Kornimate/medical-research-clean huggingface dataset:
association between fuchs' endothelial corneal dystrophy severity and estrogen exposure

Conditions: Fuchs Dystrophy

Summary: this study is being done to discover if there is a link between estrogen exposure and the severity of fuchs endothelial corneal disease. we are trying to understand if the decrease in estrogen levels in post-menopausal women may be a reason why fecd is seen more often in women than men.


Eligibility criteria:
inclusion criteria: 1. individuals with fecd grade 1-2/7 (mild) or 5-6/7 (severe) in one or both eyes 2. age ≥ 55 3. phakic and pseudophakic individuals will be included. pseudophakic patients must have evidence of routine cataract surgery (posterior chamber intraocular lens in-the-bag without clinical evidence of damage to any intraocular structures). exclusion criteria: 1. females are excluded if not post-menopause. 2. pseudophakic patients with a history of complex cataract surgery or other intraocular surgery (e.g. have an anterior chamber lens, sulcus lens, or poorly positioned posterior chamber lens, aphakia, iris damage, glaucoma surgery) will be excluded due to risk of iatrogenic damage to the corneal endothelium.
french study to highlight the unmet treatment needs of 3l+ cp-cml and with t315i-mutated cml patients

Conditions: Chronic Myeloid Leukemia

Summary: a retrospective multi-center cohort study design was used to address the study objectives, using medical records obtained from three clinical centers in france.

the index date for patients in the 3l cohort was defined as the date of initiation of 3l therapy. the index date for the t315i cohort was defined as the date of treatment initiation with tki or allogeneic stem cell transplantation (allo-sct) after identification of t315i mutation status. the baseline (i.e., pre-index) period was defined as the 6 months prior to the index date, and the post-index period was defined as the time from the index date to the date of last patient contact or patient death. patients who were alive at the end of the follow-up period were censored at the date of last contact.

Eligibility criteria:
inclusion criteria: * diagnosed with cml-cp * age ≥18 years at the time of cml-cp diagnosis * for 3l patients: initiated one of the following 3l therapies in cml-cp after failing on ≥2 tkis (i.e., bosutinib, dasatinib, imatinib, nilotinib, or ponatinib) or allo-sct * for t315i mutation patients: evidence of t315i mutation and treatment with tki or allo-sct exclusion criteria: * history of other active malignancies within the 3 years prior to the time of cml-cp diagnosis * documentation of anti-cancer therapies for any other malignancies prior to the time of 3l therapy initiation or at the time of treatment initiation after identification of t315i mutation * enrollment in a clinical trial at the time of 3l therapy initiation or at the time of treatment initiation after identification of t315i mutation

Keywords: bcr::abl, chronic myeloid leukemia, tyrosine kinase inhibitor, t315i mutation
invasive hemodynamic response to transcatheter edge-to-edge mitral valve repair

Conditions: Mitral Regurgitation

Summary: studying the effects of trans-catheter mitral valve repair (tmvr) on the hemodynamics and biomarkers in patients with severe mitral valve regurgitation.


Eligibility criteria:
inclusion criteria: * adults (age ≥ 18 years) with severe, symptomatic primary mitral regurgitation identified by doppler transthoracic echocardiogram * heart team (cardiologist and cardiac surgeon) agree that patient would be eligible for tmvr with transcatheter edge to edge repair device. * tmvr procedure will be performed in the cardiac catheterization laboratory for hemodynamic data recording exclusion criteria: * women who are pregnant or believe they could be pregnant
a study to evaluate pregabalin in patients with painful diabetic peripheral neuropathy (dpn)

Conditions: Diabetic Neuropathy, Painful

Summary: a study of pregabalin efficacy and safety in a racially and culturally diverse group of subjects with painful diabetic peripheral neuropathy (dpn).


Eligibility criteria:
inclusion criteria: * diagnosis of type 1 or 2 diabetes mellitus. * diagnosis of painful dpn for at least 12 months but less than 5 years in duration. exclusion criteria: * neurologic disorders unrelated to diabetic neuropathy that may confuse or confound the assessment of neuropathic pain. * presence of any severe pain associated with conditions other than dpn that may confuse or confound the assessment of neuropathic pain.
immunological response to intravesical bcg therapy of superficial bladder cancer by prior administration of ruti®

Conditions: High-Risk Non-Muscle-Invasive Bladder Cancer

Summary: the rutivac-1 study is a phase i clinical trial designed to evaluate the systemic and mucosal immunological response and provide safety information after the use of ruti® administration to individuals with nmibc. the study will enroll individuals treated with transurethral resection of bladder tumor (turbt), diagnosed to have high-risk non-muscle invasive bladder cancer (nmibc) and suitable candidates for bcg therapy and who meet all eligibility criteria. forty individuals will be recruited and randomized 1:1 to receive two subcutaneous shots of 25 μg ruti® or placebo. after vaccination, individuals will receive the standard induction course, of intravesical bacillus calmette-guerin (bcg)therapy (weekly bcg for six weeks). 4 to 8 weeks after the last intravesical bcg administration (bcg6) a visit will be performed (visit 1, end of the interventional phase). once all participants have performed visit 1 immunological assays will be performed and data will be analyzed. at the end of the interventional phase the blind will be opened, except for the study physicians who will remain blind during all the follow-up. all the individuals will be followed up for three years since turbt.


Eligibility criteria:
inclusion criteria: 1. written icf for participation in the study. 2. age ≥18 years. 3. general health status according to who ≤ 2. 4. have primary histologically confirmed t1 and/or high grade tumors and/or cis. 5. all visible papillary tumors must be completely resected. 6. early postoperative (within 24 hours of turbt) single dose chemotherapy is allowed. 7. bcg therapy indication. 8. never treated with bcg immunotherapy 9. willing to comply with study visits and procedures as per protocol 10. use of reliable contraception (see section 8.6) from the screening visit to 30 days after the last ruti® or placebo injection. exclusion criteria: 1. life expectancy \<5 years. 2. have a severe concomitant disease that might limit compliance or completion of the protocol. 3. have any other malignancy that might impact 3-year survival or might be potentially confused with nmibc. 4. have other neoplasms. 5. have congenital or acquired immune deficiencies or under immunomodulatory treatment. 6. be receiving cytotoxic drugs or systemic corticosteroids within 8 weeks of receiving the first administration of bcg. 7. have received radiation therapy for their bladder cancer within 4 months prior to study entry. 8. have active infections (including urinary tract infections) defined as viral, bacterial, or fungal infections requiring therapy, hiv-positive status, concurrent febrile illness, gross hematuria or other factor that could influence tolerability to intravesical bcg therapy. 9. have biopsy, turbt, or traumatic catheterization within 14 days of start of intravesical bcg treatment. 10. have active tuberculosis at screening visit. 11. active pregnancy or breastfeeding. 12. soy allergy

Keywords: nmibc immunotherapy ruti non-muscle invasive bladder cancer
validation study using the genesearch bln assay to test sentinel lymph nodes from patients with breast cancer

Conditions: Breast Cancer

Summary: the purpose of this trial is to show adequate assay performance on clinical samples tested in real time at the clinical site.

this study will determine the sensitivity, specificity, negative predictive value, and positive predictive value of the genesearch™ bln assay in patient samples by comparing its performance to that of the current methods -- permanent section hematoxylin and eosin (h\&e) staining with ihc. additional marker testing using probes associated with nodal metastases may be used in the assay performance calculations. the observed performance measures will be compared to those obtained in the larger u.s. registration trial to show that there are no differences in the assay's performance.

Eligibility criteria:
inclusion criteria: * previous diagnosis of carcinoma of the breast * patient scheduled for sentinel lymph node dissection as per standard of care at the clinical site * 18 years or older * female or male, and * able and willing to give consent to participate in the study exclusion criteria: * patients taking part in other research studies that would interfere with their full participation in this study

Keywords: sentinel lymph node metastasis molecular pathology
a study to evaluate feasibility, safety, and clinical responses of implanting autologous peripheral nerve tissue into the brain for non-motor or motor symptoms in patients with parkinson's disease undergoing dbs surgery

Conditions: Parkinson's Disease

Summary: the investigators propose a phase i single surgical-center, double-blinded randomized parallel clinical trial involving bilateral autologous peripheral nerve tissue (pnt) delivery into the nbm or the alternate target also affecting cognition in this population, the substantia nigra (sn), to address "repair cell" support of these areas. twenty-four participants with idiopathic parkinson's disease (pd) who have selected, qualified and agreed to receive as standard of care deep brain stimulation (dbs) will be enrolled and randomly allocated to receive bilateral pnt deployment to either the nbm or sn at the time of dbs surgery. participants will be allocated equally among both assignments over the course of three years (8 year 1, 10 year 2, 6 year 3). participants will be evaluated for neurocognitive, motoric function, activities of daily living, and quality of life at enrollment before surgery, two-weeks after surgery, and 6, 12, and 24 months after surgery.


Eligibility criteria:
inclusion criteria: * undergoing dbs * diagnosis of clinically established or clinically probably pd as defined by mds criteria * age 45-75, inclusive * able to tolerate the surgical procedure * able to undergo all planned assessments * available access to the sural nerve exclusion criteria: * any condition that would not make the subject a candidate for dbs * dementia diagnosis * previous pd surgery or intracranial surgery * unable to undergo an mri * an obstructed trajectory path to the substantia nigra and nucleus basalis of meynert

Keywords: parkinson's disease deep brain stimulation dbs cell and tissue based therapy
a study to examine the use of zemplar to increase serum calcium levels in icu subjects

Conditions: Hypocalcemia

Summary: a study to determine the effect of zemplar on the regulation of serum calcium levels and the need for administration of elemental calcium in hypocalcemic intensive care patients


Eligibility criteria:
inclusion criteria: * icu patients apache iii score between 70 - 150 at screening and within 24 hours of enrollment and a whole blood ionized calcium level less than 0.90 mmol/l or corrected whole blood calcium level less than or equal to 7.5 mg/dl. exclusion criteria: * serum creatinine greater than 2.5 mg/dl

Keywords: hypocalcemia, ionized calcium, intensive care
a study of hrs-4642 in patients with advanced solid tumors harboring kras g12d mutation

Conditions: Advanced KRAS G12D Mutant Solid Tumors

Summary: the study is being conducted to evaluate the safety, tolerability, and efficacy of hrs-4642 in combination with antitumor medicine in patients with advanced solid tumors harboring kras g12d mutation.


Eligibility criteria:
inclusion criteria: 1. subjects must voluntarily agree to participate in the trial and sign a written informed consent form. 2. male or female ≥ 18 years old and ≤75 years old. 3. ecog performance status of 0-1. 4. with a life expectancy of ≥12 weeks. 5. with unresectable locally advanced or metastatic solid tumors harbouring with kras g12d mutation confirmed by central laboratory testing. 6. need to provided tumor tissue samples for genetic testing. 7. have at least one measurable lesion according to recist1.1, and the dose-escalation phase allows no measurable lesion. 8. adequate laboratory parameters during the screening period. exclusion criteria: 1. accompanied by untreated or active central nervous system (cns) metastases. subjects with a history or current history of meningeal metastasis. 2. systemic antitumor therapy was received 4 weeks before the start of the study. 3. palliative radiotherapy was completed within 14 days before the first dose. 4. toxicity and/or complications from previous interventions did not return to nci-ctcae level ≤1 or exclusion criteria. 5. subjects with known or suspected interstitial pneumonia. 6. moderate or severe ascites with clinical symptoms; uncontrolled or moderate or higher pleural effusion or pericardial effusion. 7. have poorly controlled or severe cardiovascular disease. 8. subjects with active hepatitis b or active hepatitis c. 9. a history of immunodeficiency, including a positive hiv test, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation. 10. the presence of uncontrolled mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention. 11. any other factors that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate as judged by investigators.
thread-embedding acupuncture for functional and qol improvement in copd patients

Conditions: Chronic Pulmonary Obstruction

Summary: the goal of this clinical trial is to learn if thread-embedding acupuncture (tea) can improve functional capacity and quality of life of chronic pulmonary disease (copd) patients. the main questions it aims to answer are: * does tea, when combined with standard treatment, improve functional capacity measured by the six-minute walking test (6mwt) and the modified medical research council (mmrc) scale at 1, 2, and 3 months after the intervention? * does tea, when combined with standard treatment, improve quality of life as measured by the copd assessment test (cat) and the st. george's respiratory questionnaire (sgrq) at 1, 2, and 3 months after intervention? researchers will compare tea to sham tea (a placebo procedure without thread implantation) to determine if tea leads to meaningful improvements in copd patients. participants will: * complete assessment using 6mwt, mmrc, cat, and sgrq * receive one session of either tea or sham tea * return to the clinic once a month for follow-up assessments over a 3-month period


Eligibility criteria:
inclusion criteria: * male or female participants aged 18 to 70 years. * body mass index (bmi) ≥18.5 kg/m². * diagnosed with stable chronic obstructive pulmonary disease (copd) based on gold criteria. * willing to participate in the study until completion and has signed informed consent. exclusion criteria: * pregnant women. * presence of tumors, wounds, inflammation, or skin infection at the needling area. * blood disorders or use of blood-thinning medications (antiplatelets or anticoagulants) with inr \> 2.0. * uncontrolled heart disease or diabetes. * capillary blood glucose level ≥200 mg/dl (measured using glucometer). * history of malignancy, uncontrolled epilepsy, or psychiatric disorders. * known allergy to stainless steel or polydioxanone (pdo) thread. * undergoing acupuncture therapy within the last 2 weeks or thread-embedding acupuncture (tea) within the last 6 months.
acupuncture for body weight control

Conditions: Obesity

Summary: in this study, a 18-week, single-blinded, randomized controlled clinical trial will be conducted to evaluate the effectiveness, efficacy and safety of acupuncture on weight control in hong kong.

this is a pilot single-blind, randomized, sham-controlled trial. 72 participants will be randomly assigned to acupuncture group or control group. the duration of the treatment will be 8 weeks with 2 sessions per week and the follow-up period will be 8 weeks.

Eligibility criteria:
inclusion criteria: * aged between 18 and 65 years old; * body mass index (bmi)≥25 kg/m2; * having not received any other weight control measures or any medical and/or drug history within the last 3 months. exclusion criteria: * endocrine diseases; * heart diseases; * patients with pacemaker; * allergy and immunology diseases; * having bleeding tendency; * pregnant or lactating women; * having impaired hepatic or renal function; * stroke or otherwise unable to exercise.

Keywords: acupuncture chinese medicine obesity
real life evaluation of sglt2 use in type 1 diabetes

Conditions: Diabetic Ketoacidosis

Summary: the primary aim of the study is to prospectively monitor the risk of diabetic ketoacidosis (dka) during treatment with sodium-glucose cotransporter 2 (sglt2) inhibitors in type 1 diabetes after the treatment has become available as an adjunct therapy for people with type 1 diabetes.

sglt2 inhibitors have recently been approved for treatment of type 1 diabetes. sglt2 inhibitors affect renal glucose transport and promotes glucose excretion in the urine. this have attractive effects, notably by lowering of blood glucose without any increased risk of hypoglycemia as well as a reduction in body weight. since the risk of hypoglycemia and weight gain during intensification of insulin treatment is a significant barrier for optimal glycemic control, sglt2 inhibitors could be an attractive adjunct therapy in type 1 diabetes. furthermore, sglt2 inhibitors have beneficial cardiovascular and renal effects in persons with type 2 diabetes. this may also benefit persons with type 1 diabetes. however, the major limitation for an universal use of sglt2 inhibitors in type 1 diabetes is a substantial increase in ketogenesis and the risk of dka. dka remain a substantial cause of morbidity and mortality in persons with type 1 diabetes. since no data exist on the risk of dka during sglt2 inhibition outside the randomized controlled trials, the investigators will initiate a nationwide monitoring study on the use of sglt2 inhibitors in type 1 diabetes. this will ensure follow-up on the efficacy, safety and patient-reported outcome measures for sglt2 inhibitors treatment of type 1 diabetes in real-world clinical practice.

Eligibility criteria:
inclusion criteria: * all patiens with type 1 diabetes on sglt2 inhibitor treatment or where this treatment is planned. exclusion criteria: * none
effectiveness of an act-based cognitive intervention on quality of life and cognitive function in elderly residents with mci

Conditions: Mild Cognitive Impairment

Summary: this study investigates the effects of an acceptance and commitment therapy (act)-based cognitive intervention on quality of life (qol) and cognitive function among elderly residents with mild cognitive impairment (mci) in long-term care settings. the study assesses immediate and long-term impacts on cognitive function, psychological flexibility, social engagement, and overall well-being through structured act-based training.

this clinical trial explores the impact of an acceptance and commitment therapy (act)-based cognitive intervention on quality of life (qol) and cognitive function in elderly residents with mild cognitive impairment (mci) living in long-term care facilities. the intervention aims to promote psychological flexibility, which is a core process in act, and enhance the residents' ability to engage in meaningful activities despite cognitive limitations. participants will engage in structured act-based training sessions that include mindfulness exercises, values clarification, and commitment strategies designed to improve cognitive engagement, reduce emotional distress, and foster greater social connection. the study measures both the immediate effects following the intervention and the long-term benefits at follow-up periods to evaluate sustained improvements in cognitive performance, psychological resilience, social involvement, and overall well-being. by focusing on cognitive and emotional strategies, the intervention seeks to empower elderly residents to live more fulfilling and value-driven lives, even in the face of cognitive decline associated with mci.

Eligibility criteria:
inclusion criteria: * residents aged 65 and older diagnosed with mci, able to provide informed consent, and residing in participating long-term care facilities. exclusion criteria: * individuals with severe cognitive impairment, unstable medical conditions, or psychiatric diagnoses that would interfere with participation.

Keywords: mild cognitive impairment
effects of dry needling in teres major in patients with shoulder pain

Conditions: Shoulder Pain

Summary: the aim of the study is to investigate the effects of the dry needling technique in teres major muscles on pain, range of motion, strength and extensibility of the posterior part of the tissues of the shoulder in athletes with shoulder pain.


Eligibility criteria:
inclusion criteria: * athletes with shoulder pain * glenohumeral internal rotation deficit * presence of active mtrp in the teres major muscle exclusion criteria: * previous surgery in the upper limb * previous physiotherapy treatments in the shoulder * dry needling contraindications * previous dry needling experience to mantain the blinding
does the invitation by the general practitioner improve patients' participation in colorectal cancer screening?

Conditions: Colorectal Cancer

Summary: the propose of this study is to assess the effect of general practitioner's involvement on first patients' solicitation in screening for colorectal cancer by testing for faecal occult blood (fobt).


Eligibility criteria:
inclusion criteria: * aged : 50 to 74 years. * not having ever been invited to participate in colorectal screening. exclusion criteria: * patients who have a fecal occult blood test for less than 2 years or a colonoscopy within the past 5 years or excluded for medical reasons (according to information known from adeca).

Keywords: colorectal cancer screening general practitioner fecal occult blood tests
the impact of hearing loss severity on balance intervention outcomes

Conditions: Hearing Loss; Fall; Postural Balance

Summary: the goal of this study is to learn about how hearing loss impacts balance intervention outcomes and risk of falling in older adults. the main questions it aims to answer are: * how does the evidence-based a matter of balance (amob) program affect older adults' falls risk and balance-related measures? * is the severity of someone's hearing loss related to their balance intervention (amob) outcomes? participants will: * complete a hearing and balance test * answer some questions about their background and health history, their thoughts about potential falls and how this impacts them, and their current physical activity level * participate in the a matter of balance program, an evidence-based program that includes group discussion, activities, and exercises to reduce fall risk


Eligibility criteria:
inclusion criteria: * age of 60 years old or greater * absence of any major physical or health condition that would prevent participation in the intervention sessions * english speaking exclusion criteria: * severe balance disorder diagnosis * uncorrected severe vision impairment