Kornimate/medical-research-clean huggingface dataset:
"efficacy of once weekly glp 1 analogue: semaglutide. a multicenter experience from pakistan."

Conditions: Diabetes Mellitus, Type 2; Weight Change, Body

Summary: a prospective interventional trial for 9 months will be carried out on 300 type-2 diabetes mellitus volunteer patients who are above 18-year-old and participants will be selected through consecutive sampling and will be evaluated on the basis of glycemic index and history of patients. selected parameters will be measured at baseline and after the 12 weeks of therapy. statistical analysis will be carried out by spss, anova, and t-test. from this experimental design, we are expecting improvement in the management of glycemic index, reduction in systolic and diastolic blood pressure, and reduction in weight glp-1 naive patients.

patients will be recruited from all the 12 centers included in the trial across pakistan and data will be electronically transferred to the main center. all glp-1 naive patients fulfilling the inclusion criteria will be recruited after informed written consent and started on semaglutide injection 0.25mg for 2 weeks and will be escalated to 0.5 mg for the next 10 weeks. socio-demographic data and health vitals including height, weight, bmi, baseline hba1c, fbs and rbs will be recorded in preset performa. all those who agree to participate will be given structured education on diet and exercise and those willing to comply will be recruited. a research assistant will be recruited and trained to teach the injection technique and discuss the adverse effects of semaglutide to the participants. patients taking dpp-4 inhibitors will be switched to glp-1 analogue and only a single drug change in the form of adding semaglutide will be done at the time. semaglutide injection technique will be explained to the patient and one injection at a time will be provided to the patient to ensure compliance and avoid bias in the study. patients will be asked to revisit after 4 weeks with the used injection device. after completion of 3 months of treatment vitals including height, weight, bmi, baseline hba1c, fbs and rbs will be recorded in preset performa.

Eligibility criteria:
inclusion criteria: * both male and female type 2 diabetic patients with age ≥18 years. * patients with hba1c ≥ 7.5 % - ≤ 10.0% * patients with bmi ≥ 30 exclusion criteria: * patients with type 1 diabetes mellitus * patients with gestational diabetes mellitus. * patients with chronic renal failure with egfr of ≤ 30ml/min * patient already on another glp 1 analogue * the patient stopped any glp1 analogue treatment less than 3 months back. * patients with history of chronic pancreatitis or pancreatic cancer.
restoration repairs using composite resin versus glass ionomer in primary molars: a randomized clinical trial

Conditions: Dental Caries; Dental Caries in Children

Summary: the objective of this randomized clinical study is to evaluate the survival of repairs in restorations using composite resin (cr) or high viscosity glass ionomer cement (gic) in primary molars. this trial is nested to another study (nct03520309), so patients will be enrolled from cardec 3. 312 restorations will be included and randomized into two groups: glass ionomer cement (riva self cure, sdi, australia) and composite resin (filtek bulk fill and filtek bulk fill flow, 3m espe, usa). after the end of treatments, patients will be followed for 24 months to assess the success of the restorations, which will be considered as the absence of the need for reintervention. the kaplan-meier survival curves and the log-rank tests will be performed to assess survival between groups and cox regression analysis will be used to compare the outcome with the variables (α = 5%).

failed restorations in primary teeth will be repaired using gic or composite resin.

Eligibility criteria:
inclusion criteria: * children who have sought treatment in the school of dentistry, university of sao paulo * children between 3 and 10 years old * children presenting at least one restoration (of any material, any surface and any integrity status) in primary teeth exclusion criteria: * children whose parents did not agree to participate in the study * children with behavioural issues at the initial exam or who did not assent to participate in the study
study to investigate the pharmacokinetics and safety of cadazolid in patients with clostridium difficile infection

Conditions: Clostridium Difficile Infection

Summary: the study investigated the pharmacokinetics, safety, and tolerability of cadazolid in subjects with severe clostridium difficile diarrhea (cdad) and whether this influenced the quantity of cadazolid absorbed into the systemic circulation.


Eligibility criteria:
inclusion criteria: * signed informed consent prior to any study-mandated procedure. * non-pregnant females were to remain non-pregnant for 1 month after the end of the study. female subjects of child-bearing potential must have had a negative serum pregnancy test at screening and must have used a reliable method of contraception * subjects with severe cdad; clostridium difficile infection (cdi) must have been microbiologically proven, using a validated enzyme-linked immunosorbent assay (elisa) for the detection of c. difficile toxin a (tcda) and/or c. difficile toxin b (tcdb). the severity of cdad was assessed according to the current european union guidelines - european society of clinical microbiology and infectious diseases (escmid). * received oral vancomycin or oral/intravenous (i.v.) metronidazole therapy for the treatment of cdad. * ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study. exclusion criteria: * known hypersensitivity to any excipients of the drug formulation. * clinical evidence of any relevant disease other than cdad and/or existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism or excretion of the study drug. * veins unsuitable for i.v. puncture on either arm (e.g., veins that are difficult to locate, access, or puncture; veins with a tendency to rupture during or after puncture). * subjects with rare hereditary fructose intolerance, glucose-galactose malabsorption, saccharase-isomaltase deficiency or previously undiagnosed diabetes mellitus. * subjects who have a life-threatening condition, which may be related to cdad or other underlying illness. * any clinically relevant electrocardiogram (ecg) abnormality at screening. * subjects who were unable to swallow or have difficulty swallowing. * subjects with vomiting, ileus or not passing stool. * likelihood of death within 72 hours from any cause. * life-threatening or fulminant cdad (white blood cell count \> 30 × 10\^9/l; temperature \> 40 °c; or septic shock, peritoneal signs or significant dehydration). * history of ulcerative colitis or crohn's disease. * loss of 250 ml or more of blood within 3 months prior to screening. * positive results from the hepatitis serology, except for vaccinated subjects, at screening. * positive results from the human immunodeficiency virus (hiv) serology at screening. * legal incapacity or limited legal capacity at screening. * any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

Keywords: cadazolid act-179811 pharmacokinetics safety tolerability
the rapid diagnosis of mci and depression in patients ages 60 and over

Conditions: Depression; Mild Cognitive Impairment

Summary: mild cognitive impairment (mci) leading to alzheimer's disease and related disorders (adrd) represents a significant health and economic burden of the rapidly expanding senior population. the accurate detection and diagnosis of mci and its common comorbidity, late-life depression (lld), is essential for prolonging patient quality of life and developing advancements in research and treatment options. the purpose of the proposed program is to refine miro health's a.i. to accurately detect, differentiate and diagnose mci and lld.


Eligibility criteria:
inclusion criteria: * lld: age 60 or over; diagnosis of lld or symptoms consonant with lld; phq-9 score from 15 to 27 * mci: age 60 or over; diagnosis of mci or self-reported insidious onset and continued worsening of cognitive decline; intact activities of daily living * hc: age 60 or over exclusion criteria: * age 59 or younger; history of unresolved neurological or psychiatric conditions; current medications known to affect cognition; history of substance abuse; unable to perform activities of daily living; change in employment status due to condition
feeling hot 1: environmental influences of overnight measurement on skin temperature of the erectile penis

Conditions: Erectile Dysfunction

Summary: the feeling hot studies focus on the proof-of-principle of using temperature sensing as a tool to detect nocturnal erections. in the feeling hot 1 study the influence of environmental factors of overnight measurements are studied in a controlled setting. healthy individuals will have visually aroused erections in different circumstances (naked, clothing, blankets) to determine the feasibility of this new measurement method for nocturnal erection detection in the search to modernize erectile dysfunction diagnostics.

differentiation in nature of erectile dysfunction (ed) is currently made by nocturnal erection detection with the rigiscan. the rigiscan uses outdated software, measurements are user unfriendly and system components are out of stock. in the search of modernizing erectile dysfunctions diagnostics, the question has arisen whether temperature measurements can function as a tool for nocturnal erection detection. with the absence of a pressure component, the patient experience should improve. literature and mathematical modelling studies have shown that the penile temperature increases significantly during erection. however, it is unclear what the influence of environmental factors such as blankets and clothing is on the increase in penile temperature during erection. the feeling hot 1 study explores the effects of these environmental factors in a controlled setting to gain insight into the possibility of using temperature sensing to detect nocturnal erections.

Eligibility criteria:
inclusion criteria: * male * aged 18 - 29 years * capable of getting visually arousable erections exclusion criteria: * test subject unwilling to sign informed consent * test subject with erectile dysfunction * iief-5 score below 17 * medical history consisting of sickle cell anaemia, atherosclerosis and/or diabetes type i/ii

Keywords: erectile dysfunction rigiscan nocturnal erection penile temperature
post-market study of the 3dknee™ system

Conditions: Degenerative Joint Disease; Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis

Summary: the purpose of this study is to evaluate the use and efficacy of the 3dknee™ system for total knee replacement surgery.

total knee replacement surgery is widely accepted as effective treatment for degenerative joint disease (djd), osteoarthritis and rheumatoid arthritis. relief of patient pain and return of mobility are the primary goals that can be accomplished by this surgery. the purpose of this study is to evaluate the use and efficacy of the 3dknee™ system for total knee replacement surgery. the study will take place at multiple sites across the united states and be managed by the encore medical clinical affairs department. the study will include only patients who meet the indications for use criteria for the 3dknee™ system and who are candidates for primary knee arthroplasty.

Eligibility criteria:
inclusion criteria: * this must be a primary knee replacement on this knee. * patient is over 18 years of age or older * have knee joint disease related to one or more of the following * degenerative joint disease, including osteoarthritis or traumatic arthritis * avascular necrosis of the femoral condyles * post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy * moderate valgus, varus, or flexion deformities * rheumatoid arthritis * patient is likely to be available for evaluation for the duration of the study * able and willing to sign the informed consent and follow study procedures * patient is not pregnant exclusion criteria: * is younger than 18 years of age * if there has been a total knee replacement on this knee in the past (no revisions allowed in study) * infection, or history of infection, acute or chronic, local or systemic * alcoholism or other addictions * muscular, neurological or vascular deficiencies which compromise the affected extremity * obesity * insufficient bone quality * loss of ligamentous structures * high levels of physical activity * materials sensitivity * prisoner * mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements * patient is pregnant

Keywords: total knee replacement
a qualitative study about smoking practices

Conditions: Asthma

Summary: this study involves in-depth interviews with parents of urban children with asthma and focus groups with additional parents in order to understand their attitudes and beliefs about smoking.


Eligibility criteria:
inclusion criteria: * child with asthma * parents being current smokers, ex-smokers, or non-smokers exclusion criteria: * non-english speaking families
to study the effects of host genetic factors on liver cirrhosis

Conditions: Liver Cirrhosis

Summary: the purpose of this study is to identify genetic determinants of susceptibility to liver cirrhosis . it will assist in predicting individual risks of disease progression and would help to clarify pathophysiologic mechanisms of liver cirrhosis .


Eligibility criteria:
inclusion criteria: * hepatitis b exclusion criteria: * the casual aget of liver disease is not viral infection, such as alcohol abuse

Keywords: snp
study to investigate the safety and efficacy of sofosbuvir/velpatasvir in adolescents and children with chronic hcv infection

Conditions: Hepatitis C Virus Infection

Summary: this study will have 2 parts: pharmacokinetics (pk) lead-in phase and the treatment phase. the primary objective of the pk lead-in phase is to evaluate the steady state pk and confirm the dose of sofosbuvir/velpatasvir (sof/vel) fixed-dose combination (fdc) in pediatric participants with chronic hepatitis c virus (hcv) infection. the primary objective of the treatment phase is to evaluate the safety and tolerability of sof/vel for 12 weeks in pediatric participants with chronic hcv.


Eligibility criteria:
key inclusion criteria: * chronic hcv-infected, treatment-naive and treatment-experienced adolescent and pediatric individuals aged 3 to \< 18 as determined at day 1. note: other protocol defined inclusion/exclusion criteria may apply.
zinc sulfate in preventing loss of sense of taste in patients undergoing radiation therapy for head and neck cancer

Conditions: Dysgeusia; Head and Neck Cancer; Oral Complications; Radiation Toxicity

Summary: rationale: it is not yet known whether zinc sulfate is effective in preventing the loss of ability to taste food in cancer patients who are undergoing radiation therapy for head and neck cancer. purpose: randomized phase iii trial to determine the effectiveness of zinc sulfate in preventing loss of sense of taste in patients who are undergoing radiation therapy for head and neck cancer.

objectives: * determine whether zinc sulfate prolongs the time to onset of altered taste in patients with head and neck cancer undergoing radiotherapy. * determine whether this drug decreases the overall incidence of altered taste in these patients. * determine whether this drug results in fewer radiotherapy treatment interruptions in these patients. * assess the quality of life of patients treated with this drug. * determine the toxic effects of this drug in these patients. outline: this is a randomized, double-blind, placebo-controlled, multicenter study. patients are stratified according to planned radiotherapy dose (less than 6,000 cgy vs at least 6,000 cgy), estimated amount of oral mucosa in the radiation field (60% or less vs more than 60%), age (under 50 vs 50 and over), concurrent chemotherapy (yes vs no), and smoking (yes vs no). patients are randomized to 1 of 2 treatment arms. * arm i: patients receive oral zinc sulfate 3 times daily beginning the first week of radiotherapy. * arm ii: patients receive oral placebo 3 times daily beginning the first week of radiotherapy. treatment in both arms continues daily during and for 1 month after radiotherapy in the absence of unacceptable toxicity. quality of life is assessed at baseline, weekly during treatment, and then at 1, 2, 3, and 6 months after the completion of treatment. patients are followed at 1, 2, 3, and 6 months after the completion of treatment and then every 6 months for 1 year.

Eligibility criteria:
disease characteristics: * diagnosis of head and neck cancer * no stage i laryngeal cancer * planned treatment with at least 2,000 cgy of external beam radiotherapy to at least 30% of the oral cavity patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * at least 3 months gastrointestinal: * able to tolerate oral medication * no known mechanical obstruction of the alimentary tract * no malabsorption * no intractable vomiting (more than 5 episodes per week) other: * no known intolerance to zinc sulfate * no known, untreated oral thrush * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: surgery: * no prior surgery that included ablation or removal of the olfactory component of taste other: * no concurrent zinc supplements * concurrent standard multivitamins allowed
comparative study of the performance of drug anamneses in an emergency department

Conditions: Medication Adherence

Summary: after the first medical history by the nurse and the emergency physician, the pharmacist and the pharmacy assistant take a detailed history of the patient's medications separately. after checking with the patient's reference pharmacy, the pharmacist and pharmacy assistant compare their results.


Eligibility criteria:
inclusion criteria: * admission to the emergency care unit * over 18 years old * giving consent to participate exclusion criteria: * patients who do not take medication daily * unconscious patients
magnesium for peroral endoscopic myotomy

Conditions: Esophageal Spasm

Summary: postoperative pain after peroral endoscopic myotomy occurs due to involuntary esophageal smooth muscle spasms. magnesium has antispasmodic properties as a smooth muscle relaxant. this study hypothesizes that among patients having peroral endoscopic myotomy, magnesium will decrease postoperative esophgeal pain as measured by the esophageal symptoms questionnaire, while decreasing perioperative opioid requirements.


Eligibility criteria:
inclusion criteria: - planned peroral endoscopic myotomy procedure exclusion criteria: * cannot give consent * patients who are clinically unstable and/or require urgent/emergent intervention * previous esophageal myotomy * preexisting hypermagnesemia * end-stage renal disease * neuromuscular disease, including but not limited to guillain-barre syndrome, myasthenia gravis, congenital myopathy, and muscular dystrophy * preexisting heart failure * severe ventricular systolic dysfunction (left or right ventricle)
clinical research study to assess the efficacy of two brushing regimens

Conditions: Dental Plaque; Gingivitis

Summary: the objective of this twelve-week clinical research study is to assess the efficacy of two brushing regimens: 1) toothpaste with mouthwash containing sodium fluoride/zinc and manual toothbrush as compared to 2) regular fluoride toothpaste and manual toothbrush in the reduction of dental plaque and aid of gum problems.


Eligibility criteria:
inclusion criteria: * signed informed consent form. * male and female subjects aged 18-70 years, inclusive. * availability for the twelve-week duration of the clinical research study. * good general health based on the opinion of the study investigator * minimum of 20 permanent natural teeth (excluding third molars). * initial gingivitis index of at least 1.0 as determined by the use of the loe and silness gingival index. * initial plaque index of at least 1.5 as determined by the use of the quigley and hein plaque index (turesky modification) exclusion criteria: * presence of orthodontic appliances. * presence of partial removable dentures. * tumor(s) of the soft or hard tissues of the oral cavity. * moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study. * five or more carious lesions requiring immediate restorative treatment. * antibiotic use any time during the one-month period prior to entry into the study. -participation in any other clinical study or test panel within the one month prior to entry into the study. * dental prophylaxis during the past two weeks prior to baseline examinations. * history of allergies to oral care/personal care consumer products or their ingredients. -on any prescription medicines that might interfere with the study outcome. * an existing medical condition that prohibits eating and/or drinking for periods up to 4 hours. * history of alcohol and/or drug abuse. * self-reported pregnancy and/or lactating subjects.

Keywords: plaque gingivitis loe and silness gingival index quigley and hein plaque index
improvement of care of patients undergoing pancreaticoduodenectomy

Conditions: Pancreatic Diseases; Pancreas Cancer

Summary: the study is a randomised controlled trial comparing the effectivity and impact of epidural analgesia and wound catheter analgesia in patients undergoing pancreaticoduodenectomy. the aim of the study is to examine whether there are a difference in perioperative fluid therapy and complication rates between the patients in epidural and wound catheter groups.

all patients undergoing pancreaticoduodenectomy in helsinki university hospital are recruited in the study. patients meeting the inclusion criteria and giving consent to participate the study will be randomised to whether epidural analgesia group or wound catheter analgesia group. both groups receive additional analgesia with intravenous pca-oxycodone (patient controlled analgesia).

Eligibility criteria:
inclusion criteria: * age 18 years or over * patients who undergo pancreaticoduodenectomy exclusion criteria: * patients to whom are made a major vascular reconstruction * patients with significant comorbidities and inability to use pca * regural use of strong opioids or drugs preoperatively * patients with severe chronic pain issues * chronic atrial fibrillation * patients who refuse to take part to the study

Keywords: pancreaticoduodenectomy fluid therapy enhanced recovery after surgery (eras) postoperative complications