Kornimate/medical-research-clean huggingface dataset:
an observational study of the progression of intermediate age-related macular degeneration

Conditions: Age-Related Macular Degeneration

Summary: this is a multicenter prospective study in participants with intermediate age-related macular degeneration (iamd). one primary objective of this study is to assess iamd disease progression, by the timeline and rates of conversion for high-risk iamd at baseline to more advanced atrophic amd stages. the other primary objective of this observational study is to assess the feasibility of measuring the rate of photoreceptor loss as a potential clinical endpoint. the study will consist of an observation period of approximately 3 years (\~144 weeks) for participants.


Eligibility criteria:
inclusion criteria: * for women of childbearing potential, agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, during the study for at least 28 days after the last fluorescein injection for the fluorescein angiography (fa) administration * study eye: high-risk intermediate amd exclusion criteria: * macular disease in either eye with subretinal deposits not typical of amd * pigmentary abnormalities of the retina in either eye not typical of amd * atrophy in either eye due to causes other than amd * study eye: any concurrent or history of ocular or intraocular condition * study eye: intraocular surgery, including cataract surgery, within 3 months prior to day 1 * study eye: retinal tears or peripheral retinal breaks within 3 months prior to day 1 * study eye: concurrent or history of retinal laser photocoagulation or anti-vascular endothelial growth factor (anti-vegf) treatment for exudative mnv, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy * study eye: presence of choroidal nevus with overlying drusen in the circle with a radius 3600 micrometer centered on the fovea * study eye: previous participation in interventional clinical trials for ga or early stages of amd, except for vitamins and minerals, regardless of the route of administration within the last 6 months, except for sham-arm participants * study eye: history of glaucoma surgery, corneal transplant, retinal pigment epithelium tear, retinal tear that involves the macula, retinal detachment * either eye: uncontrolled progressive glaucoma * either eye: moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy * either eye: history of recurrent infectious or inflammatory ocular disease * any concurrent or history of taking medications that can induce retinal toxicity
coronary sinus pressure and microvascular disease

Conditions: Microvascular Coronary Artery Disease

Summary: macchus is a randomized, single-center, controlled, cross-over interventional study in which coronary artery resistances will be measured at baseline and during temporary occlusion of the coronary sinus.

the aim of this study is to test whether an increase in coronary sinus pressure leads to a change in coronary microvascular resistances in patients with angina pectoris and with an indication to measurement of microvascular function as per clinical guidelines. all patients with a clinical indication for the assessment of microvascular function will be invited to participate and will sign the informed consent at least 24 hours before the study. patients with an index of microvascular resistances \>25 (i.e. evidence of microvascular dysfunction) will undergo study-specific procedures in the same session (i.e. no additional invasive procedure is required for the study). study-specific procedures include the repetition of the assessment of microvascular resistances at rest and during coronary sinus occlusion. coronary sinus occlusion will be achieved by inflating a balloon sized to \~70% of the diameter of the coronary sinus. since the implantation of a coronary sinus reducer is a therapeutic option for this type of patients, also this procedure (inflation of an undersized balloon in the coronary sinus) provides clinically relevant information (sizing of the vessel, effect on microvascular resistances and feasibility of the intervention). the primary goal of the study is to study the effect of coronary sinus occlusion on microvascular resistances at rest and during hyperemia.

Eligibility criteria:
inclusion criteria: * chronic coronary syndrome (including patients with anginal equivalents). * reversible ischemia on non-invasive testing, indication to cardiac catheterization; * indication to the assessment of microvascular function (note: patients will be asked for participation and consented prior to the first measurement of microvascular function, which will be conducted as per clinical indication; only those with evidence of pure or mixed microvascular disease (index of microvascular resistances (imr)\>25 will proceed into the study); * willingness to participate and ability to understand, read and sign the informed consent; * age\>18 years exclusion criteria: * previous cabg with patent grafts to the left anterior descending coronary * epicardial coronary disease (ffr \<0.80 with evidence of a focal stenosis) in the left anterior descending territory * severe valvular heart disease * any cardiomyopathy; pulmonary or renal disease * inability to provide informed consent * any disease reducing life expectancy
physiotherapy to improve feeding skills in preterm infants

Conditions: Premature Birth; Parenteral Nutrition; Motor Disorders; Neurodevelopmental Disorders; Sucking Behavior

Summary: introduction: suction problems are very common in premature children due to a lack of maturation and orofacial control, the manifestation of a low muscle tone and the incoordination during sucking-swallow-breathe. in addition, there are some problems in different systems that get it worse. aim: compare oral stimulation programme with a neurodevelopmental stimulation intervention programme combined with an oral stimulation programme, evaluating its effectiveness on feeding development, neuromotor development and other aspects of development. methodology: we proposed a prospective parallel group clinical trial with two randomized and independent experimental groups. all preterm infants born between 2022-2023 at university hospital torrecárdenas, with nasogastric tube and gestational age between 27-32 weeks will be included. expected benefits: to have better results when the preterm infant is approached globally, also considering the postural situation of the preterm infant. in addition, it is expected that the development of children treated by combining oral stimulation with neurodevelopmental stimulation will be equated or close to healthy and born-to-term child. results applicability: improved eating performances will reduce length of hospital stay as well as a greater autonomy improving family situation. it will also allow the reduction of hospital costs and the creation of a new way to attend this problem in preterm children.


Eligibility criteria:
inclusion criteria: premature infants with a gestational age between 27 and 32 weeks, with an adequate weight for their gestational age, admitted to the unit of neonatology, hemodynamically stable and with enteral nutrition exclusion criteria: * neurological disorders * invasive mechanical ventilation * congenital disorders * necrotising enterocolitis * metabolic diseases * intraventricular hemorrhage grade 3-4 * genetic disorders * oral disorders that make this process difficult(cleft palate, cleft lip...) * serious illnesses according to medical criteria

Keywords: premature birth neurodevelopmental disorders nicu physical stimulation
clinical trial of tqb2922 for injection in patients with advanced cancers

Conditions: Advanced Cancer

Summary: this is a phase i study to evaluate the safety, tolerability, and efficacy of tqb2922 for injection in subjects with advanced cancers


Eligibility criteria:
inclusion criteria: * subjects voluntarily join this study, sign the informed consent form, and have good compliance； * age: 18-75 years; eastern cooperative oncology group (ecog) score: 0-1 ; expected survival of more than 3 months； * histologically or cytologically diagnosed with advanced cancers; * subjects with advanced malignancies who have failed standard therapy or lack effective treatment; * major organs are functioning well; * female and male subjects of childbearing potential should agree to practice contraception during the study and until 6 months after the completion of the study. exclusion criteria: * current concomitant or ever presented with other malignancies within 2 years prior to the first dose; * unresolved toxicity of grade 1 or above according to ctcae due to any prior anti-tumor therapy; * significant surgical treatment, biopsy, or significant traumatic injury within 28 days prior to the first dose; * long-term unhealed wounds or fractures * cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to the first dose; * a history of psychotropic drug abuse and cannot be abstained, or have a mental disorder; * subjects with any severe and/or uncontrolled disease; * history of live attenuated vaccination within 2 weeks prior to the first dose or planned live attenuated vaccination during the study; * previous history of unexplained severe allergies, hypersensitivity to monoclonal antibodies or exogenous human immunoglobulins, or hypersensitivity to tqb2922 for injection or its excipients; * according to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patients or affect the completion of the study, or subjects who are considered to be unsuitable for enrollment for other reasons.
epidemiology of insulin growth factor (igf) and cardiovascular events

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Myocardial Infarction; Cerebrovascular Accident; Heart Failure; Heart Failure, Congestive

Summary: to explore the role of insulin growth factor in cardiovascular disease in older men and women.

background: insulin-like growth factor-i (igf-i) is the main mediator of effects of growth hormone (gh) and an important regulator of cell cycle/differentiation and inhibitor of apoptosis. consistent with laboratory studies showing potentially beneficial effects of igf-i on the cardiovascular and cerebrovascular systems, gh-deficient individuals have high cardiovascular disease (cvd) mortality and evidence of premature atherosclerotic disease that is reversible with gh replacement. in addition, several epidemiological and clinical studies have shown an association between low serum igf-i levels and myocardial infarction (mi) and congestive heart failure (chf) among persons without frank abnormalities of the gh/igf-i axis. design narrative: the study is the first prospective investigation to assess whether serum levels of igf-i and two of its important binding proteins, igfbp-3, and igfbp-1, are associated with incidence of confirmed incident cardiovascular disease (cvd) events in older male and female adults. specimens and data for this study will be obtained from the cardiovascular health study (chs), a large, multi-center nhlbi-funded prospective cohort study of 5,888 community-dwelling men and women 65 years or older. the study uses an efficient case-cohort study design to select specimens for testing, involving evaluation of 750 incident myocardial infarction (mi)/fatal coronary heart disease (chd) cases, 500 incident stroke cases, 750 incident congestive heart failure (chf) cases, and a comparison sub-cohort of 750 individuals selected at random from the study population. the study examines the association between baseline serum igf-i, igfbp-1, and igfbp-3 level and the future occurrence of first incident mi/fatal chd, ischemic stroke, and chf. multivariate regression models are used to control for potential confounding factors including age, sex, race/ethnicity, anthropometry and body composition, fasting and 2-hour post-load glucose and insulin levels, dietary intake, physical activity, hormone replacement therapy and other medications, and other cvd risk markers such as lipids, inflammatory factors, and coagulation/fibrinolysis markers.

Eligibility criteria:
medicare-eligible adults as well as other age-eligible individuals residing in the household
pregnancy and neonatal follow-up of ongoing pregnancies established in clinical trial p05690 (care program) (p05710)

Conditions: Pregnancy; Neonates

Summary: the objective of this follow-up study is to evaluate whether corifollitropin alfa (org 36286) treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (cos) prior to in vitro fertilization (ivf) or intracytoplasmic sperm injection (icsi) is safe for pregnant participants and their offspring.

this is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcome of women who were treated with corifollitropin alfa or recfsh and became pregnant during the base study p05690 (nct00702845). for this trial no study specific assessments are required, but information as obtained in standard practice will be used.

Eligibility criteria:
inclusion criteria: * participants who participated in base study p05690 (nct00702845) and received at least one dose of either corifollitropin alfa (org 36286) or recfsh in base study p05690; * ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in base study p05690; * able and willing to give written informed consent. exclusion criteria: * none

Keywords: neonatal outcome congenital malformations in-vitro fertilization controlled ovarian stimulation follow-up
antibody responses to pneumococcal vaccines among hiv-infected adults.

Conditions: HIV Infections

Summary: streptococcus pneumoniae is the major cause of bacterial infection in hiv-infected patients. the current pneumococcal vaccine is poorly efficacious in patients with a cd4 cell count lower than 500/mm3. this study will test the efficacy and safety of a new pneumococcal vaccine strategy in patients with a cd4 cell count between 200 and 500/mm3.

streptococcus pneumoniae (sp) is the major cause of bacterial infection in hiv-infected patients. the 23-valent pneumococcal polysaccharide (ppv) is poorly immunogenic in patients with cd4 below 500 cells/mm3. the purpose of this multicentric national study is to evaluate whether a prime with a 7-valent pneumococcal conjugate vaccine (pcv), able to induce immunological memory, would improve immunogenicity against sp polysaccharides. 212 hiv-1 infected patients, with a cd4 count between 200 and 500/mm3, will be randomly assigned to one of two vaccine groups: pcv at week 0 followed by ppv at week 4 or ppv alone at week 4. evaluation will be done at week 8. the primary endpoint is the proportion of patients who had antibody responses against 7 pneumococcal polysaccharides at week 8. secondary endpoints include the persistence of antibody responses at weeks 24 and 96, vaccines safety and occurrence of pneumococcal disease over time.

Eligibility criteria:
inclusion criteria: * adult patients with proven hiv-1 infection * naïve or antiretroviral experienced * cd4 cell count between 200 and 500/mm3 * plasma hiv rna load lower than 4 log10 copies/ml * signed written informed consent exclusion criteria: * immunotherapy * immunization with the ppv within the past 5 years * splenectomy * use of intravenous immunoglobulin within the past 2 months * chemotherapy or radiation * any other vaccination within the past 2 months * severe renal failure * end-stage liver disease * pregnancy

Keywords: hiv infections pneumococcal vaccines treatment experienced treatment naive
open label immunotherapy of endometriosis

Conditions: Endometriosis

Summary: endometriosis is a chronic gynecological disease characterized by sustained painful symptoms that are responsible for a decline in the quality of life of sufferers. endometriosis is fairly common, affecting an estimated 10%-15% of women and girls, usually during their reproductive years. based on these rough estimates, the latest epidemiological studies suggest that over 200 million women are might be affected who may commonly have infertility problems. additionally, endometriosis is a major factor increasing by 33-66% risk of ovarian cancer. v-endo is a tableted preparation derived from hydrolyzed, heat-inactivated, pooled blood of women with endometriosis. when taken orally it is postulated to cause the immune tolerance and anti-inflammatory effect as a result.

anatomically endometriosis is characterized by the presence of endometrial-type mucosa outside the uterine cavity. this tissue proliferates and causes chronic inflammation resulting in pain and excessive menstrual bleeding. conventional treatment includes surgical and pharmacological therapy aiming at reducing painful symptoms. however, there is an unmet need in finding optimally safe and effective treatment. this study aimed to evaluate the effect of v-endo on pain levels in women with endometriosis, focusing on reducing inflammation by immunotherapeutic intervention.

Eligibility criteria:
inclusion criteria: * age between 18 and 50 years * pain visual analog scale (vas) score over 4 (visual linear scale from 0 to 10) * confirmation of endometriosis by laparoscopy * no drugs used at least for one month prior to enrollment, i.e., estro-progestinic, progestinic, gonadotropin-releasing hormone (gnrh) agonists and antagonists as well as nonsteroidal anti-inflammatory drugs (nsaids) exclusion criteria: * presence of other associated diseases such as malignancies * concomitant use of hormonal drugs * menopause * pregnancy * surgery for endometriosis within the last month prior to study entry * unable or unwilling to give written consent patients * adverse reaction or hypersensitivity to active substance or excipients of v-endo

Keywords: inflammation autoimmunity immunotherapy infertility pelvic pain
integrating supports to promote prep for black adolescents working with apps

Conditions: HIV

Summary: this study applies social cognitive theory to develop behavioral interventions promoting prep adherence. it seeks to adapt and test the enhanced hmp app for feasibility and acceptability among black adolescents and young adults (ayas) and adult supports.

hiv pre-exposure prophylaxis (prep) is highly effective in preventing hiv infections, reducing the risk by over 90%. however, adherence among ayas remains suboptimal, with only 34% maintaining adherence at 48 weeks. studies suggest that adult support can improve adherence in pediatric hiv treatment, but this approach has not been systematically evaluated for prep use in ayas. prior research indicates that black ayas and their families are open to incorporating adult support for prep adherence. given the success of mobile health (mhealth) interventions in promoting sexual health, this study aims to enhance the healthmpowerment (hmp) app-an existing mhealth platform designed for hiv prevention-to facilitate dyadic communication between black ayas and trusted adult support persons. the study addresses the high rates of hiv among black adolescents and young adults (ayas) in alabama, where ayas (ages 13-24) account for 31% of new hiv diagnoses, with black gay and bisexual males, transgender individuals, and heterosexual young women being disproportionately affected. nearly half of new infections occur in rural areas. the u.s. department of health and human services ending the hiv epidemic initiative prioritizes alabama as a geographic hotspot, emphasizing the need for patient-centered interventions to reduce hiv incidence.

Eligibility criteria:
inclusion criteria: * african americans * living in the state of alabama * have a prep indication (e.g. sex with a partner living with hiv, condomless sex, sex with multiple partners, engagement in transactional sex, or at least one sexually transmitted infection in the past 6 months) * support person: * \>21 years old * self-reported provision of instrumental, informational, or emotional support for a black aya 14-21 years old exclusion criteria: * hiv positive * inability to provide informed consent

Keywords: medication adherence prep
homburg cream & sugar study

Conditions: Coronary Artery Disease; Diabetes; Metabolic Syndrome; Glucose Tolerance; Hyperlipidemia

Summary: the purpose of this study is to prospectivly analyze the correlation of triglyceride tolerance and glucose tolerance with cardiovascular morbidity and mortality in patients with stable coronary artery disease within 18 months and to determine, whether measurement of triglyceride tolerance can discriminate patients at risk for cardiovascular events.


Eligibility criteria:
inclusion criteria: * stable cad exclusion criteria: * acute coronary syndrom * relevant arrhythmias * severe valvular heart disease * decompensated heart failure * severe inflammtory disease (infectious, rheumatoid) * metabolic diseases (e.g. thyroid) * inability to swallow * liver or kidney failure * lactose intolerance * fat intolerance (e.g. chronic pancreatitis, gall stones) * malignant disease * psychiatric diseases (including alcohol / drug abuse) * pregnancy
ultrasonographic and surgical assessment of endometriosis by aagl 2021 endometriosis classification

Conditions: Endometriosis; Bowel Endometriosis; Deep Endometriosis; Ovarian Endometrioma

Summary: in 2021, an international consensus developed a new endometriosis classification system, called aagl 2021 endometriosis classification, for scoring intraoperative surgical complexity and to examine its correlation with patient-reported pain and infertility. until now, no study has investigated the role of aagl 2021 endometriosis classification in ultrasonographic assessment of patient with endometriosis. this study aims to compare the use of the aagl 2021 endometriosis classification in preoperative (at ultrasound) and intraoperative (at surgery) evaluation of patients with endometriosis.


Eligibility criteria:
inclusion criteria: - patients with suspected endometriosis undergoing ultrasonographic preoperative evaluation. exclusion criteria: * patients with suspected or diagnosed malignancy; * patients a history of colorectal surgery or a surgery for endometriosis including vaginal resection, full-thickness bowel resection or excision of a endometriotic lesion of the urinary bladder; * patients with previous bilateral ovariectomy.

Keywords: preoperative ultrasound endometriosis staging surgical complexity