Kornimate/medical-research-clean huggingface dataset:
gi reflux in lung transplant and its relationship to chronic rejection

Conditions: Gastroesophageal Reflux

Summary: recent data has suggested that ger (gastric reflux) may worsen after lung transplantation and potentially increase the risk of chronic rejection (cr) after lung transplantation. the purpose of this study is to look at how often ger occurs in the lung transplant population and examine how ger may change the immune system and cause cr. in this way, we would be able to better identify patients that may benefit from anti-reflux procedures.

part of standard pre-transplant work up includes a gastrointestinal (gi) work-up to check for ger. the following procedures will be done pre-transplant. 1. standard ger questionnaire (rdq): this is a 12 item questionnaire. this questionnaire will ask questions about any reflux symptoms present. 2. esophagogastroduodenoscopy (egd): this test will determine evidence of esophageal reflux and presence of a hiatal hernia. 3. scintigraphic evaluation of solid gastric emptying: this measures the speed with which food empties from the stomach and enters the small intestine. 4. twenty-four hour ambulatory ph testing: the ambulatory 24-hour ph monitoring test will monitor the acid in the esophagus during a 24-hour period. 5. esophageal manometry testing: this procedure is done to evaluate the cause of reflux of stomach acid and contents back into the esophagus, and to determine the cause of problems with swallowing food. these procedures will be done again at 3 to 6 months post transplant. the results of the egd, scintigraphic evaluation, answers of rdq, ph testing, esophageal manometry and bronchoscopy will be collected as well as spirometries and any episodes of rejection.

Eligibility criteria:
inclusion criteria: * patients who are undergoing pre-lung transplant evaluations at the university of chicago hospital * patients who are capable of becoming pregnant must have a negative pregnancy test prior to consent. * all patients must be able to give written informed consent. exclusion criteria: * pre-transplant patients in whom study procedures are contraindicated or patients who are unable to complete all the study procedures. * patients who are unable to give consent

Keywords: gastric reflux lung transplant chronic rejection gastric reflux in lung transplant as it relates to chronic rejection
diabetic retinopathy screening in general practice

Conditions: Diabetic Retinopathy; Type2 Diabetes

Summary: diabetic retinopathy is a microvascular eye complication of diabetes, which can go unnoticed until permanent vision damage has occurred - in worst-case blindness. timely retinopathy screenings reduce the risk of sight loss since the disease can be treated if detected in time. for people with type 2 diabetes, retinopathy screenings are typically performed by specialist at private ophthalmologists' practices, and individualized screening intervals based on retinopathy level and diabetes regulation are recommended. unfortunately, 26% of people with type 2 diabetes do not follow their screening interval, and the attendance is too low compared to the national standard of minimum 90% of patients with diabetes who ought to follow the screening program. consequently, actions must be taken to improve screening attendance in denmark. the aim of this study is to investigate patients' acceptance of diabetic retinopathy screenings in general practice. patients' acceptance is explored through a questionnaire developed for the study.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes * understands danish * age between 18-70 exclusion criteria: * blindness * cannot partake in second screening

Keywords: artificial intelligence diabetic retinopathy screening general practice primary care type 2 diabetes
a study in adults with advanced classical hodgkin's lymphoma (chl) in brazil treated with brentuximab vedotin together with chemotherapy compared to chemotherapy alone

Conditions: Hodgkin Lymphoma

Summary: the main aim of this study conducted in brazil is to understand if there is a difference in the length of time that classical hodgkin's lymphoma (chl) does not grow or spread further (also called progression free survival or pfs), and in the length of time that participants live with chl if they are treated with brentuximab vedotin in combination with chemotherapy (a+avd) or chemotherapy alone (abvd). a+avd includes brentuximab vedotin + doxorubicin + vinblastine + dacarbazine; abvd includes doxorubicin + bleomycin + vinblastine + dacarbazine. the study will be conducted by reviewing and collecting already existing medical records.

this is an observational, multicenter and retrospective study to evaluate the effectiveness of a+avd regimen compared to abvd regimen as first-line therapy for the treatment of brazilian participants with advanced chl diagnosis. the study will enroll approximately 200 participants who were treated with a+avd or abvd as first line therapy for at least one full cycle of 28 days, from july 1st, 2017, to december 31st, 2020. participants will be identified from medical charts and will be assigned into following treatment groups: * abvd: doxorubicin 25 milligrams per square meter (mg/m\^2) + bleomycin 15 milligram (mg) + vinblastine 6 mg/m\^2 + dacarbazine 375 mg/m\^2 * a+avd: brentuximab vedotin 1.2 milligrams per kilogram (mg/kg) + doxorubicin 25 mg/m\^2 + vinblastine 6 mg/m\^2 + dacarbazine 375 mg/m\^2 this multi-center trial will be conducted in brazil. the duration of the study will be 12 months. participants will be followed up for at least 2 years after the last therapy cycle (treatment window considered for the study from july 1st, 2017, to december 31st, 2020).

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of advanced chl (international classification of diseases and related health problems 10th revision \[icd-10\] code c81.x). the diagnosis of chl will be confirmed according to world health organization (who) classification. advanced disease is defined as having the diagnosis at stage iib, iii or iv, based on ann arbor classification. * who received at least one full cycle of a+avd or abvd regimen as first-line treatment (first systemic therapy for chl management; systemic therapy naïve participants) from july, 1st 2017 to december, 31st 2020; and who completed the 6-cycle treatment until the end of december 2020. * at least 2 years of retrospective information from the index date (treatment window) and at least 2 years of follow-up (after the end of treatment). exclusion criteria: * with previous or concurrent malignancies, except participants with completely excised carcinoma in situ of any type and basal or squamous cell carcinoma of the skin. * who are simultaneously participating in another study. * who participated in the echelon-1 clinical study.

Keywords: drug therapy
performance and safety assessment of spring thread® elastic tensor thread in patients with mild to moderate facial ptosis.

Conditions: Ptosis; Ptosis, Mild

Summary: the purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the spring thread® elastic tensor thread. the study will evaluate the outcome of the spring thread® elastic tensor thread range over a period of 5 years.


Eligibility criteria:
inclusion criteria: * men / women aged 35 to 75 with facial ptosis (cheekbones, jowls) with or without a history of aesthetic treatment (botox, filler, surgical lift). * patient able to understand the explanations given. * patient informed and not objecting to participate in the study. * patient able to comply with protocol requirements, including follow-up visits. * patient affiliated to social security. exclusion criteria: * patient unable to understand study information and attend study visits. * patient did not give consent to participate. * patients who have had a previous facial rejuvenation treatment in the 3 months prior to the study. * patients treated with long-term systemic corticosteroids. * patients with visceral failure, chronic immunological pathology, pregnant or breasfeading women. * patient participating or having participated in another clinical trial protocol, drug or medical device within 30 days of inclusion. * patient refusing to participate in the clinical investigation.

Keywords: ptosis, moderate
thoracic manipulation and mobilization for neck pain

Conditions: Neck Pain

Summary: the purpose of this randomized clinical trial was to examine the widespread effects of thoracic spine thrust manipulation and thoracic non-thrust mobilization on pressure pain sensitivity and neck pain intensity in patients with chronic mechanical neck pain.


Eligibility criteria:
inclusion criteria: * mechanical idiopathic neck pain * bilateral pain symptoms * chronic pain (\>3 months of duration) exclusion criteria: * whiplash injury * previous spine surgery * diagnosis of cervical radiculopathy or myelopathy * diagnosis of fibromyalgia * having undergone any physical therapy intervention in the previous year * pregnancy

Keywords: manipulation mobilization spine pressure pain
increasing use of the vaccine against herpes zoster/shingles at nyulmc and bellevue hospital

Conditions: Herpes Zoster

Summary: the purpose of this study is to determine if vaccination rate of eligible patients at a major urban public hospital will increase by having ophthalmologists screen patients for eligibility and a nurse administer the vaccine in the general eye clinic.

patient vaccination behaviors will be assessed after 100 doses of the zostavax vaccine are provided to underserved patients screened by ophthalmologists at the general eye clinic at a public hospital that does not normally provide the vaccine. a nurse will be at the clinic to administer the vaccine. patients will be contacted by phone 1 month later and seen within 3 months in the eye clinic to determine whether there were any side effects.

Eligibility criteria:
inclusion criteria: * 60 years of age or older * absence of evidence of immune compromise in the medical record * ability to speak and read english, spanish or chinese and give informed consent exclusion criteria: * vulnerable patients, including the cognitively impaired, prisoners and employee * fda contraindications for zostavax vaccine
metformin to prevent late miscarriage and preterm delivery in women with polycystic ovary syndrome

Conditions: Pregnancy; Polycystic Ovary Syndrome

Summary: the overall aim of the pregmet 2 study is to investigate whether metformin prevents late miscarriages and preterm deliveries in pcos women treated with metformin from first trimester of pregnancy to delivery in a large, randomized, controlled, multi-centre trial setting. the investigators hypothesis is that metformin compared to placebo treatment from the first trimester to term, reduces the prevalence of late miscarriage (gestational week 13-22) and preterm birth (gestational week \< 37) in pcos women diagnosed according to rotterdam 2003 consensus criteria, with singleton pregnancy.


Eligibility criteria:
inclusion criteria: * age: 18-45 years * pcos diagnosed or reconfirmed according to rotterdam 2003 criteria, not more than 5 years prior to inclusion * mode of conception: any * single, viable fetus, diagnosed by vaginal ultrasound * gestational week at inclusion: week 6 + 0 to 12 + 0 * wash out for metformin: at least 7 days * able to communicate fluently in the official language at the study cite or english exclusion criteria: * any type of diabetes (except gdm in former pregnancy) * known liver disease or alat \> 100 iu/l * known kidney disease or creatinine \> 110 μmol/l * known alcohol or drug abuse * use of drugs interfering with metformin: erytromycin (or other macrolides), cimetidine, anticoagulation therapy * unsuitable for participation of other reasons

Keywords: miscarriage preterm birth prevention
initiation of first-line antiretroviral treatment with tenofovir alafenamide - emtricitabine - bictegravir at the first clinical contact in france: trial imea 055 - fast

Conditions: HIV Seropositivity

Summary: evaluation of antiretroviral treatment adherence using determination of bictegravir, emtricitabine and tenofovir with new hiv patients in france

* patient treated at the first clinical contact * 18 sites (hospitals) in france * treatment during 48 weeks with principal objective at w24 (plasma hiv-rna \< 50 copies/ml) * evaluation of antiretroviral treatment adherence using determination of bictegravir, emtricitabine and tenofovir in hair sample

Eligibility criteria:
inclusion criteria: * age \> 18 years * newly diagnosed hiv-infected individual evidenced by any of the following tests: (i) positive self-test, (ii) positive hiv rapid antibody test, (iii) positive hiv immunoassay (elisa 4th generation) test * antiretroviral-treatment naive * negative urine pregnancy test for women of childbearing potential and willing to use effective contraception (mechanical or medicamental) * willing to sign an informed written consent- * regular health insurance * willing to provide two distinct contact information (telephone number and/or email) in order to be easily reached if needed between day 0 and day 7 exclusion criteria: * clinical symptoms suggestive of opportunistic infections * participant not willing to provide two distinct contact information * a woman who is pregnant or breast-feeding or planning to become pregnant during the expected study period. * co-medication with deleterious interaction with study treatment (eg enzyme inducer)

Keywords: hiv, new diagnosis, biktarvy
efficacy and safety of vildagliptin compared to metformin in elderly drug naive patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study is designed to demonstrate the efficacy and safety of vildagliptin compared to metformin in elderly drug naive patients with type 2 diabetes


Eligibility criteria:
inclusion criteria: * age from 65 years to the upper age limit recommended by local prescribing information for metformin * drug naive patients with type 2 diabetes. * body mass index (bmi) in the range of 22-40 kg/m2. * hba1c in the range of 7 to 9% inclusive * fpg \<270 mg/dl (15 mmol/l) exclusion criteria: * a history of type 1 diabetes * evidence of significant diabetic complications * treatment with insulin or any other oral antidiabetic agents other protocol-defined inclusion/exclusion criteria may apply

Keywords: type 2 diabetes vildagliptin hemoglobin a1c metformin
plasma biomarker in amblyopia patients

Conditions: Amblyopia

Summary: this prospective study aims to observe the predictive effect of peripheral blood plasma biomarker on the outcome of treatment in children with different types of amblyopia. we also investigated the mechanism of neuromodulation in the visual development of amblyopic children.


Eligibility criteria:
inclusion criteria: * diagnosed with amblyopia * 3-12 years of age * able to tolerate amblyopia treatment * agree to be involved in this study and agree to have a follow up visit every 3 months. exclusion criteria: * have previous treatment history before * have pathological ocular anomalies known to cause reduced visual acuity * have previous psychiatric, visual or neurological disorders * have eccentric fixation and/or abnormal retinal correspondence * have attention disorder and learning disability that cannot comprehend psychophysical test instructions given and/or consent for themselves

Keywords: amblyopia plasma biomarker prediction treatment outcome
comparison of peripheral blood stem cell transplantation with bone marrow transplantation for the treatment of serious hematological malignancies

Conditions: Blood Stem Cell Transplant

Summary: this study will compare the outcomes of study participants who have had peripheral blood stem cell transplantation or with those who have had bone marrow transplantation from an unrelated donor for the treatment of serious hematological malignancies.

this study is a randomized, open-label, multicenter, prospective, comparative trial of granulocyte colony stimulating factor (g-csf) mobilized peripheral blood stem cells verses marrow from unrelated donors for transplantation in patients with hematologic malignancies. the study will be comparing two-year survival probabilities between process has many steps after a matched donor is found. the donor also needs to give permission to join this study. participants will be randomized to either peripheral blood stem cells (pbsc) or bone marrow. the kind of transplant the participant receives is random. neither the participant nor the doctor may choose the type of transplant. participants will receive vaccinations for diphtheria, tetanus, hepatitis b and pneumococcus. blood samples will be drawn as part of a participant's normal care. blood samples will also be collected to see if infection fighting cells are working. these samples will be collected at 12 weeks, one year and then yearly until three years post transplant. information will be collected from the participant's medical history. participants will also have phone interviews conducted and questions will be asked about their physical and emotional health. participants taking part in this study may be followed for up to 5 years.

Eligibility criteria:
participants may be eligible if they are between the ages of 18 to 66 years and are undergoing unrelated blood stem cell transplantation for the first time for the treatment of their hematological malignancy. additional eligibility criteria will be gathered and evaluated by the transplant physician to determine if an individual is eligible to take part.
hypnosis for chronic idiopathic pruritus

Conditions: Chronic Idiopathic Pruritus

Summary: chronic idiopathic pruritus (cip) is a frequent and disabling condition, for which there is no specific treatment. it was shown previously that hypnosis can relieve painful sensations. pain and pruritus share many similarities regarding sensory receptors and pathways, suggesting that hypnosis might help relief cip.

chronic idiopathic pruritus (cip) is a frequent and disabling condition, with significative impact on quality of life. at present, there is no specific treatment for cip. topical steroids are frequently used, with partial efficacy, and adverse effects. hypnosis is a specific state of conscience. it differs from waking state, sleeping state, relaxation, or meditation. in this state, the person is highly responsive to suggestion. in medicine, hypnosis can be used to engage the internal resources of the person against unpleasant feelings. it was shown previously that hypnosis can relieve painful sensations. pain and pruritus share many similarities regarding sensory receptors and pathways, suggesting that hypnosis might help relief cip.

Eligibility criteria:
inclusion criteria: * male or female of at least 18 years at screening * diagnosis of chronic (at least 6 wks.) idiopathic pruritus * pruritus numeric rating scale \> = 4 exclusion criteria: * pruritus caused by a dermatological or a systemic conditions * suicidal crisis, moderate, or severe * psychosis (schizophrenia, persistent delusional disorder) * bipolar disorder, not stabilized or decompensating * personality disorder, decompensated
a pilot study of thrombin generation changes in neonates undergoing placement of a blalock-taussig shunt

Conditions: Aortic Coarctation

Summary: the primary goal of this investigation is to describe perioperative thrombin generation in neonates undergoing placement of a blalock-taussig (bt) shunt to better understand the coagulation changes that precipitate postoperative shunt occlusion.

to accomplish our goal, the investigators will measure preoperative levels of one major procoagulant (prothrombin) and one major anticoagulant (antithrombin). the investigators will also measure preoperative and postoperative thrombelastograms (teg) and preoperative and postoperative thrombin generation curves (tgc).

Eligibility criteria:
inclusion criteria: 1. full-term neonates (37-42 weeks gestational age) 2. apgar score of 7 or more at 5 minutes after delivery 3. surgical placement of bt shunt or repair of an aortic coarctation 4. parent or legal guardian willing to participate, and able to understand and sign the provided informed consent exclusion criteria: 1. preterm neonates (less than 37 weeks gestation) 2. apgar score of less than 7 at 5 minutes after birth 3. emergent procedure 4. surgical procedure other than placement of bt shunt or repair of aortic coarctation 5. neonates with a known coagulation defect or coagulopathy 6. mother with a known coagulation defect or coagulopathy 7. parent or legal guardian unwilling to participate or unable to understand and sign the provided informed consent

Keywords: neonatal surgery blalock-taussig shunt
cytology study of cells from patients with low back pain

Conditions: Back Pain

Summary: the investigators are doing this study to learn more about the cause of back pain with or without pain shooting down one or both legs. the investigators specifically want to know if cells that move into injured areas of the body are present in a space in the spine (epidural space) of patients with back pain and with or without shooting pain. the investigators will collect cells when patients are being treated, then examine the cells using a microscope. the investigators also will shine different colors of light into the epidural space to see if there is a correlation between how different colors of light are reflected and the types of cells present.

the objective of this study is to examine the cell population in the epidural space of patients with low back pain +/- radiculopathy to determine if the cell population reveals pathological processes sustaining the pain. cells will be collected for microscopic inspection and will be examined in situ during exposure to white and uv light. the overall goal is to advance our knowledge about the etiology of low back pain +/- radiculopathy to guide mechanistic based therapy. the primary information sought is to determine if description of pathological processes based upon direct observation with percutaneously placed epiduroscopes can be confirmed by cytological analysis. the observations described include: 1) increased fibrosis from slight to complete replacement of other tissue, or obliteration of the epidural space; 2) alteration of color and/or appearance of epidural fat; 3) increased or decreased vascularity. the overall description range from acute inflammatory changes to advanced fibrosis (scarring). specimens for cytological analysis will be obtained from different sites in the epidural space by using commercially available cytology specimen collecting brushes and/or catheters. these are inserted through the working channel of an epiduroscope into the lumbar epidural space to aid treatment.

Eligibility criteria:
inclusion criteria: * understand and voluntarily sign an informed consent form * age \>18 years at the time of signing the informed consent form * a diagnosis of low back pain with or without radiculopathy and scheduled for epiduroscopy assisted epidural neurolysis exclusion criteria: * patients not scheduled for epiduroscopy assisted epidural neurolysis * are female who is pregnant * are a female of childbearing age and are not using an acceptable form of contraception * have a medical history or condition that would not make the patient a good candidate for epiduroscopy procedure * are unwilling or unable to provide written informed consent and/or to obey the study procedures

Keywords: back pain low back pain cytology epiduroscopy pain radiculopathy