Kornimate/medical-research-clean huggingface dataset:
efficacy of early multimodal physiotherapy in patients with reverse shoulder prosthesis

Conditions: Shoulder Fractures; Prosthesis User

Summary: the present study try to evaluate the effectivenness of an early intervention program based on multimodal physiotherapy and focused on therapeutic exercise to improve the results of patients with a reverse shoulder phrostesis. this trial will be a randomized controlled trial with parallel groups, and outcomes variables will include psychometric properties through the use of specific questionnaries, and laboratory variables such as strength with a dynamometer, range of movement with a goniometer, muscle mass with an ultrasound, and kinematic parameters with inertial sensors. this study aims to develop an original intervention program in order to try to establish new protocols in the management of these patients.

background: shoulder fractures, shoulder osteoarthritis and rheumatoid arthritis have a high prevalence and many times they require a surgery, in which a reverse shoulder phrostesis is colocated. nonetheless, nowadays there is no a clear consensus protocol in order to manage the prehabilitation and rehabilitation of this patient, so each physiotherapist use different techniques to treat this pathology. objective: this study aims to evaluate the effectiveness of an original intervention program (remove program) focused on an early intervention based on therapeutic exercise, manual therapy and education to improve the functionality of these patients after surgery. methods: this study is a randomized controlled trial with parallel groups. the control group receive standard care, and the experimental group is subjected to the remove program. both groups are evaluated five times, pre-surgery, at baseline, at 6 weeks, at 12 weeks and at 24 weeks to assess psychometric and laboratory outcomes.

Eligibility criteria:
inclusion criteria: * adults with a reverse shoulder prosthesis. * age between 18 and 90 years. * signed informed consent. exclusion criteria: * language or cultural barriers. * other upper limb injury. * treatment that affect physical activity capacity.
an extension study of tak-664 for japanese people with primary immunodeficiency disease

Conditions: Primary Immunodeficiency Disease

Summary: this study is an extension study for participants with primary immunodeficiency disorders who were previously treated with igsc, 20% in the tak-664-3001 study. they must have completed that study or be about to complete it before joining this study. participants will continue treatment with igcs, 20% in this study. the main aim of this study is to check for side effects from long-term treatment with igsc, 20% . this medicine is not yet licensed in japan, so participants will be treated with igsc, 20% until it becomes commercially available.


Eligibility criteria:
inclusion criteria: 1. participant has completed or is about to complete takeda clinical study tak-664-3001. a participant is considered to have completed study tak-664-3001 successfully if they fulfill the following criterion: completed epoch 2, in which igsc, 20% is administered weekly (completion of epoch 3, in which igsc, 20% is administered biweekly, is not mandatory for participation in tak-664-3002 study). 2. written informed consent is obtained from either the participant or the participant's legally authorized representative prior to any study-related procedures and study product administration. 3. participant is willing and able to comply with the requirements of the protocol. exclusion criteria: 1. participant has developed a new serious medical condition during participation in study tak-664-3001 such that the participant's safety or medical care would be impacted by participation in the extension study tak-664-3002. 2. participant is scheduled to participate in another non-takeda clinical study involving an investigational product or device-used-in-clinical-trial in the course of this study. 3. if a female of childbearing potential, participant is pregnant or has a negative pregnancy test but does not agree to employ adequate birth control measures for the duration of the study.
safety and efficacy investigation on the effects of clearskin non-ablative er:glass 1540nm laser module in the treatment of acne scars.

Conditions: Acne Scars - Mixed Atrophic and Hypertrophic

Summary: the clearskin module, er: glass 1540nm, is largely used in the treatment of acne vulgaris and acne scars. the non-ablative er:glass 1540 nm laser deeply penetrates the skin, causing thermal damage to the sebaceous glands, destroying p. acnes bacteria and reducing sebum production, while leaving the epidermis intact. the integrated vacuum mechanism extracts accumulated sebaceous material from the pores, while contact cooling protects the skin, reducing pain and allowing for safer and more effective treatment of the sebaceous glands within the dermis. based on this background, the investigators have considered a pilot study aimed at assessing the efficacy and safety of the clearskin module in treating subjects with facial acne scars.


Eligibility criteria:
inclusion criteria: * men or women aged 18 to 50 years * presence of mild to moderate facial acne scars (according to goodman \& baron's scale) * subjects in reasonably good general health, according to the investigator's judgment; * subjects who agree to avoid tanning during the entire investigational period; * subjects who agree to avoid any other facial procedure during the entire investigational period; including but not limited to: injectables or threads, peeling of any kind, dermabrasion, facial hair removal, or application of any cosmeceutical/pharmaceutical without the consent from the pi only. * subjects able to understand the full nature and the purpose of the investigation, including possible risks and side effects, able to cooperate with the investigator and comply with the requirements of the entire investigation (ability to attend all the planned investigation visits according to the time limits included) based on investigator's judgment. * subjects willing to sign an informed consent, consent to use their photos for future scientific or marketing purposes, according to the sponsor's needs. exclusion criteria: * subjects with active infections * subjects with a history of keloid scarring or hypertrophic scar formation * subjects with previous medical treatment of the area, or oral retinoid drug prescribed within the past six months * subjects who have been tanning within the past 30 days; * previous surgical treatment of the area selected for the treatment with the investigational device; * subjects with any inflammatory skin condition e.g., eczema, active herpes simplex, etc. at the treatment site; * subjects with the presence of tattoos at the treatment site * subjects with skin cancer or any other cancer and/or any cancer drug therapy (such as ducabaxine, fluorouracil, methotrexate, etc.) * subjects with history of autoimmune disorder or evidence of immunosuppression; * subjects with collagen vascular diseases * subjects with thrombocytopenia * subjects with peripheral vascular disease * subjects with melasma * pregnant or lactating subjects
gentamicin in cardiac surgery

Conditions: Cardiac Infection

Summary: surgical site infection (ssi) is a serious postoperative complication after cardiac surgery that have a negative impact on a patient's health and survival. this study aims to investigate the effectiveness of administering gentamicin in reducing the incidence of ssi with monitoring to the effective therapeutic level.

gentamicin is an aminoglycoside antibiotic that exhibits a wide range of antibacterial effects, mostly targeting gram-negative bacteria, while its effectiveness against gram-positive organisms is comparatively weaker. gentamicin has significant efficacy against multidrug-resistant bacteria as well. gentamicin is often used in conjunction with beta-lactam antibiotics to provide enhanced therapeutic efficacy via a synergistic effect, particularly in cases of gram-positive and multidrug-resistant bacterial infections. this study aims to evaluate the efficacy of administering gentamicin in combination with flucloxacillin as a pre-medication and for 48 hours after surgery in reducing the incidence of surgical site infections in patients undergoing cardiac surgeries, as compared to using a combination of ceftriaxone and flucloxacillin. additionally, the study aimed to observes the therapeutic level of gentamicin required to achieve an effective concentration of the drug. a prospective comparative study was conducted using an appropriate sample of 50 iraqi patients undergone several types of cardiac surgeries. a total of 50 patients (34 males and 16 females) between the ages of 18 and 75 were included in this study. these patients were admitted to the surgical department of the iraqi center for heart disease over a one-year period from january 2020 to january 2021. all patients underwent various types of cardiac surgery, such as coronary artery bypass graft (cabg), valve replacement, or device placement. the same surgical and anesthesia teams conducted the procedures. a computerized randomization method was used to allocate patients into two groups in a randomized manner. following the first interview, the patients were sequentially assigned numbers and then randomized into two groups via the online program research randomizer

Eligibility criteria:
inclusion criteria: * the research included individuals of both genders. * patients aged 18 and above. * patients had undergone any type of cardiac surgery. exclusion criteria: * patients having a prior diagnosis of organ failure. * patients already on antibiotics. * patients with elevated baseline renal function test before operation. * patients with contraindications to any of the prescribed medications were excluded from this study.

Keywords: infection antibiotics antimicrobial prophylaxis aminoglycoside gentamicin
glulisine pre- and postmeal

Conditions: Diabetes Mellitus Type 1

Summary: to investigate in type 1 diabetic patients the glucodynamic response to hmr1964 insulin and rhi (hoe31hpr100) injected subcutaneously before and after a standard meal


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus exclusion criteria:

Keywords: insulin glulisine diabetes mellitus type 1 postprandial period pharmacokinetics glucodynamics
study to evaluate the bioavailability of tislelizumab via subcutaneous injection in first-line treatment of participants with advanced or metastatic non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: this is an open-label, multicenter, phase 1 clinical study to evaluate the bioavailability of tislelizumab subcutaneous (sc) injection in the first-line treatment of participants with advanced or metastatic non-small cell lung cancer (nsclc). this clinical study will be divided into 2 parts: dose/injection site exploration (part 1) and dose expansion (part 2).


Eligibility criteria:
inclusion criteria: * able to sign a written consent form, understand, and agree to comply with requirements of the study. * documented locally advanced or recurrent nsclc that is not eligible for curative surgery and/or definitive radiotherapy, with or without chemotherapy, or metastatic non-squamous or squamous nsclc. * no prior systemic treatment for advanced or metastatic nsclc, including but not limited to chemotherapy or targeted therapy. * at least one measurable lesion as assessed by recist v1.1. * eastern cooperative oncology group (ecog) ps ≤ 1. * adequate organ function as indicated by laboratory tests. exclusion criteria: * participants diagnosed with nsclc that harbor a driver mutation (eg, egfr-sensitizing mutation, alk fusion oncogene, and braf v600e mutation or ros1 mutation). * participant has received any chinese herbal medicine or chinese patent medicines used to control cancer within 14 days before first dose of study drug. * active leptomeningeal disease or uncontrolled, untreated brain metastasis. * active autoimmune diseases or history of autoimmune diseases that may relapse. * any cancer ≤ 5 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, localized prostate cancer, carcinoma in situ of the cervix or breast). * any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before first dose of study drug. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: lung cancer non-small cell lung cancer
effects of incretin on the blood pressure and lipid in patients with overweight or obese diabetes

Conditions: Type 2 Diabetes; Overweight; Obesity; Masked Hypertension

Summary: obesity is one of the characteristics of type 2 diabetes mellitus. most of the obese diabetes patients are combined with dyslipidemia or hypertension. the clustering of diabetes, obesity, hypertension and dyslipidemia increases the risk of cardiovascular events for patients. glp-1 (glucagon like peptide-1) is a kind of incretin discovered in recent years. it was reported that beside its hypoglycemic and losing weight effects, activator of glp-1 receptor could decrease blood pressure and improve lipid metabolism. therefore, activation of glp-1 receptor may become a new comprehensive treatment strategies for improving glucose and lipid metabolism, blood pressure level and cardiovascular complication. but, it is lack of evidence-based medicine proof on the relationship between glp-1 and blood pressure or serum lipid. so, investigators designed a prospective, randomized, open-label, active control study, and try to evaluate the effects of activator of glp-1 receptor (liraglutide) on lowering blood pressure, improving vascular function and lipid metabolism in overweight or obese type 2 diabetic patients with masked hypertension.


Eligibility criteria:
inclusion criteria: 1. male or female, age between 35-60 years old 2. type 2 diabetes 3. 24kg/m²≤bmi≤32kg/m², or wc≥90cm for male and wc≥85cm for female 4. grade 1 hypertension or masked hypertension diagnosed via 24-h ambulatory blood pressure monitoring (daytime blood pressure load 50%≥135/85 mmhg, night time blood pressure load 50%≥125/75 mmhg or 24h blood pressure load 50%≥130/80 mmhg） exclusion criteria: 1. type 2 diabetes with serious complications, such as diabetic neuropathy, diabetic retinopathy, stage iv diabetic nephropathy, or acute diabetic complications. 2. type 1 diabetes. 3. diagnosed moderate to severe sleep apnea syndrome(sas). 4. grade 2 or grade 3 hypertension. 5. triglyceride≥5.65mmol/l 6. history of cardio-cerebral vascular events such as congestive heart failure, myocardial infarction or stroke within 3 months. 7. hypohepatia (ast or ast is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy. 8. renal insufficiency ( serum creatinine is 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome. 9. chronic obstructive pulmonary disease (copd), chronic respiratory failure or hyoxemia. 10. acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction. 11. fertile woman without contraceptives. 12. any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs. 13. allergic to or have contraindication to the intervention drugs.

Keywords: glp-1 masked hypertension lipid metabolism
routine versus aggressive upstream rhythm control for prevention of early atrial fibrillation in heart failure

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to investigate whether in patients with early persistent atrial fibrillation and mild to moderate early heart failure an aggressive upstream rhythm control approach, including aldosterone receptor antagonists and statins, dietary restrictions, counseling and cardiac rehabilitation programs, increases persistence of sinus rhythm compared with conventional rhythm control after one year of follow-up. a randomized long term extension of the race 3 will be performed with a total follow-up of 5 years to investigate the long term effects on persistence of sinus rhythm and cardiovascular morbidity and mortality of the two treatment strategies.


Eligibility criteria:
inclusion criteria: * early symptomatic persistent atrial fibrillation * mild to moderate early heart failure * optimal documentation and treatment of underlying heart disease * no contra-indication for oral anticoagulation * eligible for cardiovascular rehabilitation * age \>= 40 years exclusion criteria: * on waiting list for pulmonary vein isolation or expected to be placed on waiting list within one year * heart failure nyha class iv * lvef \< 25% * left atrial size \> 50 mm (parasternal axis) * present aldosterone receptor antagonist use * previous use of class i or iii antiarrhythmic drugs (except for sotalol, which should be discontinued at inclusion and replaced with betablocker) * cardiac resynchronization therapy
multicenter evaluation of near vision and outdoor time in kids study

Conditions: Myopia

Summary: currently, optical and pharmacological interventions have been developed to prevent the progression of childhood myopia. however, no myopia control strategy has been shown to have complete efficacy in controlling myopia progression in children. one possible reason is that risk factors contributing to the development of myopia were not controlled in previous clinical studies including time outdoors and near vision behaviour. this study aims to quantify time spent outdoors and near vision behavior in myopic children and its impact on myopia control efficacy. the outcomes of this study will guide clinicians on risk management and improve responses to existing treatments for progressive myopia.


Eligibility criteria:
inclusion criteria: 1. aged 6 to below 14 years old 2. spherical equivalent myopic refractive error greater than -0.50 d 3. best corrected logmar visual acuity of 0.1 or better in each eye for 6- to 14-year-old children, and 0.2 logmar or better than in each eye for 4 and 5-year-old children (adjusted for age-related expectations) 4. good ocular and general health that would not preclude them from myopia control 5. competent enough in english to fully understand the participant information and consent form 6. willing to undergo treatment to slow myopia progression for one year exclusion criteria: 1. strabismus at distance or near, or amblyopia 2. systemic or ocular conditions that may affect contact lens use (e.g. severe allergy) or refractive development (e.g. ptosis) 3. previous history of ocular surgery, trauma or chronic ocular disease that may affect their vision 4. ocular or systemic medication use which may interfere or interact with myopia treatment or ocular development 5. child, parents or guardians not willing to comply with treatment and/or follow-up schedule and planning to migrate or move during the one-year study duration

Keywords: myopia myopia control progressive myopia near vision behavior outdoor activity environment light exposure
virtual reality compared to nitrous oxide for labor analgesia

Conditions: Labor Pain

Summary: the purpose of this study is to determine if non-invasive distracting devices (virtual reality headsets) are non-inferior to conventional therapy (nitrous oxide) for addressing maternal needs during labor who desire non-epidural pain relief.

the investigators will use a commercially available consumer-grade virtual reality (vr) device and nitrous oxide, a standard of care therapy for laboring women desiring non-epidural analgesic, to determine satisfaction with pain relief with each therapy.

Eligibility criteria:
inclusion criteria: * singleton pregnancy at \>34 weeks * regular uterine contractions * pain \> 2/10 * english speaking exclusion criteria: * bmi \> 40 * preeclampsia with severe features * use of iv analgesics during labor * diabetes requiring insulin therapy * claustrophobia * history of epilepsy

Keywords: virtual reality
lentiviral fix gene therapy

Conditions: Hemophilia B

Summary: this study is a phase i trial using an advanced lentiviral vector to deliver a functional gene for human clotting factor ix into patients with hemophilia b, to evaluate the safety and efficacy of infusion of lentiviral gene modified autologous stem cells in patients.

hemophilia b is a genetic bleeding disorder caused by the lack of ability to produce blood-clotting factor ix (fix). individuals with hemophilia b suffer repeated bleeding episodes, which can cause chronic joint disease and sometimes even death due to the inability for blood to clot efficiently. the current treatment is intravenous infusion of clotting factor concentrates, either prophylactically or in response to bleeding. the procedure is life time long and expensive while still cannot achieve a cure.gene therapy is a novel technology that has been successfully demonstrated in a number of clinical studies for diseases such as cancer and genetic diseases. in this study, an advanced lentiviral vector system nhp/tyf will be used to deliver a functional fix gene to overcome human clotting fix gene defect in patients with hemophilia b. this study is a phase i trial evaluating the safety and efficacy for infusion of gene modified autologous stem cells in patients with hemophilia b.

Eligibility criteria:
inclusion criteria: * 1. able to provide informed consent and comply with requirements of the study. 2. males ≥2 years with confirmed diagnosis of hemophilia b (endogenous factor ix ≤2 iu/dl or ≤2% of normal). 3. a minimum average of 4 bleeding events per year requiring episodic treatment of factor ix infusions or prophylactic factor ix infusions. 4. no measurable factor ix inhibitor as assessed by the central laboratory and have no prior history of inhibitors to factor ix protein. 5. agree to use reliable barrier contraception until 3 consecutive samples are negative for vector sequences. exclusion criteria: * 1. significant liver dysfunction as defined by abnormal alanine transaminase, bilirubin and alkaline phosphatase. 2. history of inhibitor against factor ix. 3. evidence of active hepatitis b or c and currently on antiviral therapy. 4. have serological evidence of hiv-1 or hiv-2 with cd4 counts ≤200/mm3 (subjects who are hiv+ and stable with cd4 count \>200/mm3 and undetectable viral load are eligible to enroll). 5. any evidence of active infection or any immunosuppressive disorder. 6. participated in a gene transfer trial within the last 6 months or in a clinical trial with an investigational drug within the last 12 weeks. 7. unable or unwilling to comply with study assessments.

Keywords: hemophilia b factor ix gene therapylentiviral vector
early socioemotional intervention for children with autism spectrum disorder in hong kong and mainland china

Conditions: Autism Spectrum Disorder

Summary: this study aims to develop a culturally-sensitive parent-training intervention to enhance socioemotional functioning of young children (aged 3-6) with autism spectrum disorder (asd) in mainland china. the investigators will conduct randomized controlled trials to evaluate the effectiveness and feasibility of this program in a pilot study and then a large-scale community-based study in shenzhen, china, to examine the generalizability of the treatment outcomes of this intervention for chinese children with asd.


Eligibility criteria:
inclusion criteria: * children aged 3-6 * living in shenzhen, mainland china * diagnosed with asd or suspected of having asd

Keywords: autism spectrum disorder asd socioemotional functioning intervention study