Kornimate/medical-research-clean huggingface dataset:
anti-angiopoeitin 2 plus anti-vascular endothelial growth factor as a therapy for neovascular age related macular degeneration: evaluation of a fixed combination intravitreal injection

Conditions: Neovascular Age-Related Macular Degeneration

Summary: the primary objective of the study is to compare the efficacy of intravitreal (ivt)-administered regn910-3 compared to intravitreal aflibercept injection (iai).


Eligibility criteria:
key inclusion criteria: 1. men or women ≥50 years of age with active subfoveal cnv secondary to amd, including juxtafoveal lesions that affect the fovea as evidenced by fa in the study eye as assessed by a central reading center 2. bcva etdrs letter score of 73 to 24 (snellen equivalent of 20/40 to 20/320) in the study eye. 3. willing and able to comply with clinic visits and study-related procedures. 4. provide signed informed consent. key exclusion criteria: 1. evidence of cnv due to any cause other than amd in either eye 2. prior ivt anti-vegf in the study eye 3. evidence of dme or diabetic retinopathy (defined as more than 1 microaneurysm) in either eye in diabetic patients 4. any history of macular hole of stage 2 and above in the study eye
combined plexus block for hip fracture surgery.

Conditions: Hip Fractures

Summary: hip fracture surgery requires high risk anesthetic procedure for elderly patients (1). general anesthesia, continuous spinal anesthesia and peripheral nerve blocks are three anesthetic techniques possible. continuous spinal anesthesia has proven its efficacity to provide an intraoperative haemodynamic stability wich guarantees good patients outcomes (2), in comparison with general anesthesia but there is poor evidence in the literature concerning the use of peripheral nerve blocks. the primary objective of this study was to compare intraoperative haemodynamic stability provides by peripheral nerve block versus general anesthesia and continuous spinal anesthesia. secondary outcomes included : use of vasoactive drugs, opioids consumption, lengh of stay and inhospital mortality.

after receiving the ethic approval from the "cerar", the investigators retrospectively identified all patients who underwent hip fracture surgery from january 1 2015, to december 31, 2016 in the chu of montpellier. the exclusion criteria were: multiple trauma victims, two hip fractures in the same patient and single shot spinal anesthesia. in our institution the investigators used to perform three types of anesthesia: general anesthesia (ga), continuous spinal anesthesia (csa) and combined plexus blocks (cpb). the investigators therefore made three groups ga, csa and cpb and used a propensity score to make these groups comparable. the matching criteria were age, arterial hypertension, asa status, frailty score, chronic cardiac failure and type of surgery.

Eligibility criteria:
inclusion criteria: * adult * hip fracture surgery exclusion criteria: * multiple trauma victims * second hip fracture in same patient * single shot spinal anesthesia

Keywords: adults
topical application to relieve gout: efficacy trial & safety (targets)

Conditions: Gout

Summary: this overall goal of this trial will be to demonstrate that dyv700 is safe and effective as a treatment for acute gout flares.

gout presents as intermittent acute painful and debilitating gout flares. high serum uric acid levels lead to the deposition of urate crystals in and around the joints, most commonly the big toe (also called podagra) and other peripheral joints. an acute gout flare causes extreme pain and inflammation of the afflicted joints. it initially presents as a monoarticular condition but can affect several joints as the disease progresses. gout flares typically take 7-10 days to resolve. currently, the inflammation and pain associated with acute gout flares are treated anti-inflammatories, including non steroidal anti-inflammatory drugs (nsaids), colchicine, corticosteroids, and adrenocorticotropic hormone. however these drugs are limited in efficacy, contraindicated for some patients and may take more than 24 hours to relieve gout symptoms (e.g. colchicine). dyv700 will be developed to reduce the pain associated with acute gout flares. dyv700 is applied topically and utilizes a proprietary drug delivery system to deliver it's active ingredients.

Eligibility criteria:
key inclusion criteria: 1. females and males, age 18 to 75 years of age. 2. diagnosis of gout using acr/eular criteria (must have a score of equal to or greater than 8) 3. subjects must have experienced ≥2 gout flares in the 12 months prior to screening; 4. subjects that have not changed their urate lowering therapy (ult) in the 2 weeks prior to the start of the gout flare and who will remain on the same dose throughout the follow-up period of the trial. 5. if taking nsaid, oral steroids, opioids, or other pain medications at standard doses (as stated on drug label) for pain unrelated to their gout flare, must be taking the same drug for at least 7 days prior to the gout flare and throughout the length of the trial. 6. women of childbearing potential are excluded. women not considered of childbearing potential must have one of the following documented in their study medical history: 1. postmenopausal for at least 12 months prior to study; 2. without a uterus and/or both ovaries; or 3. bilateral tubal ligation at least six months prior to study enrollment. key exclusion criteria: 1. bmi of \>40kg/m2 at the time of screening 2. subjects that have not changed their urate lowering therapy (ult) in the 2 weeks prior to the start of the gout flare and who will remain on the same dose throughout the follow-up period of the trial. 3. subjects who are contraindicated for the use of colchicine or whom are unable to take the soc dose of 1.2mg followed by 0.6mg an hour later. 4. subjects with rheumatoid arthritis, psoriatic arthritis, evidence/suspicion of infectious/septic arthritis, acute polyarticular gout (4 or more joints), with arthritis due to any cause other than gout that may confound any study assessments per investigator discretion. 5. subjects who have experienced \>2 gout flares per month, or \>12 attacks overall in the months prior to randomization. -
efficacy of cervical stabilization exercises on hand grip strength in chronic myofascial neck pain

Conditions: Chronic Neck Pain

Summary: the purpose of this study is to examine effect of cervical stabilization exercises on hand grip strength, key pinch strength, pain intensity, pain pressure threshold and hand function in chronic myofascial neck pain patients.

myofascial pain of the trapezius is considered one of the main causes of neck pain and characterized by deep, intense pain of the skeletal muscles and their fascia and by the presence of one or more mtrps, although mtrps can be formed in any muscle or muscle group, previous studies concluded that the upper trapezius(ut) muscle is the most commonly affected muscle. considering the role of synergistic function of the ut muscle in scapula-humeral rhythm during shoulder movement, it is not surprising that mtrps in ut muscle can result in shoulder dysfunction and disability. muscle activity of proximal parts is necessary for activation of distal parts. in fact, the stable activity of distal parts needs controlling the proximal parts. thus, the stability of shoulder girdle is required for activity of distal parts such as fingers, wrists and elbows. in addition, trigger points in the ut can affect grip strength, which depends on shoulder joint and scapular stability. thus, ut muscle dysfunction can reduce grip strength. however, little research has been carried out to determine the therapeutic effects of cervical stabilization exercises on chronic neck pain, and up till now, there is a gap in literature to explore efficacy of cervical stabilization exercises on chronic neck pain and hand grip strength. therefore, this study aims to investigate whether cervical stabilization exercises has an effect on hand grip strength in chronic myofascial neck pain.

Eligibility criteria:
inclusion criteria: 1. chronic neck pain for more than 3 months. 2. active mtrps in the ut muscle with a tender nodule. 3. constant neck pain, a jump sign during palpation of ut muscle. 4. referred pain. 5. symptoms of ipsilateral hand muscles weakness. exclusion criteria: 1. signs of severe pathology such as malignancy of the cervical area. 2. fractures of the cervical spine. 3. cervical radiculopathy or myelopathy. 4. diabetes. 5. trauma, congenital anomalies and surgery around neck, shoulder and hand. 6. fibromyalgia or vascular syndromes such as vertebra-basilar insufficiency. 7. pregnancy.

Keywords: cervical stabilization hand grip myofascial neck pain
patients derived organoids in ovarian cancer

Conditions: Ovarian Cancer

Summary: among cancer models, patients derived organoids (pdos) best reproduce tumor's tissue architecture, intratumor heterogeneity and are able to mimic in vivo patients' drugs response. for these reasons, it has been designed a study to assess the feasibility of pdos immune cells co-culture in oc patients and the concordance between ex vivo sensitivity and in vivo treatment response. if proven effective and reliable, pdos could be introduced into clinical practice as empirical predictor of patients' response to antineoplastic drugs.


Eligibility criteria:
inclusion criteria: 1. preoperative clinical, serological and radiologic suspicion of international federation of gynecology and obstetrics (figo) stage iiic or greater ovarian, fallopian tube, or primary peritoneal cancer; 2. histologic diagnoses of epithelial ovarian cancer at frozen section 3. age \>18 and years; 4. estimated life expectancy of at least 4 weeks; 5. performance status (ps) according to eastern cooperative oncology group (ecog) \< 2 exclusion criteria: 1. non-serous histology at frozen section; 2. patients with a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (\> 10 mg equivalent prednisone/daily) or any other form of immunosuppressive therapy within 7 days prior to the enrollment.
interest of the bruxense occlusal splints for bruxism diagnosis: a feasibility study

Conditions: Bruxism, Sleep-Related

Summary: there is no accurate diagnosis method for bruxism for now. consequences of bruxism over teeth, muscles and articulation of the jaw are important. this study aims to develop a innovative tool in order to accurately rapidly diagnose bruxism in ambulatory evaluation.


Eligibility criteria:
inclusion criteria: * adult from 18-70 * patients diagnosed with bruxism according to the following criteria: * positive question at one of the following question: * are you aware of your grinding? * does your partner hear you grinding? * are you aware that you are frequently tighten your jaws during the day and/or the night? * are you tired and/or do experience jaws 'muscular pain in the morning. * presence of at least one criteria: * abnormal tooth wear or tooth prosthesis damages * hypertrophy of the masseter muscles * patients agreeing to participate * patient able to understand and follow the protocol * patient with health insurance exclusion criteria: * patients with more than 2 missing tooth * severe troubles to correctly close the mouth. * neurological disorder (parkinson, alzheimer) or psychiatric disorder * sleep disorder (insomnia, narcolepsy, sleep apnea, restless leg disorder) * use of drugs that potentially impair sleep (benzodiazepines, neuroleptics, tricyclic antidepressants) alcohol or narcotics. * complete or partial removal dental prosthesis or orthodontic device * patient under legal protection * pregnant women * patients deprived of their freedom by a judicial or administrative decision
comparison of the prediction derived by the cardiovascular performance reserve index with the clinical evaluation

Conditions: Healthy; Heart Failure

Summary: the study hypothesizes that an assumed cardiovascular performance reserve is physiologically detectable. high reserve at rest characterizes a healthy person while low reserve at rest characterizes low functional capacity e.g. heart failure. the lower the reserve the severer the morbidity. the reserve may be estimated through cvri (cardiovascular reserve index) which is computed by an algorithm composed of physiological measurements taken during the patient visit. in this study the investigators evaluate cvri capability in prediction of functional capacity in comparison with the clinical evaluation during the same visit.

the study hypothesizes that an assumed cardiovascular performance reserve is physiologically detectable and continuously monitored by a physiological control (reserve control)not yet discovered. high reserve at rest characterizes a healthy person while low reserve at rest characterizes low functional capacity e.g. heart failure. the lower the reserve the severer the morbidity. the reserve is decreased reversibly with aerobic activity and may reach an exhaustion threshold in which the assumed reserve control induces a reversible fatigue and dyspnea which dissolve once the activity decreased. the reserve may be estimated through cvri (cardiovascular reserve index) which is computed by an algorithm composed of physiological measurements taken during the patient visit (composed of blood pressure, heart rate, respiratory rate, central venous pressure or its estimation, weight, height and gender. in this study the investigators evaluate cvri capability in prediction of functional capacity in comparison with the clinical evaluation during the same visit (cross sectional comparison).

Eligibility criteria:
inclusion criteria: * adult informed consent exclusion criteria: * an emergency case

Keywords: functional capacity nyha class
placebo-controlled trial of safety and efficacy of thalidomide in patients with infections due to mycobacterium and/or hiv

Conditions: Mycobacterium Avium-Intracellulare Infection; HIV Infections; Tuberculosis, Mycobacterium Infection

Summary: to demonstrate, in patients with tubercular or nontubercular mycobacterium infections with or without hiv infection, the safety of thalidomide use as judged by symptoms, physical exam, and studies of microbiologic, immunologic, hematologic, renal, and hepatic status. to demonstrate efficacy of the drug as judged by status of fever, nutrition, tuberculosis lesions, and immune responses.

patients are randomized to receive thalidomide or placebo orally at 9 pm the night before beginning anti-tuberculosis chemotherapy and continuing nightly for 7 nights. patients are followed for 28 days. patients are stratified according to hiv status and stage of hiv infection.

Eligibility criteria:
inclusion criteria patients must have: * positive afb smear and/or culture for mycobacterium tuberculosis, m. avium, or other mycobacterial infection, with or without documented hiv infection. note: * hiv-positive patients must have cd4 count \< 500 cells/mm3 and be on antiretroviral therapy. * one of the following manifestations: * temperature over 38 c on at least two occasions in the week prior to study entry. * recent weight loss of more than 5 kilograms. * pulmonary involvement of one or more lobes or involvement of other tissues due to tuberculosis or other mycobacterial infections, or symptomatic infections related to hiv status. * night sweats on two or more occasions in the week prior to study entry. note: * patients must be hospitalized men aged 18-65 and postmenopausal women to age 65. anticipated requirement for hospitalization must be at least 10 days. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * neuropathy or other disorders with risk of neuropathy. required for hiv-positive patients if cd4 count \< 500 cells/mm3: * antiretroviral therapy.

Keywords: mycobacterium tuberculosis mycobacterium infections aids-related opportunistic infections mycobacterium avium-intracellulare infection acquired immunodeficiency syndrome aids-related complex mycobacterium infections, atypical thalidomide
clinical trail to evaluate the efficacy and safety of dwj1451

Conditions: Hypertension, Dyslipidemia

Summary: * the change of sitsbp based on baseline between treatment arm and control 1 arm \[ time frame: 8 weeks \] * the change of ldl-c based on baseline between treatment arm and control2 arm \[ time frame: 8 weeks \]


Eligibility criteria:
inclusion criteria: * age 19 to 80 years * patients with hypertension and hyperlipidemias exclusion criteria: * orthostatic hypotension * history of ventricular tachycardia, atrial fibrillation * uncontrolled diabetes mellitus
evaluating prenatal exome sequencing study

Conditions: Congenital Anomalies; Mendelian Disorders; Genetic Diseases, Inborn

Summary: this study evaluates the impact of the various outcomes of pes (definitive diagnosis, probable diagnosis and if) on clinical decision making and on parental psychological wellbeing, compared between different analysis strategies to investigate the clinical utility, defined as the balance between potential harms and benefits.

foetal anomalies as detected on prenatal ultrasound are present in 2-3% of pregnancies. the diagnosis of a genetic syndrome as the underlying cause often has significant consequences for the prognosis and therefore also a significant impact on parental reproductive decision making. in addition to chromosomal testing, prenatal exome sequencing (pes) is increasingly being offered. although prenatal diagnostic rates are promising, no studies report on the actual implementation of pes in routine care and thus several important knowledge gaps remain regarding clinical utility (the balance between potential harms and benefits) and the preferred analysis strategy (broad versus targeted analysis). a broad analysis has a possible higher diagnostic yield, but it is unknown whether the increased chance of finding an uncertain diagnosis and incidental findings outweighs this benefit when it comes to clinical decision making and parental psychological wellbeing. the central aim of this study is to address the knowledge gaps raised above, and increase clinical utility by using the obtained data to improve analysis strategies and to potentially identify new genes.

Eligibility criteria:
inclusion criteria: * at least one fetal anomaly detected in the current pregnancy, irrespective of gestational age; * pregnancy ongoing; * mother at least 18 years old and providing consent for pes; * if father is available: father at least 18 years old and providing consent for pes. exclusion criteria: there are no exclusion criteria.

Keywords: prenatal diagnosis next generation sequencing whole exome sequencing patient perspectives clinical utility
mk0524 asthma poc study (0524-008)(completed)

Conditions: Asthma

Summary: the purpose of the study is to demonstrate the benefit of mk0524 compared to placebo in patients with chronic asthma.


Eligibility criteria:
inclusion criteria: * has symptoms of chronic asthma (shortness of breath, wheezing, chest tightness, etc.) for at least 1 year * nonsmoker for at least 1 year with a smoking history of no more than 7 pack-years (i.e., 1 pack per day for 7 years) exclusion criteria: * any clinically significant disease of heart, intestinal, kidney, liver, lung or uncontrolled blood pressure * any surgery within 4 weeks prior to visit 1 * patient is intending to move or vacation for more than 5 days during the study * patient is pregnant or breast-feeding

Keywords: chronic asthma
study of cyclosporine in the treatment of dry eye syndrome (st-603-007)

Conditions: Dry Eye Syndromes

Summary: the purpose of this phase 3 study is to determine the safety and efficacy of cyclosporine in the treatment of dry eye syndrome.


Eligibility criteria:
inclusion criteria: * diagnosis of moderate to severe dry eye syndrome with or without sjogren's syndrome or other autoimmune disease exclusion criteria: * intraocular or refractive surgery in the study eye within 3 months prior to study start * unwilling to discontinue use of contact lenses during the run-in and duration of the study * pregnancy or lactation
study of generic pimecrolimus cream, 1% in the treatment of mild to moderate atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this is a randomized, double-blind, placebo-controlled, parallel-group, multiple-site study to evaluate the therapeutic equivalence of a generic pimecrolimus cream, 1% (glenmark pharmaceuticals ltd) to the marketed product elidel® (pimecrolimus) cream, 1% (valeant pharmaceuticals north america llc) in the treatment of mild to moderate atopic dermatitis (ad).


Eligibility criteria:
inclusion criteria: * male or non-pregnant, non-lactating female subjects 12 years of age and older. * non-immunocompromised, with a clinical diagnosis of mild to moderate ad that has failed to respond adequately to other topical prescription treatments for atopic dermatitis, or for whom those treatments are not advisable. * confirmed diagnosis of ad for at least 3 months using the diagnostic features as described by hanifin and rajka. * iga score of 2 (mild) or 3 (moderate) and ≥ 5% bsa affected at baseline. exclusion criteria: * active cutaneous bacterial, viral or fungal infection in any treatment area at baseline (e.g., clinically infected ad). * sunburn, extensive scarring or pigmented lesion(s) in any treatment area at baseline and history or presence of skin conditions that would interfere with evaluations. * history or presence of netherton's syndrome, immunological deficiencies or diseases, organ transplant, hiv, diabetes, malignancy, malignant or pre-malignant skin conditions, serious active or recurrent infection, systemic immunosuppressive regimens, clinically significant severe renal insufficiency or severe hepatic disorders. * use within one month before baseline of 1) oral or intravenous corticosteroids, 2) uva/uvb therapy, 3) psoralen plus ultraviolet a therapy (puva), 4) tanning booths, 5) non-prescription ultraviolet (uv) light sources, 6) immunomodulators or immunosuppressive therapies, 7) interferon, 8) cytotoxic drugs, 9) tacrolimus or 10) pimecrolimus. * use within 14 days before baseline of: 1) systemic antibiotics, 2) calcipotriene or other vitamin d preparations, or 3) retinoids. * use within 7 days before baseline of: 1) antihistamines, 2) topical antibiotics, 3) topical corticosteroids or 4) other topical drug products.

Keywords: mild to moderate