Kornimate/medical-research-clean huggingface dataset:
the effect of laser-assisted zona thinning on the implantation rate in the women of advanced age

Conditions: Female Urogenital Diseases

Summary: the purpose of this study is to determine whether laser-assisted zona thinning improve the implantation rate of the women of advanced age in the first ivf/icsi cycles

registry procedures： 1. it's required to sign an informed consent form prior to the recruitment of all patients. 2. data collection and entry need double check and supervision. the outcome measures: the implantation rate per embryo transfer miscarriage live birth

Eligibility criteria:
inclusion criteria: * age: 35y ≤age≤46y * basal fsh value: fsh≤10iu/l * day-3 embryos transferred in the fresh ivf/icsi cycles * the number of embryos available to be transferred on day-3: ≥one embryo exclusion criteria: * cycles with thawed/warmed embryos biopsied for pgd/pgs. * cycles with oocyte donation transfer. * the maximum number of previous unsuccessful ivf attempts: ≥ 3 cycles(transfer cycles) * any cycles with the risk of ohss, fluid in the uterine cavity, abnormal endometrium, uterine abnormalities,pelvic inflammation, and other acute maternal problems. * one or both spouses have an abnormal karyotype (including polymorphism)
safety, tolerability, and pharmacokinetic and pharmacodynamic characteristics of jp-2266 in healthy subjects

Conditions: Diabetes Mellitus

Summary: phase i clinical trial to investigate the safety, tolerability, and pharmacokinetic and pharmacodynamic characteristics of jp-2266 after oral administration in healthy male caucasian subjects

a dose-randomized, double-blind, placebo-controlled, single- and multiple-dose, dose-escalation, phase i clinical trial to investigate the safety, tolerability, and pharmacokinetic and pharmacodynamic characteristics of jp-2266 after oral administration in healthy male caucasian subjects

Eligibility criteria:
inclusion criteria: * healthy male caucasian subject aged 18 to 50 years inclusive * body mass index (bmi) between 18 and 27 kg/m2 inclusive and body weight ≥ 50 kg at screening * signing a written informed consent prior to selection; exclusion criteria: * any history (including family history) or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic or infectious disease;
cell phone intervention to support antiretroviral therapy (art) adherence in kenya

Conditions: HIV; AIDS; HIV Infections

Summary: a clinical study to evaluate the use of cell phones to support drug adherence and follow-up of patients taking antiretroviral therapy (art) for treatment of hiv. the intervention involves health-care providers sending regular short-message-service (sms) text messages to patients and following up their responses. the hypothesis is that the cell phone intervention will improve art adherence and health outcomes compared with the current standard of care.

this rct study focuses on enrolling and following patients initiating art. note, a second parallel prospective cohort study enrolls and follows art experienced patients who have already been taking art for at least one year before and after the same intervention.

Eligibility criteria:
inclusion criteria: * hiv infected and starting antiretroviral therapy * adequate (daily) access to a cell phone * intending to attend the enrollment clinic for 2 years * consent to participate exclusion criteria: * not meeting inclusion criteria

Keywords: hiv/aids adherence antiretroviral therapy, art, arv mobile phone, cell phone, telephone text message, sms telemedicine africa resource-limited setting counseling, support treatment experienced
air optix® colors registration trial

Conditions: Refractive Error

Summary: the purpose of this study was to evaluate the subjective and objective performance and the physiological response to air optix® colors soft contact lenses compared with air optix® aqua contact lenses in participants with normal eyes and prescription needs.

this study consisted of 7 scheduled visits conducted over a 3-month period. enrolled participants were randomized (2:1) to receive either air optix® colors lenses in both eyes or air optix® aqua lenses in both eyes.

Eligibility criteria:
inclusion criteria: * be of legal age of consent and sign informed consent document. if under legal age of consent, legally authorized representative must sign informed consent document and subject must sign assent document. * normal eyes and not using any ocular medications. * willing to wear visitint or gray-colored spherical contact lenses in both eyes within available power ranges. * manifest cylinder less than or equal to 0.75 diopter. * best spectacle corrected visual acuity greater than or equal to 20/25. * have current prescription glasses. * other protocol-defined inclusion criteria may apply. exclusion criteria: * anterior segment infection, inflammation, or abnormality. * any active anterior segment ocular or systemic disease that would contraindicate contact lens wear. * use of ocular or systemic medications for which contact lens wear could be contraindicated as determined by the investigator. * history of refractive surgery or irregular cornea. * history of pathologically dry eye. * corneal vascularization greater than 1 millimeter of penetration. * history of herpetic keratitis. * eye injury within 12 weeks immediately prior to enrollment in this trial. * currently enrolled in any clinical trial or participation in any clinical trial within the previous 30 days. * other protocol-defined exclusion criteria may apply.

Keywords: myopia contact lenses
safety, tolerability and pharmacokinetics of single dose intravenous moxifloxacin in pediatric patients

Conditions: Infections

Summary: the purpose of this study is to describe the pharmacokinetics of moxifloxacin in children to see what the best dose should be for children in the future. pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of the study drug. the pharmacokinetics of certain drugs may be altered in children due to developmental differences in various organ functions responsible for drug elimination, as well as in general distribution characteristics. the safety of moxifloxacin in children with infections will also be looked at. results from this study will be used to guide dosing strategies of the larger clinical trial planned for children


Eligibility criteria:
inclusion criteria: * males or females, ages 3 months through 14 years inclusive * receiving antibiotics for suspected or proven infection exclusion criteria: * body weight greater than 45 kg * patients taking anti-seizure medications within 30 days of moxifloxacin dosing * known or suspected allergy to quinolones * history of tendon disease/disorder related to quinolone treatment * severe, life-threatening disease with a life expectancy of less than 48 hours and/or known rapidly fatal underlying disease (death expected within 2 months) * abnormal musculoskeletal evaluation at baseline assessment; or chronic musculoskeletal disease (eg, juvenile rheumatoid arthritis); or chronic illness with high risk for chronic or recurrent arthritis or tendinitis (eg, cystic fibrosis, chronic inflammatory bowel disease) * cardiac arrhythmia * evidence of renal or hepatic disease, based on laboratory findings (serum creatinine, total bilirubin, or alt, \> 1.5 times upper limit of normal) and physical exam * patients receiving class ia (e.g., quinidine, procainamide) or class iii (e.g., amiodarone, sotalol) antiarrhythmic agents * patients taking any medication known to increase the qt interval, eg, amiodarone, astemizole, bepridil, chloroquine, chlorpromazine, cisapride, disopyuramide, dofetilide, droperidol, halofantrine, haloperidol, ibutilide, levomethadyl, mesoradazine, methadone, pimozide, procainamide, quinidine, sotalol, terfenadine * pregnancy * clinically relevant findings in the ecg * participation in another clinical study during the preceding 30 days1 (last treatment from previous study to first treatment of new study) * criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the patient's safety * patients taking another fluoroquinolone at the time of planned moxifloxacin dosing

Keywords: pharmacokinetics
pravastatin for acute myocardial infarction with minimally to mildly increased levels of serum cholesterol study

Conditions: Acute Myocardial Infarction

Summary: the purpose of the study is to determine whether early treatment with pravastatin can reduce adverse cardiac events in patients with acute myocardial infarction and minimally to mildly elevated serum low density lipoprotein -cholesterol (ldl-c) levels.

the investigators previously reported the beneficial effect of early use of low-dose pravastatin on major adverse cardiac events in patients with acute myocardial infarction and mild to moderate hypercholesterolemia in the oacis-lipid study. the practic study is designed as the oacis-lipid ii trial to determine whether early treatment with pravastatin can reduce adverse cardiac events in patients with acute myocardial infarction and minimally to mildly elevated serum low density lipoprotein -cholesterol (ldl-c) levels.

Eligibility criteria:
inclusion criteria: 1. the presence of 2 of the following 3 criteria: 1. a clinical history of central chest oppression, pain, or tightness lasting for ≥30 minutes 2. typical electrocardiographic changes (i.e., st-segment elevation of \>0.1 mv in ≥1 limb or 2 precordial leads, st-segment depression \>0.1 mv in ≥2 leads, abnormal q waves, or t-wave inversion in ≥2 leads) 3. an increase in the serum creatine kinase levels to \>2 times the normal laboratory value. 2. the serum level of ldl-c is ≥70 and 130\> mg/dl in the first blood examination soon after admission exclusion criteria: 1. concurrent therapy with any hmg-coa reductase inhibitor 2. previous history of the side effects associated with any hmg-coa reductase inhibitor 3. life-threatening arrhythmia 4. severe chronic congestive heart failure 5. hepatic dysfunction 6. renal failure 7. cerebrovascular disease 8. poor controlled diabetes 9. pregnancy, lactation 10. age \<20 years 11. disability of taking medicine or absence of a written informed consent 12. patients whom the doctors consider inappropriate by any other reason
progressive resistance exercise in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: a randomized controlled trial with rheumatoid arthritis patients will be realized. patients will be randomized into two groups. experimental group will do a 12 weeks training of progressive resistance exercise for global muscles and remain with the clinical treatment and the control only remain with the clinical treatment. patients will be evaluated at baseline, after 6, 12 and 24 weeks.


Eligibility criteria:
inclusion criteria: * rheumatoid arthritis according to american college of rheumatology 2010 * both genders * age between 18 and 65 years * functional class i, ii and iii * stable medication within the three months preceding the study * haven't done any kind of regular exercise (two or more times per week) for at least three months before study start * have agreed to participate in the study and signed an informed consent form. exclusion criteria: * participating in another type of study * have difficulty understanding the evaluation tools with fibromyalgia * joint deformities that make impossible do the exercises * other musculoskeletal diseases * other diseases that contraindicate exercises.

Keywords: rheumatoid arthritis progressive resistance exercise pain functional capacity quality of life muscle strength
effects of rewin(d) supplementation on the recovery of doms induced by acute exercice

Conditions: Muscle Soreness; Delayed-onset Muscle Soreness

Summary: the study will assess the recovery and performance of young athletes suffering from muscle damage induced by physical exercise. model by comparing the safety and efficacy of rewin(d) supplemention during 4 weeks to placebo over 72 hours post exercice.

double-blind, randomized, placebo controlled, parallel group, pilot safety and efficacy study. 40 healthy young male athetes were randomly assigned to the rewin(d) or placebo group. after 4 weeks supplementation (either 2 g daily of rewin(d) capsules or placebo capsules). the participants were subjected to a 1 hour plyometric exercise session to induce doms. at 0 hours, 24 hours, 48 hours and 72 hours post exercise, the volunteers have been assessed to determine: (i) pain perception, (ii) fatigue rate, (iii) sport performance (effectiveness of a jump) and (iv) muscle damage and inflammation by i-r thermography and biomarkers

Eligibility criteria:
inclusion criteria: * \> 18 years old * young athletes * training at least 3 times per week * agree not to initiate any new exercise or diet programs during the entire study period * agree not to change their current diet or exercise program during the entire study period * agree not to stretch, utilize ice massage, take anti-inflammatory medications (eg, aspirin, ibuprofen), or use any other treatment for the duration of the trial. exclusion criteria: * previous history of upper extremity injury or knee joint pain * use of anti-inflammatory medications or pain medications 1 week before the screening visit and during the study * daily use of dietary supplements and herbal supplements beginning at the screening visit and during the study * antibiotic use in past 3 months * chronic disease

Keywords: doms fatigue rate heart rate variability pain jump performance
problem-solving therapy for cancer caregivers in outpatient palliative care

Conditions: Depression, Anxiety; Palliative Care; Caregivers; Cancer

Summary: this study is a randomized clinical trial of a problem-solving therapy intervention for family caregivers of individuals with cancer receiving outpatient palliative care.

this study is a randomized clinical trial of a problem-solving therapy intervention for family caregivers of individuals with cancer receiving outpatient palliative care. study participants will be randomized to receive either a three-session problem-solving therapy intervention in addition to usual care or three sessions of attention-matched control in addition to usual care.

Eligibility criteria:
inclusion criteria for family caregivers (fcgs) * must be 18 years of age or older * must serve as the unpaid family caregiver of a patient with cancer receiving outpatient palliative care from one of the participating clinical sites. as is common in caregiving research, we will define "family caregiver" as anyone substantially involved in a patient's care on an unpaid basis; a legal or biological relationship will not be required * must consent to participate inclusion criteria for non-family caregiver stakeholders * must be 18 years of age or older * must be employed by or affiliated with the healthcare system housing one of the participating clinical sites. * must consent to participate. exclusion criteria for family caregivers (fcgs) * younger than 18 years of age * paid caregiver exclusion criteria for non-family caregiver stakeholders * younger than 18 years of age * not employed by or affiliated with the healthcare system housing one of the participating clinical sites.
transcranial photobiomodulation for adult adhd

Conditions: ADHD

Summary: this study aims to assess the behavioral as well cognitive changes in adhd symptoms in terms of improvement of inhibitory control and attention in adults with adhd

this study is a randomized double blind trial. after selection and enrollment, participants will be screened at baseline with a complete diagnostic and clinical assessment, and randomized to receive active or placebo t-pbm. at visit 1 patients will undergo a (pre-treatment) neuropsychological testing followed by the first t-pbm session. after the first t-pbm session, the patients will undergo another (post-treatment) neuropsychological testing. after visit 1, which includes the first treatment, patients will receive additional 4 weeks of t-pbm treatments. after the last treatment, patients will come to clinic for undergo a clinical and neuropsychological assessment (visit 2). after the visit 2, patients will receive other 4 weeks of t-pbm treatments. after the last t-pbm treatment session, patients will come to clinic to undergo the final clinical and neuropsychological assessment (visit 3). at the visits 1, 2 and 3 patients will be asked if they believe they received active or sham treatment.

Eligibility criteria:
inclusion criteria: • subjects diagnosed with adhd exclusion criteria: * schizophrenia or other psychosis * current acute depressive episode * bipolar disorder with current manic or depressive episode * active substance use disorder * autism * dementia.

Keywords: adhd attention photobiomodulation
per oral versus intravenous postoperative antibiotics after surgery for complicated appendicitis.

Conditions: Complicated Appendicitis

Summary: the pipa trial is a prospective, multicentre, cluster randomized cluster crossover non-inferiority study. we aim to test whether a three-day postoperative course of per oral antibiotics is non-inferior to a three-day postoperative course of intravenous antibiotics as standard care after laparoscopic surgery for complicated appendicitis in regards to the risk of postoperative intraabdominal abscess formation within 30-days

complicated appendicitis increases the risk of postoperative intra-abdominal abscess. treatment of complicated appendicitis are usually with a postoperative course of intravenous antibiotics. there is need for a study confirming the results of retrospective studies showing that a postoperative course of oral antibiotics is not inferior to intravenous antibiotics after laparoscopic surgery for complicated appendicitis. the pipa trial will be a prospective, multicenter, cluster randomized cluster crossover non-inferiority study designed to test whether a three-day postoperative course of per oral antibiotics is non-inferior to a three-day postoperative course of intravenous antibiotics as standard care after laparoscopic surgery for complicated appendicitis in regards to the risk of postoperative intraabdominal abscess formation within 30-days. participating hospitals will be randomized to either a 6-month period with a per oral antibiotic regime followed by a 6-month period with an intravenous antibiotic regime, or 6-month period with an intravenous antibiotic regime followed by a 6-month period with a per oral antibiotic regime for the postoperative treatment after laparoscopic surgery for complicated appendicitis. primary outcome will be the incidence of intra-abdominal abscess by the postoperative day 30. the study duration has been extended by three months in both arms, totaling six months, due to insufficient patient recruitment. by addressing this challenge, the research team seeks to achieve a more representative sample size to ensure robust and reliable research outcomes.

Eligibility criteria:
inclusion criteria: * on cluster level, hospitals with emergency surgical admissions performing laparoscopic appendectomies are eligible for inclusion. * on an individual level, participants are eligible for inclusion if they undergo a laparoscopic appendectomy for appendicitis (both uncomplicated and complicated), are ≥ 18 years of age, and provide a signed written consent form. exclusion criteria: * exclusion criteria are specifically related to the therapy and individual participants will be excluded if they undergo any other procedures than laparoscopic appendectomy during index surgery.
vital-signs-integrated patient-assisted intravenous opioid analgesia

Conditions: Respiratory Depression

Summary: this is a closed-loop system which is embodied in a novel and intelligent algorithm that takes into account patients' vital signs. the system allows better and responsive titration of personalized pain relief together with non-invasive physiological monitoring that measures oxygenation, breathing and heart rate continuously.

a glaring safety gap in the administration of commonplace patient controlled analgesia (pca) opioids unfortunately exists. a significant proportion of patients may suffer from respiratory depression with the use of pca opioids and it is imperative to discover solutions to improve the safety of pca opioids, therein improving medication safety, enhancing quality of postoperative care and providing economic cost savings. currently, no continuous monitoring system that integrates an intelligent decision making response exists. the investigators primary aim is to develop and commercialise a vital-signs-integrated (using oxygen saturation, respiratory rate, heart rate) patient-assisted intravenous opioid analgesia (vpia) that can be integrated into the hospital-wide monitoring systems is capable of making intelligent decision making responses to bridge the pca safety gap within 12 months. this vpia delivery system will be a closed-loop system for safety and efficacy. it will be integrated with continuous vital signs monitoring, and provide appropriate response to breach of safety parameters. it will be part of a larger surveillance system that provides tiered medical and nursing alerts to safety parameters.

Eligibility criteria:
inclusion criteria: * age 21-70 years old, female * healthy participants who are american society of anesthesiologists physical status 1 and 2 (with well controlled medical problems) * undergoing elective surgery with the intent of using postoperative pca with morphine for postoperative analgesia exclusion criteria: * allergy to morphine * with significant respiratory disease and obstructive sleep apnea * unwilling to place oxygen saturation monitoring devices during study period * unable to comprehend the use of patient controlled analgesia * pregnant

Keywords: respiratory depression