Kornimate/medical-research-clean huggingface dataset:
treatment of type 2 diabetes with long acting basal insulin in jordan

Conditions: Diabetes Mellitus, Type 2

Summary: primary objective: -to assess the change in glycosylated hemoglobin (hba1c) in uncontrolled type 2 diabetes patients on oad agent in jordan after 6 months of treatment with basal insulin (insulin glargine). secondary objectives: * to evaluate the percentage of patients achieving target of hba1c ˂7%. * to evaluate the change in fasting plasma glucose (fpg). * to assess the following safety criteria: hypoglycemic events, body weight changes, and overall safety. * describe the titration process: changes in glargine insulin dose at 3 months and 6 months, changes in the titration doses used (if any), and time to reach control.

the total duration of study period per patient is up to 6 months.

Eligibility criteria:
inclusion criteria : * patient ≥ 18 years old. * male or female. * type 2 diabetes patients. * uncontrolled with previous therapy (hba1c \>7%), evident in hba1c test within the last 1 month before study entry. * insulin naïve patients: any patient uncontrolled after one or a maximum of two lines of therapy including: monotherapy (metformin alone or any other oral anti-diabetic agent (oad) if contraindicated or intolerance) and/or dual therapy (any oad combination), at maximum tolerated dose in the last 3 months. * signed informed consent. * signed informed consent. exclusion criteria: * patient not willing or not able to perform self-monitoring blood glucose. * patient not willing or not able to self-titrate insulin glargine under physician's guidance. * patient not suitable for participation according to what is specified in the approved summary of product's characteristics or according to medical or clinical conditions, as judged by the investigator. * history of impaired hepatic function defined as alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) greater than three times the upper limit of normal, evident in testing done in the last 3 months. * history of impaired renal function defined as serum creatinine \>135 μmol/l (\>1.525 mg/dl)in men and \>110 μmol/l (\>1.243 mg/dl) in women, evident in testing done in the last 3 months. * pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method at physician's discretion). * treatment with systemic corticosteroid within 3 months prior to study entry. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
treatment of shallow periodontal pockets using prf as an adjunct to scaling and root planing in periodontitis patients

Conditions: Periodontitis

Summary: platelet rich fibrin (prf) has been widely used in regenerative dentistry since it provides plenty amount of growth factors that enhance wound healing and tissue regeneration. platelet derived growth factor-bb (pdgf-bb) is a growth factor with essential functions such as regulation of cell migration, proliferation, and differentiation. this study aims to evaluate the efficacy of prf in improving the clinical periodontal parameters and gcf level of pdgf-bb.

split mouth randomized clinical trial is the design of the study. 12 periodontitis patients with 24 opposite shallow periodontal pockets (4-6 mm in depth) will be selected. randomization in this study will be achieved using toss of coin method in which periodontal pockets will be designated either control site or test site. prf will be used as an adjunct to scaling and root planing to treat the test sites. while control sites were treated by scaling and root planing only. clinal periodontal parameters were recorded and gcf level of pdgf-bb will be measured at baseline and1- and 3- month follow-up visits to evaluate the healing response to the treatment.

Eligibility criteria:
inclusion criteria: •periodontitis exclusion criteria: * periodontal therapy for the last 3 months * medical history of systemic diseases such as diabetes. * patients wearing dental prosthesis * alcoholic patients * teeth with grade ii mobility, endodontic lesions, and teeth with untreated caries
local anesthetic nebulization for pain control after laparoscopic cholecystectomy

Conditions: Laparoscopic Cholecystectomy

Summary: intraperitoneal nebulization of local anesthetic is a novel approach to pain management after laparoscopy. preoperative compared with postoperative administration of analgesia remains controversial. this randomized, double blind, placebo-controlled trial compared the analgesic efficacy of preoperative with postoperative peritoneal ropivacaine nebulization in patients undergoing elective laparoscopic cholecystectomy.

previous studies evaluating intraperitoneal local anesthetic administration for pain relief after laparoscopic surgery have suggested that the timing of local anesthetic administration may be critical in the success of the technique. a meta-analysis of randomized trials of intraperitoneal local anesthetic instillation in patients undergoing laparoscopic surgery found that local anesthetic instilled before surgical dissection provided superior pain relief compared to instillation at the end of surgery. intraperitoneal nebulization of local anesthetic is a novel approach to pain management after laparoscopic surgery. recently, alkhamesi et al reported that bupivacaine nebulization performed at the end of laparoscopic cholecystectomy significantly reduced postoperative pain. however, clinical benefits of preoperative administration of analgesia, compared with postoperative administration, remains controversial. the investigators hypothesized that pain relief after preoperative and postoperative ropivacaine nebulization would be similar but better than placebo.

Eligibility criteria:
inclusion criteria: * asa score i-iii * scheduled for laparoscopic cholecystectomy * free from pain in preoperative period * not using analgesic drugs before surgery * without cognitive impairment or mental retardation * written informed consent exclusion criteria: * emergency/urgency surgery * postoperative admission in an intensive care unit * cognitive impairment or mental retardation * progressive degenerative diseases of the cns * seizures or chronic therapy with antiepileptic drugs * severe hepatic or renal impairment * pregnancy or lactation * allergy to one of the specific drugs under study * acute infection or inflammatory chronic disease * alcohol or drug addiction

Keywords: laparoscopic cholecystectomy nebulization ropivacaine
alzheimer's disease imaging with pet/mri - beta-amyloid

Conditions: Dementia; Alzheimer Disease

Summary: the early detection of a preclinical ad or early stage of ad with amyloid imaging could improve the diagnosis and provide knowledge for better therapeutical approach by combining the best of imaging: structural mr sequences and newly fda-approved biomarker for amyloid pet imaging, all these two techniques with their strengths in one machine. specific aims and hypotheses can be summarized as follows: 1. to assess image quality and diagnostic performance of 18f-florbetapir (amyvid) pet/mri, including direct comparison to corresponding pet/ct images of the same patients. 2. to evaluate the incremental value of using 18f-florbetapir (amyvid) in addition to 2-\[f-18\]-fluoro-2 deoxy-d-glucose (fdg) versus fdg alone. does quantification of plaque burden correlate with degree of neuronal degeneration as depicted by fdg as well as with clinical severity? 3. to determine plaque burden quantitatively with 18f-florbetapir (amyvid) in pet (form pet/ct and from pet/mr) using novel software developed specifically for these brain application; computer-aid diagnosis for dementia for amyloid imaging - cad4d-amyloid


Eligibility criteria:
inclusion criteria: * patients with suspected ad, mci and other cognitive impairment will be referred by their neurologist to have a clinical ordered fdg-pet/ct and clinically indicated amyvid in addition, * patients equal to or greater than 21 years old, * signed informed consent by patient or legal guardian, * physically capable to cooperate. exclusion criteria: * subjects who do not meet the above mentioned inclusion criteria, * subjects unwilling or unable to sign the informed consent form, * subjects with any significant psychiatric or neurologic disorder or disease other than dementia expected to interfere with the study, * subjects unable to undergo mr scanning due to exclusion via uhcmc mr restrictions (e.g. certain implanted metallic or electronic devices), * history of adverse events related to a previous mr or pet/ct, * pregnant women, * minors.
immediate simultaneous bilateral cataract surgery

Conditions: Bilateral Cataract

Summary: to evaluate the safety and efficacy of treating visually significant bilateral cataract with the newer technique of immediate simultaneous bilateral cataract surgery (isbcs) versus the conventional technique of delayed sequential bilateral cataract surgery (dsbcs) in a select patient population.


Eligibility criteria:
inclusion criteria: * age 30-100 * candidate for topical anesthesia * signed the informed consents exclusion criteria: * allergies to medications used in study * cannot have topical anesthesia * unwilling to participate in research trial * have any other significant ocular comorbidities * have known systemic immuno-compromised state

Keywords: bilateral cataract simultaneous cataract surgery isbcs
correlation of feno, blood eosinophils, bronchoalveolar lavage findings and bronchial epithelium histopathology in patients with chronic obstructive pulmonary disease and asthma

Conditions: Obstructive Lung Diseases

Summary: scientific research focuses on "eosinophilic inflammation" as it seems to guide the therapeutic regimen in patients with asthma and copd. the primary objective of this prospective trial is to evaluate which parameter(s) best reflects eosinophilic inflammation by correlating tissue eosinophils (endobronchial biopsy, protected specimen brush sampling) with feno, peripheral blood eosinophils, and eosinophils in the bronchoalveolar lavage of patients with obstructive pulmonary disease.

this is a multicenter prospective trial. enrollment will continue until 150 patients with chronic obstructive pulmonary disease and 50 patients with severe asthma have been entered into this trial and have completed bronchoscopic evaluation. in this trial, the following parameters are to be evaluated: * blood eosinophils (absolute and relative) * feno * eosinophils in bronchoalveolar lavage * tissue eosinophilia (protected specimen brush sampling, endobronchial biopsy)

Eligibility criteria:
inclusion criteria: * patients with diagnosis of copd or asthma (according to the guidelines) * age \>18 years * indication for bronchoscopy for medical reasons (not study-related) * ability to provide informed consent exclusion criteria: * pao2 \ 55 mmhg on room air * fev1 \<20% * pulmonary infection or exacerbation within the last 4 weeks * additional pulmonary diseases (pneumonia, lung cancer, tuberculosis, interstitial lung disease) * contraindication for bal, psb sampling or endobronchial biopsy * current use of anticoagulants that can not be stopped for bronchoscopy * heart failure with left ventricular ejection fraction \<30% * myocardial infarction in previous 6 months * significant pulmonary hypertension (paps \>45 mmhg, right heart failure \[echocardiography\] and/or papm \>35 mmhg \[right heart catheter\])
early intervention to promote return to work for people with spinal cord injury

Conditions: Spinal Cord Injuries; Spinal Cord Diseases

Summary: for many people with spinal cord injury, seeking employment after injury is an important goal. there are services available to help people with disabilities. however, the best ways to coordinate and deliver these services are not yet known. this project will compare two ways of coordinating and delivering services that are designed to help people with spinal cord injury obtain employment.

employment is important for financial security, social connection, and life satisfaction. unfortunately, rates of unemployment remain high among people with spinal cord injury (sci). to help address this challenge, the northern new jersey spinal cord injury system (nnjscis) is conducting a single-site, randomized, controlled trial to compare two programs intended to increase rates of employment among people with sci. the project will enroll 162 recently injured adults with sci who are interested in becoming employed or returning to work and will compare different ways of delivering employment-related services in the first year after injury. services will begin in inpatient rehabilitation and may include education, therapy, equipment provision, counseling, and other interventions. information about employment status, earnings, community participation, and health will be collected through a combination of questionnaires and databases. participants and service providers will also share their impressions of the programs via survey and focus groups. analyses will examine the rate of participants employed at 1 year in each group, time to employment, earnings, community participation, and other aspects of well-being. findings from this study will be used to determine which ways of delivering services are most effective in enabling employment by 1 year after injury, and to provide information to help other rehabilitation centers adopt effective programs.

Eligibility criteria:
inclusion criteria: * adults age 18 to 62 * a neurological impairment secondary to an sci that occurred less than 12 months prior to enrollment * receiving inpatient rehabilitation at kessler institute for rehabilitation (kir) * community living in the state of nj after discharge from kir * have a goal to pursue competitive integrated employment or education/retraining leading to competitive integrated employment

Keywords: employment vocational rehabilitation
network dysfunction, schizophrenia and pharmacological magnetic resonance imaging (phmri)

Conditions: Healthy Volunteers

Summary: alterations of functional brain networks have been frequently demonstrated in schizophrenia, although the exact underlying molecular mechanisms remain unrevealed. ketamine is known to exert its schizophrenia-like effects through modulation of the glutamatergic system, thus facilitating the investigation of the impact of this specific transmitter system on resting state functional brain networks. the aim of the study is therefore to use pharmacological functional magnetic resonance imaging (phmri) to examine changes in brain networks involved in schizophrenia in response to ketamine application compared to placebo. 30 healthy subjects (15 females) will be examined twice using a double-blind, placebo-controlled, randomized, crossover, counterbalanced-order design. resting state fmri will be investigated before, during and after either placebo or ketamine intravenous infusion for 20 minutes. prior to the main trial 10 additional participants will be included in an open pilot trial. hypothesis: ketamine application will induce changes in resting state networks previously associated with schizophrenia and in the connectivity of relevant brain regions such as the striatum, thalamus, caudate, hippocampus and amygdala. furthermore, the application of ketamine will provoke changes in the bold-activation in three fmri paradigms each performed before and after ketamine infusion.


Eligibility criteria:
inclusion criteria: * general health based on history, physical examination, ecg, laboratory screening and structured clinical interview for dsm-iv(scid) * willingness and competence to sign the informed consent form * aged 18 to 55 years exclusion criteria: * any medical, psychiatric or neurological illness * current or former substance abuse * any implant or stainless steel graft and any other contraindications for mri * pregnancy * first degree relatives with a history of psychiatric illness or substance abuse * failures to comply with the study protocol or to follow the instructions of the investigating team * lifetime use of antipsychotic drugs * treatment with psychotropic agents such as ssris within the last 6 months
internet-based positive psychological intervention for hispanic/latino adult with hypertension in a primary care setting

Conditions: Uncontrolled Hypertension; Cardiovascular Risk Factor

Summary: the largest epidemiologic study of hispanic/latino participants thus far, i.e., the hispanic community health study/study of latinos (hchs/sol) documented that 80% of men and 71% of women have at least one major cardiovascular disease (cvd) risk factor. the american heart association emphasizes that current cvd prevention efforts are sparse and ineffectual in minority populations and acknowledges the need for new and more effective disease prevention strategies. this proof-of-concept study and pilot randomized clinical trial seeks to implement and evaluate a novel internet-based 5-week positive psychology (pp) intervention (compared to an attention control condition) in hispanic/latino adults with uncontrolled hypertension, i.e., elevated 24-hour ambulatory blood pressure, with primary interest in testing efficacy for clinically meaningful improvements in cardiovascular function.

the study features piloting of a randomized trial to determine whether an internet-based positive psychology (pp) intervention is associated with greater improvements in blood pressure compared to an attention control condition. the pilot trial additionally evaluates the efficacy of the internet-based pp intervention with respect to psychological well-being, hypertension-related health behaviors, autonomic cardiac control, and high-sensitivity c-reactive protein. serum blood assays will facilitate exploration of mechanistic indicators linking psychological well-being to cardiac functioning.

Eligibility criteria:
inclusion criteria: * hispanics/latinos recruited from ui health pilsen family health center lower west * aged ≥18 * fluent in english or spanish with ≥8th grade education * elevated sitting blood pressure (≥140/90) * ability to read and understand the informed consent * ability to access internet from home or in public setting (note, tablet pcs will be made available to all enrolled participants at no charge), and * self-reported comfort in with handling of a table computer and website navigation. exclusion criteria: * cognitive impairment denoting dementia (assessed using the short portable status questionnaire-see appendix e) * severely reduced life expectancy (e.g., self-reported diagnosis of metastatic cancer, congestive heart failure, or end-stage kidney disease) * self-reported diagnosis of sickle cell disease * skin damage or rash in the upper arm region where ambulatory blood pressure monitor is to be placed * currently enrolled in psychotherapy, and * self-reported history or current diagnosis of bipolar disorder, dissociative disorder, psychosis, or substance abuse; or have severe depression.

Keywords: hispanics/latinos underserved population internet-based
pan facial volume restoration

Conditions: Volume Loss (Soft Tissue Ptosis or Atrophy )

Summary: the aim of this study is to assess performance and tolerance as well as investigator and subject satisfaction further to pan-facial volume restoration with a new cross-linked hyaluronic acid dermal filler containing lidocaine 0.3%.

clinical hypothesis: the global approach of the subject pan-facial dermal volume depletion and face soft-tissue contour defects correction using specific dermal filler for all indications to be injected will satisfy both subjects and investigators. this device will be used for full face correction of volume loss: chin, temporal areas, jawline, cheek, cheekbones, deep to very deep nasolabial folds (only if cheekbones are injected concomitantly). study duration will be up to 19 months. injections will be performed at baseline. if necessary, investigator will perform touch-up injections at the following visit (3 weeks after baseline injection).

Eligibility criteria:
inclusion criteria: * subjects seeking treatment for correction of volume loss. * subjects presenting a score of at least 2 (visible depression or descent) for whole face on the volume loss scale and at least 2 indications affected by volume loss among the following: chin temporal areas, jawlines, cheeks, cheekbones, deep to very deep nasolabial folds (severity score 4 at least on lemperle rating scale) if cheekbones are injected. exclusion criteria: * subjects at risk in term of precautions, warnings and contraindication referred in the package insert of the study device, * subjects who underwent previous injection of permanent filler in the injected area.

Keywords: volume loss
bay2586116 nasal spray and osa severity

Conditions: Sleep Apnea, Obstructive

Summary: this investigator-initiated study aims to determine the effects of bay2586116 (a novel task channel blocker nasal spray) on sleep apnoea severity and the potential influence of route of breathing.


Eligibility criteria:
inclusion criteria: * male or female participants aged 18 years or older at screening * must have completed part a of the koala study (nct04236440) * must be willing to sleep three nights in the sleep lab without osa therapy (this includes continuous positive airway pressure therapy (cpap) and/or a mandibular advancement device (mad)) * must be willing to refrain from drinking alcohol on the study days. * must be willing to limit consumption of tobacco to four cigarettes or one cigar a day and not smoke while at the sleep laboratory. this might be up to 12 hours. * must be willing to limit caffeinated beverage intake (coffee, tea, cola, and other soft drinks) to 400 mg / day or less of caffeine and not to be used within 4 hours of bedtime on study days. * contraceptive use required by men or women according to the methods of contraception for those participating in clinical studies exclusion criteria: * any medications or herbal supplements that may interfere or be contraindicated with the study drug as determined by the investigator * severely impaired breathing within two days prior to randomization (e.g., acute nasal congestion during upper airway infection). * known allergies or hypersensitivities to the study drugs (active substances or excipients of the preparations). * any other condition which at the discretion of the investigator would make the participant unsuitable for participation in the study and will not allow participation for the full planned study period (e.g., active malignancy or other condition limiting life expectancy to less than 12 months)
the effects of crocin supplementation on metabolic parameters, oxidative stress, amp- activated protein kinase and inflammation-promoting genes expression in peripheral blood mononuclear cells in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: to study the effects of crocin supplement in patients with type 2 diabetes, 50 patients will be randomly allocated to placebo group and 2 tablets of crocin for 12 weeks. at the first and the end of the intervention, lipid profiles, blood pressure, blood sugar, inflammatory and anthropometric factors will be assessed and compared between groups.


Eligibility criteria:
inclusion criteria: age of 40 to 65 years type 2 diabetes: and body mass index range of 18.5 to 30 kg/m2 exclusion criteria: pregnancy or lactation a history of cardiovascular disease, pulmonary disease, renal disease