Kornimate/medical-research-clean huggingface dataset:
evaluate the safety of recombinant human papillomavirus bivalent (types 16 and 18) vaccine (yeast) in healthy females

Conditions: Human Papillomavirus

Summary: this study will evaluate the safety of a novel recombinant human papillomavirus bivalent ( types 16 and 18 ) vaccine ( yeast ) with different dose in healthy females between 9-45 years of age at enrollment.


Eligibility criteria:
inclusion criteria: * healthy female between, and including, 9 and 45 years of age at the time of the first vaccination * provide legal identification for for the sake of recruitment. * be able to understand and sign informed consent prior to enrollment (for subjects below the legal age of consent, informed consent must be signed by parent(s)/legal guardian(s) in addition). * subject must be not pregnant at the enrollment and agree to using adequate contraceptive precautions within 7 months. exclusion criteria: * history of cervical cancer * history of severe allergic reaction requiring medical intervention (such as oral and throat swelling, difficulty breathing, hypotension or shock) * history of allergic to vaccine, or to any ingredient of vaccine. * history of epilepsy, seizures or convulsions, or family history of mental illness * subjects are immunocompromised or have been diagnosed as suffering from congenital or acquired immunodeficiency, hiv infection, lymphoma, leukemia, systemic lupus erythematosus (sle), rheumatoid arthritis, juvenile rheumatoid arthritis inflammation (jra), inflammatory bowel disease or other autoimmune diseases, administration of immunosuppressants with six months prior to the first vaccine dose. * history of asthma, thyroidectomy, angioneurotic edema, diabetes or malignant * asplenia, functional asplenia, or any circumstances result of asplenia or splenectomy * medical diagnosis of coagulation abnormalities (eg, clotting factor deficiency, coagulation disorders, platelet anomaly) or obvious bruising or coagulation disorder * acute disease or chronic disease acute exacerbation 7 days prior to vaccination * administration of immunoglobulins and/or any blood products within 3 months, or administration of any live attenuated vaccine within 28 days, or administration of any subunit or inactivated vaccines within 14 days. * fever or axillary temperature\> 37.0 °c before vaccination * during menstrual period, breastfeeding, pregnancy(pregnancy test positive), or planned pregnant within 7 month * history of hypertension, physical examination systolic blood pressure\> 150mmhg and/or diastolic blood pressure\> 100mmhg * abnormal laboratory tests parameters * any clinical significant disease or findings during study screening that, in the opinion of the investigator may interfere with the study

Keywords: human papillomavirus vaccine cervical infection cervical cancer
relative hand grip strength and functional fitness in diabetic patient in egypt

Conditions: Type II Diabetes Mellitus

Summary: to show if there is significant relationship between hand grip strength and physical fitness in diabetic type ii patients over 60 years old.

to show if there is significant relationship between hand grip strength and physical fitness in diabetic type ii patients over 60 years old.

Eligibility criteria:
inclusion criteria: * diabetes type ii * ability to walk independently * the cognitive and mental capacity to understand and perform tests exclusion criteria: * musculoskeletal, neurological, rheumatological problems, or hand deformities that could hinder grasping
crispr-edited allogeneic anti-bcma car-t cell therapy in patients with relapsed/refractory multiple myeloma

Conditions: Relapsed/Refractory Multiple Myeloma

Summary: this is a phase 1 study to evaluate the safety of cb-011 (the study treatment), an allogeneic chimeric antigen receptor (car-t) cell therapy that targets the b cell maturation antigen (bcma), to determine the best dose of cb-011, and to assess the effectiveness of cb-011 in treating multiple myeloma that has come back (relapsed) or that is no longer responding to other treatment (refractory).


Eligibility criteria:
inclusion criteria: 1. documented diagnosis of relapsed/refractory multiple myeloma (mm) with measurable disease (according to imwg diagnostic criteria.) 2. received at least 3 prior mm treatment lines of therapy which must include a proteasome inhibitor (pi), an immunomodulatory drug (imid), and an anti-cd38 monoclonal antibody as part of a prior line of therapy, either in monotherapy or in combination. 3. eastern cooperative oncology group performance status grade of 0 or 1. 4. adequate hematologic, renal, hepatic, pulmonary, and cardiac function. exclusion criteria: 1. prior treatment with car-t cell therapy directed at any target. 2. autologous stem cell transplant within the last 6 weeks before lymphodepletion. 3. allogeneic stem cell transplant within 6 months before lymphodepletion. 4. known active or prior history of cns involvement. 5. stroke or seizure within 6 months of signing icf. 6. seropositive for or history of human immunodeficiency virus. 7. vaccinated with live, attenuated vaccine within 4 weeks prior to lymphodepletion. 8. hepatitis b infection. 9. hepatitis c infection. 10. known life-threatening allergies, hypersensitivity, or intolerance to cb-011 or its excipients.

Keywords: cammouflage allogeneic multiple myeloma relapse refractory multiple myeloma car-t cells bcma cell therapy cellular immuno-therapy cb11a cb-011 cb-011a car-t anti bcma allo car t
conception of an icf core set for systemic sclerosis

Conditions: Systemic Sclerosis

Summary: the purpose of this study is to create and validate an icf core set for systemic sclerosis

in 2002 was published who's international classification of functioning, disability and health (icf). icf defines disability as "the negative aspects of the interaction between an individual (with a health condition) and that individual's contextual factors (personal and environmental factors)". interactions are specified in five domains, classified from body, individual and societal perspectives by means of two lists: a list of body functions and structure, and a list of domains of activity and participation. since an individual's functioning and disability occurs in a context, the icf also includes a list of environmental factors. icf core sets, which are short lists of icf categories relevant for specific conditions, serve as practical tools for clinical practice and allow standardisation of data for health information and research. core sets have already been developed and validated for several musculoskeletal diseases, such as low back pain, osteoarthritis, or osteoporosis, but not yet for systemic sclerosis.

Eligibility criteria:
inclusion criteria: * male or female aged 18 and older * diagnosis of scs made according to acr and/or leroy et medsger criteria * patient giving his informed consent to participate in the study exclusion criteria: * severe chronic disease associated with scs : stroke, multiple sclerosis, parkinson's disease,... * cognitive or behavioral disorders making assessment impossible * inability to speak and write french

Keywords: icf core sets systemic sclerosis function evaluation
ultrasound guided versus conventional arthrocentesis in treatment of temporomandibular joint internal derangement.

Conditions: Internal Derangement of the Tempromandibular Joint

Summary: the use of ultrasound as a guide in arthrocentesis of tempromandibular joint versus conventional anatomically guided arthrocentesis in treatment of temporomandibular joint internal derangement: a randomized clinical trial.


Eligibility criteria:
inclusion criteria: * adult patients aged 16 to 45 years of age having temporomandibular joint internal derangement. * patients free from any systemic conditions and bone metabolic diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing. * asa 1-2 patients with no contraindications for ga * patients who did not respond to conservative treatment. exclusion criteria: * patient with uncontrolled systemic diseases precluding administration of general anesthesia. * handicaps and special needs patients. * prisoners.
a study to evaluate the effect of rosuvastatin on intravascular ultrasound-derived coronary atheroma burden (asteroid)

Conditions: Coronary Arteriosclerosis

Summary: the purpose of this study is to see if 40 mg of rosuvastatin taken daily will reduce the atherosclerosis (fatty deposits) in your arteries


Eligibility criteria:
inclusion criteria: * clinical indication for coronary catheterization. target coronary artery: the target vessel must have .50% reduction in lumen diameter by angiographic visual estimation throughout a segment of at least 40 mm in length (the target segment) and the vessel must be large enough to accommodate the ivus catheter. a lesion of up to 60% is permitted distal to the target segment. side branches of the target (imaged) vessel may be narrowed up to 70% by visual estimation, provided the target segment contains no lesion greater than 50%. exclusion criteria: use of lipid-lowering medication for more than 3 months within the previous 12 months. longer periods of treatment are not permitted because of the potential effects of such therapy on coronary atherosclerosis. subjects receiving treatment with a lipid-lowering medication within the past 4 weeks require a 4-week wash-out period following which a baseline lipid profile will be taken at visit 2. clinically significant heart disease which, in the opinion of the principal investigator (or designee), is likely to require coronary bypass surgery, cardiac transplantation, surgical repair and/or replacement during the course of the study. -

Keywords: coronary artery disease
this study is to assess the efficacy and safety of zd6474 in subjects with metastatic breast cancer

Conditions: Breast Neoplasms; Metastases, Neoplasm

Summary: the purpose of this study is to assess the efficacy of zd6474 in patients with metastatic breast cancer at 2 dose levels.


Eligibility criteria:
inclusion criteria: * histological and/or cytological confirmation of metastatic breast cancer which is refractory to anthracycline, taxane, with or without capecitabine therapies; * who performance status 0, 1 or 2 on the day of registration; * females, aged \>= 18 years; * no gastrointestinal pathology which could affect the bioavailability of zd6474. exclusion criteria: * any evidence of severe or uncontrolled systemic diseases including known cases of hepatitis b or c or human immunodeficiency virus (hiv). * significant cardiac event (including symptomatic heart failure or unstable angina) within 3 months of entry or any cardiac disease that in the opinion of the investigator increases risk for ventricular arrhythmia; * history of clinically significant cardiac arrhythmia (multifocal pvcs, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (ctc grade 3) or asymptomatic sustained ventricular tachycardia; * chronic atrial fibrillation; * previous history of qt / qtc prolongation with other medication; * congenital long qt syndrome; * systemic anti-cancer therapy or other investigational agent within the last 4 weeks (6 weeks for nitrosoureas, mitomycin c, or suramin); * currently receiving drugs with known significant 3a4 inhibitory (ie, ketoconazole, itraconazole, troleandomycin, erythromycin, diltiazem, verapamil) or stimulatory (ie, phenytoin, carbamazepine, barbiturates, rifampicin) effects; * currently receiving therapeutic doses of warfarin (coumadin?)

Keywords: metastatic breast cancer
evaluation of hba1c levels and ovarian reserve and type 1 diabetes

Conditions: Diabetes; Ovarian Failure

Summary: the human ovary is the target of an autoimmune attack, usually in organ or non-specific autoimmune disorders. serum anti-müllerian hormone (amh) levels decrease early in menopause and menopause is seen in women with type 1 diabetes mellitus (dm1) at a young age. dm1 is aimed to show dm1 relationship with ovarian reserve based on the assumption that it will have lower amh levels than controls, secondary to bad glycemic control and autoimmune attack in women.

the study was designed prospectively. ovarian functions in healthy volunteer women and patients who use dm1 diagnosed between 18-40 years old will be examined. gonadotropin and amh levels will be measured in follicular phase. to calculate the number of antral follicles (afc) and ovarian volume, ultrasound will be looked at. fasting and satiety blood glucose, hba1c and c-peptide levels will be evaluated.

Eligibility criteria:
inclusion criteria: * female patients between 18 and 40 years of age who had consent and had gynecological examination in our polyclinic; * study group for patients with type 1 diabetes mellitus healthy volunteers control group exclusion criteria: * other endocrine and / or autoimmune disorders, polycystic ovary syndrome (pcos) and * previous surgery, which may reduce ovarian reserves; * medical and / or radiotherapy

Keywords: antral follicle count anti müllerian hormone ovarian reserve hba1c type 1 diabetes mellitus
thread lifting and microfocused ultrasound for face tightening ultrasound for lifting and tightening the face

Conditions: Skin Lifting and Tightening

Summary: skin aging is a continuous and inevitable presses usually starting at the age of mid-twenties, this prosses affects all facial layers including skin, subcutaneous fat, superficial muscular aponeurotic system (smas), deep facia, the retaining ligaments, muscle activity, and even facial bony structure . the clinical outcome of this process causes the aging signs of the face and neck, including loose facial skin, sagging cheeks, excess skin hanging from the lower jawline and excess fat in the neck . in the last decade with the introduction of absorbable threads, thread lifting has gained interest and popularity among patients and physicians, as noninvasive technique to treat ptotic skin and reposition of ptotic soft tissue into a more anatomical direction. histopathological studies indicated that dermal and subcutaneous foreign body reaction after inserting the threads, in forms of collagen deposition, and fibrosis , could explain the tightening effect throughout contracture and remodeling. however, some studies question efficacy especially in the aspects of durability and patient satisfaction . another nonsurgical alternative for facial rejuvenation is high-intensity focused ultrasound (hifu) therapy, during the past decade, hifu has been used as a clinical noninvasive surgical tool to treat tumors, including those of the liver, prostate, and uterus (10-12) the hifu devices heat tissue with acoustic energy in a focused, controlled manner. the thermal injury within the tissue leads to focal necrosis and cellular damage, initiating an inflammatory cascade that culminates in tissue remodeling, similar to changes that occur after ablative or nonablative laser treatments . the investigators hypothesis that the hifu treatment followed immediately by thread insertion can amplify and enhance the skin fibrosis, tissue lifting capacity and might give better and longer clinical results in treating ptotic skin.


Eligibility criteria:
inclusion criteria: 1. healthy individuals. 2. ages ≥ 30 y.o. 3. male and female 4. mild to moderate facial laxity and skin ptosis (modified fitzpatrick wrinkle scale class 1 and 2 ) exclusion criteria: 1. pregnancy 2. breastfeeding, 3. immunosuppressed individual or individual taking immunosuppressive medications. 4. active systemic or local infections e) collagen vascular disease f) scaring in the planed treatment area g) history of vascular or bleeding disorders h) psychiatric illness i) inability to provide informed consent j) ablative or non-ablative skin procedures in the last 6 months k) surgical procedures within a year to the proposed treatment sites l) excessive skin laxity on the lower face and neck
new rehabilitation protocol for patients with pppd

Conditions: Rehabilitation; Balance; Vestibular Disorder; Dizziness

Summary: the investigators will test a new rehabilitation protocol on patients with persistent postural perceptual dizziness (pppd). the investigators hypothesize that patients with pppd, in the absence of vestibular deficits, do not benefit from standard vestibular rehabilitation but instead need a rehabilitation that acts on visual and postural stability, through training of saccadic movements in dynamic contexts of cognitive-motor dual-task and rehabilitation of postural stability.

persistent postural-perceptual dizziness (pppd) is a chronic functional vestibular disorder that manifests as a sensation of non-vertiginous dizziness and instability. the most common triggers of pppd are peripheral vestibular conditions such as vestibular neuritis (vn) and benign paroxysmal positional vertigo (bppv), although vestibular migraine, central vestibular disorders and non-vestibular conditions such as panic attacks, minor injuries traumatic brain injury and also orthostatic intolerance have been reported as precipitants of pppd. pppd persists after the triggering events have resolved. the diagnostic criteria for pppd were established by the barany society. once the negativity of the routine vestibular tests has been ascertained, the diagnosis is based on additional criteria such as the persistence of the symptom of dizziness for most of the time for at least 3 months, the worsening of the symptoms when standing, during active movement or passive, during exposure to moving visual stimulation or to visual stimuli with complex textures. existing treatments (e.g., selective serotonin reuptake inhibitors, vestibular habituation) are only partially successful in pppd. methods. experimental design. single-blind randomized controlled trial. 40 individuals affected by pppd will be recruited. the patients will be randomly divided into 2 groups and evaluated before the rehabilitation training (t0), immediately after the end of the training (t1), 4 weeks after the end of the training (t2) and 8 weeks after the end of the training (t3). all patients will undergo 5 rehabilitation sessions supervised by a physiotherapist with experience in rehabilitation of balance disorders. the experimental group will carry out a interactive visuo-vestibular training (ivv) in order to facilitate postural visual stability and the control group will carry out a conventional vestibular rehabilitation training aimed at training the vestibular reflexes. the rehabilitation protocols (ivv and vestibular) will consist of 1 session of 40 minutes per week, for a total of 5 sessions. ivv training consists of exercises that stimulate saccadic movements during motor activities on the treadmill and walking on the treadmill blindfolded with the support and supervision of the physiotherapist.

Eligibility criteria:
inclusion criteria: * diagnostic criteria established for pppd by the barany society (staab et al., 2017) will be adopted exclusion criteria: * patients with neurological, otological or psychiatric disorders other than pppd will be excluded.
perioperative longitudinal study of complications and long-term outcomes

Conditions: Perioperative Complication; Infections; Myocardium; Injury; Kidney Injury; Delirium

Summary: purpose: with an increased risk of complications. improved preoperative risk stratification and earlier diagnosis of these complications may ameliorate postoperative recovery and improve long-term outcomes. the perioperative longitudinal study of complications and long-term outcomes (pluto) aims to establish a comprehensive biorepository that will facilitate research in this field. patients undergoing elective intermediate to high-risk non-cardiac surgery are eligible for enrolment. for the first 7 postoperative days (or longer as indicated), participants will be subjected to daily bedside visits by dedicated observers, who adjudicate clinical events and perform non-invasive physiological measurements (including handheld spirometry and single-channel eeg). in addition, we will collect blood samples as well as microbiome specimens at selected time points. primary study outcomes are the postoperative occurrence of nosocomial infections, major adverse cardiac events, pulmonary complications, acute kidney injury and delirium. secondary outcomes include mortality as well as long-term psychopathology, cognitive dysfunction, and quality of life. pluto is the first perioperative biobank worldwide that includes a broad range of high-risk surgical patients, collecting prospective bedside data as well as both blood and microbiome specimens during the entire perioperative period. the data and materials collected in pluto will be used to develop, externally validate, and update prognostic prediction models for improved risk assessment, to test novel biomarkers for early detection of postoperative complications and to study the aetiology, attributable morbidity and mortality related to these events.


Eligibility criteria:
inclusion criteria: - undergoing an elective, high-risk gastro-intestinal or vascular procedure, or intermediate risk procedure (including gynaecological, orthopaedic and head and neck surgery) if the procedure includes a laparotomy and/or is associated with a scheduled hospital length of stay ≥ 5 days. exclusion criteria: * \< 18 years of age * emergency surgery * severe anaemia (hb \< 4.5 mmol/l) * unable to provide informed consent
up to me: erasing the stigma of mental illness on college campuses

Conditions: Mental Illness; Behavior Disorders; Severe Mental Illness; Psychiatric Diagnosis; Psychiatric Diseases; Psychiatric Disorders; Psychiatric Illness

Summary: this is a three-lesson, disclosure-based stigma reduction program meant to reduce barriers to community living and participation for college students with psychiatric disabilities. the goal is to improve community living and participation of individuals with psychiatric disabilities within their postsecondary community using the honest open proud (hop) program. there are 3 specific objectives of the project:1) evaluate program fidelity, 2) assess program feasibility, and 3) conduct a randomized controlled trial of the hop program with college students with mental illness to examine its efficacy. anticipated outcomes include increases in 1) community integration, 2)self-esteem and self-efficacy, 3) empowerment and self-determination, 4) disclosure of mental illness in order to obtain needed support, and 5) care seeking/service engagement for mental illness. ultimately, we expect to see increased academic persistence and achievement among hop program completers.


Eligibility criteria:
inclusion criteria: * college students enrolled at usf * over 18 years of age * individuals with psychiatric disability(ies) who feel shame regarding their mental illness or keep it secret exclusion criteria: * individuals with a sole substance abuse disorder * individuals who plan to graduate before the conclusion of the data collection period; for intervention participants, this would be a graduation date within 6 months of starting the intervention.

Keywords: mental illness disclosure empowerment stigma
effectiveness of antrodia cinnamomea mycelia on improving immune response in subhealth people

Conditions: Fatigue Syndrome, Chronic; Cold

Summary: this study aims to assess the effect of antrodia cinnamomea mycelia on immune modulation in subhealth people.

this study aims to assess the effect of antrodia cinnamomea mycelia on immune modulation in subhealth people: a randomized, double-blind, placebo-controlled, and parallel clinical investigation.

Eligibility criteria:
inclusion criteria: * subjects are easy to feel fatigued * subjects have poor sleep quality exclusion criteria: * pregnant women or preparing for pregnancy. * lactating women. * women gave birth 6 months before the study. * poor kindy and livers funcitons * severe cardiovascular or other chronic diseases * alcohol abuser * using immune-associated supplements