Kornimate/medical-research-clean huggingface dataset:
post market, retrospective study to evaluate patients implanted with medacta versafit cup dm ™️ 2 years post-op

Conditions: Hip Arthritis

Summary: this is a post-market, retrospective with one prospective visit, multi- center study, designed to assess the clinical outcomes, surgical details including anterior or posterior surgical approach, and collect all complication data of medacta versafit cup dm used for primary or revision total hip arthroplasty at minimum two year post- operatively.


Eligibility criteria:
inclusion criteria: 1. subjects age 18 years and above at the time of consent 2. able to understand the requirements of the study, provide a written informed consent and comply with the study protocol. written informed consent must be obtained prior to any study procedure. 3 patients must be willing to comply with the prospective visit schedule. 4. patient underwent a primary or revision total hip replacement for any etiology (osteoarthritis, avascular necrosis, inflammatory arthritis, post- traumatic arthritis, hip fracture, failed prior procedures, etc.). 5. patients must have received a medacta versafit cup dm component 6. patient must have adequate pre-operative and post-operative radiographs 7. patients must be at minimum 2 year (24 months) post-treatment 8. the operation was performed by the investigator. exclusion criteria: 1. history of alcoholism 2. currently on chemotherapy or radiation therapy 3. habitual use of narcotic pain medications prior to surgery or after surgery for reasons other than hip pain 4. history of a metabolic disorder such as gout affecting the skeletal system other than osteoarthritis or osteoporosis 5. history of chronic pain issues for reasons other than hip pain 6. women that are pregnant 7. patients who underwent total hip arthroplasty (tha) using standard polyethylene
big data supporting public health hearing policies

Conditions: Hearing Loss

Summary: hearing loss (hl) affects over 5% of the world's population (who 2014) and is the 5th leading cause of years lived with disability. hl is currently managed with hearing aids (has), i.e. programmable sound amplification devices that are worn by the hearing impaired subjects to address their hearing difficulties. ha use however is often problematic, costly and with poor overall benefits. the holistic management of hl requires appropriate public health policies for hl prevention, early diagnosis, long-term treatment and rehabilitation; detection and prevention of cognitive decline; and socioeconomic inclusion of hl patients. currently the evidential basis for forming such policies is limited. the evotion project proposes to address this by collecting and analysing a big set of heterogeneous data, including ha usage, audiological, physiological, cognitive, clinical and medication, personal, behavioural, life style, occupational and environmental data. this will be done by: i. accessing big datasets of existing ha user data from the evotion clinical partners (ucl/uclh and gst in the uk; oticon in denmark) ii. collection of prospective ha user data who will be recruited to the prospective evotion study and who will undergo some additional assessments iii. collection of real time dynamic data of the human participant ha users who will be given a smart phone with different apps (auditory tests; auditory training), sensors (recording of heart rate, blood pressure, respiratory rate etc.) and smart has (recording environmental factors such as noise levels, type of noise etc.) so that real life contextual factors that affect ha usage and outcome can be identified. these data will be analysed with big data analysis/data mining techniques in order to identify relationships between these in order to use this information to derive and support public health decisions.


Eligibility criteria:
inclusion criteria: * age \>18 years * basic understanding of oral and written english * unilateral and/or bilateral mild to severe sensorineural hearing loss * willing to use smart hearing aids for at least 2 hours daily on average * willing/capable to use a mobile phone exclusion criteria: * dementia (moca\<22 ) * not agreeing or able to attend for f/u appointments * not agreeing or able to use ha \>2 hours daily (average) * not sufficient vision to use smartphone ap
eeg & behavioral predictors of changes in smoking trajectories in young light smokers

Conditions: Nicotine Dependence

Summary: the purpose of the proposal is to identify new predictors of smoking progression in young light smokers (yls: 18-25 years \& cpd \< 5) using an 18-month longitudinal design and to relate these predictors of progression to the genetic profile most highly associated with smoking progression. a number of novel predictors will be assessed in 128 yls. predictors will include individual differences (ids) in eeg, reward sensitivity, attentional performance, and mood during abstinence and in response to standardized and to self-selected acute nicotine doses (anic), as well as genetically influenced affective traits, and smoking history. the associations of a compelling genetic functional variant polymorphism, rs16969968, in the alpha5 nicotinic receptor subunit will also be related to smoking progression and the novel predictors. the study is expected to provide insights into ids in mechanisms and predictors that contribute to smoking trajectories in yls and thereby lead to targeted pharmacotherapy and behavioral interventions for at-risk yls.

the purpose of the proposal is to identify new biobehavioral endophenotypes that predict smoking progression in young light smokers (yls: 18-25 years \& cpd \< 5) using an 18-month longitudinal design and to relate these endophenotypes and progression to the genetic profile most highly associated with smoking progression. a number of novel predictors will be assessed in 128 yls. predictors will include individual differences (ids) in eeg, reward sensitivity, attentional performance, and mood during abstinence and in response to standardized and to self-selected acute nicotine doses (anic), as well as genetically influenced affective traits, and smoking history. the associations of a compelling genetic functional variant polymorphism, rs16969968, in the alpha5 nicotinic receptor subunit will also be related to smoking progression and the novel predictors. the study is expected to provide insights into ids in mechanisms and endophenotypes that contribute to smoking trajectories in yls and thereby lead to targeted pharmacotherapy and behavioral interventions for at-risk yls.

Eligibility criteria:
inclusion criteria: * smokers of 3 to 30 cigarettes per week for past 6 months exclusion criteria: * smoking fewer than 3 or more than 30 tobacco cigarettes per week * never smoked more than 30 cigarettes per week * psychoactive drug use other than caffeine or occasional marijuana * current serious psychiatric diagnosis (e.g., major depressive disorder) * recent drug dependence * left-handed * color blind

Keywords: nicotine smoking progression eeg young adults light smokers rs1051730 genotype
the combined utility of angio-ct and mri in managing chronic musculoskeletal pain: a prospective study to evaluate the efficacy of transarterial microembolization

Conditions: Chronic Musculoskeletal Disease; Transarterial Embolization; Magnetic Resonance Imaging; Angiography; Computed Tomography

Summary: transarterial microembolization (tame) is a novel treatment option for chronic musculoskeletal pain, especially suitable for patients who have not responded to conservative treatment or are unsuitable for surgical procedures. this minimally invasive technique primarily targets abnormal neovascularization for embolization, relying heavily on precise information provided by various imaging techniques to ensure the effectiveness and safety of the treatment. this study aims to explore the application of integrating preoperative magnetic resonance imaging (mri) evidence of patient pain and intraoperative high-resolution synchronous imaging information from fused computed tomography (ct) and angiography systems. this integration is intended to enhance preoperative planning, intraoperative guidance, and final treatment outcome assessment, focusing on its crucial contribution to treatment success. it is hoped that this approach will provide pain intervention physicians with reliable diagnostic tools and safe treatment methods, thereby improving treatment outcomes for patients with chronic musculoskeletal pain.


Eligibility criteria:
inclusion criteria: * patients with chronic musculoskeletal shoulder or knee joint pain in our hospital, including degenerative knee arthritis, adhesive capsulitis of the shoulder, and those confirmed by physical examination or ultrasound-guided injection to have tendinopathy or ligamentopathy, who have failed drug therapy, rehabilitation, or injection treatments, with a duration of symptoms greater than three months, are the target population of this study. exclusion criteria: * pregnancy, coagulation disorders, symptoms of relevant local infections or tumors, and patients allergic to contrast agents. patients must have complete medical records; those who do not meet the inclusion criteria will be excluded.
ambulosono rasagiline musical walking study

Conditions: Parkinson's Disease

Summary: this study will investigate the effects of a contingency-based musical walking intervention program called ambulosono on neural mechanisms in the brain. the investigators will investigate the long-term impact of ambulosono on brain plasticity with functional mri technique. participants will undergo 3 months of ambulosono training and their pre-training and post-training fmri brain scans will be compared to understand the neural networks and brain mechanisms following this intervention. the investigators hypothesized that ambulosono may induce functional compensatory reorganization of neural networks in the brain. this project will allow us to address the important potential confound of placebo influence and to aid in optimizing this intervention program. additionally, the investigators are hoping to investigate the synergistic effects of rasagiline and exercise; the investigators' hypothesis is that there will be a positive synergistic effect, and that exercise will augment the effectiveness of rasagiline in treating parkinson's symptoms.


Eligibility criteria:
inclusion criteria: * over 19 years of age * confirmed diagnosis of parkinson's disease * can walk 5 to 10 minutes unassisted * have a safe place to walk (outdoor or indoor) * have mild to moderate parkinson's disease (hy1-3) * be able to lay flat in the scanner for the period of the study * no reliance on wheelchair or other walking aid for ambulation * absence of any other serious medical conditions such as hearing impairment and dementia * no history of other neurological and psychiatric illnesses * no recent musculoskeletal impairment or injuries that may prevent walking exclusion criteria: * under 19 years of age * unconfirmed pd diagnosis * require walking aid, wheelchair-bound * no access to safe walking pathway * severe pd (hoehn \& yahr stages\>3) * impaired hearing * atypical parkinsonism * concurrent dementia * recent knee, hip or foot injury (need permission from doctor) exclusion criteria for fmri * pacemaker * brain aneurysm clip * cochlear implant * recent surgery within the past 6 weeks * possibility of pregnancy * electrical stimulator for nerves or bones * implanted infusion pump * history of any eye injury involving metal fragments * history of working with metals (grinding, machining, or welding) * artificial heart valve * orthopaedic hardware (artificial joint, plate, screws, rods) * other metallic prostheses * coil, catheter or filter in any blood vessel * ear or eye implant * recent tattoos within the past 6 weeks * shrapnel, bullets, or other metallic fragments * medication releasing skin patches (nicotine, birth control, nitroglycerine)
extension of the psychometric validation study orchestra in patients with pah

Conditions: Pulmonary Arterial Hypertension

Summary: prospective, multi-center, open-label, single-arm, phase 3b extension study of macitentan in patients with pah. to assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (pah) beyond treatment in the ac-055-310 study.

to assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (pah) beyond treatment in the ac-055-310 study.

Eligibility criteria:
inclusion criteria: 1. signed informed consent prior to any study-mandated procedure. 2. patients with pah who completed the orchestra study (ac-055-310) as scheduled 3. women of childbearing potential (as defined below) must: * have a negative serum pregnancy test at visit 1 (i.e., visit 4 of study ac 055 310) and agree to perform monthly serum pregnancy tests. * agree to use two reliable methods of contraception in parallel, from visit 1 until 1 month after study drug discontinuation (see details below). * a female is considered to have childbearing potential unless she meets at least one of the following criteria: * previous bilateral salpingo and/or oophorectomy, or hysterectomy. * premature ovarian failure confirmed by a specialist. * pre-pubescence, xy genotype, turner syndrome, uterine agenesis. * postmenopausal, defined as 12 consecutive months with no menses without an alternative medical cause. * of the two contraceptive methods that must be used, one must be from group 1, and one must be from group 2, defined as follows: * group 1: oral, implantable, transdermal or injectable hormonal contraceptives, intrauterine devices, female sterilization (tubal ligation or non-surgical sterilization, e.g., permanent contraception with essure procedure), or partner's sterilization (vasectomy). if a hormonal contraceptive is chosen from this group, it must be taken for at least one month prior to enrollment. alternatively, if the essure procedure is chosen as a contraceptive method, a hysterosalpingogram must have been performed to confirm correct location of the microinserts and tubal occlusion (as per manufacturer's recommendations). * group 2: female or male condoms, diaphragm or cervical cap, any of them in combination with a spermicide. * sexual abstinence, rhythm methods, or contraception by the partner alone are not considered as acceptable methods of contraception for this study. exclusion criteria: 1. patients who prematurely discontinued study drug in study ac-055-310. 2. females who are lactating or pregnant (positive visit 1 pregnancy test) or plan to become pregnant during the study. 3. ast and/or alt more than 3 x uln.

Keywords: pulmonary arterial hypertension pah-sympact pah psychometric instrument
vitamin d intervention in infants - 6 years follow-up (vidi2)

Conditions: Bone Strength; Growth; Body Composition; Infection; Allergic Diseases; Dental Health

Summary: exposure to vitamin d intervention in early life may have permanent effects on physiology and metabolism. bone growth and mineralization, development of immunity, body composition and brain structure and functioning may be affected. the importance of a long-term surveillance includes follow-up of both beneficial but also harmful effects of vitamin d. vitamin d intervention in infants (vidi) study was conducted in 2013-2016. vidi study was a large randomized trial that aimed to evaluate effects of two vitamin d supplemental doses of daily 10 ug and 30 ug from the age 2 weeks until 2 years on bone strength, infections, immunity, allergy, atopy and asthma, neurologic and cognitive development, and genetic regulation of mineral homeostasis. current study is a 6 years follow-up (vidi2) study of the original vidi trial. our focuses of interest in the follow-up are: bone strength, growth pattern, body composition, and morbidity due to infections and allergic diseases, and the development of immunity. further, in addition to more classical associates of vitamin d, our aim is to continue to follow-up children's neurocognitive development and mental health. we will also focus on the effect of vitamin d supplementation on occurrence of molar-incisor hypomineralization, dental caries, and oral immunity.


Eligibility criteria:
inclusion criteria: all who participated in the original vidi study until last study visit at the age of 2 years. exclusion criteria: none
study evaluating subcutaneous moa-728 for the treatment of opioid-induced constipation (oic) in subjects with chronic non-malignant pain

Conditions: Constipation

Summary: the primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of subcutaneous moa-728 versus placebo in subjects with chronic non-malignant pain who have opioid-induced constipation (oic).


Eligibility criteria:
inclusion criteria: * adult outpatients with opioid-induced constipation and chronic non-malignant pain. * taking oral, transdermal, intravenous, or subcutaneous opioids. * willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives. exclusion criteria * history of chronic constipation before the initiation of opioid therapy. * other gi disorders known to affect bowel transit. * women who are pregnant, breast-feeding, or plan to become pregnant.

Keywords: opioid-induced constipation
evaluation of mechanisms responsible for coma in patients affected by fulminant, acute and chronic hepatic failure

Conditions: Acute and Chronic Hepatic Failure With Developing Coma

Summary: the purpose of this study is to understand mechanisms associated with the development of coma during hepatic failure. as of today, those mechanisms are not understood and it is difficult to intervene and prevent coma development which is often associated with mortality. understanding the mechanism involved, may allow us to prevent coma and develop new therapies to treat this disease.


Eligibility criteria:
inclusion criteria: * patients (male or female), 18 years or older hospitalized or seen at utmb clinics for chronic or acute hepatic failure will be included in the study. exclusion criteria: * patients (male or female), 18 years or older hospitalized or seen at utmb clinics that do not have a diagnosis of chronic or acute hepatic failure

Keywords: acute hepatic failure chronic hepatic failure coma
effect of varenicline on fixed-dose alcohol administration in participants with alcohol use disorders

Conditions: Alcohol Reactivity

Summary: the purpose of this study is the examine the effect of varenicline on cognition to a high dose (0.08 g/dl) of alcohol (vs. placebo alcohol) over the ascending and descending limb of the blood alcohol curve.


Eligibility criteria:
inclusion criteria: * 21 years old or older * able to read and write in english * smokers and nonsmokers * meet criteria for alcohol use disorders * currently enrolled in nct00580645 exclusion criteria: * any significant current medical or psychiatric conditions that would contraindicate the consumption of alcohol * significant hepatocellular injury * positive test results at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines * women who are pregnant or nursing * suicidal, homicidal, or evidence of severe mental illness * prescription of any psychotropic drug in the 30 days prior to study enrollment * blood donation within the past 8 weeks * individuals who are seeking treatment for drinking or smoking or who have attempted to quit drinking or smoking within the past 3 months * known allergy to varenicline or taking h2blockers * participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current protocol * subjects likely to exhibit clinically significant alcohol withdrawal during the study

Keywords: alcohol reactivity smoking cessation medications
cmv-tcr-t cells for cmv infection after allogenic hsct

Conditions: CMV Infection After Allogenic HSCT

Summary: this is a multi-center, single arm, open-label, phase i study to determine the safety and effectiveness of cmv-tcr-t cell immunotherapy in treating cmv virus infection after allogenic hsct.

cytomegalovirus (cmv) infection after allogeneic hematopoietic stem cell transplantation (hsct) is common and can be lethal without prompt treatment. in this prospective study, hla-a\*02:01/11:01/24:02-restricted cmv-specific t cell receptor (tcr) will be introduced into the t cells of hsct donors by ex vivo lentiviral transduction to generate cmv-tcr-t cells. an escalated dose ranging from 1×10\^3/kg to 5×10\^5/kg of cmv-tcr-t cells will be infused into patients with cmv infection. the safety, efficacy, pharmacokinetics and cytokine levels of allogenic cmv-tcr-t cell therapy will be evaluated.

Eligibility criteria:
inclusion criteria: 1. age 1-60 years, gender unlimited. 2. diagnosed with hematologic malignancies and have undergone allogeneic hematopoietic stem cell transplantation (allo-hsct), with cmv infection after allo-hsct. 3. karnofsky score ≥ 70 or lansky score ≥ 50. 4. tcr-t cell donor inclusion criteria: 1) age ≥ 8 years; 2) understand and voluntarily sign informed consent and are willing to comply with laboratory tests and other research procedures; 3) ≥ 3/6 hla match with tcr-t cell recipients enrolled; 4) lymphocyte count = (0.8\~4) × 10\^9/l; 5) have sufficient venous circulation, without any symptoms that do not allow blood cell isolation. exclusion criteria: 1. patients with active agvhd one day before tcr-t cell infusion. 2. patients with severe kidney disease (cr \> 3×normal value), liver damage (tbil \>2.5×upper limit of normal value, alt and ast \> 3×upper limit of normal value) or heart failure (nyha heart function grade iv) one week before tcr-t cell infusion. 3. anticipated to take immunosuppressive hormones on the day of tcr-t cell infusion. 4. have other malignancies. 5. have relapsed and uncontrolled hematologic malignancies. 6. serologically positive for hiv-ab or tap-ab. 7. pregnant or lactating women. 8. anticipated to have other cell therapies in 4 week post tcr-t cell infusion. 9. participated in any other clinical study of drugs and medical devices before 30 days of enrollment. 11. any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data. 12. tcr-t cell donor exclusion criteria: 1. positive for any of the following: hbsag, hbeag, hbv-dna, hcv-ab, hcv-rna, hiv-ab, tp-ab, ebv-dna or cmv-dna; 2. other uncontrolled infection; 3. have taken immunosuppressive drugs 1 week before pbmc collection; 4. any condition that would, in the investigator's judgment, make it unsuitable for the donors to be enrolled.

Keywords: cmv hsct