaging mri perometre
a clinical study of b007 in the treatment of generalized myasthenia gravis.

Conditions: Generalized Myasthenia Gravis

Summary: the purpose of this study is to evaluate the efficacy and safety of b007 in subjects with generalized myasthenia gravis.


Eligibility criteria:
inclusion criteria: 1. sign informed consent form; 2. subjects with generalized myasthenia gravis; 3. serum achr(acetylcholine receptor)-ab or musk-ab was positive during screening; 4. mg-adl ≥5 at screening and baseline; 5. before randomization, subjects received at least one gmg stable dose of soc, and maintain a stable dose throughout the test; 6. subjects agree to use effective contraceptive methods for contraception from signing the informed consent form to 1 year after the last dose. female subjects considered fertile by the investigator must have negative serum pregnancy tests before the first dose. exclusion criteria: 1. subjects with mgfa i and v type; 2. subjects usingprescribed drugs; 3. subjects with a prescribed disease or history of disease; 4. the subjects has prescribed examination abnormalities that are assessed as unsuitable for participation in the study by the investigator; 5. known history of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of b007; 6. subjects who received live vaccine at the specified time before the first dose and are expected to receive the vaccine at the specified time after the last dose; 7. subjects who have received major surgery or participated in other clinical trials within the prescribed time before screening; 8. pregnant and lactating women; 9. fertile female subjects do not agree to use effective contraception from signing the informed consent form to 1 years after the last dose. 10. sexually active male subjects who do not intend to use an effective contraceptive method during the trial period or within1 years after the last dose, or male subjects who plan to donate sperm during the trial or within 1 year after the last dose; 11. a history of alcohol or drug abuse within the past 12 months; 12. other conditions deemed unsuitable for participation in this study by the researchers.
immunogenicity and tolerability study of fluvalab fl-k-004 trivalent influenza vaccine

Conditions: Influenza

Summary: this is a single blind, reference drug controlled, one center viral immunogenicity and tolerability study of fluvalab fl-k-004 trivalent influenza vaccine with 6 μg ha/strain/dos antigen content to assess immunogenicity and tolerability. the aim of the study is to assess the immunogenicity and tolerability of fluvalab fl-k-004 trivalent influenza vaccine with 6 μg ha/strain/dos antigen content (study drug) in age groups 18-60 years and over 60 years, with the objective to verify efficacy and tolerability of the study drug according to cpmp/bwp/214/96: "note for guidance on harmonization of requirements for influenza vaccines", 12 march 1997.


Eligibility criteria:
inclusion criteria: * adult volunteers in good health aged over 18 years, both sexes; * full contractual capacity of the participants; * are in good health (as determined by vital signs and medical history); * negative urine or serum pregnancy test for females of childbearing potential; * are able to understand and comply with planned study procedures; * signed informed consent prior to initiation of study procedures; * absence of existence of any exclusion criteria. exclusion criteria: * known allergy to eggs or other components of the vaccine; * history of guillain-barré syndrome; * pregnancy or breast feeding or positive pregnancy test prior to vaccination; * immunosuppressive therapy in the preceding 36 months; * active neoplasm (i.e. requiring any form of anti-neoplastic therapy); * concomitant corticosteroid therapy, including inhaled corticosteroids; * psychiatric illness and/or concomitant psychiatric drug therapy; * immunoglobulin (or similar blood product) therapy within 3 months prior to vaccination; * vaccine therapy within 4 weeks prior to the study; * influenza vaccination within 6 months prior to the study; * chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the immune response; * documented hiv, hbv or hcv infection; * acute febrile respiratory illness within one week prior to vaccination; * experimental drug therapy within 1 month prior to vaccination; * alcohol or drug abuse.

Keywords: prevention influenza infection vaccine influenza vaccine influenza in humans
first-in-human study of ak1320 encapsulated microspheres (ak1320 ms)

Conditions: Degenerative Spondylolisthesis; Spinal Stenosis

Summary: the safety and efficacy of ak1320 ms will be evaluated in patients with degenerative spondylolisthesis and concomitant symptomatic spinal stenosis who are undergoing decompression and single level instrumented posterolateral lumber autograft fusion surgery.

this will be a first in human phase i, ascending dose, multi-center, randomized patient study evaluating the efficacy, safety, pk of ak1320 ms. the study will enroll up to 4 dose escalating cohorts with each cohort having 2 treatment groups. cohort 1 and cohort 2 (ak1320 ms group (n=3-7); control group (n=0-3)) and cohort 3 and cohort 4 (ak1320 ms group (n=6-7); control group (n=0-3)).

Eligibility criteria:
inclusion criteria: 1. involved level l1 to s1 2. use of local autologous bone only. 3. degenerative spondylolisthesis up to meyerding's classification grade 1 or 2. 4. moderate or higher disability as assessed by oswestry disability index. 5. neurogenic claudication and/or radiculopathy with or without back pain. 6. male or female over 22 years of age and less than 81 years of age. exclusion criteria: 1. prior lumbar decompression or spine fusion attempt (any level). 2. undergoing concurrent interbody fusion. 3. requires spinal fusion at more than one lumbar level. 4. degenerative scoliosis. 5. bmi \> 40. 6. radiographically confirmed significant spinal instability. 7. active or recent (within the past two (2) years) worker's compensation litigation.

Keywords: degenerative spondylolisthesis spinal stenosis posterolateral lumber fusion surgery autograft
evaluation of serum amyloid a in early diagnosis of spontaneous bacterial peritonitis

Conditions: Spontaneous Bacterial Peritonitis

Summary: one of the most common and serious complications in decompensated cirrhotic patients (dcps) is bacterial infection.the most common infections in dcps are cases of spontaneous bacterial peritonitis (sbp), which account for 40% 70% of cases, followed by urinary tract infections, pneumonia and cellulitis. serum amyloid a (saa) and c-reactive protein (crp) are acute-phase proteins predominantly produced and secreted by hepatocytes. other cells including lymphocytes, monocytes, and macrophages can also produce these proteins. the induction of saa and crp synthesis is triggered by a number of cytokines, chiefly il-6, which is released from a variety of cell types, but mainly from macrophages and monocytes at inflammatory sites

increased serum crp and saa levels have been found in a number of disorders, including bacterial infections, malignancies tissue injuries and tissue rejection. therefore, new studies of early diagnosis, prevention and treatment are needed to improve clinical outcomes.

Eligibility criteria:
inclusion criteria: * • decompansated cirrhosis with ascites, defined by a combination of any of the following: * laboratory findings * endoscopic results * ultrasound * histology exclusion criteria: * creatinine\>1.5 mg/dl * other infection e.grespiratory,uti ,gastrointestinal and skin infection. * hepatocellular carcinoma * other extrahepatic malignancy e.g ; chest * any significant psychiatric illness or other medical comorbidity. * any degenerative diseases.
clinical outcomes of slow developing blastocysts

Conditions: Infertility

Summary: this study evaluates which transfer strategy will result in a higher probability of pregnancy in patients whose single best day 5 embryo resulting from an ivf cycle is classified as expansion grade \<4 by gardner and schoolcraft classification. all cycles will be cultured to day 6 and half the patients will undergo a fresh embryo transfer and the other half a frozen embryo transfer.

a lack of established markers for predicting blastocyst development increases the risk of having no embryos or embryos not-fully expanded available for transfer. slower but non-arrested embryos are frequently found to have progressed to blastocyst stage by the time of a day 6 transfer. in the absence of a receptive endometrium, embryo selection for fresh transfer may be futile, and cryopreservation could be a better option. the objective is to determine which transfer strategy will result in a higher probability of pregnancy in patients whose single best day 5 embryo resulting from an ivf cycle is classified as expansion grade \<4 by gardner and schoolcraft classification. the investigators hypothesize that in bad prognosis patients with slow-developing blastocysts, vitrified-warmed embryo transfer will result in higher implantation, clinical and ongoing pregnancy and live birth rates than fresh embryo transfer.

Eligibility criteria:
inclusion criteria: * all ivf cycles undergoing autologous fresh blastocyst embryo transfer * all ivf cycles in which the best available embryo for transfer is at expansion grade \<4 * all ages exclusion criteria: * ovum donation cycles * preimplantation genetic testing cycles

Keywords: in vitro fertilization slow developing blastocyst fresh embryo transfer frozen embryo transfer live birth rate
study to evaluate subclinical atherosclerosis (an early sign of heart disease) in healthy adult immigrant asian indians

Conditions: Healthy

Summary: previous research has shown that asian indians are at relatively high risk for developing diabetes, heart problems and high blood pressure. the purpose of this study is to evaluate subclinical atherosclerosis (an early sign of heart disease) which may be associated with abnormalities like diabetes mellitus, hypertension (high blood pressure), high cholesterol and heart problems. endothelium is the inner lining of your blood vessels. endothelial dysfunction is found more in people with diabetes. in addition, high body mass index (bmi) is a strong risk factor for developing metabolic abnormalities like diabetes mellitus. this research study may provide information as to how useful endothelial dysfunction will be to detect people at risk of metabolic abnormalities and heart disease at an early stage. two groups of subjects will be enrolled. caucasians and asian indians there will be a total of 100 subjects participating in this study. approximately 50 caucasians and 50 asian indians will be enrolled. caucasians will serve as the control group for this study.


Eligibility criteria:
inclusion criteria: * asian indians and caucasians between the ages of 20 and 65 living in the boroughs of new york city and the long island area. subjects must provide a record of blood results completed within the past year to determine eligibility (hematology and chemistry results). exclusion criteria: * subjects with major underlying medical problems, including diabetes, hypertension, coronary artery disease (cad), hyperlipidemia, systolic blood pressure below 90 mm hg and liver or kidney disease will be excluded.

Keywords: healthy asian indians and caucasians
skin barrier biophysical properties and clinical appearance after moisturizer in dry skin

Conditions: Xerosis; Xerosis Cutis; Dry Skin; Eczema

Summary: the purpose of the study is to compare the changes in the appearance of dry skin after the use various moisturizers: white petrolatum ointment, coconut oil, jojoba oil, and almond oil in patients with dry skin.

the goal of this study is to compare how the appearance of dry skin changes before and after the use of following moisturizers: white petrolatum, coconut oil, jojoba oil and almond oil). up to 40 subjects from banner-university medical center/university of arizona dermatology clinics and university of california, davis dermatology clinics (up to 20 subjects per site) who have dry skin will be enrolled in this study and randomized to receive the four moisturizers on four locations on their forearms.there will be a total of 3 study sessions: baseline, and approximately 1 and 2 weeks for follow up assessment. at each visit, dry skin severity will be evaluated by a trained observer using a validated dry skin score, skin barrier biophysical properties (transepidermal water loss and hydration) will be measured, and digital photos of the test sites will be taken for image analysis.

Eligibility criteria:
inclusion criteria: 1. male and female, at least 18 years of age 2. subject must receive a diagnosis of dry skin by a dermatologist. 3. subject must be able to comprehend and read the english language. exclusion criteria: 1. subjects who do not fit the inclusion criteria. 2. subjects unable to or unwilling to comply with the study procedures 3. prior known allergy to white petrolatum, coconut oil, almond oil, or jojoba oil. 4. people who have used products containing white petrolatum, jojoba oil, coconut oil, or almond oil within the past week. 5. people with a known diagnosis of ichthyosis. 6. a subject who, in the opinion of the investigator, will be un-cooperative or unable to comply with study procedures. 7. subject unable to speak or read the english language, since all consents and instructions will be provided in english. 8. those that are prisoners or cognitively impaired