Kornimate/medical-research-clean huggingface dataset:
metformin treatment on cognitive impairment of schizophrenia co-morbid metabolic syndrome

Conditions: Schizophrenia

Summary: in this study, the investigators will investigate the impact and the related mechanism of metformin treatment on cognitive impairment of schizophrenia with a high risk of metabolic syndrome. patients will be randomized to the metformin group or non-metformin control group (40 patients per arm) for 24 weeks. clinical assessment will be done at screen/baseline, 4 weeks, 12 weeks, and 24 weeks. the specific aims are to compare the metformin group versus controls on 1) clinical core symptoms; 2) cognition. biological samples also will be collected, and stored to research related mechanisms.

in this study, the investigators will investigate the impact and the related mechanism of metformin treatment on cognitive impairment of schizophrenia with a high risk of metabolic syndrome. patients will be randomized to the metformin group or non-metformin control group (40 patients per arm) . clinical assessment will be done at screen/baseline, 4 week, 12 week and 24 week. the specific aims are to compare the metformin group versus controls on: 1) clinical core symptoms; 2) cognition. biological samples also will be collected, and stored to research related mechanisms. clinical symptoms will be measured by the positive and negative syndrome scale and calgary depression scale for schizophrenia (chinese version). cognitive function will be assessed by the matrics consensus cognitive battery. the investigators hypothesize that 1) metformin may improve the cognitive impairment of schizophrenia patients; 2) metformin may alter oxidative stress indexes or inflammatory biomarkers thus influencing the oxidative and inflammatory mechanism, and the structure and function of the hippocampus that may be significantly associated with cognitive function.

Eligibility criteria:
inclusion criteria: 1. meet the diagnostic and statistical manual (dsm-5) diagnostic criteria for schizophrenia; 2. duration of illness less than 5 years with current symptoms exacerbation; 3. male and female aged 18 to 65 years; 4. panss total score \< 60 and cdss-c total score \< 6; 5. signed the study consent for participation; 6. patients with higher risk factors for mets, or patients who gained weight \> 10% of their pre-drug weight within the first year after antipsychotic medication. exclusion criteria: 1. having a history of substance dependence or abuse or whose symptoms are caused by other diagnosable mental disorders; 2. having a history of traumatic brain injury, seizures, or other known neurological or organic diseases of the central nervous system; 3. taking antidepressants, stimulants, mood stabilizers or accepting electricity shock treatment; 4. having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be managed in an inpatient setting; 5. the routine blood tests showing abnormal renal, and liver function; 6. pregnant or lactating women.

Keywords: schizophrenia metabolic syndrome metformin cognitive impairment clinical trial
safety and efficacy of cardiac shockwave therapy in patients undergoing coronary artery bypass grafting

Conditions: Heart Failure Patients; Cardiac Ischemia

Summary: this randomised, controlled clinical trial aims to evaluate the safety and efficacy of cardiac shockwave therapy (cast-hf) in patients with ischaemic heart failure requiring surgical revascularization. the main questions to answer are: * does cardiac shockwave therapy, in addition to cabg surgery, improve left ventricular ejection fraction? * is cardiac shockwave therapy in addition to cagb surgery safe? participants will be randomised into intervention (cardiac shockwave therapy) and control (sham treatment with an inactive applicator) groups.

this study investigates the safety and performance characteristics of the direct epicardial shockwave therapy system (deswt) as applied with the cardiac shockwave probe (csp).

Eligibility criteria:
inclusion criteria * male or female patients between 21 and 90 years of age undergoing primary coronary artery bypass grafting * presentation with reduced left ventricular function, defined as lvef ≤ 40% measured by cardiac mri * presentation with regional left ventricular wall motion abnormalities * written informed consent from the patient for participation in the study exclusion criteria * significant concomitant aortic valve disease requiring surgical treatment (other than significant aortic valve disease not detected in preoperative cardiac ultrasound but detected during surgery) * serious radiographic contrast allergy * patient in cardiogenic shock or presenting with acute myocardial infarction (stemi or nstemi) * patient with a contraindication for cardiac mri * history of significant ventricular arrhythmia, other than mi-associated arrhythmia * comorbidity reducing life expectancy to less than one year * presence of a ventricular thrombus * presence of a cardiac tumour * pregnancy
plasmafit® revision structan® hip endoprosthesis cup

Conditions: Osteolysis; Arthroplasty Complications; Instability of Prosthetic Joint; Degenerative Osteoarthritis; Rheumatic Arthritis; Fractures, Hip; Femoral Head Avascular Necrosis; Prosthesis Failure

Summary: the aim of this observational study is to collect clinical and radiological results of the new plasmafit® revision structan® hip endoprosthesis cup in a standard patient population and when used in routine clinical practice.


Eligibility criteria:
inclusion criteria * indication for the cementless plasmafit® revision structan® hip endoprosthesis cup (primary and revision cases, with bone conditions typically demanding a press-fit revision cup) * written informed consent * cases where a press-fit cup fixation is possible exclusion criteria * patients \< 18 years * pregnant patients * patients not able to comply with the study demands, i.e. follow-up visits (mentally or physically) * patient has an infection in the hip joint region

Keywords: revision of the acetabular implant orthopaedic surgery osteolysis wear particles cup loosening malpositioned cup
clinical and radiographic evaluation of different thickness of vacuum formed retainer (essix retainer) during retention phase after orthodontic treatment

Conditions: Temporomandibular Joint Disorders After Using Essix Retainer

Summary: vacuum formed retainer act as bite raiser that increase vertical dimension which may affect tempromandibular joint and aim of this study is to perform clinical and radiographic evaluation of different thickness of vacuum formed retainer (essix retainer) during retention phase after orthodontic treatment


Eligibility criteria:
inclusion criteria: * patients finished fixed orthodontic treatment with no signs or symptoms of temporomandibular joint disorders * patients indicated for removable retainer exclusion criteria: * any systemic disease * chronic medication uptake * bad oral hygiene pathological conditions of temporomandibular joint
safety and pk of nikkomycin z for coccidioides pneumonia treatment

Conditions: Coccidioidomycosis

Summary: the purpose of this study is to determine if nikkomycin z is safe when administered at different dose levels for 14 days. the study will also determine blood levels and urinary excretion of nikkomycin z in relation to dose administered. patients with mild forms of valley fever pneumonia will be eligible to participate and will be allocated to receive treatment with nikkomycin z (various doses) or a placebo. a secondary goal of this study is to evaluate the effectiveness and dose response of nikkomycin z in an exploratory analysis.

every year there are 50,000 new u.s. cases of coccidioidomycosis (valley fever). the majority of these illnesses occur as a result of endemic exposure in arizona and california. the benefits of antifungal therapy for uncomplicated disease are not currently established. current therapies for serious and complicated forms of coccidioidomycosis are only partially effective and in themselves are unable to eradicate the fungus from sites of infection, commonly resulting in breakthrough infection and/or relapse. nikkomycin z is effective in the mouse model and results in improved microbiological response over fluconazole. the goals of this study include: 1) evaluating the safety and tolerance of nikkomycin z following administration of multiple doses (50 mg q 12 h to 750 mg q 8 h) for two week and 2) evaluating the pharmacokinetics of nikkomycin z after single and multiple doses in relationship to dose. the study will include patients with uncomplicated coccidioides pneumonia (mild illness) which will allow exploratory analysis of efficacy and dose response based on biomarkers.

Eligibility criteria:
inclusion criteria: * age \>= 18 years and \<= 50 years * male or female (if female, must have a negative pregnancy test and agree to use an acceptable contraception method) * able to understand study and give written informed consent * have a respiratory illness with at least one of the following: cough, chest pain dyspnea or tachypnea, sputum production, or fever/chills/night sweats * have a new or suspected new pulmonary infiltrate on chest x-ray * have a positive coccidioidal serology by eia or immunodiffusion exclusion criteria: * patients under the age of 18 years or over 50 years * patients with a prior history of confirmed coccidioidal infection * laboratory diagnosis of another etiology for the inclusion-defining illness * inability to comprehend study and provide informed consent * history of or current evidence of major organ disease * concomitant use of prednisone and other corticosteroids not permitted * concomitant immunosuppressive therapy is not permitted * concomitant antibacterial therapy is not permitted

Keywords: coccidioidomycosis valley fever nikkomycin z
sensory evaluation of taste and smell in oncology

Conditions: Digestive Cancers

Summary: nutritional status is a major issue in the management of cancer patients. forty to 60% of patients are undernourished at diagnosis. this undernutrition has a direct impact on patients' health and quality of life, with a reduction in survival associated with an increase in the risk of toxicity from anti-cancer treatments (chemotherapy, radiotherapy, surgery), the risk of infection and the risk of hospitalization. thus, it is estimated that 10-20% of cancer patients die from the consequences of their undernutrition rather than from the tumor itself (muscaritoli et al. 2021). it is therefore recommended to systematically implement a multimodal nutritional intervention in cancer patients (recommendations of the learned societies espen, esmo and asco), combining nutritional support (oral and/or enteral and/or parenteral) with physical exercise (muscaritoli et al. 2021). however, despite the systematic provision of dietary management, the effectiveness of nutritional interventions varies from patient to patient in terms of nutritional status, quality of life and overall survival (cintoni et al. 2023). among the factors impacting patient compliance with dietary measures and their efficacy, sensory alterations occurring under chemotherapy potentially have a major impact (drareni et al., 2019). indeed, the vast majority of patients describe an alteration in tastes and smells after starting chemotherapy treatment. however, few studies have focused on the specific parameters associated with these alterations. the aim of this study is to prospectively assess changes in sensory perceptions and eating habits in patients undergoing chemotherapy for digestive cancer at the start of treatment and after the first cycle of chemotherapy, and to correlate these alterations with patients' nutritional profile and clinical course.


Eligibility criteria:
inclusion criteria: * able to complete the proposed questionnaires * patients over 18 years of age * non-opposed patients * digestive cancers starting chemotherapy and/or immunotherapy * able to eat by mouth exclusion criteria: * concomitant treatment for a non-digestive cancer (excluding basal/spinocellular carcinoma and chronic haemopathy) * previous ent surgery (face/neck) * exclusive enteral feeding (nasogastric tube, gastrostomy) or parenteral nutrition * previous chemotherapy/immunotherapy \< 5 years * individuals deprived of liberty by a judicial or administrative decision

Keywords: digestive cancers chemotherapy food preference sensory perceptions
ulcerative colitis and vitamin d supplementation

Conditions: Ulcerative Colitis

Summary: ulcerative colitis (uc) is an inflammatory disease involving the colonic mucosa, with bleedings and ulcerations. consequences are destroyed mucosal barrier and increased permeability. several cytokines are described to mediate the progressive course of ulcerative colitis and it is considered nowadays an immunologic disease. patients with uc have often low levels of vitamin d and elevated prevalence of osteoporosis. in vitro studies demonstrate that vitamin d has an immunomodulating effect, and may have a direct healing action on colonic mucosa has been described in animal studies. one can therefore rise a hypothesis that vitamin d supplementation could be crucial in patients with uc. to our knowledge, it has not been performed randomized clinical trials to study these possible effects of vitamin d and it has not been studied the effects of vitamin d on the relapse frequency and immunological composition of colic mucosa in patient with moderate to severe ulcerative colitis. objectives for our study are as follows: to examine if high-dose vitamin d supplementation in patients with moderate to severe ulcerative colitis: * reduces relapse frequency and increase the duration of the infliximab induced remission * mediates and changes the cytokines composition in the colic mucosa * decreases the excretion of calprotectin in feces and reduces the concentration of inflammation markers * augments bone mass


Eligibility criteria:
inclusion criteria: * men and women older than18 years old, diagnosed with uc (either debut or relapsed chronic uc), moderate or severe, where it is an indication to treat with infliximab. exclusion criteria: * primary hyperparathyroidism (phpt) * sarcoidosis * renal failure (serum creatinine \> 125 mumol/l in men or \> 105 mumol/l in women) * those, who use solarium routinely are not included * pregnant or breastfeeding women, otherwise women of fertile age must be on approved birth control methods during the study * renal stones last 15 years * cancer of any origin, diagnosed during last 5 years * unstable angina pectoris
intraoperative spillage of bile and gallstones during laparoscopic cholecysetectomy

Conditions: Cholecystitis; Gallstone

Summary: 1. determine the most important factors which is responsible for the outcome post bile and gallstones spillage during laparoscopic cholecystectomy 2. the management of complications of bile and gallstones spillage

laparoscopic cholecystectomy is preferred surgical treatment for symptomatic gallstones .laparscopic procedure is superior to open procedue .the incidence of gallbladder perforation and spillage of bile and gallstones has been found as high as 40% .complications and management of gall bladder perforation and spillage of gallstones and bile

Eligibility criteria:
inclusion criteria: * all age groups * only laparoscopic cholecystectomy * all types ,numbers and sizes os gall stones exclusion criteria: * open cholecystectomh * patient refuse to enrol this study
post-marketing surveillance study for the safety of a dtap-ipv- hb-prp~t vaccine in republic of korea

Conditions: Hepatitis B; Haemophilus Influenzae Type b Immunisation

Summary: primary objectives: to investigate the incidence of adverse events occurred following administration of hexaxim in infants from 2 months of age under routine clinical practice, as per approved indications

the duration of each enrolled participant's participation in the study will be up to 36 or 43 days.

Eligibility criteria:
inclusion criteria: * an infant aged 2 months or more on the day of enrollment * infant whose parent or legal representative has signed and dated the icf * receipt of 1 dose of hexaxim on the day of enrollment according to the approved local product label (regardless of vaccinated dose) exclusion criteria: * deviational use (off-label vaccination) from the approval local product label of hexaxim * previous history of enrollment in this study * participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device or medical procedure
music for insomnia

Conditions: Insomnia; Sleep Disorders

Summary: the aim of this study is to determine the effect of listening to music on sleep quality (subjective and objective), daytime dysfunction and neurophysiological arousal in patients with insomnia.

sleep problems are highly prevalent in modern society and poor sleep is associated with impaired physical and mental health with large costs for both individuals and society. pharmacological treatment is recommended only for short-term use, and there is a need to study promising drug-free aids to improve sleep. furthermore, the mechanisms of insomnia are not well understood. in the present project we will investigate if listening to music can improve sleep quality in persons suffering from insomnia. we will use a randomized controlled trial design including both subjective and objective measures of sleep.

Eligibility criteria:
inclusion criteria: * insomnia diagnosis exclusion criteria: * use of hypnotic medications * alcohol or substance abuse * pregnant or breastfeeding women * sleep apnea with an apnea hypopnea index (ahi) \>15 * clinically significant restless leg syndrome or periodic limp movement disorder (plms\>25)
cryoablation therapy or radiotherapy therapy for stage iii prostate cancer

Conditions: Stage III Prostate Cancer

Summary: this trial is going to evaluate tumor control and quality of life in patients with prostate cancer treated with radiotherapy or cryoablation.

objectives: * to determine the tumor control in patients with prostate cancer treated with radiotherapy or cryoablation * to determine the quality of life of these patients. outline: this is a multicenter study. patients are stratified according to gleason score (≥ 8 vs 7 vs ≤ 6), persistent prostatic specific antigen (psa) at allocation (\> 0.5 ng/ml vs ≤ 0.5 ng/ml), participating center. patient are allocated to two treatment arms.

Eligibility criteria:
inclusion criteria: * prostate adenocarcinoma, t3an0m0, t3bn0m0 * previously untreated disease or undergone endocrine therapy without reaching to castration resistant prostate cancer * survival ≥ 12 months * who performance status 0-2 * white blood cell ≥ 3.5 ×10\*9/l * platelets ≥ 5×10\*9/l * hemoglobin ≥ 10 g/dl exclusion criteria: * history of malignant disease * history of coronary artery disease * uncontrolled infection * other concurrent severe or uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes mellitus, uncontrolled cardiac disease, uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within the past six months, chronic liver or renal disease, and active upper gastrointestinal tract ulceration) * psychological, familial, sociological, or geographical condition potentially hampering compliance with the study treatment and follow-up schedule
randomized trial comparing misoprostol and foley bulb for labor induction in the preterm gestation

Conditions: Premature Birth; Cervical Ripening

Summary: the purpose of this study is to compare the time to delivery of two different cervical ripening methods on the preterm gestation.

labor induction for the preterm gestation is indicated for various maternal and fetal indications. the preterm cervix, however, is frequently not favorable for induction. multiple methods have been evaluated in the term gestation. as these comparison studies have not included the preterm gestation, this study seeks to evaluate these two methods in terms of safety, efficacy and time to delivery.

Eligibility criteria:
inclusion criteria: * singleton gestation, gestational age 23-35 weeks, indication for induction exclusion criteria: * multiple gestation, non-cephalic presentation, previous uterine surgery, rupture of membranes, intrauterine fetal death

Keywords: preterm gestation cervical ripening labor induction misoprostol foley bulb
uterine artery ligation to decrease blood loss with central placenta previa

Conditions: Placenta Previa Without Hemorrhage

Summary: this trial will address the effect of uterine artery ligation during cesarean section in cases with placenta previa to decrease blood loss.

this study will address the effect of uterine artery ligation prior to fetal delivery during cesarean section in cases with central placenta previa to guard against postpartum hemorrhage and to minimize blood loss.

Eligibility criteria:
inclusion criteria: * placenta previa is diagnosed when the lowest placental edge is located within 5 cm of the internal os at ultrasound * symptomatic placenta previa with at least one episode of bleeding * estimated gestational age within 28 to 40 weeks * maternal age \> 18 years * informed consent * social affiliation exclusion criteria: * premature rupture of membranes * severe bleeding. * abnormal fetal heart rates. * pre-eclampsia, chorioamnionitis, severe chronic renal disease.

Keywords: placenta previa, uterine artery ligation
neurodevelopmental therapy-bobath approach in the early term of stroke; safe and effective

Conditions: Stroke, Acute; Ischemic Stroke

Summary: early term rehabilitation initiated after stroke should be based on motor learning principles and neural plasticity. to achieve motor learning and neural plasticity, exercises consisting of intense and repetitive training should be given according to the patients' functional level. the neurodevelopmental treatment-bobath (ndt_b) approach is based on motor learning principles. in literature, studies that show the early term effects of ndt-b on functional recovery are inadequate. the aim of this study was to investigate the effects ndt-b applied in the early term of stroke, on postural control, functional movement, balance and activities of daily living.

when literature is examined, it can be seen that evidence is limited. studies investigating the effects of the bobath approach in the early term in stroke, state that ndt-b is reliable and feasible. however none of these studies have examined the effects of ndt-b in acute term stroke on functionality and daily living. additionally, in all of these studies it was also stated that further studies should be conducted.

Eligibility criteria:
inclusion criteria: * patients older than 18 years of age * systolic blood pressure between 120 and 220 mmhg * oxygen saturation \>92% (with or without o2 support) * a heart rate of 40 to 100 beats/min * a body temperature of \<38.5°c * a disability level of ≤4 according to the modified rankin scale * those who could respond to verbal commands exclusion criteria: * a history of previous stroke * concomitant progressive neurological disturbances * acute coronary disease * severe heart failure * concomitant rheumatologic diseases * a fracture or an acute orthopedic disorder that would prevent mobilization

Keywords: stroke early term bobath neurodevelopmental treatment rehabilitation