Kornimate/medical-research-clean huggingface dataset:
evaluating of the safety, pharmacokinetics and pharmacodynamics of ql1205 and lucentis® in patients with wet amd

Conditions: Wet Age-related Macular Degeneration

Summary: this is a randomized, double-blind, two-group parallel, positive-controlled clinical phase i trial comparing the safety, pharmacokinetics and pharmacodynamics of ql1205 and lucentis® in patients with wet age-related macular degeneration.

this is a phase i, randomized, double-blind, two-group parallel, positive-controlled clinical trial at four centers. the primary objective is to assess the initial clinical safety of intravitreal injection of ql1205 or lucentis® in patients with wet age-related macular degeneration (wet-amd). the secondary objective are to assess the initial clinical effectiveness and pharmacokinetic characteristics of intravitreal injection of ql1205 or lucentis® in patients with wet age-related macular degeneration (wet-amd). subjects would sequentially enrolled according to the protocol in one of two cohorts.subjects would receive a single 0.5mg of ql1205 or lucentis® once a month for three months through vitreous injection.

Eligibility criteria:
inclusion criteria: 1. sign the informed consent form, and willing to receive follow-up according to the time stipulated by the trial; 2. aged ≥50 years or ≤80 years, male or female (including the boundary value); 3. the target eye must meet the following requirements; has newly occurring or relapsed subfoveal and perifoveal active choroidal neovascularization (cnv) lesions secondary to amd; the total area of all types of lesions is ≤30 mm2(the area of 12 optic discs); the best corrected visual acuity is 78-19 letters (equivalent to snellen visual acuity of 20/32 to 20/400); no refractive media opacity or myosis affecting fundus examination; 4. the best corrected visual acuity of the subject's non-target eye is ≥19 letters (equivalent to snellen visual acuity of 20/400). note: if the subject's eyes both meet the inclusion criteria, the investigator will determines the target eye from a medical point of view. exclusion criteria: patients with any of the following eye conditions: 1. the investigator judges that the target eye is currently suffering or used to suffer from non-exudative amd disease affecting macular detection, or ocular diseases affecting central visual acuity (including central venous obstruction, diabetic retinopathy, uveitis, vascular striation, pathological myopia, retinal detachment, macular hole, etc.); 2. the target eye's cnv is secondary to diseases other than amd, such as trauma, pathological myopia,etc.; 3. either eye has previously received drug treatment for cnv (e.g., lucentis, avastin, eylea, composin, acaconac, triamcinolone, steroids, etc.) 4. the target eye has subretinal hemorrhage, and hemorrhagic area is ≥ 50% of the total area of the lesion, or the subfoveal bleeding area is ≥ 1 optic disc area;
a study to compare emotional changes in subjects with social anxiety disorder

Conditions: Social Phobia

Summary: to compare by neuroimaging techniques the way social anxiety patients respond to public speaking before and after a drug administration


Eligibility criteria:
inclusion criteria: * outpatient with social anxiety disorder * the subject is healthy * willing to restrict alcohol intake * capable of giving informed consent exclusion criteria: * subjects with depression or any other psychiatric condition * subjects positive for hiv or hepatitis * subjects taking drugs or other medication * pregnant or becoming pregnant during the study * subjects who have donated blood * subjects who are left-handed * subjects with claustrophobia * subjects with an electronic device or ferromagnetic metal foreign body

Keywords: pet social anxiety disorder frmi
transcranial direct current stimulation (tdcs) as a treatment for cognitive deficits in schizophrenic

Conditions: Schizophrenia

Summary: this trial attempts to evaluate the effects of intensive transcranial direct-current stimulation (tdcs) on improving cognition in schizophrenia patients and changes in resting state brain network connectivity, especially increasing connectivity in the tasks related network, and increasing activation the dlpfc in a working memory task. half of the participants will be randomized to tdcs group, while the other half will be randomized to receive sham tdcs.

schizophrenia patients (sz) show profound and persistent cognitive deficits in attention, executive processing, and verbal and visuospatial memory, which persist even after psychotic symptoms are ameliorated. cognitive deficits may be more important in preventing functional, occupational, and social recovery in sz than other symptom domains and are not effectively treated by current pharmacological approaches. transcranial direct-current stimulation (tdcs) is less expensive than other modalities (e.g. repetitive transcranial magnetic stimulation; rtms), easily available, and has a good safety profile in healthy controls (hc) and sz. however, these prior studies did not make use of a validated measure such as the matrics consensus battery (mccb), which is now established as the standard for assessing cognitive improvement in sz. despite these promising preliminary results, this effect of tdcs in sz needs to be confirmed and the underlying biological mechanism elucidated. therefore, the investigators employed mccb to evaluate the effects on improving cognition and functional mri to explore the underlying mechanism. half of the participants will be randomized to tdcs group, while the other half will be randomized to receive sham tdcs. active vs. sham treatment will be randomly using computer generated lists. subjects and researcher-administrators of tdcs and testers or evaluators will be blind to treatment.the main cognitive outcome measure, the mccb, will be administered at baseline and 1 day after the last tdcs session.participants will be scanned once prior to tdcs sessions, and within one day after the 10th tdcs sessions using our siemens 3t verio mri scanner.

Eligibility criteria:
inclusion criteria: * subjects who have cognitive deficits as indicated by a score of \< 85 on rbans, and meet criteria for dsm-5 diagnosis of chronic sz, schizoaffective disorder (sa), or schizophreniform disorder (szf), and who are stably treated with antipsychotic medications and are not in acute exacerbation of illness symptoms. exclusion criteria: * patients with risk factors for an mri scan, seizure disorder, and for women of childbearing age who are pregnant or regularly engaging in sexual activity and not regularly using an acceptable birth control method (systemic or double-barrier).

Keywords: tdcs schizophrenia cognition fmri
sphenopalatine ganglion block in endoscopic transphenoidal pituitary gland surgery

Conditions: ULTRASOUND-GUIDED PERCUTANEOUS VERSUS TRANS-NASAL PTERYGOPALATINE FOSSA BLOCK in ENDOSCOPIC TRANS-SPHENOIDAL PITUITARY GLAND SURGERY

Summary: the primary aim of this study is to compare the effect of bilateral us guided percutaneous ppfb versus transnasal approach on intraoperative anaesthetic requirements (guided by entropy) in patients undergoing endoscopic transsphenoidal resection of pituitary gland surgery in conjucation with general anaesthesia (ga).secondary aims: total dose of intraoperative dexmedetomidine, intraoperative analgesia (fentanyl), haemodynamics, the surgical field conditions, recovery pattern, and side effects

endoscopic endonasal transsphenoidal resection of pituitary gland is the currently most used method for the resection of pituitary tumors. it is a minimally invasive surgical technique to access sellar and parasellar lesions. the main goal in endoscopic pituitary surgery are minimal tissue manipulation and clear bloodless field with better panoramic visualization under haemodynamic stability and good postoperative analgesia to improve the outcome .pterygopalatine fossa block (ppfb) is used to maintain haemodynamic stability and to decrease intraoperative anaesthetic requirements (ppfb)can be done transnasal or percutaneous ultrasound guided

Eligibility criteria:
inclusion criteria: * patients belonging to american society of anesthesiologists (asa) class i or ii * patients scheduled for endoscopic transphenoidal pituitary gland surgery exclusion criteria: patients will be excluded if; .history of allergy or contraindication to any of the studied drugs. * patients for whom pterygopalatine fossa block is contraindicated (patient refusal, fascial anomalies, coagulation disorder, skin infection at the injection site) .obese patients with bmi more than 35 kg/m2.

Keywords: sphenopalatine ganglion block transphenoidal pituitary gland surgery ultrasound guided sphenopalatine ganglion block
opioid sparing anesthesia care for pediatric patients having tonsil surgery

Conditions: Tonsillitis; Post-operative Nausea and Vomiting (PONV); Emergence Delirium; Opioid Analgesic Adverse Reaction; Anesthesia; Pain

Summary: this is a prospective, randomized, controlled, non-inferiority study of patients undergoing tonsil surgeries at boston children's hospital waltham. the overall aim is to evaluate the efficacy of an opioid anesthetic plan (morphine, ketorolac, and acetaminophen versus an opioid sparing anesthetic plan (dexmedetomidine, ketorolac and acetaminophen) for perioperative analgesia and recovery time in patients undergoing tonsillectomies and tonsillotomies at boston children's hospital waltham. secondary measures include rescue opioids administered in post-anesthesia care unit (pacu), re-operation secondary to bleeding, emergence delirium, post-operative nausea and vomiting, intraoperative hemodynamics, intraoperative vasopressor administration, and length of procedure.


Eligibility criteria:
inclusion criteria: * american society of anesthesia classification status i-iii * ages 3 years to 17 years * scheduled for tonsillectomy or tonsillotomy with or without adenoidectomy at boston children's hospital waltham exclusion criteria: * patients not scheduled for primary tonsillectomy/tonsillotomy. * patients with known coagulopathies * patients with previous chronic pain syndromes * patients with any condition/indication that would prevent them from being able to be randomized (i.e. allergy to one of the study medications)
the value of hpv testing for cervical cancer screening in women living with hiv (papillo-vih)

Conditions: HIV Seropositivity

Summary: the main objective of this study is to evaluate the interest of a screening strategy based on the hpv test in patients living with hiv, compared to the cell smear alone in the same population. the secondary objective of this study is to verify if the use of hpv testing could allow for a longer follow-up of these patients in case of negativity, and thus allow for a standardization of clinicians' practices.

since 2019, a new screening strategy has been implemented and is based on high-risk, hpv tests, which, when negative, allow for spaced monitoring in the general population after age 30 (every 5 years instead of every 3 years.) these tests therefore allow for earlier detection of patients at risk but also for longer follow-up when they are negative. to our knowledge, there is currently no evaluation of hpv testing as part of routine screening in patients living with hiv. the recommendations for this population are based on the use of the cervico-vaginal smear with cytological analysis. the smear should be taken every year and surveillance may be repeated every 3 years. if there are 3 consecutive smears without abnormalities and a controlled viral load with cd4 counts \> 500 mm3. in practice, many patients do not meet these criteria and must, therefore, undergo annual screening; the increase in the number of smears also leads to an increase in the number of second-line examinations such as colposcopy. since there is no recommendation for hpv testing in this population, the use of dual detection (cytology and hpv testing) is left to the discretion of the clinician. by mutual agreement with the clinicians of the maternity department of the saint-denis hospital (chsd), this double detection was introduced in 2021, using the same sample (single swab for both analyses: cytology and hpv test). therefore, it seems interesting to verify the possibility of a screening strategy based on hpv testing in patients living with hiv, by correlating the results of hpv testing and cell smears in the population of patients living with hiv.

Eligibility criteria:
inclusion criteria: * women living with hiv * age 25-65 years * managed in the chsd maternity ward: consultation or hospitalization * having signed a consent form exclusion criteria: * age ≤ 24 years, or ≥ 66 years * women who are not hiv positive * patients under legal protection (guardianship, curatorship) * patients deprived of liberty * patients not affiliated to a social security system * refusal to participate in the research

Keywords: hpv test cervical cancer
a study of idasanutlin with cytarabine versus cytarabine plus placebo in participants with relapsed or refractory acute myeloid leukemia (aml)

Conditions: Leukemia, Myeloid, Acute

Summary: this is a multicenter, double-blind, randomized, placebo-controlled study designed to compare overall survival in participants with relapsed or refractory aml treated with idasanutlin in combination with cytarabine versus participants treated with placebo and cytarabine. participants will receive induction treatment with idasanutlin/placebo and cytarabine (cycle 1). responding participants may continue to receive a maximum of further two cycles of consolidation (cycle 2 and cycle 3). complete remission (cr), cr with incomplete platelet count recovery (crp), overall remission rate (orr), event-free survival (efs) and percentage of participants with an allogeneic hematopoietic stem cell transplant (hsct) will also be compared between treatment arms. this study will include participants with and without tp53 wild type (tp53 wt) mutations.


Eligibility criteria:
inclusion criteria: * documented/confirmed first/second refractory/relapsed aml using world health organization classification, except acute promyelocytic leukemia * no more than 2 prior induction regimens (excluding prior hsct) in their first line treatment and one must have included cytarabine with an anthracycline (or anthracenedione) * eastern cooperative oncology group performance status of 0 to 2 * adequate hepatic and renal function * white blood cell (wbc) count at randomization less than or equal to (\</=) 50000 cells per cubic millimeter (/mm\^3) exclusion criteria: * first relapsed participants aged less than (\ ) 1 year * participants with prior documented antecedent hematological disorder (ahd) * aml secondary to any prior chemotherapy unrelated to leukemia * participants who are either refractory to or relapsed within 90 days of receiving a regimen containing a cumulative dose of greater than or equal to (\>/=) 18 g/m\^2 of cytarabine * participants who have received allogeneic hsct within 90 days prior to randomization * participants who have received immunosuppressive therapy for graft versus host disease or for engraftment syndrome after autologous stem cell transplantation within 2 weeks prior to randomization * prior treatment with an murine double minute 2 (mdm2) antagonist * participants receiving any other investigational or commercial agents or therapies administered with the intention to treat their malignancy within 30 days from first receipt of study drug * participants with a history of other malignancy within 5 years prior to screening except for malignancy that has been in remission without treatment for at least 2 years prior to randomization * participants who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study * participants with extramedullary aml with no evidence of systemic involvement * pregnant or breastfeeding participants
influence of alcohol marketing stimuli in adults with regular alcohol consumption

Conditions: Alcohol Abuse

Summary: alcohol use is the second leading cause of preventable death after smoking. the evin law was built in 1991 with the goal of reducing exposure to alcohol marketing among the youngest. but this law is currently extremely weakened, and in a press release of february 26, 2018, the french society of alcoology is alarmed by these developments. studies on the impact of alcohol marketing focus for the most part on young adolescents and the links between marketing exposure and alcohol initiation. but beyond these links, little work has been done on the impact of alcohol marketing on vulnerable subjects with regular alcohol consumption. alcohol consumption is one of the very first causes of hospitalization in france. the damage is often limited to the notion of risks of dependence, but it can appear as soon as consumption of 1 standard unit/day and mainly concerns the 45-64 year olds. to investigator knowledge, there are no studies on the impact of alcohol marketing carried out among regular alcohol users with moderate or severe alcohol use disorders.


Eligibility criteria:
inclusion criteria: * patient over 18 years of age * patient with moderate to severe alcohol use disorders (beyond 3 out of 11 criteria on the dsm-5 scale) * non-opposition of the patient exclusion criteria: * minor patient * patient who has already participated in phase 1 of the project * non-comprehension of the written french language * refusal to participate in the study * patient of legal age, deprived of liberty by a judicial or administrative decision or unable to express their consent
pharmacokinetics & safety of serelaxin on top of standard of care therapy in pediatric patients with acute heart failure

Conditions: Acute Heart Failure

Summary: the purpose of the study was to evaluate the safety, tolerability and pharmacokinetics of an intravenous infusion of serelaxin on top of standard of care therapy, in pediatric patients with acute heart failure (ahf)

the study was terminated early and the pediatric development of serelaxin in the treatment of acute heart failure (ahf) discontinued, following the results of the phase iii study relax-ahf-2 (crlx030a2301/nct01870778) study in adult patients with ahf. whilst no new safety concerns associated with serelaxin were observed, the study in adults did not meet either of its primary endpoints

Eligibility criteria:
key inclusion criteria: * body weight ≥2.5 kg to ≤120 kg * hospitalized in an intensive care unit or step-down unit with the following: * - signs and symptoms of acute heart failure of any etiology * - stable dose of vasoactive and/or inotropic drugs * - for non-surgical patients echocardiographic evidence of reduced ventricular function (ejection fraction \<50% or fractional shortening \<28%) * systolic blood pressure (sbp) ≥25th percentile sbp for age and gender. key exclusion criteria: * moderate to severe left ventricular outflow tract, mitral stenosis, or aortic arch obstruction * single ventricle physiology * fixed pulmonary hypertension * blood lactate levels \>5 mmol/l at screening * birth \< 36 weeks post-conceptual age (for patients \<1year old) * confirmed or clinically suspected systemic infection or severe localized infection * dyspnea or acute lung injury primarily due to non-cardiac causes * patients with severe renal impairment, those known to have significant renal disease and those having renal replacement therapy * high use of inotropic and/or vasoactive agents at screening * electrocardiographic abnormalities * solid organ transplant recipient within 1 year of transplantation or one who presents with severe organ rejection

Keywords: acute heart failure relax-ahf-pediatric pk ahf
ef intervention in children with severe congenital heart disease

Conditions: Heart Defects, Congenital; Executive Dysfunction

Summary: survival rates of children with severe congenital heart disease (chd) have increased with ongoing medical progress over the past decades. however, many children with chd face academic challenges during adolescence, which are associated with executive dysfunction. executive functions (ef), higher-order cognitive processes allowing goal-directed behavior, can be particularly affected in children with chd. to improve ef in affected children, a specific ef intervention has been developed. the intervention lasts a total of 8 weeks and is structured in 3 modules. the first module consists of a weekly strategy training in which problems resulting from executive dysfunction are addressed. online games form the second module. these are games implemented online to promote ef through play. the third module is also based on games: the families receive several board games to play together at home. this third module is voluntary. this intervention is tested on its feasibility. as the intervention was built in a patient centered manner, we expect it to be feasible, showing in a high adherence rate and satisfaction.


Eligibility criteria:
inclusion criteria: * born with chd * underwent cardiopulmonary bypass surgery * no genetic syndrome detected, no known dysmorphic-syndrome * aged 10 to 12 * written informed consent of parents and verbal informed consent of children * ef deficits showing in screening exclusion criteria: * failure to provide a signed informed consent * heart surgery without cardiopulmonary bypass * heart surgery not performed in switzerland * any genetic syndrome detected * large cerebral lesions (stroke, hie) or severely neurologically impaired as a result of a serious event
measurement of the distribution of optical properties in adult human muscle

Conditions: Muscle Disorder

Summary: the researcher can use diffuse optical spectroscopy technique that uses harmless levels of near-infrared light to probe the concentrations and states of important physiological molecules such as hemoglobin water and lipids in human muscle,.

the researcher can monitor muscle physiology, for example during exercise or in response to external factors such as shock by diffuse optical spectroscopy technique. the diffuse optical spectroscopy technique can determine significant changes in muscle, muscle structure, muscle tissues metabolism and hemodynamics.

Eligibility criteria:
inclusion criteria: * male or female age 18 years and older * diagnosed of cachexic condition * diagnosed of cellulite adult female 18 years and older exclusion criteria: * pregnant women * taking light sensitive drugs for use in photodynamic therapy