Kornimate/medical-research-clean huggingface dataset:
a phase 2 study to evaluate the efficacy and safety of enn0403 in subjects with dme

Conditions: Diabetic Macular Edema (DME)

Summary: this is a multicenter, randomized, parallel study to evaluate the efficacy and safety of two doses of enn0403 in subjects with diabetic macular edema (dme). approximately 60 subjects will be randomized to receive enn0403 capsule orally once a day at the low dose or high dose with a 1:1 ratio. the study period consisted of up to 2 weeks of screening, 12 weeks of treatment and 2 weeks of follow-up, and the entire trial period was up to 16 weeks.


Eligibility criteria:
inclusion criteria: 1. provide written informed consent; 2. aware of the entire study process and requirements, understands the importance of medication compliance and completing all assessments on time throughout the study, and agrees to strictly follow the protocol and study procedures, including restrictions on drug combination during the study; 3. diagnosis of type 1 or type 2 diabetes mellitus and hba1c≤10.0% with regular use hypoglycemic drugs and stable glycemic control 1 month before screening (at the discretion of the investigator); 4. the decrease of bcva is mainly caused bydiabetic macular edema in the study eye; 5. bcva letter score of ≤ 73 (snellen 20/40) and ≥ 24 (snellen 20/320) at screening visit and at baseline. if both eyes meet the inclusion criteria, the study eye will be determined by the investigator from a medical perspective. ( if both eyes meet the inclusion criteria，the eye with poor baseline vision will be selected as the study eye; if the bcva number is the same, choose the eye with the thicker crt as the study eye) ； 6. optical coherence tomography (oct) foveal crt at screening measuring ≥300 μm. exclusion criteria: 1. study eye with any eye disease or medical history other than dme that causes or may cause irreversible vision loss; 2. study eye had glaucoma filtration surgery in the past or may have the surgery during the study; 3. study eye had previously undergone vitreoretinal surgery; 4. study eye received intraocular hormone drugs within 6 months prior to baseline or periocular or systemic hormone drugs within 3 months prior to baseline; 5. any eye received intraocular injection of vegf within 3 months prior to baseline; 6. history of idiopathic or autoimmune uveitis in any eye; 7. uncontrolled glaucoma in any eye (defined as iop ≥25 mmhg after treatment with anti-glaucoma drugs) 8. history of allergy to the investigational drug or any ingredient, or to any ingredient used during the treatment; 9. use of any other investigational drug or device within 3 months or 5 half-lives prior to baseline (whichever is longer); 10. other factors considered inappropriate for inclusion in this study at the discretion of the investigator.
a study of tarceva (erlotinib) in combination with avastin (bevacizumab) in patients with advanced non-small cell lung cancer.

Conditions: Non-Small Cell Lung Cancer

Summary: this 2 arm study will compare the efficacy and safety of tarceva plus avastin, and chemotherapy plus avastin, in the first-line treatment of patients with advanced non-small cell lung cancer. patients will be randomized to receive either tarceva 150mg p.o. daily plus avastin 15mg/kg i.v. every 3 weeks, or standard platinum-based chemotherapy (4-6 cycles) plus avastin. the anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * advanced (stage iiib and iv) non-small cell lung cancer; * measurable disease; * ecog ps 0-1. exclusion criteria: * prior chemotherapy or treatment with another systemic anti-cancer agent; * radiotherapy within 4 weeks prior to first dose of study treatment; * cns metastases; * other malignancies in past 5 years, except for adequately treated cancer in situ of the cervix, basal or squamous cell skin cancer.
effectiveness of physical teraphy in the treatment of myogenic temporomandibular disorders

Conditions: Temporomandibular Disorder

Summary: the aim of study is evaluate the effectiveness of physical therapy in of the treatment myogenic temporomandibular disorders. they will enrolled 100 patient which will be divided into two groups. the primary objective is evaluate the effectiveness of physiotherapy on pain (measured with the visual analogic scale - vas scale). the second objective is evaluate mandibular motion (by measuring the range of motion - rom) and investigate the presence of psychosocial factors (using the anxiety and depression scale - hads questionnaire).

randomized controlled clinical trial with randomization according to a multi-phase design. phase 1 involves the enrollment of patients with dtms based on diagnostic criteria. phase 2 includes the algogenic, kinetic and gnathological evaluation of the enrolled patients. phase 3 provides for the adoption of the criterion to one of the 2 treatment groups on the basis of the randomization list. the 2 therapeutic protocols are: * gnathological therapy (splint) associated with education and physiotherapy (test group); * gnathological therapy (splint) associated with education (control group). during the first visit the patient will be enlisted by evaluating the inclusion and exclusion criteria and signed the informed consent, he / she will be assigned a unique identification code. the code consists of a progressive number followed by the patient's initials (eg 01-f.r.). subsequently, the patients will be randomized blinded and assigned to one of the two study groups. randomization will be performed using random, computer-generated, centralized numbers placed in sealed opaque envelopes provided by the study coordinator. both types of treatment will be performed by a single operator respectively.

Eligibility criteria:
inclusion criteria: * patients with myogenic temporomandibular disorders assessed with clinical examination as established by the dc / tmd1; * patients older than 18 years; * good knowledge of italian language; * patients who have signed informed consent exclusion criteria: * edentulism which makes it impossible to apply gnathological bite; * patients with psychiatric problems; * patients included in other experimental protocols; * patients already undergoing surgical and / or radial therapy of the cervical and facial areas; * other temporomandibular disorders without a myogenic component; * treatment of the cervical and tmj district in the previous 3 months; * history of drug abuse.
minimal invasive approaches for aortic valvular and subvalvular surgeries

Conditions: Rheumatic Heart Disease With Valvulitis

Summary: to compare intraoperative and immediate postoperative outcomes of mini-sternotomy versus mini-thoracotomy as less invasive techniques in patients with isolated aortic valvular and subvalvular disease requiring surgery according to inclusion criteria.

1. it has been demonstrated that minimally invasive aortic valve replacement (miavr) approaches are safe and effective for the treatment of aortic valve diseases. to date, the main advantage of these approaches is represented by the reduced surgical trauma, with a subsequent reduced complication rate and faster recovery. this makes such approaches an appealing choice also for frail patients \[obese, aged, chronic obstructive pulmonary disease (copd)(1). 2. minimally invasive aortic valve replacement (miavr) has been increasingly accepted in the surgical community as a potential alternative to conventional sternotomy, with advantages of reduced trauma, improved cosmotic and reduced hospitalization(2). 3. the mini sternotomy (ms) approach represents the most common technique used for minimally invasive avr. the ms approach is achieved through 6 to 10cm midline vertical skin incision, performing a partial j sternotomy at the third to fifth intercostal space (3). miavr via right mini thoracotomy (rt) is performed through five to seven cm skin incision placed at the level of the second intercostal space without rib resection. after sacrificing the right internal thoracic artery(4). 4. despite these excellent results, there have been an increasing number of cases performed via minimally invasive aortic valve replacement (miavr). this approach has now become an established alternative to fs in order to reduce the "invasiveness" of the surgical procedure, while maintaining the same efficacy, quality and safety of a conventional approach (5).

Eligibility criteria:
inclusion criteria: 1. patients with isolated aortic valve and subvalvular disease. 2. sexes included with acceptance of patients to participate in this study and approval of ethical committee. exclusion criteria: 1. patients ages who less than 16 yrs and more than 60yrs. 2. emergent open heart surgery. 3. patients with current infective endocarditis. 4. patients with chest deformity pectus excavatum or carinatum due to difficult access. 5. the patient refused to sign the informed consent to participate in the research. 6. patients with aortic root abscess or aortic dilatation at root or ascending parts.
a pharmacokinetic and pharmacogenetic study in patients receiving sulfamethoxazole-trimethoprim therapy

Conditions: Pneumocystis Jirovecii Pneumonia

Summary: in this study, we aim to investigate the incidence of the adverse reactions, the effectiveness and the gene polymorphism associated with the plasma level of sulfamethoxazole-trimethoprim and their metabolites (including n4-acetyl-sulfamethoxazole, sulfamethoxazole hydroxylamine and sulfamethoxazole-nitroso). and we also aim to investigate the factors associated with the sulfamethoxazole-trimethoprim induced acute psychosis.


Eligibility criteria:
inclusion criteria: * males and females aged 20 years or older * using oral or intravenous form of sulfamethoxazole-trimethoprim exclusion criteria: * patients who are under 20 years of age
lotus trial: lumbar ultrasound in obstetric patients with bmi > 40

Conditions: Obesity, Morbid; Labor Pain

Summary: the goal of this clinical trial is to compare traditional palpation to pre-procedural lumbar ultrasound prior to epidural placement in obese (bmi \>40) obstetric patient population. the main questions it aims to answer are: * is a pre-procedural lumbar ultrasound superior to traditional palpation in terms of total number of epidural needle redirections during epidural placement? * is there no difference in time to epidural loss between pre-procedural lumbar ultrasound and traditional palpation during epidural placement? participants will be randomized to either a pre-procedural lumbar ultrasound or traditional palpation at the time of epidural placement.


Eligibility criteria:
inclusion criteria: * 18 years or older * english speaking * bmi (body mass index) \> 40 * ability to provide informed consent and verbally disclose their medical history exclusion criteria: * history of spine surgery, scoliosis, or other spinal abnormality which could complicate epidural placement * patients with platelet counts \<70,000 or patients who are on anticoagulation, or patients who are on anticoagulation, both would exclude any patient from receiving an epidural. * minors * adults unable to make their own decisions or with cognitive issues or developmental delays * prisoners

Keywords: labor epidural
transgender, silicone and blood smear

Conditions: Injection; Complications, Sepsis; Injection Site Disorder; Injection Site Extravasation; Intentional Poisoning by Silicone

Summary: this cross-sectional monocentric study will describe transgender men transitioning into women and who had cosmetic silicone injection. the principal objective is to estimate the prevalence of transgender with circulating monocytes containing silicone vacuoles in blood smears among male to female transgender population with a history of cosmetic silicon injections. the secondary objectives are to describe the transgender population, to describe the quantity of silicone in vacuoles of circulating monocytes, and the association between dermatological complications (inflammatory and not inflammatory) and several clinical and biological characteristics (hiv status, level of immunosuppression, inflammatory syndrome, quantity of silicone which was injected , silicone quantity in blood smears).

injectable liquid silicone is a permanent filling product which is no more used in france because of a high risk of complications. cosmetic silicone injection is a common feminization approach for transgender populations. this cross-sectional monocentric study will describe transgender men transitioning into women and who had cosmetic silicone injection. the principal objective is to estimate the prevalence of transgender with circulating monocytes containing silicone vacuoles in blood smears among male to female transgender population with a history of cosmetic silicon injections. the secondary objectives are to describe the transgender population, to describe the quantity of silicone in vacuoles of circulating monocytes, and the association between dermatological complications (inflammatory and not inflammatory) and several clinical and biological characteristics (hiv status, level of immunosuppression, inflammatory syndrome, quantity of silicone which was injected , silicone quantity in blood smears).

Eligibility criteria:
inclusion criteria: * adults * not in opposition to data collection * transgender men transitioning into women patients with cosmetic silicone injection * consultation in bichat hospital exclusion criteria: * unable to communicate * guardianship, curatorship

Keywords: silicone transgender dermatology blood contamination adverse event after injection
pre-operative tamsulosin and time to spontaneous void after hysterectomy

Conditions: Urinary Retention Postoperative

Summary: the aim of this study is to determine if a one time dose of tamsulosin given pre-operatively decreases the time to void and the time to discharge after minimally invasive hysterectomy.


Eligibility criteria:
inclusion criteria: * women 18-80 undergoing outpatient minimally invasive hysterectomy exclusion criteria: * inability to provide informed consent * bladder malignancy * intra-operative bladder or ureteral injury; anticipated prolonged bladder catheterization * plan for sling or anterior repair
comparative effects of dry needling versus soft tissue mobilization on hamstring tightness

Conditions: Hamstring Tightness; Chronic Low-back Pain

Summary: the hamstring tightness is considered as the inability to achieve knee extension greater than 160 degrees while hip is flexed at 90 degrees. when low back pain (lbp) persists for 12 weeks or longer, it is termed as chronic low back pain. the objective of study is to see the effect of dry needling versus soft tissue mobilization on hamstring muscle on pain, range of motion and functionality in patients with chronic low back pain.

a randomized clinical trial will be conducted at hameed latif medical centre through non probability convenient sampling technique on 30 subjects which will be divided into two groups' 15 subjects in group a and 15 subjects in group b through computer generated software for randomization. both groups will be conventional therapy and spinal mobilization (posterior anterior glide) of grade 1 and 2 (3 sets of 6 repetitions) as baseline treatment. group a was will be dry needling and group b will be soft tissue mobilization.

Eligibility criteria:
inclusion criteria: * reduction in active knee extension test \>25 * current back pain between 4 to 6 on numeric pain rating scale * low back pain for at least 12weeks0r 6 months exclusion criteria: * subjects using anticoagulants and having vascular diseases * subjects with needle phobia and allergic to metals * subjects with cognitive impairment * history of fracture in lumbar region * history of systemic diseases e.g. cancer or systemic joint pathologies * history of congestive heart failure in past 24 months * subjects have used medications like narcotics or muscle relaxants 30 days before enrolment into study

Keywords: chronic low back pain disability dry needling hamstring tightness soft tissue mobilization
treatment of chronic wounds in diabetic foot syndrome with allogeneic adipose derived mesenchymal stem cells

Conditions: Diabetic Foot Ulcer

Summary: the aim of this study is to investigate efficiency of applying of adipose-derived mesenchymal stem cells (adsc) in treatment of chronic wounds in diabetic foot syndrome.

the product will contain an active ingredient- human allogeneic adipose-derived mesenchymal stem cells (adsc) cells suspended in the fibrin solution applied directly onto prepared wound bed, to form thin gel layer on the wound surface.

Eligibility criteria:
inclusion criteria: 1. signing informed consent form. 2. above the age of 18 3. voluntary participation in the research, following the requirements of the protocol and acceptance for procedures related with its implementation 4. chronic wound in the course of diabetic foot syndrome, with the wound surface between 1 - 25 sq. cm, without evidence of active infection of the wound at the time of qualification to participate in the study 5. blood level of glycated haemoglobin (hba1c) \<=11% 6. satisfactory blood supply to the wound verified by the measurement of the oxygen level in the foot tissue (\>=30 mmhg), or by the measurement of systolic blood pressure in posterior or anterior tibial artery (\>=50 mmhg) of the affected limb. 7. general health condition, which according to the investigator's opinion, allows patient's participation in all study procedures. exclusion criteria: 1. lack of patient's cooperation 2. wound etiology other than diabetic foot syndrome 3. clinicaly significant limb ischemia as verified by the measurement of the oxygen level in the foot tissue (\<30 mmhg), or by the measurement of systolic blood pressure in posterior or anterior tibial artery (\<50 mmhg) 4. active wound infection, which would require the treatment with antibiotics 5. known allergy to ingredients of study product (thrombin, penicillin). 6. active venous thromboembolism 7. any systemic disease (acute or chronic) in the stage of exacerbation or not stabilized, that in the opinion of the investigator may hinder or make impossible a patient's participation in the study 8. active cancer during chemotherapy or radiotherapy, or recent cancer, if the remission occured less than 5 years before joining the study

Keywords: stromal vascular fraction adipose-derived mesenchymal stem cells chronic wounds diabetes foot ulcer
pain neurophysiology education and exercise for adolescents with chronic idiopathic neck pain

Conditions: Neck Pain

Summary: this study compared the effectiveness of pain neurophysiology education and neck/shoulder exercises with no intervention in adolescents with chronic idiopathic neck pain (cinp).

forty three adolescents with chronic idiopathic neck pain were randomly allocated to receive pain neurophysiology education and shoulder/neck exercises (n=21) or no intervention (n=22). data on pain intensity (visual analogue scale), pain disability, neck flexor and extensor muscles endurance, scapulae stabilizers endurance, pain catastrophizing (pain catastrophizing scale), trait and state anxiety (state-trait anxiety inventory) and knowledge of pain neurophysiology (neurophysiology of pain questionnaire) were collected. measurements were taken before and after the intervention. statistical analysis were performed using a mixed-methods anova.

Eligibility criteria:
inclusion criteria: * to be invited to enter the study participants had to have chronic idiopathic neck/shoulder pain, defined as pain felt in the neck/shoulder regions at least once a week in the previous 3 months. exclusion criteria: * no exclusion criteria
effectiveness of the distraction methods during cystoscopy

Conditions: Pain; Anxiety; Satisfaction

Summary: cystoscopy is a pain procedure and patients may experience anxiety and dissatisfaction before and during the procedure. especially male patients feel more pain than females during cystoscopy. the aim of this study is to compare effectiveness of three different distraction methods on pain, anxiety and satisfaction of the male patients during cystoscopy.

cystoscopy is a reliable and effective method used commonly to investigate tumors and pathological or suspicious views related to bladder and urethra. the patients may feel pain, anxiety and dissatisfaction when cystoscope is inserted into the bladder. thus nonpharmacological and pharmacological methods are used to decrease pain, anxiety and dissatisfaction levels of the patients during the procedure. music is the most commonly used distraction method during cystoscopy, but there are few studies in this issue (only music) on literature. in additon, there isn't any study related to stress ball use during cystoscopy and there isn't any study which comparatives effectiveness of the multiple distraction methods to reduce pain, anxiety and dissatisfaction levels during this procedure. therefore the investigators aimed to compare effectiveness of three different distraction methods (music, stress ball and dvd) on pain, anxiety and satisfaction of the patients during cystoscopy.

Eligibility criteria:
inclusion criteria: * to be male and over 18 years old * to be first csytoscopy * to be rigid csytoscopy exclusion criteria: * to have a contradiction for csystoscopy (lidocaine allergies, urinary tract infection, no anatomical problems with the urethra etc.) * to be used any analgesic drug at least 24 hours prior to cystoscopy * to be made manipulations such as double j stent placement or removal, and bladder biopsy

Keywords: anxiety pain satisfaction cystoscopy music video stress ball nursing