Kornimate/medical-research-clean huggingface dataset:
group b streptococcus (gbs) polymerase chain reaction (pcr) concordance study

Conditions: Group B Streptococcus

Summary: the investigators are comparing three different methods of testing for an infection which is commonly found in women. the infection is caused by a bacterium called group b streptococcus. about 10-30% of women carry gbs in the vagina or rectum. during labour this infection can be passed to the neonate. this can lead to the baby developing a serious infection. however, research has shown that if antibiotic treatment is given to gbs carrying women during labour most of these infections can be avoided. a new bedside test known as pcr has been shown to produce a gbs diagnostic result in less than an hour. in clinical trials conducted in the us and france this method has been shown to be more accurate than either prenatal vaginal swabs or risk factor assessment. for this reason, pcr may be helpful in screening and treating gbs positive women in the uk. in this study the investigators will compare each of the following three methods of diagnosis to a gold standard. * prenatal vaginal culture swab (at 35 to 37 weeks gestation)- the us approach. * risk factor assessment (at the time of admission for labour)- the uk approach * the new pcr test (at the time of your labour admission) the investigators will compare the accuracy of each of these methods with the most accurate method for determining the gbs status during labour. this 'most accurate' method is a highly sensitive swab test which unfortunately takes several days to produce a result. for this reason this test will not tell the investigators whether prophylactic antibiotics may be useful during labour (receiving them after birth is ineffective). if pcr is shown to be a more accurate method of identifying gbs positive women this may help to reduce the number of infections in new born infants and as a result may help to save lives.


Eligibility criteria:
inclusion criteria: * patients will be included in the study if they are; * 18 years or older * pregnant and planned admission to portland hospital whether full-term or otherwise. * willing and able to give informed consent prenatally. exclusion criteria: * scheduled for non vaginal birth

Keywords: group b streptococcus polymerase chain reaction pcr intrapartum screening risk factors arly onset group b streptococcus infection
self-centering guide catheter feasibility study

Conditions: Aortic Stenosis

Summary: an evaluation of the feasibility of using the self-centering guide catheter to deliver a guide wire across a stenotic native aortic valve into the left ventricle.

a prospective, open-label, single-arm feasibility study evaluating the self-centering guide catheter. all subjects who are candidates for transcatheter aortic valve replacement (tavr) of a native valve with a transcatheter aortic valve that is introduced percutaneously via the femoral artery using conventional catheterization techniques will be evaluated for enrollment in this study. the self-centering guide catheter is intended to facilitate delivery of a guidewire across a stenotic native aortic valve and into the left ventricle.

Eligibility criteria:
inclusion criteria: * subject must be at least 18 years of age. * subject (or legal guardian) understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed. * subject is eligible for and is an acceptable candidate for transcatheter aortic valve replacement of a stenotic (aortic valve area ≤1 cm2, aortic jet velocity ≥4.0 m/s, or mean gradient ≥40 mmhg) native valve with a transcatheter aortic valve that is introduced percutaneously via the femoral artery using conventional catheterization techniques. exclusion criteria: * subject has known hypersensitivity to the components of the device (e.g., polyether block amide, fluoropolymers, nickel, platinum, tantalum, titanium). * subject has a pre-existing prosthetic aortic valve.
study of patritumab deruxtecan in participants with gastrointestinal cancers (mk-1022-011) (herthena-pantumor02)

Conditions: Gastrointestinal Cancer

Summary: researchers want to learn if patritumab deruxtecan (mk-1022) can treat certain gastrointestinal (gi) cancers. the gi cancers being studied are advanced (the cancer has spread to other parts of the body). the goals of this study are to learn: * about the safety and how well people tolerate of patritumab deruxtecan * how many people have the cancer respond (get smaller or go away) to treatment


Eligibility criteria:
inclusion criteria: the main inclusion criteria include but are not limited to the following: * has one of the following cancers: * unresectable or metastatic colorectal cancer. * advanced and/or unresectable biliary tract cancer (btc) * hepatocellular carcinoma (hcc) not amenable to locoregional therapy * has received prior therapy for the cancer. * has recovered from any side effects due to previous cancer treatment exclusion criteria: the main exclusion criteria include but are not limited to the following: * has a history of (noninfectious) interstitial lung disease (ild)/pneumonitis that required steroids, or has current ild/pneumonitis, and/or suspected ild/pneumonitis that cannot be ruled out by standard diagnostic assessments at screening * has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses * has evidence of any leptomeningeal disease * has clinically significant corneal disease * has uncontrolled, significant cardiovascular disease or cerebrovascular disease * has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection
a study of cdx-0159 in patients with chronic spontaneous urticaria

Conditions: Chronic Spontaneous Urticaria

Summary: this is a study to determine the safety of multiple doses of cdx-0159 in patients with chronic spontaneous urticaria.

the purpose of the study is to explore the safety, pharmacodynamics, and pharmacokinetics of ascending doses of cdx-0159 in patients with chronic spontaneous urticaria who remain symptomatic despite treatment with antihistamines. there is a screening period of up to 2 weeks, a 12-week double-blind treatment period and a 12-week follow-up period after treatment. patients will receive multiple doses of cdx-0159 or placebo as add on therapy to their antihistamine.

Eligibility criteria:
key inclusion criteria: 1. males and females, 18 - 75 years old. 2. diagnosis of chronic spontaneous urticaria (csu) despite the use of h1-antihistamines alone or in combination with h2-antihistamines and/or leukotriene receptor antagonists, as defined by: 1. diagnosis of csu for \>/= 6 months. 2. the presence of itch and hives for \>/= 6 consecutive weeks at any time prior to visit 1 despite current use of h1-antihistamines. 3. uas7 of \>/= 16 and hss7 of \>/= 8 during the 7 days before treatment 4. in-clinic uas \>/= 4 on one of the screening visit days 5. use of h1-antihistamines alone or in combination with h2-antihistamines and/or leukotriene receptor antagonists for at least 3 days immediately prior to study entry and throughout the study. 3. other than csu, have no other significant medical conditions that would cause additional risk or interfere with study procedures. 4. normal blood counts and liver function tests. 5. both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days afterwards after treatment. 6. willing and able to complete a daily symptom electronic diary for the duration of the study and adhere to the study visit schedule. key exclusion criteria: 1. women who are pregnant or nursing. 2. cleary defined cause for chronic urticaria. 3. known hiv, hepatitis b or hepatitis c infection. 4. vaccination with a live vaccine within 4 weeks prior to study drug administration (subjects must agree to avoid vaccination during the study). inactivated vaccines are allowed such as seasonal influenza for injection. 5. history of anaphylaxis. there are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Keywords: cdx-0159
retrain your brain in children/adolescents with bipolar disorder: a pilot study

Conditions: Bipolar Disorder; Pediatric Bipolar Disorder; Childhood-onset Bipolar Disorder

Summary: the main aim of this study is to test a new, non-medication computer-based potential treatment for bipolar disorder in children and adolescents. in the study, children and adolescents with bipolar disorder will come to our lab at bradley hospital 2-times per week for 8-weeks to "play" a custom computer "game" designed to retrain the brain--to build a skill that my work has shown is impaired in children/adolescents with bipolar disorder. before and after this 8-week trial, children will have a special magnetic resonance imaging (mri) scan. this is a test of feasibility--meaning we want to see if the 8-week trial results in brain changes. if it does, we will conduct a second study to see if it improves how bipolar children function--i.e., if it helps their illness.

prior studies have shown that "computer assisted cognitive remediation"--meaning using computer "games" to build up a skill that has been shown to be impaired in a specific disorder--can result in improvement in psychiatric illnesses--including schizophrenia. this will be the first national institute of mental health (nimh)-funded study to use this "retrain your brain" approach in children and adolescents with bipolar disorder. during this study, we are seeking 40 children and adolescents with bipolar disorder to: * come to our lab at bradley hospital in east providence r.i. twice per week (each lasting 1 hour) to "play" a special computer game for a total of 8 weeks * to have a special mri before and after this 8-week trial to see if our "game" improves brain activity * it does not matter if your child is already on medications--they can continue during this study * all children/adolescents with bipolar disorder are welcome--as long as they do not have implanted metal (no braces, no cochlear implants, etc) because of magnetic resonance imaging (mri) safety. this is a test of feasibility--meaning we want to see if the 8-week trial results in brain changes. if it does, we will conduct a second study to see if it improves how bipolar children function--i.e., if it helps their illness.

Eligibility criteria:
inclusion criteria: * 7-17 years old * bipolar disorder type i preferred (at least 1 week of mania) exclusion criteria: * no implanted metal (no braces, no cochlear implants) * can not have full diagnostic and statistical manual 4th edition (dsm-iv) autistic disorder * no active drug/alcohol abuse/dependence

Keywords: bipolar disorder child adolescent
effect of ultrasound-guided transversus abdominis plane block after laparoscopic bariatric surgery

Conditions: Nausea and Vomiting; Laparoscopic Bariatric Surgery

Summary: purpose: to explore and compare ultrasound-guided transversus abdominis plane block on postoperative nausea and vomiting and early outcome after laparoscopic bariatric surgery to evaluate and examine tapb can reduce the application of intraoperative and postoperative opioids and the duration of analgesia

poor postoperative nausea and vomiting control is a leading factor that hinders the physical rehabilitation, and causes acute cognitive impairment and chronic pain syndrome. recently, the multimodal analgesia strategies to minimise opioid-related side effects are highly desirable in open surgical procedures. the transversus abdominis plane block is a novel technique involving injection of local anaesthetic between the internal oblique and the transversus abdominis muscles of the abdominal wall. although ropivacaine is most commonly used for this technique, the analgesic duration remains not dissatisfied. herein, we will evaluate the efficacy of ultrasound-guided transversus abdominis plane (usg-tap) block with ropivacaine in laparoscopic bariatric surgery

Eligibility criteria:
inclusion criteria: 1. subject is scheduled to undergo laparoscopic bariatric surgery 2. subject's american society of anesthesiologists physical status is i-iii. 3. bmi\>35kg/m2 4. the subject's parent/legally authorized guardian has given written informed consent to participate exclusion criteria: 1. subject has a diagnosis of renal or liver failure. 2. subject has a diagnosis of mental illness 3. subject is allergy and contraindication to ropivacaine. 4. subject has a history of chronic pain, a history of alcohol or opioid abuse, pre-existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery. 5. subject has any contraindication for the use of patient-controlled analgesia (pca). 6. subject is pregnant or breast-feeding.
interface: hiv patients tracer for clinical assistance and research during covid 19

Conditions: HIV Infections

Summary: the health emergency related to the sars cov2 pandemic has highlighted the problems of health management of patients at risk of covid19 and with chronic diseases, suggesting the need for new methods of patient monitoring. teleconsultation, and telemedicine in general, are applications that allow, at these times when access to hospitals is by definition limited, to monitor patients with chronic conditions who need regular and consistent care and monitoring. people living with hiv/aids (plwha) represent a paradigm of chronic patients on whom the development of e-health-based remote monitoring could have a significant impact in terms of maintaining an adequate standard of care. for these reasons, in a large teaching hospital we are planning the creation and use of an application to enable remote monitoring of plwha by combining the covid19 prescreening system and chronicity monitoring.


Eligibility criteria:
inclusion criteria: * age of patients\>18 years. patients able to use apps and smart devices without caregivers or, if the patient is unable to use them, patients with caregivers able to use apps and smart devices. * able to provide informed consent exclusion criteria: * patients unable to use smart devices and apps without the presence of caregivers - recent diagnosis of hiv infection (\<3 months) * any unstable clinical condition requiring hospitalization
treatment of plantar warts

Conditions: Plantar Wart

Summary: this study is to compare the efficacy and safety of topical 30% potassium hydroxide solution and topical 45% hydrogen peroxide solution in treatment of plantar warts.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis by clinical and dermoscopic examination of plantar warts exclusion criteria: * history of hypersensitivity to any component used in this study * pregnancy and breastfeeding * patients who receive immune suppressive therapy * patients who received any wart treatments during the last 2 months before enrollent in the study * patients who refused participation in the study
reduction of postoperative radiotherapy in head and neck squamous cell carcinoma

Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC)

Summary: to explore the control rate and quality of life of participants with late head and neck squamous cell carcinoma who have obtained postoperative pcr after cervical lymph node surgery with neoadjuvant chemotherapy combined with immunotherapy, and the cervical lymph node removal prophylactic irradiation eni in the low-risk area.

in order to understand whether it can better protect normal tissues such as pharyngeal constriction muscles, thyroid, parotid glands, and submandibular glands without affecting the efficacy of tumors, and reduce the negative impact of radiotherapy on immunotherapy, the investigators plan to conduct a prospective phase ii study to explore the control rate and quality of life of patients with late head and neck squamous cell carcinoma who have obtained postoperative pcr after cervical lymph node surgery with neoadjuvant chemotherapy combined with immunotherapy.

Eligibility criteria:
inclusion criteria: * preoperative pathologically confirmed initial treatment of head and neck squamous cell carcinoma * receive neoadjuvant chemotherapy combined with pd-1 monoclonal antibody immunotherapy, and meet one of the following conditions: preoperative clinical stage was t3-t4 or n2-n3 (ajcc 8th edition). patients with oral cancer/oropharyngeal cancer had positive lymph nodes in the iv/v region with imaging diagnosis or biopsy confirmation before surgery. hpv/ p16-positive oropharyngeal cancer patients with clinical lymph node invasion (ene), one positive cervical lymph node \> 3cm or multiple positive cervical lymph nodes before surgery * the pathology of at least one cervical lymph node was determined by pcr； * karnofsky's physical status score ≥70 points； * age: 18 \~ 70 years old； * laboratory examination results within 1 week before enrollment met the following conditions: neutrophils (anc) ≥1.5×109/l, platelets (plt) ≥ 75×109/l * patients participate voluntarily and sign informed consent forms. exclusion criteria: * previous head and neck radiation treatment * severe complications； * pregnant or lactating women * who were deemed unsuitable for inclusion by the researchers.

Keywords: hnscc post-radical surgery adjuvant radiotherapy radiation dose reduction quality of life
accelerating the implementation of a breast and cervical cancer screening and hpv vaccination intervention

Conditions: Cancer Prevention

Summary: the proposed study will develop and test an implementation strategy called salud en mis manos-dissemination and implementation assistance (semm-dia) which is an internet-accessible cross-platform that includes additional implementation support strategies to increase the reach, effectiveness, and implementation of an evidence-based breast and cervical cancer screening and hpv vaccination program for latinas (semm).

this study tests a multicomponent and multifaceted implementation strategy, semm-dia and serves as a model for developing other implementation strategies designed to build the capacity of clinic leadership, intervention champions, and lhws to plan, manage, and deliver semm. investigators will examine the effect of semm-dia program implementation in a randomized group trial comparing the impact of semm-dia vs. semm- usual implementation practice on the reach, effectiveness, implementation, and cost-effectiveness of semm in safety-net clinics.

Eligibility criteria:
inclusion criteria: organization inclusion criteria: * clinic or community health center (chc) with lhws serving latina populations. * expressed intent to participate in the implementation of semm. * serve low-income populations with low or no-cost screening and vaccination. * provide comprehensive primary health care services. semm participant inclusion criteria: * latinas who self-identify as hispanic/latina. * latinas who have at least one unmet breast or cervical cancer prevention need, following electronic clinical quality measures. * (1) latinas aged 21-64 years who have not had a pap test in the past 3 years, and (2) latinas aged 30-64 who have not had a hpv test in the past 5 years (cms ecqm id: cms124v9). * (3) latinas aged 51-74 years who have not had a mammogram in the past 2 years (cms ecqm id: cms125v9). * (4) latinas aged 18-26 years who have not initiated hpv vaccination. * note: some women will have more than one unmet need (e.g., hpv vaccination and pap test), so they will be included in more than one non-adherent group. exclusion criteria: organization exclusion criteria: - clinics/community health centers not located in texas. semm participant exclusion criteria: - latinas with a prior or current cancer diagnosis due to modified cancer screening surveillance guidelines for cancer survivors.

Keywords: implementation intervention cervical cancer breast cancer hpv vaccination
trial of late surfactant for prevention of bronchopulmonary dysplasia

Conditions: Bronchopulmonary Dysplasia

Summary: the purpose of this study is to determine if late doses of infasurf surfactant given when patients are receiving inhaled nitric oxide will interact to improve surfactant function and increase survival without bpd in treated infants.

this is a multi-center, blinded, randomized controlled clinical trial to evaluate the effects of booster doses of exogenous surfactant (infasurf®, calfactant) in addition to inhaled nitric oxide (ino) on the outcome of survival without bronchopulmonary dysplasia (bpd, or chronic lung disease of prematurity, characterized by chronic lung dysfunction) at 36 weeks' post-menstrual age (pma) in extremely low gestational age (elgan) infants that are at high risk of the development of bpd. this multi-center trial, with a planned enrollment of 524 infants, will also enable us to evaluate for any adverse effects of late surfactant treatment on short- and long-term outcomes, as we will be collecting data on effects of dosing of late surfactant, co-morbidities of prematurity and neurodevelopmental and pulmonary outcome at 1 year and 24 months corrected age. in addition, we will collect biological specimens for evaluation of the effects of late surfactant replacement therapy (administered as described in this trial) on surfactant function and inflammatory markers.

Eligibility criteria:
inclusion criteria: * \<=28 0/7 weeks gestational age * day of life 7-14 * intubated and mechanically ventilated * plan to treat with inhaled nitric oxide exclusion criteria: * serious congenital malformations or chromosomal abnormalities * life expectancy \<7 days from enrollment * clinically unstable * less tha 48 hours since last dose surfactant * ability to obtain 36 week primary outcome information is unlikely

Keywords: nitric oxide surfactant bpd prematurity neonates ino pulmonary outcome neurodevelopmental outcome infasurf lung function surfactant dysfunction bronchopulmonary dysplasia
a study of ro5093151 and ro5027838 in patients with type 2 diabetes mellitus on a stable dose of metformin

Conditions: Diabetes Mellitus Type 2

Summary: this 5 arm study will evaluate the efficacy and safety of ro5093151 and ro5027838 in patients with type 2 diabetes mellitus on a stable dose of metformin. after a 4 week pre-randomization period for glucose control, patients will be randomized to one of 5 groups to receive a)ro5093151 400mg po bid b)ro5093151 10mg po bid c)ro5027838 200mg po qd d)ro5027838 50mg po qd or e)placebo po bid for 4 weeks. the anticipated time on study treatment is \< 3 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 35-65 years of age; * type 2 diabetes for \>=3 months; * treated for \>=3 months with stable dose of metformin \>=1.5g/day or maximum tolerated dose. exclusion criteria: * history of diabetic ketoacidosis; * currently or previously treated with insulin; * currently or within previous 6 months treated with a thiazolidinedione or dual peroxisome proliferator activated receptor (ppar) agonist; * treated with lipoprotein-modifying therapy within a month before screening.
bevacizumab versus triamcinolone acetonide for the treatment of keloids.

Conditions: Keloids

Summary: the study compares the efficacy and safety of intralesional bevacizumab versus corticosteroids for the treatment of keloids. assessment will be done clinically by the use of modified vancouver scar scale. erythema index will be measured by spectrophotometry. the levels of vascular endothelial growth factor, collagen type 1 and collagen type 3 in the lesions before and after each treatment modality.


Eligibility criteria:
inclusion criteria: * patients with keloids (post-traumatic, any site, any duration) * age \>18 years * patients who didn't receive any treatment for the lesions in the past 6 weeks exclusion criteria: * patients who are pregnant, willing to get pregnant or lactating * history of any liver or renal disease * history of any cardiovascular disease * history of hypertension * history of thrombo-embolic events * known cases of bleeding disorders * history of peptic ulcer * patients who underwent any surgeries in the last month