Kornimate/medical-research-clean huggingface dataset:
time-in-range using continuous glucose monitoring management of gestational diabetes mellitus

Conditions: Gestational Diabetes

Summary: the continual glucose is going to increase time-in-range compared to the standard method in women with gestational diabetes


Eligibility criteria:
inclusion criteria: * age 18-55 years * singleton pregnancy ≥20 weeks gestation * diagnosed with gdm by either 1-step (iadpsg) or 2-step (carpenter-coustan) * compatible, validated phone and operating system to support dexcom g6 cgm app (see supplementary table 1) or option to use receiver exclusion criteria: * chronic immunosuppression * concomitant disease or condition that may compromise patient safety or the ability to complete study tasks including and not limited to: severe mental illness or a diagnosed or suspected eating disorder * known allergy to medical grade adhesives * pre-gestational diabetes * multifetal gestation * current alcohol or illicit drug use * simultaneous participation in another clinical study with investigational medicinal product(s) that might have an impact on the study objectives.

Keywords: female pregnancy gestational diabetes
non-inferiority clinical trial of dexchlorpheniramine (cream versus lotion) in the relief of insect bite related symptoms

Conditions: Insect Bites

Summary: insect bite related symptoms (pruritus and papules) are caused by the release of histamine by mast cells in the skin. topical anti-histaminics can be used to promote relief of these symptoms. dexchlorpheniramine maleate 1% cream is a topical anti-histaminic formulation approved by anvisa in brazil for the relief of skin irritation and allergies, including the ones caused by insect bites. the aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% lotion) with the standard preparation (1% cream) for the relief of insect bite related symptoms and to demonstrate the safety of both preparations.


Eligibility criteria:
inclusion criteria: * presence of papules resulting from insect bites within the last 72 hours * presence of symmetric lesions to compare one side to the other * compliance of the subject to the treatment protocol * agreement with the terms of the informed consent by the participants or their legal guardians when younger than 18 years old exclusion criteria: * pregnancy or risk of pregnancy * lactation * use of topical or systemic anti-inflammatory, anti-histaminics or immunosuppressive drugs within the last 48 hours prior to the study * history of atopy or allergic diseases * history of allergy of any component of the formulations * other conditions considered by the investigator as reasonable for non-eligibility

Keywords: insect bites dexchlorpheniramine lotion cream
a study of mircera for the treatment of anemia in dialysis patients

Conditions: Anemia

Summary: this study will assess the efficacy and safety of mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently receiving epoetin or any other erythropoietic substance. the anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients \>=18 years of age; * chronic renal anemia; * dialysis therapy for at least 2 weeks before screening. exclusion criteria: * women who are pregnant, breastfeeding or using unreliable birth control methods; * administration of any investigational drug within 4 weeks before screening.
a clinical study of sph5030 tablets in the treatment of her2-positive/mutated biliary tract or colorectal cancer patients.

Conditions: Biliary Tract or Colorectal Cancer With Her2-positive/Mutated

Summary: to evaluate the efficacy and safety of sph5030 tablets in subjects with her2-positive/mutated biliary tract or colorectal cancer.


Eligibility criteria:
inclusion criteria: 1. metastatic and/or unresectable advanced colorectal adenocarcinoma, or locally advanced, recurrent, metastatic and/or unresectable advanced biliary tract carcinoma 2. her2 positive or her2 gene mutation; 3. meet the requirements of previous treatment; 4. ecog performance status of 0 or 1； 5. expected survival ≥ 3 months; 6. no serious abnormalities in hematopoietic function, liver or kidney function; 7. females who are not pregnant, non-lactating.. subjects who complied with the contraceptive requirements of the protocol.; 8. fully informed subjects who voluntarily sign the icf. exclusion criteria: 1. subjects who have previously received anti-her2 molecular targeted therapy; 2. subjects who have been treated with any other clinical trial drug within 4 weeks prior to the first dose; 3. subjects with uncontrolled or severe cardiovascular and cerebrovascular diseases; subjects with severe lung disease; 4. subjects who may have conditions that affect the absorption, distribution, metabolism, or excretion of the study drug determined by the investigator; 5 subjects who are taking potent cyp3a4 or cyp2c8 inhibitors or inducers; 6 subjects with other malignancies in the past 5 years; 7 subjects with cns system metastasis with clinical symptoms; 8 subjects who do not meet the protocol requirements for hepatitis b and c at screening, have a history of immunodeficiency, or other acquired、congenital immunodeficiency diseases, or have a history of organ transplantation; 9. other situations that do not meet the requirements of the protolol.
the impact of long covid on people living with pre-existing ltc

Conditions: Long COVID; Multiple Chronic Conditions

Summary: the goal of this observational study is to learn about the impact of long covid on people who have multiple (two or more) pre-existing long-term conditions (such as diabetes and asthma). the main question it aims to answer is: • how does long covid impact the lives of adults living with multiple pre-existing long-term conditions and what are their rehabilitation needs? participants will be asked to: * take photos of things they feel represent the impact of long covid on their day-to-day lives across seven days and, * take part in an interview to discuss the impact of long covid.

this qualitative study will involve participants taking photographs (during their usual day-to-day activities), followed by 1:1 semi-structured interviews. participants will be adults living with multiple pre-existing long-term conditions (ltc) and long covid or their carers/supporters. stage 1: photographs participants will be asked to take photographs of things they feel represent or symbolise the impact of long covid on their day-to-day lives across seven days in advance of the interview. stage 2: interviews semi-structured 1:1 interviews will be held face-to-face, online or telephone (in accordance with participant preference to optimise inclusivity). the iterative interview topic guide will continue to be informed by patient and public involvement and engagement, evidence (including preceding projects of the phd), and the participants' photographs. photographs will be viewed during the interview with participants. the findings of this qualitative study will be used to inform the adaptation of exercise-based rehabilitation programmes to improve health and well-being which meets the needs of individuals living with multiple pre-existing ltc and long covid.

Eligibility criteria:
inclusion criteria: * adult (≥18 years) living with long covid (or 'post-covid-19 condition' in accordance with the world health organisation definition) and ≥2 pre-existing long-term conditions or carer/supporter for someone who is * living in leicester (uk) * able to take photographs or carer/supporter who is able and willing * able and willing to provide informed consent exclusion criteria: * child (\<18 years) * unable to participate in a face-to-face, online or telephone interview * unable to access interpreter for first language

Keywords: covid-19
prevalence of attr cardiac amyloidosis in patients undergoing tavr

Conditions: ATTR Amyloidosis Wild Type; Severe Aortic Stenosis; Aortic Valve Stenosis; Middle East Studies

Summary: attr-cardiac amyloidosis (ca) is present in 4% to 16% of elderly patients with severe calcific aortic stenosis (as). the reasons for this association are not fully known. it is hypothesized that an amyloidotic infiltration of the aortic valve acts as a trigger for the development of endothelial damage and subsequent calcification. elderly patients undergoing tavi will be evaluated for the presence of attr-ca in jordan.

attr-cardiac amyloidosis (ca) is present in 4% to 16% of elderly patients with severe calcific aortic stenosis (as). the reasons for this association are not fully known. two hypotheses may explain this association 1. amyloidotic infiltration of the aortic valve acts as a trigger for the development of endothelial damage and subsequent calcification. 2. the increased myocardial strain induced by as may locally favor the process of amyloidogenesis and tissue infiltration. transarterial av replacement (tavi) is the treatment of choice for elderly patients with severe calcific as. studies have shown a prevalence of about 10% of attr cardiac amyloidosis in patients undergoing tavi. the diagnosis is based on a positive nuclear scan (pyp, dpd or hmdp) and ruling out al amyloidosis in patients with positive scans. while studies have shown no impact of attr on prognosis in tavi patients, there is evidence of poorer quality of life, increased in-hospital acute ischemic stroke, increased cardiac and heart failure hospitalizations, increased conduction abnormalities, compared to patients without attr undergoing tavi. the prevalence of attr in tavi patients in jordan and middle eastern populations has not been previously evaluated. the purpose of this study is to evaluate the prevalence of attr cardiac amyloidosis in elderly middle eastern patients undergoing tavi and to document the clinical characteristics, procedural outcomes and 1 year follow up of such patients compared to patients without attr.

Eligibility criteria:
inclusion criteria: * age ≥65 years * severe aortic stenosis * patient underwent tavr procedure * positive pyruvate po4 scan exclusion criteria: * diagnosis of al amyloidosis base on free light chain assay, serum and urine immune electrophoresis.

Keywords: attr cardiac amyloidosis severe aortic stenosis transarterial aortic valve replacement
acceleration of alignment of crowded lower anterior teeth

Conditions: Malocclusion, Angle Class I; Crowded Teeth

Summary: patients at the orthodontic department of university of damascus dental school will be examined and subjects who meet the inclusion criteria will be included. then, initial diagnostic records (diagnostic gypsum models, internal and external oral photographs, as well as radiographic images) will be studied to ensure that the selection criteria are accurately matched. the aim of this study is to compare two groups of patients with moderate crowding of the lower anterior teeth first group (experimental): the patients in this group will be treated with orthodontic fixed appliances + surgery to the alveolus of the lower anterior teeth in order to induce remodeling of the bony structures and enhance orthodontic movement. second group (control): the patients in this group will be treated using fixed appliances with any acceleration method.


Eligibility criteria:
inclusion criteria: * class i malocclusion with moderate crowding (4-6 mm of tooth-size-arch-length-discrepancy). * good oral hygiene and periodontal health. * no severe skeletal discrepancy. * normal inclination for the upper and lower incisors. * no congenitally missing or extracted teeth (except for the third molars). exclusion criteria: * bi-maxillary severe dental protrusion. * previous orthodontic treatment. * subject with psychological abnormalities. * subject with systemic diseases.
e-reporting of adverse drug reactions by patients in relapsing-remitting multiple sclerosis

Conditions: Multiple Sclerosis

Summary: adverse drug reactions are collected exhaustively during the experimental development phase of the drug, but the trial population is not representative. in post-marketing authorization, the use in the real life of medicines requires to specify the profile of adverse effects through pharmacovigilance. however, in clinical practice, under-reporting of adverse drug reactions prevents a satisfactory knowledge of the risks. for example, in the multiple sclerosis (ms) patients population in 2015, only 1 case of congestive flushing was reported by physicians, none by patients, for approximately 7,800 patients treated with tecfidera® dimethyl-fumarate, while trials reported 39% of flush. the investigators propose a study measuring the impact of the deployment of e-reporting to patients in a population suffering from multiple sclerosis in initiation of first line drug therapy. the study design will be a randomized controlled trial. twenty-four direct or indirect partner centers of the ofsep will be randomized in 2 arms (1 standard arm without intervention, and one interventional arm), each arm including 6 chu, 3 chg and 3 liberal neurologists. chus will include 10 patients in 6 months, and chgs and liberal neurologists 5 patients, a total of 180 patients will be included. the expected duration of this study is 12 months, 6 months of inclusion of patients, and one 6-month follow-up period for each patient. at 1 month (+/- 15 days) of the follow-up period of each patient, a questionnaire will be made by telephone call to each patient. the study is part of the pharmacovigilance system in place in france and aims to improve its efficiency by increasing declarations and therefore earlier detection of signals in order to prevent and minimize risks. the comparison of the two arms should make it possible to decide on the usefulness of national support for e-reporting, while respecting a good integration with the french pharmacovigilance system.


Eligibility criteria:
inclusion criteria: patient (\> 18 years) with relapsing-remitting multiple sclerosis. initiation of treatment of 1st line: interferon β, peginterferon β, glatiramer acetate, teriflunomide, dimethyl-fumarate. exclusion criteria: patient with progressively progressive secondary or multiple sclerosis. patient suffering from multiple sclerosis not treated with a first line treatment.
clinical trial of coenzyme q10 and lisinopril in muscular dystrophies

Conditions: Duchenne Muscular Dystrophy; Becker Muscular Dystrophy; Limb Girdle Muscular Dystrophy

Summary: the study will include 120 participants aged 8 and up with duchenne, becker, or autosomal recessive limb-girdle (specifically: lgmd 2c-2f and 2i) muscular dystrophies that have no clinical cardiac symptoms. participants will be randomized to one of four arms: arm 1 coq10 alone, arm 2 lisinopril alone, arm 3 coq10 and lisinopril or arm 4 no study medication. randomization will be stratified by ambulatory status and corticosteroid use. the primary outcome for the study is the myocardial performance index (mpi), measured by standard doppler echocardiography. the study will last 24 months with visits at months 0.5,1.5, 6, 12, 18 and 24. following completion of the clinical trial of coenzyme q10 and lisinopril, participants will be offered participation in a companion protocol: pitt1215 a natural history companion study to pitt0908: clinical trial of coenzyme q10 and lisinopril in muscular dystrophies. the objective of this study is to evaluate the longitudinal natural history of dmd, bmd, and lgmd2i and to evaluate the effects of coenzyme q10 and/or lisinopril on prevention of cardiac dysfunction in these disorders.this will be an 18-month longitudinal natural history study designed to accompany the clinical trial of coenzyme q10 and lisinopril in muscular dystrophies.


Eligibility criteria:
inclusion criteria: * 8 years of age or older * confirmed genetic diagnosis of duchenne, becker, or limb girdle muscular dystrophy * beta-blocker naïve * screening doppler echocardiographic mpi measurement greater than or equal to 0.40 for the highest mpi value (spectral and tissue) or circumferential strain measured by ste that is less negative than or equal to - 23 * normal left ventricular fractional shortening (≥28%) and no clinical cardiac symptoms * has not participated in other therapeutic research protocol within the last 6 months prior to screening * ability to swallow tablets exclusion criteria: * spine curvature greater than 30% (based on the x-ray performed at screening) * history of significant concomitant illness or significant impairment of renal or hepatic function * history of hypersensitivity to ace inhibitors * history of idiopathic or hereditary angioedema or a history of angioedema with prior ace inhibitor use * use of carnitine, creatine, glutamine, or any herbal medicines (this would not include herbal teas unless they are consumed daily with intended medicinal effect) in the 3-months prior to enrollment * coq10 and/or ace inhibitor use for a duration greater than 6 months * coq10 and/or ace inhibitor use in the 3-months prior to enrollment * coq10 serum level of 2.5 ug/ml or higher * investigator assessment of inability to comply with protocol

Keywords: cardiac muscular dystrophy randomized
role of immune activation in response of head and neck squamous cell carcinoma to therapy

Conditions: Head and Neck Cancer; Oropharyngeal Cancer; Human Papillomavirus; Squamous Cell Cancer

Summary: the purpose of this study is to investigate the role of the immune system in the response of squamous cell cancers of the head and neck to treatment that includes radiation therapy. current research demonstrates that several natural immune cells and molecules affect the way the body's immune system interacts with a cancerous growth. some cancers may be related to infection with a virus, such as the human papilloma virus (hpv). studying the activity of the immune system in head and neck cancers, especially cancers related to hpv infections, can provide valuable information to better understand the body's interaction with cancer cells.

this is a study of the immune response in patients with oropharyngeal cancer who undergo treatment with radiation, chemoradiation, or robotic surgery. many oropharyngeal cancers are caused by infection with the human papillomavirus (hpv), and patients with hpv-mediated tumors have much better prognosis and treatment response compared to patients with hpv-negative tumors. the investigators will test the hypothesis that radiation-based therapy of oropharyngeal cancer is associated with activation of the endogenous hpv-specific immune response. in this study the investigators will collect blood at several time points before, during, and after treatment to monitor the immune response in patients with tumors positive and negative for hpv versus normal healthy volunteers.

Eligibility criteria:
inclusion criteria: * the patient has biopsy-proven squamous cell carcinoma, stage ii-iv, of the oropharynx or larynx. * the patient is to undergo treatment with radiation, chemo-radiation, or robotic surgery. * the patient is able to give informed consent. * the patient is at least 18 years old. * the patient's ecog performance status is \</=2. exclusion criteria: * the patient has had prior head and neck squamous cell carcinoma, with the exception of superficial cutaneous basal cell or squamous cell carcinomas. * the patient has active cancer in another part of the body, with the exception of superficial cutaneous basal cell or squamous cell carcinomas. * if a cancer survivor, the disease free interval is less than 5 years, with the exception of superficial cutaneous basal cell or squamous cell carcinomas. * the patient is a minor. * the patient is pregnant. * the patient is a prisoner. * the patient is incapable of understanding the consent process. * the patient has previously received definitive surgical, radiation, or chemoradiation treatment for hnscc. * the patient has a history of hiv or other known cause of immunosuppression, or is actively taking immunosuppressive medications due to organ transplantation, rheumatoid disease, or other medical conditions.

Keywords: head and neck cancer oropharyngeal cancer human papillomavirus squamous cell carcinoma radiation treatment chemotherapy induction chemotherapy immune status immune monitoring head and neck robotic surgery
a mentor-based approach to long-term weight loss

Conditions: Weight Loss; Obesity

Summary: the purpose of this study to examine the effect of having a weight loss mentor on long-term weight loss in overweight adults.


Eligibility criteria:
inclusion criteria: 1. female 2. 21-55 years of age 3. bmi = 25-35 kg/m2 4. ability to provide informed consent. 5. ability to provide consent from their personal physician to participate in this study. exclusion criteria: 1. reporting regular exercise participation of at least 20 minutes per day on at least 3 days per week during the previous six months. (this study is designed to recruit relatively sedentary adults.) 2. diabetes, hypothyroidism, or other medical conditions which would affect energy metabolism. 3. currently pregnant, pregnant within the previous six months, or planning on becoming pregnant within the next 12 months. (pregnancy will be based on self-report and will be included on the detailed medical history that is completed by subjects.) 4. non-medicated resting systolic blood pressure \>160 mmhg or non-medicated resting diastolic blood pressure \>100 mmhg, or taking medication that would affect blood pressure. 5. taking medication that would affect resting heart rate or the heart rate response during exercise (e.g., beta blockade). 6. arrhythmia on resting or exercise electrocardiogram that would indicate that vigorous exercise was contraindicated. 7. history of myocardial infarction or valvular disease. 8. history of orthopedic complications that would prevent optimal participation in the exercise component (e.g., heel spurs, severe arthritis).
analysis of postoperative bandage use protocols in otoplasty

Conditions: Prominent Ears

Summary: the aim of the study is to investigate the possible influence of different durations of use of postoperative elastic bandaging (seven days vs. thirty days) in the results of otoplasty. we hypothesize that the duration of elastic bandage use has no significant influence on the incidence of relapse of prominence of the ears and need for reoperation.


Eligibility criteria:
inclusion criteria: * congenital bilateral ear prominence * 10 years-old or older * no previous attempt of surgical treatment exclusion criteria: * pregnant women * breastfeeding women * blod clotting disorders or current anticoagulant use * uncontrolled systemic diseases

Keywords: external ear ear abnormalities external ear cartilages