Kornimate/medical-research-clean huggingface dataset:
vascular compression assessment using transcutaneous oxymetry in patients suspected of having thoracic outlet syndrome

Conditions: Thoracic Outlet Syndrome

Summary: thoracic outlet syndrome (tos) is characterized by nervous, venous or arterial symptoms resulting from a compression of the thoracic bundle in the thoracic outlet. the diagnostic approach of tos is still controversial. the investigating team is interested in arterial tos and have already been able to demonstrate the presence of arm ischemia during dynamic maneuvers using transcutaneous oximetry (tcpo2). the correlation between the measurement of tcpo2 during dynamic maneuvers and the vascular compression type (arterial, venous or both) will be evaluated. the evaluation the correlation between tcpo2 and degree of arterial compression observed in dynamic arteriography (considered as a gold standard examination) will be calculated too. the use of tcpo2 could be developed in the diagnosis assessment of tos.


Eligibility criteria:
inclusion criteria: * patient suspected of having a thoracic outlet syndrome * patient having carried out additional examinations as part of the diagnostic assessment : venous and arterial doppler or dynamic arteriography and venography * patient having carried out a dynamic tcpo2 recording exclusion criteria: * patient under 18 year old * non french speaker * patient who expressed his/her refusal

Keywords: transcutaneous oximetry thoracic outlet syndrome arteriography vascular compression
efficacy and safety of rec-2282 in patients with progressive neurofibromatosis type 2 (nf2) mutated meningiomas

Conditions: Neurofibromatosis Type 2

Summary: this is a two-staged, phase 2/3, randomized, multi-center study to investigate the efficacy and safety of rec-2282 in patients with progressive nf2 mutated meningiomas.

this is a two-staged, phase 2/3, randomized, multi-center study to investigate the efficacy and safety of rec-2282 in patients with progressive nf2 mutated meningiomas, with either nf2 disease-related meningioma or recurrent sporadic meningiomas that have nf2 mutations. cohort a will provide early data on efficacy and safety of rec-2282 in participants with progressive nf2 mutated meningiomas, and provide guidance for the dose in the confirmatory part of the study (cohort b). the purpose of cohort b of the study is to assess the efficacy and safety of rec-2282 compared with placebo in participants with progressive nf2 mutated meningiomas. in both cohorts, there will be a screening period of up to 8 weeks, a treatment period, a 4-week safety follow-up period after the end of treatment, and a 6-month post-study follow-up. the first 8 participants enrolled in cohort a will complete a food effect run-in sub study. at the end of the study period, participants may be offered participation in an open-label extension (ole) period. in cohort a, adult participants will be randomized to one of two dose levels of rec-2282. in cohort b, participants will be randomized to rec-2282 treatment (dose to be determined from cohort a) arm or placebo arm in a ratio of 2:1.

Eligibility criteria:
inclusion criteria: 1. ≥12 years of age and weighing at least 40 kg 2. progressive meningioma that is amenable to volumetric analysis 3. has either 1) sporadic meningioma with confirmed nf2 mutation; or, 2) confirmed diagnosis of nf2 disease (revised manchester criteria); or, 3) at least one nf2-related tumor (with pathogenic germline or proven mosaic nf2 variant) 4. adequate bone marrow function 5. has provided written informed consent/assent to participate in the study exclusion criteria: 1. progressive disease associated with significant or disabling clinical symptoms likely to require surgery or radiation therapy within the next 3 months. 2. received prior surgery, radiosurgery, or laser interstitial thermal therapy in the target tumor, or immediately adjacent to the target tumor within 6 months prior to screening. 3. received an anti- tumor agent for meningioma within 3 months, or 5 half-lives (whichever is longer), prior to screening. 4. history of an active malignancy within the previous 3 years except for localized cancers that are considered cured, and, in the opinion of the investigator, present a low risk of recurrence. 5. received another investigational drug within 30 days prior to screening 6. pregnant, lactating, or is planning to attempt to become pregnant or impregnate someone during this study or within 90 days after the last dose of imp.

Keywords: neurofibromatosis type 2; neurofibromatosis type ii
comparison of ceramic-on-ceramic and ceramic-on-highly-cross-linked polyethylene bearings

Conditions: Osteonecrosis; Osteoarthritis

Summary: the purpose of this prospective, randomized study was to compare the clinical and radiographic results and the prevalence of osteolysis of the cementless total hip arthroplasty with an alumina-on-alumina bearings one side and alumina-on-highly cross-linked polyethylene bearings on the other side in the young and active patients.


Eligibility criteria:
inclusion criteria: * primary hip osteoarthritis * secondary hip osteoarthritis * avascular necrosis of femoral head exclusion criteria: * previous surgical history of hip

Keywords: cementless total hip arthroplasty ceramic on ceramic bearing ceramic on highly cross linked polyethylene young patient
study of navtemadlin plus pembrolizumab as maintenance therapy in locally advanced and metastatic non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: this study evaluates navtemadlin (krt-232) in combination with pembrolizumab as a maintenance therapy in patients with locally advanced and metastatic non small cell lung cancer.

this is a 2 part, phase 1b/2, maintenance study for patients who have achieved a partial response (pr) or complete response (cr) after completion of up to 4 cycles of a combination platinum-based chemotherapy plus cpi regimen. phase 1b is a 3+3 dose escalation design that will be used to determine the maximum tolerated dose (mtd) and/or the recommended phase 2 dose (rp2d) of navtemadlin in combination with pembrolizumab. a safety review committee (src) will review the safety data during the dose escalation to decide on dose escalation and/or exploration of intermediate doses. phase 2 will evaluate the efficacy and safety of the rp2d of navtemadlin plus pembrolizumab compared to navtemadlin placebo plus pembrolizumab. each arm will have approximately 40 subjects enrolled for a total of approximately 80 subjects. eligible subjects will be randomized 1:1. this part of the study has a randomized, controlled, double-blind design. a stratified, permuted-block randomization scheme will be used for treatment allocation.

Eligibility criteria:
inclusion criteria: * ecog 0-1 * histologically or cytologically confirmed diagnosis of nsclc documented as tp53wt * locally advanced or metastatic disease; must have completed up to 4 cycles of platinum-based chemo plus cpi and achieved a cr or pr per recist v1.1 * adequate hematologic, hepatic and renal function (within 14 days) exclusion criteria: * symptomatic or uncontrolled central nervous system (cns) metastases * prior treatment with a mdm2 inhibitor * grade 2 or higher qtc prolongation (\>480 msec per nci-ctcae criteria version 5.0) * history of bleeding diathesis; major hemorrhage or intracranial hemorrhage within 24 weeks * history of major organ transplant * active pneumonitis or known history of interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis * prior radiotherapy, cytoreductive therapy, cytokine therapy or any investigational therapy within 28 days * medical condition, serious intercurrent illness, psychiatric condition or other circumstance that, in the investigator's judgment could jeopardize the subject's safety, or that could interfere with study objectives

Keywords: navtemadlin
effect of quetiapine on marijuana withdrawal and relapse

Conditions: Marijuana Smoking

Summary: the objective of this study is to investigate the interaction between marijuana and quetiapine, with the goal of using this information to improve marijuana treatment outcome.

the purpose of this study is to determine if quetiapine decreases marijuana relapse in a controlled lab setting. for the purposes of this model, relapse is defined as a return to marijuana use after a period of abstinence. the study will utilize an inpatient/outpatient, counter-balanced design, with each participant maintained on placebo and quetiapine (200 mg/day) for 18 days. participants will begin taking capsules as outpatients so that the dose can be incremented prior to the inpatient phase. while inpatient, participants will have the opportunity to self-administer placebo (0.0%) or active marijuana (6.2%) 6 times per day, depending on the study day. our laboratory model, which has distinguished the effects of a range of medications on marijuana withdrawal and relapse, will provide important information on the effect of quetiapine as a potential short-term pharmacotherapy to facilitate abstinence in the initial stages of marijuana treatment.

Eligibility criteria:
inclusion criteria: * current marijuana use:average of 2 marijuana cigarettes per day at least 4 times per week for the past 4 weeks * able to perform study procedures * 21-45 years of age * women practicing an effective form of birth control (condoms, diaphragm, birth control, pill, iud) * normal body weight exclusion criteria: * current, repeated illicit drug use (other than marijuana) * presence of significant medical illness (e.g., diabetes, cardiovascular disease, hypertension, clinically significant abnormalities) * history of heart disease or current conduction system disease as indicated by qrs duration \> 0.11 * request for drug treatment * current parole or probation * pregnancy or current lactation * recent history of significant violent behavior * major current axis i psychopathology (major depressive disorder, bipolar disorder, suicide risk, schizophrenia) * current use of any prescription or over-the-counter medication * prior allergic or otherwise serious adverse reaction to quetiapine

Keywords: quetiapine smoked marijuana marijuana use
efficacy and safety of pro-155 versus nevanac in post phacoemulsification

Conditions: Cataract; Phacoemulsification Cataract Surgery

Summary: the purpose of this study is to evaluate efficacy and safety of the ophthalmic solution pro-155 in patients post phacoemulsification.

postsurgical inflammation is an inevitable condition after cataract surgery. the use of non-steroidal anti-inflammatory drugs is a safe option for treating ocular inflammation. this is a phase ii randomized double-blind clinical trial. the aim is to compare and to evaluate efficacy and safety of two ophthalmic solutions in patients post phacoemulsification. patients will be randomized to receive either pro-155 or nevanac for 60 days.

Eligibility criteria:
inclusion criteria: * patients older than 18 years who require cataract surgery * both genders * provide informed consent * normal laboratory results exclusion criteria: * patients with visual acuity of 20/40 or less in the contralateral eye of the surgery * patients with any trans-surgical complication * patients with a cataract \>nc4, c4 or p4 classified with the system locs * patients with any active corneal pathology * patients under any steroidal treatment (topic, systemic or inhaled)14 days prior surgery or nsaids 7 days before the surgery (except low-dose aspirin) * patients with iop \ 21 mmhg * patients that have ocular pain, cellularity or flare at the moment of selection * patients with ocular exfoliation, trauma or any inflammatory disease * patients with diabetic retinopathy that need treatment or uncontrolled diabetes mellitus * patients who are planning cataract surgery of the contralateral eye 14 days after surgery of the study eye * patients with history of hypersensitivity or contraindication for any drug used in the study * patients under anticoagulant treatment * contact lens users * pregnant patients, at risk of pregnancy or breastfeeding * patients without birth control treatment * patients with any active toxicomania (alcoholism, cigarette, cannabis or others) * patients who had participated in any clinical trial in the last 90 days * legal or mentally disabled patients who could not give informed consent * patients who cannot comply with all study requirements

Keywords: bromfenac nepafenac cataract phacoemulsification cataract surgery
strongest families (formerly family help program): pediatric anxiety

Conditions: Anxiety Disorder

Summary: the purpose of the strongest families (formerly family help program)is to evaluate the effectiveness of the strongest families distance intervention compared to usual or standard care that is typically provided to children with mild to moderate anxiety symptomology. this is a single-center trial based at the iwk health center. the primary outcome is change in diagnosis.

the purpose of the strongest families (formerly family help program)is to deliver, primary care mental health services to children and their families in the comfort and privacy of their own home. approximately 128 children (6-12 years of age)suffering from mild to moderate (but clinically significant) symptoms of pediatric anxiety will be randomized. the intervention is delivered from a distance, using educational materials (manuals, video-tapes, audio-tapes) and telephone consultation with a trained paraprofessional "coach" who is supervised by a licensed health care professional. the telephone coach delivers consistent care based on written protocols, with on-going evaluation by a professional team. fifty percent of the eligible participants will receive strongest families (formerly family help program) telephone-based treatment and 50% will be referred back to their family physician to receive standard care as determined by that physician. those receiving standard care will be evaluated for outcome results and then compared to the family help treated participants. it is anticipated that family help treatment will be proven to be as or more effective than standard care.

Eligibility criteria:
inclusion criteria: * child 6 to 12 years of age * child had anxiety symptoms for 6 months or longer * access to a telephone in the home * speak and write english * mild to moderate anxiety symptomology exclusion criteria: * severe anxiety symptomology * received similar intervention within past 6 months * excessive anxiety following a significant traumatic event
physiological validation of current machine learning models for hemodynamic instability in humans

Conditions: Hypotension and Shock

Summary: this study will be collecting data on participants undergoing lower body negative pressure (lbnp) to simulate progressive blood loss. the goal of the study is to collect data to allow for development of an algorithm with machine learning to predict blood pressure responses to hyporvolemia by analyzing the arterial waveforms collected during lbnp.

death from exsanguination continues to be a major problem in combat casualty care and the care of civilians subjected to trauma. the ability to detect significant blood loss using traditional vital signs (heart rate, blood pressure) is marginal due to a variety of compensatory mechanisms that maintain blood pressure in the face of marked reductions in circulating blood volume. along these lines, it is critical to develop monitoring devices and algorithms to non-invasively assess central blood volume in humans for the purposes of facilitating more timely interventions. the standard way to simulate hemorrhage in humans is to use lower body negative pressure (lbnp). in this technique, the lower body of a supine volunteer is enclosed in an airtight container while suction is applied to cause venous pooling in the legs and reduce central blood volume. this technique generates many physiological adaptations that are similar to that observed during blood loss studies in animals and human volunteers. thus, the purpose of this study is to obtain data for use in developing monitoring technology to detect hemorrhage and other surrogate markers of central blood volume in humans.

Eligibility criteria:
inclusion criteria: * non-obese (bmi \< 30) * non-smokers * free of any systemic diseases including hypertension, diabetes, coronary artery disease, neurologic disease, or any other major medical co-morbidity * women will be either surgically sterilized or non-pregnant as determined by a urine pregnancy test
antibacterial effect of the infusion of green tea used as a mouthwash on saliva and bacterial plaque

Conditions: Dental Plaque

Summary: given that the participation of oral microorganisms in the development of the most prevalent pathologies of the oral cavity is unquestionable, efforts have been made to create agents that allow controlling these bacteria. the objective of this work was to analyze the antibacterial effect of green tea infusion used as a mouthwash on saliva and bacterial plaque. the green tea infusion was prepared at 13% at approximately 90 ° c, being the same applied to 14 participants from the 1st to the 5th grade (experimental group); and to other 14 participants the placebo was applied (control group). the antibacterial effect was determined by counting the colony forming units (cfu) in the cultures of samples of bacterial plaque and saliva, taken before the application of the infusion and immediately after.

oral diseases, including dental caries, is one of the most prevalent in the population. it is multifactorial and originates from the formation of the bacterial plaque and its non-elimination by physical and chemical hygiene methods. the use of chemical agents to aid in the control of bacterial plaque has been the subject of study in many investigations. today there is a variety of elements that can be use to carry out proper oral hygiene, such as toothbrushes, toothpastes, dental floss and mouthwash, all of them in a wide variety. often the lack of accessibility to these means problems in the hygiene in the population, either due to the lack of knowledge or the cost of obtaining them. therefore, the objective of analyzing the antibacterial effect of the infusion of green tea (camellia sinensis) used as a mouthwash on saliva and bacterial plaque was presented. the proposed research topic is relevant, since if green tea (camellia sinensis) is found to produce positive effects on bacterial plaque, it would serve to prevent its formation, thus helping to improve dental hygiene with an easy acquisition product and lower cost compared to other mouthwashes offered in the market, constituting a natural mouthwash.

Eligibility criteria:
inclusion criteria: * participants that signed the informed consent exclusion criteria: * allergic to green tea (camellia sinensis) * ongoing medical or dental treatment that could interfere with the results.

Keywords: saliva mouthwash green tea oral bacteria
a cross-sectional survey to evaluate diabetes management, control, complications, psychosocial aspects of patients with type 2 diabetes in bangladesh, indonesia, malaysia, philippines, sri lanka and vietnam

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. the aim of this non-interventional study is to evaluate the current status of diabetes management, control, and complications in diabetic subjects in vietnam.


Eligibility criteria:
inclusion criteria: * people with type 2 diabetes mellitus (dm) who are being treated, with any of the non-pharmacological or pharmacological options, at a particular centre for at least 1 year and who have visited the centre within the last 3-6 months * patients willing to sign informed consent form exclusion criteria: * previous participation in this study * unable to comply with protocol requirements * confirmed or suspected pregnancy
ezetimibe-rosuvastatin evaluation study

Conditions: Hypercholesterolemia; Hyperlipidemias; Combinations of Drugs; Dependence

Summary: evaluation of the efficacy of the stable ezetimibe-rosuvastatin combination in patients with primary hypercholesterolemia in achieving the target plasma lcl-c level.

additional study objectives: 1. evaluation of the efficacy of the stable ezetimibe-rosuvastatin combination in patients with primary hypercholesterolemia with respect to changes in the rest of the lipid profile (hdl-c, tc, tg). 2. evaluation of the efficacy of the stable ezetimibe-rosuvastatin combination in patients with primary hypercholesterolemia in altering non-hdl cholesterol (non-hdl - cholesterol) levels. 3. the assessment of the achievement of the lcl-c target of patients receiving the stable ezetimibe-rosuvastatin combination according to their cardiovascular risk category. 4. assessing patient safety throughout treatment.

Eligibility criteria:
inclusion criteria: * adult patients who have voluntarily consented to participate in the study. * adult patients who are already on treatment with the stable combination of ezetimibe-rosuvastatin (lipopen), at the discretion of the treating physician. * adult patient adequately controlled with rosuvastatin and ezetimibe according to esc / eas 2019 guidelines. exclusion criteria: * patients who have not fully understood the study procedures and have not signed the consent form. * patients who are contraindicated for taking the drug according to the summary of product characteristics (msf) of the study drug. hypersensitivity to the active substances or to any of the excipients of lipopen. * pregnancy and breastfeeding. * active liver disease involving unexplained, persistent increases in serum transaminases and any increase in serum transaminases that exceeds 3 times the normal upper limit (uln) or unexplained persistent increases in serum transaminases. * patient with severe renal impairment (creatinine clearance \<30 ml / min). * patient with myopathy * patient receiving concomitant treatment with cyclosporine