Kornimate/medical-research-clean huggingface dataset:
for nasotracheal intubation with video rigid stylet, which nostril is better?

Conditions: Intubation; Video Rigid Stylet

Summary: to determine which nostril is more suitable for nasotracheal intubation with video rigid stylet.

head and neck surgeries usually require nasal intubation, which allows leeway for operative maneuvering in the mouth, pharynx, larynx, and neck. previous studies have found that the right nostril is more appropriate for nasal intubation using direct laryngoscope or videolaryngoscope. it has been shown that the optical rigid stylet was also an appropriate tool for nasal intubation. however, nasal intubation with rigid optical stylet is technically different from that with laryngoscope. it is unknown whether the choice of nostril could affect the intubation using rigid optical stylet. the main aim is to determine which nostril is more suitable for nasal intubation with video rigid stylet.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. american society of anesthesiologists physical status i\~ii; 3. scheduled to undergo elective oral and maxillofacial surgery requires nasal intubation; 4. the expected operation time \< 3 hours; 5. extubation in operation room and do not scheduled to preventive tracheotomy; 6. patients who were able to breathe clearly and equally through both nostrils. exclusion criteria: 1. patients had history of difficult intubation or presented with an anticipated difficult airway; 2. patients requiring nasogastric tube insertion; 3. presence of contraindications of nasal intubation; 4. due to surgical requirement, intubation must be completed through one nostril; 5. presence of severe nasal obstruction,deformities of the nasal cavity, or other serious nasal diseases; 6. history of severe epistaxis or epistaxis within a month; 7. previous history of nasal and/or laryngeal surgery; 8. previous experience with nasal intubation; 9. history of schizophrenia, parkinson's disease or profound dementia, or language barrier; 10. participate in other clinical studies; 11. refusal to sign informed consent.

Keywords: nasotracheal intubation nostril video rigid laryngoscope
topical metformin versus topical ketotifen in melasma treatment

Conditions: Melasma

Summary: the study aims to evaluate and compare the efficacy and safety of a new formulation of topical metformin (nanoparticles) versus topical ketotifen (nanoparticles), both alone and combined with micro-needling, for the treatment of melasma. it is a double-blinded, randomized, split-face controlled clinical study involving 102 female patients diagnosed with bilateral melasma.

this research investigates the therapeutic effects of two nanoparticle-based topical treatments-metformin and ketotifen-on melasma. the study employs a split-face design where each patient receives different treatments on each half of their face. patients are divided into two groups: group 1: undergoes micro-needling sessions for the entire face, followed by the application of topical ketotifen on one half and topical metformin on the other half. group 2: receives only topical applications of ketotifen on one half of the face and metformin on the other half without micro-needling. the study includes detailed pre-procedure preparation (cleaning and anesthetizing the face) and post-procedure care (application of spf 50+ sunblock). clinical assessments include photographic documentation, h-masi and mh-masi scoring for melasma severity, patient satisfaction surveys, melasqol questionnaires to assess quality-of-life impacts, and monitoring for side effects. assessments are conducted at baseline, monthly during treatment, and one month after the final session.

Eligibility criteria:
inclusion criteria: * female adults of 18 years and above with bilateral melasma . * clinical diagnosis of melasma. * mental capacity to give informed consent. exclusion criteria: * pregnant or nursing women. * current use of hormonal birth control medication or any hormonal therapy. * current or previous treatment by depigmenting agents within 3 months * history of laser or mn to the face within 3 months of study enrollment. * patients with poor wound healing, recurrent herpes simplex and current skin infection (facial warts, molluscum contagiosum) and history of hypertropic scar/keloids. * photosensitivity. * patients with unrealistic expectations.
zika-vaccine dose finding study regarding safety, immunogenicity and tolerability (v186-001)

Conditions: Zika Virus

Summary: double blinded, randomized, placebo-controlled, dose finding, multi-center, phase 1 trial in 48 healthy volunteer subjects. after completion of screening procedures, the subjects are randomized to one of four treatment groups (different dosage strengths and placebo) all subjects will receive study treatment at day 0 and will return on day 28. subjects randomized to treatment groups with two vaccinations will receive a second treatment at day 28. subjects will return on day 56 for the final visit.


Eligibility criteria:
inclusion criteria: * healthy volunteers aged 18 to 55 * subjects of child bearing potential must perform reliable method of contraception exclusion criteria: * immune deficiency, history of hiv, hbv, hcv * drug addiction * vaccination within 4 weeks prior to study or planned vaccination during study * prior receipt of any zika vaccine * recent infection 1 week prior to screening * relevant medical history interfering with aim of study * neoplastic disease, hematological malignancy * history of autoimmune disease * psychological condition that affects ability to participate in the study * history of severe adverse reactions to vaccine administration * history of anaphylaxis * allergic reactions, abnormal lab values, or concomitant medication per decision of the investigator * use of immunosuppressive drugs within 30 days before screening or planned use during study * receipt of blood products within 120 days before screening or planned use during study * pregnancy, unreliable contraception method * decision of the investigator * regular blood plasma donor
allogenic stem cell transplantation in patients with high risk cd33+ aml/mds/jmml

Conditions: Acute Myeloid Leukemia; Juvenile Myelomonocytic Leukemia; Myelodysplastic Syndrome

Summary: the addition of gemtuzumab ozogamicin (go) in combination with busulfan/cyclophosphamide followed by allosct in patients with high risk cd33+ aml/jmml/mds will be safe and well tolerated. this study will attempt to determine the maximum tolerated dose of the immune therapy (gemtuzumab) when given in combination with the myeloablative (high dose) drugs used in this study for allogeneic stem cell transplant. (part a)

gemtuzumab ozogamicin (cma-676) is a chemotherapeutic agent consisting of recombinant humanized anti-cd33 antibody conjugated with calicheamicin, a highly potent cytotoxic antitumor antibiotic. the antibody portion of gemtuzumab binds specifically to the cd33 antigen, a sialic acid-dependent adhesion protein expressed on the surface of leukemia blasts, normal and leukemic myeloid colony-forming cells, including leukemic clonogenic precursors, but excluding pluripotent hematopoietic stem cells and nonhematopoietic cells. this results in formation of the complex that is internalized, upon which calicheamicin derivative is released with in the lysosomes of the myeloid cell. the free calicheamicin derivative then binds to the dna, resulting in dna double strand breaks and consequential cell death.

Eligibility criteria:
eligibility inclusion criteria: disease status * aml induction failure * aml in 1st, 2nd, or 3rd relapse (\>10% bone marrow blasts) * aml greater than or equal to 3rd cr * mds with \>6% bone marrow blasts at diagnosis * secondary mds with less than or equal to 5% bone marrow myeloblasts at diagnosis * jmml with \>6% bone marrow myeloblasts at diagnosis disease immunophenotype patients (aml only) receiving gemtuzumab ozogamicin must express minimum of \>10% or =10% cd33 positivity. patients with \<10% cd33 positivity will not receive gemtuzumab ozogamicin. organ function patients must have adequate organ function as defined below: * adequate renal function defined as: * serum creatinine \<1.5 x normal, or * creatinine clearance or radioisotope gfr 40 ml/min/m2 or \>60 ml/min/1.73 m2 or an equivalent gfr as determined by the institutional normal range * adequate liver function defined as: * total bilirubin 1.5 x normal, or sgot (ast) or sgpt (alt) \<2.0 x normal or =2.0 x normal * adequate cardiac function defined as: * shortening fraction of \>27% by echocardiogram, or * ejection fraction of \>47% by radionuclide angiogram or echocardiogram * adequate pulmonary function defined as: * dlco \>55% or =55% by pft * for children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \>94% on room air exclusion criteria: * patients with active cns aml/jmml/mds disease at time of conditioning therapy * female patients who are pregnant (positive hcg) * karnofsky \<50% or lansky \<50% if 10 years or less * age \>65 years * has received gemtuzumab in the previous 30 days or has not recovered from prior gemtuzumab therapy.

Keywords: aml jmml mds allogenic atem cell transplant gemtuzumab ozogamicin
arq 501 in combination with docetaxel in patients with cancer

Conditions: Carcinoma

Summary: the purpose of this study is to determine the safety of arq 501 in combination with docetaxel in patients with advanced or metastatic cancer. in addition, the study is designed to observe the potential the combination of arq 501 and docetaxel have in treating cancer.

arq 501 has demonstrated activity in vitro against a wide range of solid tumors including lung, colorectal, breast, prostate, pancreatic, ovarian, and myeloma. to date, no histological cancer type studied appears inherently resistant to treatment with arq 501. in animal xenograft models of human tumors, arq 501 monotherapy has been effective in treating ovarian, colon, prostate, and breast cancer. when used in combination with taxane therapy, arq 501 has demonstrated efficacy in treating a variety of human cancers, including ovarian, breast, and colon. this study is designed to explore whether the addition of arq 501 to a once every three week schedule of docetaxel is a safe and tolerable regimen. the study is designed to collect safety and pharmacokinetic data on the combination regimen and to measure the antitumor activity observed in patients.

Eligibility criteria:
inclusion criteria: * have a histologically or cytologically confirmed diagnosis of a locally advanced or metastatic carcinoma. (patients may have either measurable or nonmeasurable disease.) * be ≥18 years old. * must not be eligible for therapy of higher curative potential. * have a karnofsky performance status (kps) of ≥70%. * have an estimated life expectancy of ≥12 weeks. * be male or non-pregnant, non-lactating female patients. patients who are fertile agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, or cervical cap) to avoid pregnancy. * have a negative serum or urine pregnancy test within 7 days prior to the first dose of study drug (if patient is a female of childbearing potential). * sign a written informed consent document. * have adequate organ function as determined per protocol defined laboratory value exclusion criteria: * have received previous treatment with arq 501. * have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment. * are pregnant or lactating. * have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up. * have received any chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational, within 2 weeks of treatment in this study. * have not recovered from acute toxicity of all previous therapy prior to enrollment. * have any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study. * have symptomatic or untreated central nervous system (cns) metastases. * have a known severe hypersensitivity to docetaxel or drugs formulated with polysorbate 80.

Keywords: cancer solid tumor advanced solid tumor
phase 2 study with cis-uca ophthalmic solutions in subjects with dry eye

Conditions: Dry Eye Syndrome

Summary: the objective of the phase 2 study is to compare the safety and efficacy of cis-uca ophthalmic solutions to placebo for the treatment of the signs and symptoms of dry eye.


Eligibility criteria:
key inclusion criteria: * be at least 18 years of age; * provide written informed consent; * have a subject reported history of dry eye; * have a history of use or desire to use eye drops. key exclusion criteria: * have any clinically significant eye findings that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; * have worn contact lenses within 7 days of visit 1 or anticipate using contact lenses during the study; * have previously had laser-assisted in situ keratomileusis (lasik) surgery within the last 12 months; * have used restasis® within 30 days of visit 1; * have any planned ocular and/or lid surgeries over the study period; * be a woman who is pregnant, nursing or planning a pregnancy; * be unwilling to submit a urine pregnancy test at visit 1 and visit 4 (or early termination visit) if of childbearing potential; * have a known allergy and/or sensitivity to the study drug or its components; * have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study; * be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of visit 1; * be unable or unwilling to follow instructions, including participation in all study assessments and visits.
effect of mother's supplementation omega-3 in the dynamics of fetal ductus arteriosus: a randomized clinical trial.

Conditions: Pregnancy

Summary: the effect of anti-inflammatory substances on the dynamics of the fetal ductus arteriosus is well documented, but the anti-inflammatory property of polyunsaturated fatty acid omega-3 about changing this dynamic is not established. this study evaluate the relationship between supplementation of omega-3 in the dynamics of the fetal ductus arteriosus in the third trimester. women with gestational between 28 to 32 weeks will receive capsules of omega-3 or placebo, to be consumed daily for 3 weeks.

the omega-3 features similar the statins to be antioxidants and anti-inflammatory drugs and their derivatives have the function of slowing the neuro-inflammation, oxidative stress and apoptotic cell death anti-inflammatory properties. also, they have antithrombotic effects, being related to prevent disease. studies show that supplementation with omega-3 has a positive impact on several outcomes like cardiovascular disease, asthma, rheumatoid arthritis and alzehimer. objective: evaluate the relationship between supplementation of omega-3 in the dynamics of the fetal ductus arteriosus in the third trimester. methodology: randomized double blind clinical trial. women with gestational age between 28 to 32 weeks, literate, over 18 years will be invited. pregnant women with anti-inflammatory drugs, they have a higher intake of dietary polyphenols to 127mg / day or using drugs that may interfere with the absorption of omega-3 are excluded. the selected women will be randomized to receive capsules of omega-3 or placebo, to be consumed daily for 3 weeks. in the first interview, and after 3 weeks, they will respond the questionnaire food frequency (qff) to quantify polyphenols and omega 3 in their diet, weight and height will be measured and the examination of fetal echocardiography is performed.

Eligibility criteria:
inclusion criteria: women between 28 - 32 weeks pregnancy who accept participate in the study. - exclusion criteria: hypertensive , diabetic , who use anti-inflammatory drugs , hiv positive , do not take mate, black or green tea, had inflammation in the last 5 days, allergic to fish or soy. -

Keywords: polyunsaturated fatty acid fetal ductus arteriosus inflammation
comparison between atenolol,propnalol and ivabradine

Conditions: Intraoperative Bleeding

Summary: the aim of this work is to compare atenolol, propranolol, and ivabradine as a premedication to achieve bloodless field anesthesia primarily controlling heart rate in lumbar spine surgery.

this study will investigate the effect of atenolol, propranolol, and ivabradine as oral premedication in adult patients undergoing lumbar spine surgery to achieve bloodless field anesthesia. aim of the work * the primary aim of this work is to compare atenolol, propranolol, and ivabradine as a premedication to achieve bloodless field anesthesia primarily controlling heart rate in lumbar spine surgery. * the secondary aims are to assess field visibility and measure the amount of blood loss in patients, and surgeon satisfaction and also to asses if there are any associated undesirable side effects of atenolol, propranolol, or ivabradine will appear.

Eligibility criteria:
inclusion criteria: * asa physical status i and ii, * aged from 18 to 50 years old * scheduled for elective lumber spine surgeries will be included in this study. exclusion criteria: * hypertension. * hepatic or renal disease. * diabetes mellitus. * pregnancy. * coagulation disorders. * anemia (hb \< 10 g/dl). * ischemic heart disease * drug or alcohol abuse. * allergy to any of atenolol, propranolol, and ivabradine. * history of beta-blockers, calcium channel blockers, tricyclic antidepressants, anticoagulant or clonidine intake.
a novel surgical irrigation solution in post-mastectomy reconstruction: evaluating xperience™

Conditions: Surgical Site Infection; Surgical Complication; Implant Infection; Implant Complication

Summary: goal of the clinical trial: the purpose of this clinical trial is to learn whether xperience™ surgical irrigation solution is more effective than a standard dilute povidone-iodine solution in reducing surgical site infections (ssis) following implant-based breast reconstruction in female patients, aged 18 and older. it will also assess the safety and overall surgical outcomes when using xperience™ compared to povidone-iodine. main questions the study aims to answer: * does the use of xperience™ decrease the incidence of surgical site infections compared to povidone-iodine? * what are the differences in the rates of premature implant removal due to infection between patients treated with xperience™ and those treated with povidone-iodine? * are there fewer post-surgical complications with xperience™ compared to povidone-iodine? study design: participants in this study will be randomly assigned to receive either xperience™ or a dilute povidone-iodine solution during their bilateral implant-based breast reconstruction. only the research team will know which irrgiation is given- the participant will not know. participant will: * undergo the surgical procedure using one of the two irrigation solutions. * receive regular post-operative check-ups to monitor for signs of infection and other complications. * have data collected on any post-surgical complications, the necessity for early implant removal, and overall surgical outcomes.


Eligibility criteria:
inclusion criteria: * older than 18 years old * willing to comply with all study-related procedures * available for the duration of the study * participants undergoing double mastectomy surgery followed by one of the following: (1) immediate reconstruction with tissue expander placement, (2) delayed reconstruction with tissue expander or implant placement, (3) immediate reconstruction with implant placement, (4) second-stage reconstruction with tissue expander to implant exchange exclusion criteria: * participants unable to participate in follow-up visits * participants undergoing unilateral mastectomy * tissue expanders placed by a surgeon outside of the unc chapel hill hospital system * undergoing autologous reconstruction * participant is unable to provide signed and dated informed consent * unwilling or unable to comply with all study-related procedures. * known history of sensitivity or allergic reaction to any of the components of the xperience™ irrigation solution or dilute povidone-iodine irrigation * participant with any conditions that would be a contraindication to receiving surgery such as contraindications to general anesthesia * pregnant, planning to become pregnant or breast feeding participants * individuals providing informed consent with any mental impairment or condition that would make them unable to properly consent without use of legally authorized representative (lar) or additional participant protections. * incarcerated participants
open-label extension study of rn624

Conditions: Osteoarthritis; OA Knee Pain; Arthritis

Summary: study rn624-cl007 is planned to be an open-label protocol to enroll subjects who have previously participated in study no. rn624-cl006. in this study, subjects will receive rn624 on an open-label basis.


Eligibility criteria:
inclusion criteria: * enrolled in study rn624-cl006 exclusion criteria: * the occurrence of any adverse event or condition during the controlled studies that, in the opinion of the investigator, should exclude the subject from participating in the open-label extension * pregnant or lactating female subjects or subjects who do not agree to use an appropriate form of birth control throughout the study and for 3 months after completing the study

Keywords: monoclonal antibody
automated oxygen titration with o2matic home oxygen therapy (o2matic hot) phase 1

Conditions: COPD; Chronic Hypoxemic Respiratory Failure

Summary: o2matic hot is a further development of o2matic and is intended for home oxygen use with patients in need of long-term oxygen treatment (ltot). o2matic hot is a closed-loop system which on basis of signals from pulse oximetry titrates the oxygen flow to the patient. in this crossover trial patients are admitted for 24 hours twice. once with usual fixed dose oxygen and once with oxygen titration by o2matic hot.

the purpose of this study is to examine if automated oxygen control based on pulse oximetry to patients with domiciliary long-term oxygen treatment (ltot) is better than manually controlled oxygen treatment in keeping spo2 within intended target interval. in manually controlled oxygen treatment flow is usually kept constant for months between visits from specialist nurse, whereas in automated control the patient can titrate oxygen flow several times a day based on pulse oximetry in a closed-loop system.

Eligibility criteria:
inclusion criteria: * verified copd with fev1/fvc \< 0.70 * need of ltot (pao2 \<= 7.3 kpa or spo2 \< 88 % on ambient air) * cognitively able to participate * willing to provide informed consent exclusion criteria: * moderate or severe exacerbation in copd within 4 weeks from study start * major comorbidities (cancer, uncontrolled chronic disease) * asthma or other disease with need of higher spo2 * pregnancy * fall in ph below 7.35 or increase in paco2 \> 1 kpa on 5 liters of oxygen * active smoking * ltot use less than 1 hours/day

Keywords: o2matic closed-loop pulse oximetry