Kornimate/medical-research-clean huggingface dataset:
bioavailability study of amlodipine besylate/atorvastatin calcium tablets 10/80 mg under fed condition

Conditions: Healthy

Summary: this study is to assess the bioequivalence between amlodipine besylate/atorvastatin calcium tablets 10mg/80mg of dr. reddy's laboratories limited, india and caduet® (amlodipine besylate and atorvastatin calcium) tablets 10mg/80mg of pfizer ireland pharmaceuticals dublin, ireland in healthy, adult,human subjects under fed conditions.

open label, randomized, two-treatment, two-period, two-sequence, oral bioequivalence study of amlodipine besylate/atorvastatin calcium tablets 10mg/80mg under fed conditions.

Eligibility criteria:
inclusion criteria: 1. subjects aged between 18 and 45 years (both inclusive). 2. subjects' weight within normal range according to normal values for body mass index (18.5 to 24.9 kg/m2) with minimum of 50 kg weight. 3. subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable reference range. 4. subjects having normal 12-lead electrocardiogram (ecg). 5. subjects having normal chest x-ray (p/a view) whose x-ray was taken not more than 6 months prior to the dosing of period 01. 6. subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine). 7. subjects having negative alcohol breath test. 8. subjects willing to adhere to the protocol requirements and to provide written informed consent. exclusion criteria: 1. hypersensitivity to amlodipine and atorvastatin or related class of drugs. 2. history or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder. 3. any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting. 4. history or presence of significant alcoholism or drug abuse. 5. history or presence of significant smoking (more than 10 cigarettes or beedi's/day). 6. history or presence of asthma, urticaria or other significant allergic reactions. 7. history or presence of significant gastric and/or duodenal ulceration. 8. history or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor. 9. history or presence of cancer. 10. difficulty with donating blood. 11. difficulty in swallowing solids like tablets or capsules. 12. use of any prescribed or otc medication during last two weeks prior to dosing in period 01. 13. major illness during 3 months before screening. 14. participation in a drug research study within past 3 months. 15. donation of blood in the past 3 months before screening. 16. consumption of grapefruit juice, xanthine-containing products, tobacco containing products or alcohol for within 48 hours prior to dosing. 17. positive screening test for any one or more: hiv, hepatitis b and hepatitis c. 18. history or presence of significant easy bruising or bleeding. 19. history or presence of significant recent trauma.
relation between serum igf-1 & bmi in acne vulgaris

Conditions: Evaluation of Serum Level of Insulin Like Growth Factor 1

Summary: cross-sectional study in which participants will be recruited at dermatology \& andrology out-patient clinics in assuit university hospital, egypt after patients examination by dermatologists \& obtaining an informed consent


Eligibility criteria:
inclusion criteria: 1. patients aged from 15 to 45 years old suffering from acne vulgaris. 2. both sexes. exclusion criteria: 1. insulin resistance and diabetic patients 2. females with polycystic ovarian syndrome 3. treatment with drugs that can influence igf-1level such as corticosteroid, insulin, hypoglycemic agents, and isotretinoin within one year before the date of study. 4. other causes of acne or acneform eruption as steroid-induced
4-point vs 4-roll canne as walking aids after stroke

Conditions: Stroke

Summary: stroke patients frequently necessitate walking aids such as 4-point canne. however, the 4-point canne has to be lifted by the patient which limited gait speed. the adjunction of small wheel below the 4 point of the canne (4-roll) gives the possibility to the patient to walk without having to lift the canne as it will roll over the ground. the aim of our study is to compare gait parameters (gait speed and energy cost) with a classical 4-point canne and with 4-roll canne.

stroke patients frequently need walking aids such as 4-point canne. however, the 4-point canne has to be lifted by the patient which limited gait speed. the adjunction of small wheel below the 4 point of the canne (4-roll) gives the possibility to the patient to walk without having to lift the canne as it will roll over the ground. objective to compare the gait parameters with a 4-point canne and with a 4-roll canne methods the investigators will recruited stroke patients who necessitate 4 point-canne as walking aids. a 10 meters walking test, a 6 minutes walking test, an estimated energy cost and a patient's satisfaction will be monitored with a 4-point canne (day 1) and with a 4-roll canne (day 2) in a cross-over study. the first tested device will be randomized. perspective the investigators hope to demonstrate that a 4-roll canne makes possible to walk faster in a safe way after stroke

Eligibility criteria:
inclusion criteria: * post stroke patient * able to walk 10 meters exclusion criteria: * cognitive impairment limiting walking capacities * need support when walking

Keywords: stroke walking rehabilitation
review of enteral formulas in children

Conditions: Enteral Feeding Intolerance; Tube Feeding; Nutrition Disorder, Child

Summary: retrospective review of nutrition enteral formula data documented in medical records.

this is a retrospective review to assess nutrition (calorie and protein) intake of enteral formula data documented in medical records of patients that consumed enteral tube feeding formulas at home.

Eligibility criteria:
inclusion criteria: * minimum 12 months enteral feeding * history of enteral feeding with intact or semi-elemental formula exclusion criteria: * medical records lacking enteral nutrition feeding use
quickvue influenza a + b test field study

Conditions: Influenza A, Influenza B

Summary: demonstrate improved clinical performance of visually read quickvue influenza a+b test.

the objective of this study is to demonstrate an improved clinical performance of the visually read quickvue influenza a+b test with nasal and nasopharyngeal swab specimens. clinical performance will be based on comparison of quickvue results to either cell culture or an fda-cleared molecular test at one or more reference laboratories.

Eligibility criteria:
inclusion criteria: subjects will be recruited from the general population as they present to the clinical facility. subjects must have had a fever within the last two days and exhibiting one or more symptoms characteristic of influenza. they must meet the following criteria to be eligible for enrollment: 1. male or female of all ages (with appropriate consent). 2. the subject must have had of a fever, ≥ 37.8º c (100º f), within the last two days. 3. must also be currently exhibiting one or more of the following symptoms characteristic of influenza-like-illness (ili). 1. nasal congestion 2. rhinorrhea 3. sore throat 4. cough 5. headache 6. myalgia 7. malaise exclusion criteria: * 1. has undergone treatment with anti-influenza antivirals within the previous 7 days, to include but not be limited to, amantadine, rimantadine, ribavirin, oseltamivir, zanamivir or any other antiviral currently available in these classes. 2. has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days. 3. unable to understand and consent to participation; for minors this includes parent or legal guardian.
a clinical study of the cryoablation technique for peripheral lung malignancies

Conditions: Lung Cancer Patients

Summary: to assess the safety and effectiveness of bronchoscopy-guided cryoablation with cold verification for peripheral lung malignancies.


Eligibility criteria:
inclusion criteria: * (1) age ≥ 18 years, with no gender restrictions; (2) diagnosed as having peripheral lung cancer, with the maximum diameter of the tumor being ≤ 3 cm and the number of tumors being ≤ 3; (3) the lesion intended for ablation is evaluated as feasible for bronchoscopy-guided cryoablation therapy; (4) the subject refuses or is deemed unsuitable for radiotherapy/chemotherapy, or has no response to previous radiotherapy/chemotherapy, or has disease progression after radiotherapy/chemotherapy; (5) assessed as ineligible for surgery or refuses surgery and radiotherapy, consents to receive initial ablation treatment and signs the informed consent form. exclusion criteria: * (1) diffuse lesions in both lungs where ablation therapy fails to improve the condition; (2) examinations within one month prior to the operation reveal the presence of hilar lymph node metastasis or extrapulmonary metastasis (except for cases where extrapulmonary metastasis has been controlled through local treatment); (3) existence of contraindications for bronchoscopy, or inability of the patient to tolerate or cooperate with bronchoscopy; (4) severe bleeding tendencies or uncorrectable coagulation dysfunctions (prothrombin time \> 18 seconds, prothrombin activity \ 2; (10) the lesion to be ablated has received radiotherapy within the past 6 months; (11) active hepatitis b, active hepatitis c, human immunodeficiency virus (hiv) infection history (known positive for hiv1/2 antibodies), or other active infections that are judged by the researcher to potentially affect the patient's treatment; (12) accompanied by epilepsy, history of mental illness or cognitive impairment; (13) pregnant or lactating women, as well as male or female patients who plan to have children or become pregnant during the trial; (14) participation in any other clinical trials within 3 months before signing the informed consent (excluding non-interventional studies); (15) other circumstances deemed by the researcher as inappropriate for participation in this clinical trial.
implementation research on scaling up kangaroo mother care (kmc)

Conditions: Low Birth Weight Babies; Kangaroo Mother Care Scale up

Summary: this implementation research aims to accelerate effective and high coverage of kangaroo mother care in district sonipat in the state of haryana, india. the project is being led by government of haryana. kmc units will be set up in selected government and private delivery facilities. kmc will be initiated for all babies with birth weight less than 2000 gm in the facilities (either in born or referred from elsewhere) and continued at home post discharge. these babies may be either born in the facility or referred to the facility. a linkage with community health workers will be established to support mothers to continue kmc at home.

babies born with low birth weight are at increased risk of mortality. the global burden of low birth weight babies is high with 15 million neonates being born preterm each year. complications from preterm births result in over one million deaths, comprising 35% of all newborn mortality. the way forward is to achieve an effective and equitable implementation of all those interventions for which evidence of efficacy is well established. one of the efficacious interventions is kangaroo mother care (kmc). kmc has been demonstrated to promote physiologic stability, facilitate early breastfeeding, provide a thermally supportive environment, reduce the risk of serious infections, and reduce the mortality of hospitalized, stable preterm and low birth weight infants. this practice also promotes bonding between infants and their mothers during the first hours and days of life. the "every newborn action plan" endorsed and launched by the world health assembly in may 2014 includes the goal of scaling up kmc to 50% of babies weighing under 2000 grams by 2020, and to 75% of these babies by 2025. this implementation research aims to promote kmc scale up in a district of haryana. the steps include formative research to identify barriers and facilitators; designing of scalable models to deliver kmc across the facility-community continuum; implementation and evaluation of these models aiming towards wider national or state-level scale-up. learning at each stage of this process will be applied to refining and improving the kmc delivery model. this proposal aims to develop, implement and evaluate a delivery model for kmc. the study will be implemented in two phases: i) development of a delivery model and ii) implementation and evaluation of the model. the performance of the model will be assessed against a pre-defined success criterion of 80% or higher coverage of effective kmc at the population level. kmc will be implemented at three levels, pre-facility, facility and post-facility.

Eligibility criteria:
inclusion criteria: * babies with birth weight less than 2000g born in the study area. exclusion criteria: * newborns who are severely sick will have the initiation of kmc delayed until stabilization.

Keywords: kangaroo mother care low birth weight implementation research
catheterless water vapor therapy for the treatment of bph

Conditions: Benign Prostatic Hyperplasia

Summary: the rezum system is an ablative procedure for patients with benign prostatic hyperplasia (bph). one of the limitations of the technology is the need for post-operative catheterization up to 5 days. the aim of this study is to assess the feasibility of employing catheterless rezum post-operatively in patients with normal or strong bladder contractility. upon a positive outcome of interim analysis, the effectiveness of catheterless rezum will be assessed at five sites for the multicenter phase.


Eligibility criteria:
inclusion criteria: * male subject of 40 - 80 years of age * has provided informed consent * has a diagnosis of bladder outlet obstruction due to benign prostatic enlargement * able to complete self-administered questionnaires * is a surgical candidate for rezum * has medical record documentation of qmax \< 15 ml/s * has medical record documentation of prostate volume from 30-80 ml by transrectal ultrasound (trus) * has a bladder contractility index score ≥ 100, calculated by detrusor pressure at qmax (pdet@qmax) + (5xqmax). * willing to undergo pressure-flow studies to calculate bci prior to surgical intervention. * has serum creatinine within the normal range. * able to perform intermittent catheterization. exclusion criteria: * has a life expectancy \< 2 years * is currently enrolled in or plans to enroll in any concurrent drug or device study * has an active infection (e.g., urinary tract infection or prostatitis) * has a diagnosis of or has received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis) * has been diagnosed with a urethral stricture or bladder neck contracture within the last 180 days * has been diagnosed with 2 or more urethral strictures and/or bladder neck contractures within 5 years * has a diagnosis of lichen sclerosis * has a diagnosis of neurogenic bladder or other neurologic disorder that affects bladder function * has a diagnosis of polyneuropathy (e.g., diabetic) * has a history of lower urinary tract surgery * has a diagnosis of stress urinary incontinence that requires treatment or daily pad or device use * has an inability to perform intermittent self-catheterization * has been catheterized or has a post-void residual (pvr) of \> 400 ml in the 14 days prior to the surgical procedure * has a current diagnosis of bladder stones

Keywords: water vapor therapy
pd1-cd19-cart in patients with r/r b-cell lymphoma

Conditions: B-cell Lymphoma

Summary: this is an open label, single-site, dose-escalation study in up to 25 participants with relapse/refractory b-nhl. this study aims to evaluate the safety and efficacy of the treatment with pd1-cd19-cart.

pd1-cd19-cart is a kind of chimeric antigen t cell targeting cd19 with both cd19-car gene integration and also pd1 knockout by one-step gene-editing. after completion of study treatment, subject participation for this study will be followed up to 15 years post t cell infusion.

Eligibility criteria:
inclusion criteria: 1. have the capacity to give informed consent; 2. all patients with the age between 18 and 70 years old; 3. expected survival \>3 moths; 4. with no severe heart and lung disease; 5. previously confirmed diagnosis as cd19+ nhl within 6 months; 6. hematological index as following, white blood cell (wbc)≥1.5×10\^9/l，absolute neutrophil count (anc) ≥0.8×10\^9/l, platelet count≥50×109/l, hemoglobin (hgb) ≥ 90mg/l, lymphocyte count≥ 0.4×10\^9/l； 7. blood biochemical index as no more than 1.5\* uln, including total bilirubin (tbil), transglutaminase (ast), alanine aminotransferase (ast), creatinine (scr), urea in patients with no tumor metastasis in liver and kidney; blood biochemical index no more than 5\* uln in patients with tumor metastasis in liver and kidney; 8. with a stable cardiac function, the left ventricular ejection fraction (lvef) ≥ 55%; 9. virological tests were negative for ebv, cmv, hiv, tp and hcv; a negative hbv dna test is acceptable if hbsag is positive; 10. ecog \<2; 11. relapsed or refractory (r/r) nhl including, diffuse large b cell lymphoma(dlbcl, nos), stage ⅲ-ⅳ;primary mediastinal large b-cell lymphoma (pmbl), stage ⅲ-ⅳ; high grade b-cell lymphoma (hgbl), stage ⅲ-ⅳ; mantle cell lymphoma (mcl), stage ⅲ-ⅳ; follicular lymphoma (fl), stage ⅲ-ⅳ and with aggression. r/r nhl defined as following, demonstrate disease that persists or relapse after achieving complete response (cr) after \> 2 cycles of standard chemotherapy, or relapse after autologous hematopoietic stem cell transplantation (auto-hsct), or not achieving cr after auto-hsct. exclusion criteria: 1. pregnant or lactating women; 2. with a pregnancy plan in the next 2 years; 3. prior treatment of anti-gvhd therapy; 4. acceptance of allogeneic stem cell transplant (asct); 5. isolated extramedullary relapse of all; 6. severe mental disorders, active autoimmune diseases, active infectious diseases, severe cardiovascular diseases; 7. partial prothrombin time or activated partial thromboplastin time or international standardized ratio \> 1.5\*uln without anticoagulant treatment; 8. history of other type of maligant tumors; 9. any circumstances that possibly increase the risk of subjects or interfere with study results, which judged by investigator.
educational video on pain management and subsequent opioid use after cesarean delivery

Conditions: Opioid Use, Unspecified

Summary: this is a randomized controlled trial assessing the utility of an educational video on pain management after a cesarean section to reduce opioid use. the educational video will be shown during the patient's postpartum stay and the amount of opioid and adjunct medications will be assessed in those who watched the video compared to those who received the standard of care discharge instructions without the video. participants will be contacted 7 and 14 days after cesarean birth (post operative day number 7 and number 14) to complete a telephone survey on their overall pain management and to determine how many opioid tablets have been used.


Eligibility criteria:
inclusion criteria: * greater than 18 years of age * underwent repeat or primary c-section * literate in english language exclusion criteria: * complicated cesarean section including cesarean hysterectomy, bowel injury, bladder injury, and/or take-back * history of opioid use disorder and/or on chronic opiates in pregnancy * contraindications to nsaids or acetaminophen
short-term and long-term effects of ankle joint taping and bandaging on balance, proprioception and vertical jump among volleyball players with chronic ankle instability

Conditions: Chronic Ankle Instability

Summary: objective: this study aimed to 1) investigate the long-term effect of taping and bandaging on proprioception, balance, and vertical jump among volleyball players with ankle instability, 2) compare the short-term effects of taping and bandaging on these outcome measures, 3) compare the long-term effects of taping and bandaging on these outcome measures. design: a single-blinded randomized controlled study setting: rehabilitation laboratory at istanbul gelisim university, turkey subjects: one-hundred participants with a chronic ankle sprain (cai) primary outcome measures: proprioception (ankle range of motion absolute error), balance(y-balance test), and vertical jump (vertical jump tester) interventions: participants were distributed into three groups: taping group (n=33) received ankle rigid taping, bandaging group (n=33) received ankle bandaging, and control group (n=34) received placebo taping. all three previous external supports were applied for 8 weeks. the measurements were performed at baseline, immediately after applying for support, two weeks after support and eight months after support.


Eligibility criteria:
inclusion criteria: * volleyball player * 18-30 years old * athletes with chronic ankle instability exclusion criteria: * previous hip/pelvis knee, or foot surgery within the past year * leg length discrepancies * known balance impairment due to neurological disorder * vestibular disorder * pregnancy * brain concussion within the previous three months * taking any medication that may affect alertness or balance
comparing labial and lingual orthodontic appliances on root resorption and bone height

Conditions: Crowding of Anterior Maxillary Teeth; Crowding of Anterior Mandibular Teeth

Summary: patients who have moderate crowding that could be treated on a non-extraction will be treated in this study. the apical root resorption and alveolar bone height of the lingual and labial fixed appliances will be assessed. all patients will receive a cone-beam computed tomography (cbct) scan at two different times (t0: before treatment, t1: after treatment). there are two groups: the first group (experimental): the patients in this group will be treated using lingual fixed orthodontic appliances. the second group (control): the patients in this group will be treated using labial fixed orthodontic appliances.

recently, the therapeutic results of lingual orthodontics have become similar to those produced by labial orthodontics. however, lingual appliances act differently. the application of force near the center of resistance and the distance between the lingual brackets leads to an increase in friction and, thus, an increase in the force applied during treatment. in addition, the contact of the lower incisors with the brackets of the upper incisors in the lingual technique can lead to the intrusion of these incisors. therefore, these factors can be potential risks for apical root resorption and alveolar bone height in lingual orthodontics. 2d radiographs may not accurately depict the true amount of root resorption due to magnification errors and difficulties in obtaining repeatable images. besides, conventional two-dimensional radiographs cannot accurately assess alveolar bone height in the anterior region. cbct has proven to be valuable in diagnosing root resorption due to its capability to produce distortion-free images, as well as its ability to maintain a high level of reproducibility despite changes in tooth positions after treatment, with high sensitivity and specificity. on the other hand, the use of cbct allows for an evaluation of alveolar bone height in the anterior region with high accuracy and precision.

Eligibility criteria:
inclusion criteria: 1. class i molar and canine relationships on both sides. 2. moderate crowding of both arches of about 4 to 6 mm treated on a non-extraction basis. 3. age from 18 to 25 years. 4. the presence of permanent dentition (except third molars). exclusion criteria: 1. the existence of craniofacial syndromes, cleft lip and/or palate (soft and/or hard). 2. skeletal or dental crossbite. 3. patients with missing teeth or periodontal diseases. 4. previous orthodontic treatment.