Kornimate/medical-research-clean huggingface dataset:
curedrpla global patient registry

Conditions: DRPLA

Summary: the objective of the curedrpla global patient registry is to establish a longitudinal database of patient-reported data on individuals affected with dentatorubral-pallidoluysian atrophy (drpla) from anywhere in the world. the curedrpla global patient registry will address patient needs by: * expanding patient engagement by documenting quality of life outcomes. * providing anonymized data to the drpla research community on patient experience with the disease and priorities for treatment. * connecting drpla patients with opportunities to participate in clinical research.

the curedrpla global patient registry aims to collect data from dentatorubral-pallidoluysian atrophy (drpla) patients worldwide to identify a well-characterized cohort for participation in retrospective and prospective research. participants will be required to read and sign an irb-approved informed consent document prior to accessing questionnaires within the registry. the registry is solely for patients diagnosed with drpla. after informed consent is given, and assent for those age 12 to the age of consent, participants will be asked to complete a series of questionnaires to include information on demographics, specifics of diagnosis, medical history, research, functional mobility, quality of life, and health economics. participants will be asked to indicate if they are interested in being contacted by the registry coordinator for potential participation in future clinical trials and/or studies. participants will have the option to withdraw from the registry at any time, and upon withdrawal, they will no longer be contacted from the registry for any reason. data that they have entered will remain part of the registry, but their identification will not be released for any reason. active participants in the registry will receive yearly email reminders to update their questionnaire data to reflect the current status of disease progression. the registry is available in english, french, italian, japanese, korean, and portuguese to encourage drpla patients worldwide to register. participation is completed online, please visit our website for more information https://curedrpla.org/en/global-patient-registry/ the redcap cloud platform will serve as the registry data coordinating center and will manage data entered into a web based electronic data capture (edc) system that is 21 cfr part 11 validated, iso 27001 certified, hippa, cdisc, and gdpr compliant.

Eligibility criteria:
inclusion criteria: * individuals of all ages with a self-reported diagnosis of drpla. * understand and sign the informed consent form (ifc). participants who lack the capacity to consent (e.g. cognitively impaired individuals) will require consent from the legal authorized representative, and the assent of the subject will be obtained to the extent compatible with their capacity. participants at age 12 to age of consent will require assent along with the consent of their parent or legal guardian. exclusion criteria: * ataxia conditions other than drpla. * failure to sign the ifc (and assent form, as needed).
the choice registry

Conditions: Metastatic Colorectal Cancer

Summary: the choice registry will describe real-world treatment patterns and physician and patient (and caregiver)-reported outcomes associated with patients who have progressed beyond 2nd line metastatic colorectal cancer.

a prospective, non-interventional, observational, approach will be employed. all patient follow-up visits and other interactions will be established by the physician investigator: the choice registry will not impose a fixed schedule of follow-up visits. data will be obtained in conjunction with actual follow-up visits to support treatment and various assessments of disease progression, patient quality of life and caregiver burden, and resource utilization. patients will be followed for minimum of 15 months. all prescribed and administered medications, treatment adjustments and duration will be documented by the physician investigator treating the patient as per standard of care. the choice registry will not impose any change to the treatment regimen prescribed by physicians participating in the registry. adult males and females with metastatic colorectal cancer (having received first and second line treatment, and upon initiation of third line or later treatment) will be eligible to participate. approximately 1000 patients will be enrolled by approximately 30 to 40 physician investigators representing both community and academic medical centers in the united states. descriptive statistics will be employed to address the key research objectives of the choice registry, such as a description of patients receiving various second (and/or subsequent) lines of treatment in the management of metastatic colorectal cancer in real world clinical settings, and the associated clinical, economic, and humanistic (patient-reported) outcomes.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 2. diagnosis of metastatic crc 3. having completed first and second lines of treatment for metastatic crc 4. intending (at time of enrollment) to initiate a third (or subsequent) line of treatment 5. ability to understand and read english or spanish 6. willing and able to sign an informed consent form (icf), or have a legally authorized representative willing and able to consent on the patient's behalf exclusion criteria: 1. patient is unwilling or unable to participate in the registry at the time of enrollment 2. the patient is currently participating in an investigational clinical trial 3. patients not having mental capacity and or ability to participate in the registry

Keywords: metastatic colorectal cancer registry patient reported outcomes treatment patterns prescription use
prospective study on diabetes mellitus and its complications in newly diagnosed adult patients

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: the aim of the prospective observational gdc-study in patients with newly diagnosed diabetes mellitus aged 18-69 years at inclusion into the study is to characterize in detail the clinical, metabolical and immunological phenotype and monitor the progression of the disease and to compare the phenotype to glucose tolerant humans of similar age, body mass and sex distribution.

in detail, the following questions will be answered: 1. are there different phenotypes with respect to insulin secretion, insulin sensitivity, micro- and macrovascular status and diabetic neuropathy at time of diagnosis? 2. which factors modify the progression of the disease (nutrition, subclinical inflammation, energy metabolism and physical activity)? 3. can we identify subgroups at baseline with different progression of the disease? patients are thoroughly examined at baseline and after 2, 5, and 10 years with annual telephone contacts in between.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of diabetes mellitus according to ada criteria * age 18-69 * diabetes duration since diagnosis \< 12 months * control cohort: proven normal glucose tolerance according to ada criteria exclusion criteria: * diabetes mellitus category 3 b-h (ada criteria) * pregnancy * severe renal, liver or heart disease * malignant cancer * severe psychiatric illness or addiction * participation in an intervention trial

Keywords: diabetes mellitus prospective observational study diabetic complications
real-world validation of photoplehtysmography (for atrial fibrillation detection)

Conditions: Atrial Fibrillation

Summary: mobile health solutions for rhythm monitoring (e.g. atrial fibrillation detection) using photoplethysmography (ppg) technology on a smartphone have been developed. this study validates the performance of a digital health application (fibricheck®) using ppg technology on a smartphone against a single-lead ecg device (kardia mobile®).


Eligibility criteria:
inclusion criteria: * subject is scheduled for an ablation procedure for af, at least 4 weeks after the inclusion. * subject provides informed consent. * subject understands and agrees to comply with planned study procedures. * subject is able to perform measurements of the heart rhythm using the fibricheck application at home. exclusion criteria: * insufficient cognitive or comprehensive level of dutch to participate to the trial. * no access to a smartphone or unable to perform fibricheck measurements at home. * pacemaker.

Keywords: atrial fibrillation photoplethysmography single-lead ecg electrocardiogram digital health
upper endoscopy in ulcerative colitis patients in assiut university

Conditions: Upper Gastrointestinal Disorder

Summary: aim of study: primary outcomes: patients with ulcerative colitis-associated upper gas- trointestinal inflammation may require specific treat- ment for the gastroduodenal lesions. hence, recogni- tion and detection of the upper gastrointestinal lesions are important. here we describe 2 cases of ulcerative colitis and summarize the results of our investigation of the prevalence of upper gastrointestinal involvement detected by esophagogastroduodenoscopy. we also analyzed the macroscopic and microscopic features of the upper gastrointestinal lesions secondary outcomes: correct and timely treatment of upprt git lesions in uc .

ulcerative colitis (uc) is an idiopathic, chronic, relapsing inflammatory bowel disease (ibd) occurring in the colon and rectum . the main typical symptoms of uc include frequent bowel movement, mucus pus, bloody diarrhea, abdominal pain and discomfort, urgency, weight loss, and tenesmus . apart from these typical symptoms, emerging evidence supports that there are a variety of accompanying symptoms involving the upper gastrointestinal (ugi) tract in patients with uc upon macroscopic and microscopic analyses, such as eosinophilic esophagitis\[9\], gastroduodenitis, ulcers, or ugi inflammation in addition, the positive rate of ugi endoscopy in asymptomatic individuals was lower than that in symptomatic patients. the reported clinically significant ugi lesions include multiple erosions, granular changes, white spots, friable mucosa, ulcer, and purulent deposits during fibrogastroduodenoscopy (fgds)\[ط ugi involvement may be unnoticed by the attending physician due to the lack of the knowledge of gastroduodenal lesions, which should raise concerns during uc treatment. furthermore, there is no established standard or criteria available for patients with uc who should undergo fgds , because the clinical backgrounds of these patients with uc-associated ugi lesions have not been fully and exactly demonstrated. specific management may be required for patients with uc-associated ugi lesions. henceforth, we conducted this study with the aim of describing various ugi tract presentations in uc and their differential diagnosis

Eligibility criteria:
inclusion criteria: * patients' age is 18 years or above. * patient who are diagnosed with uc.. * patient who are fit to undergo upper endoscopy . exclusion criteria: * pediatric patients. * patient refuse to participate at this study * patient with known upper git disorder .
real-life surveillance study of patients with chronic hepatitis c treated with pegintron injector and rebetol (study p04538)(completed)

Conditions: Hepatitis C, Chronic; Hepatitis C

Summary: the objective of the study is to assess the safety and efficacy of pegintron injector and rebetol administered to participants with chronic hepatitis c. participants will be treated by general practitioners in clinical practice as part of the post-marketing surveillance study. the study will assess the rates of eradication of the hepatits c virus and the rates of serious adverse events reported with pegintron (1.5 μg/kg/week) and rebetol (800-1200 mg/day) in common medical practice in germany.


Eligibility criteria:
inclusion criteria: * participants with chronic hepatitis c * at least 18 years old * treatment-naïve or relapse to interferon monotherapy * platelets \>= 100,000/mm\^3 * neutrophil counts \>= 1,500/ mm\^3 * thyroid stimulating hormone (tsh) must be within normal limits * hemoglobin \>= 12 gr/dl (females); \>= 13 gr/dl (males) * intravenous drug abusers (ex-ivda) participants being under stable substitution for at least 6 months * women of childbearing potential must have a routine pregnancy test performed monthly during treatment and for 7 months thereafter. sexually active female participants of childbearing potential must be practicing adequate contraception (intrauterine device, oral contraceptives, implanted contraceptives, surgical sterilization, barrier method, or monogamous relationship with a male partner who has had a vasectomy or is using a condom (+ spermicide) during the treatment period and for 7 months after stopping treatment * sexually active male participants must be practicing acceptable methods of contraception (vasectomy, use of condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 7 months after stopping treatment exclusion criteria: * contraindications as per the spc and approved european labeling * hypersensitivity to the active substance or to any inteferons or to any of the excipients * pregnant woman * woman who are breast-feeding * existence of or history of severe psychiatric condition, in particular severe depression, suicidal ideation or suicide attempt * a history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months * severe debilitating medical conditions, including participants with chronic renal failure or creatinine clearance \< 50 ml/min * autoimmune hepatitis or history of autoimmune disease * severe hepatic dysfunction or decompensated cirrhosis of the liver * pre-existing thyroid disease unless it can be controlled with conventional therapy * epilepsy and/or compromised central nervous system function
brivaracetam to reduce neuropathic pain in chronic spinal cord injury

Conditions: Spinal Cord Injuries

Summary: spinal cord injury (sci) is associated with severe neuropathic pain that is often refractory to all pharmacological intervention. preliminary data suggest brivarecetum is a mechanism-based pharmacological intervention for neuropathic pain in sci. this randomized, placebo-controlled pilot clinical trial will assess feasibility of a 3-month treatment course with brivarecetum.

the investigations will assess changes in pain intensity and periaqueductal gray hyperactivity. baseline periaqueductal gray hyperactivity and microrna levels will be measured as potential biomarkers of response to treatment. these preliminary findings will be used to design larger clinical trials to establish efficacy of brivarecetum to treat neuropathic pain in sci.

Eligibility criteria:
inclusion criteria: * spinal cord injury (sci) * participants must have completed inpatient rehabilitation and are living in the community * participant who have severe below-level neuropathic pain (daily average 9/10 or 10/10) * participants must have tried and failed to achieve adequate pain relief with the use of other drugs (i.e treatment failed to decrease their pain below a level of 9) and can continue to take spasmolytics, pregabalin, gabapentin, and opioids in unchanged dosing throughout the trial exclusion criteria: * pprogressive myelopathy secondary to posttraumatic cord tethering * syringomyelia * brain injury limiting the ability to follow directions * pregnancy or lactation * epilepsy * impaired liver or renal function * contraindications to brivaracetam or pyrrolidine derivatives including allergy, or contraindications to mri including retained bullet fragments, noncompatible metal implants, and implanted devices such as baclofen pumps
effect of bromfenac on pain related to pterygium surgery

Conditions: Pterygium; Pain

Summary: to evaluate the efficacy and ocular safety of bromfenac ophthalmic solution (bromfenac) 0.1% dosed twice daily for the treatment of ocular inflammation and pain after pterygium excision with amniotic membrane transplantation(amt).

patients scheduled to undergo pterygium excision with amt were randomized to receive added topical bromfenac or artificial lacrima at 3 days before and 7 days after the surgery. pain intensity was evaluated with the visual analog scale(vas) and present pain index(ppi) with the short form of the mcgill pain questionnaire. psychological state used self-rating of depression scale(sds) and self-rating of anxiety scale (sas) to assess. ocular inflammation was assessed with an automated bulbar redness grading technique. the irritative symptoms evaluation was carried out by an independent investigator at each visit with questionnaires of ocular symptom scores(oss). corneal epithelial healing rate was calculated after following up. all patients had follow-ups at the day 1, day 3, day7 and day 10.

Eligibility criteria:
inclusion criteria 1. patients with unilateral or double pterygium 2. the gender is not limited, age 45-75 years old 3. intraocular pressure \<21mmhg 4. follow the preoperative and postoperative drug regimen and ensure regular follow-up exclusion criteria 1. patient factors: lack of cooperation and poor compliance. 2. severe dry eye, sjogren's syndrome, cicatricial pemphigoid, and other systemic diseases that seriously affect the structure or function of the ocular surface. 3. glaucoma or high intraocular pressure (above 21 mmhg), active uveitis, retinal detachment and other diseases. 4. history of systemic diseases, such as uncontrolled diabetes and hypertension, rosacea, severely impaired cardiopulmonary function or other diseases that cannot tolerate surgery; central nervous system disorders affect patient perception, trigeminal neuritis, trigeminal neuralgia, and tongue pharyngeal neuralgia, migraine and period of toothache attack. 5. history of drug allergies, such as nsaid drugs, tobramycin, anesthetics and so on. smokers and alcoholics (smoking volume \>15 cigarettes/day, pure alcohol consumption\>100 ml/week). 6. other history of eye surgery, such as history of eye trauma, history of glaucoma surgery, history of cataract surgery, history of retinal surgery, or other serious injuries to the eyelids, conjunctiva, cornea, and other tissues of the eye surface.

Keywords: pterygium bromofenac pain
b.subtilis attenuate symptoms in diarrhea-predominant irritable bowel syndrome by increasing hypoxanthine biosynthesis

Conditions: Irritable Bowel Syndrome with Diarrhea; Purine Metabolism Disorder

Summary: this is a prospective, single-blind, randomized parallel study to investigate whether b. subtilis could improve clinical symptoms of ibs-d patients. patients are randomly assigned by envelope method. a senior gastroenterologist is responsible for prescribing medication. researchers are blind to patients' medication. participants with ibs are recruited and randomized to receive a 4-week administration of b. subtilis-based probiotics. clinical symptoms and stool samples are collected before and after the trial.


Eligibility criteria:
inclusion criteria: patients are diagnosed with ibs. ibs was diagnosed based on the rome iv criteria. subjects aged from 16-80 years old without any gut medical conditions like inflammatory bowel diseases, infectious diarrhea, colon tumors were included. exclusion criteria: subjects who are taking any probiotics, ppis, antibiotics or any drugs affecting uric acid levels for at least one month before the study. subjects who decline to participate into the study.
immunevasion of human papillomavirus (hpv) in vulvar intraepithelial neoplasia 2/3 and anogenital warts and efficiency and mechanisms of imiquimod treatment

Conditions: HPV

Summary: the occurance and clinical course of human papillomavirus (hpv)-induced lesions is largely determined by the nature of the cellular immune defense generated. even tough both genital warts and vulvar intraepithelial neoplasia (vin) are hpv-associated genital lesions they differ in their risk of malignant progression. imiquimod (imq) is a topically applied toll-like receptor (tlr) 7 agonist that has been approved for the treatment of superficial (pre-) carcinomas of the skin (basal cell carcinomas, actinic keratosis) and hpv-associated lesions (genital warts). it acts by activation of the immune system exerting anti-tumor and anti-viral properties. the aim of the study is to evaluate the mechanisms of imq treatment and to analyze the differences in hpv-affected and non affected tissue at cellular and molecular level as determined by immunofluorescence stainings and real time pcr, respectively.


Eligibility criteria:
inclusion criteria: * female patients with histologically proven vulvar intraepithelial neoplasia 2/3 and/or anogenital condyloma acuminata * age 18-50 * informed consent exclusion criteria: * malignancy * pregnancy * therapeutic immunosupression * severe systemic dermatologic disease
accuracy of lasik flaps created with the lensx® femtosecond laser - a pilot study

Conditions: Myopia; Hyperopia

Summary: the purpose of this study is to evaluate the thickness accuracy of laser-assisted in situ keratomileusis (lasik) flaps created with the lensx® laser.


Eligibility criteria:
inclusion criteria: * diagnosed with myopia or hyperopia and eligible for femtosecond laser initiated lasik surgery; * best corrected visual acuity (bcva) correctable to at least 20/25 in each eye; * if contact lens wearer, willing to discontinue contact lens wear prior to screening procedures; * willing and able to return for all scheduled follow-up examinations; * willing and able to provide written informed consent; * eligible for bilateral lasik procedures to be done on the same day; * other protocol-specified inclusion criteria may apply. exclusion criteria: * previous corneal surgery, corneal lesions that will impede laser treatment, corneal edema, hypotony, glaucoma, existing corneal implant, or keratoconus; * known sensitivity to planned study concomitant medications; * participation in any other ophthalmic drug or device clinical study for 30 days prior to or during the time of participation in this study; * irregular astigmatism, based on the investigator's judgement; * pregnant, lactating or planning to become pregnant during the course of the study; * other protocol-specified exclusion criteria may apply.