Kornimate/medical-research-clean huggingface dataset:
measurement properties of the turkish version of the patellofemoral pain and osteoarthritis subscale of the koos

Conditions: Patellofemoral Pain Syndrome; Patellofemoral Osteoarthritis; PROMs

Summary: the purpose of this study is to translate and culturally adapt the subscale of the knee injury and osteoarthritis outcome score for patellofemoral pain and osteoarthritis (koos-pf) into turkish, and to determine the measurement properties of the turkish version.

patellofemoral pain and patellofemoral osteoarthritis are highly prevalent knee disorders associated with pain and functional limitations. patient-reported outcome measures (proms) are suggested for clinical and research use; however, there is a lack of objective disease-specific proms for patellofemoral pain and osteoarthritis. the purpose of this study is to translate and culturally adapt the subscale of the knee injury and osteoarthritis outcome score for patellofemoral pain and osteoarthritis (koos-pf) into turkish, and to determine the measurement properties of the turkish version.

Eligibility criteria:
inclusion criteria: * peripatellar or retropatellar knee pain persisting for at least 3 months and exacerbated by activities that load the patellofemoral joint; * pain intensity of at least 3 mm according to the visual analogue scale (vas) exclusion criteria: * diffuse or generalized knee pain * severe trauma to the target knee in the previous year * moderate to severe concomitant tibiofemoral osteoarthritis * recent knee injection (within 3 months) * systemic inflammatory conditions

Keywords: patellofemoral pain syndrome patellofemoral osteoarthritis patient-reported outcome measures proms validity reliability
dietary lutein and the retinopathy of prematurity

Conditions: Lactation

Summary: the clinical trial aspect of this study is the provision of a lutein supplement to lactating women and compare the amount of lutein in the milk and blood with lactating women who do not receive the lutein supplement.

about one-fourth of preterm infants who weight less than 2 3/4 pounds at birth develop an eye problem. this problem occurs in the retina (back of the eye) and may result in blindness. this eye problem is called the retinopathy of prematurity(rop). there are two yellow pigments in the retina called lutein and zeaxanthin. these pigments may protect the retina from being damaged by light. they may also protect the retina from being damaged by oxygen. these pigments are transferred from the mother to the baby. most of this takes place during the last trimester of pregnancy. the situation could be worse if the baby receives formula. most baby formulas do not contain lutein and zeaxanthin; breast milk does. another worry is that breast milk may not have enough lutein and zeaxanthin if the mother does not eat enough vegetables and fruits. the purpose of this study is to measure the transfer of lutein and zeaxanthin from the mother to the baby, to measure the amount of lutein and zeaxanthin in breast milk, to find out if taking a lutein supplement will increase the amount of lutein in breast milk and to find out if dietary lutein and zeaxanthin are involved in the development of the retinopathy of prematurity (rop).

Eligibility criteria:
inclusion criteria: * planning to breast feed for at least 12 weeks * willing to be randomized to take the lutein supplement exclusion criteria: * insufficient quantity of breast milk

Keywords: lactation breast milk lutein lutein supplement
evaluation of the therapeutic usability of respira advanced device in patients under invasive mechanical ventilation

Conditions: Respiratory Insufficiency

Summary: the objective of the clinical investigation presented is to guarantee the safety and usability of the respira advanced medical device in patients undergoing mechanical ventilation in the icu, both stable patients and in the weaning phase. through the clinical investigation, the reliability and durability of the device, the adequacy of the ventilatory parameters and their consistency over time, and the response of the patients wills be checked. during the entire course of the patient's participation in the study, the patient will be closely monitored following the protocol specifications, to guarantee safety and evaluate the effectiveness of the device.


Eligibility criteria:
inclusion criteria: * age equal to or greater than 18 years * availability of a family member or legal representative capable of understanding and signing the informed consent * patient admitted to the intensive care unit requiring invasive mechanical ventilation, who shows: * hemodynamic stability: map ≥ 65 mmhg and norepinephrine requirements ≤ 0.5 µg / kg / min, and * respiratory stability: pao2 / fraction of inspired oxygen (fio2)\> 100 and stable oxygen requirements in the previous 6 hours. * in case is considered to start phase of "weaning" or awakening, the level of sedation should allow adequate triggering of the inspiratory trigger, in a patient with improvement of respiratory failure and / or radiological image. exclusion criteria: * age under 18 years * weight less than 50 kg * body weight greater than 120 kg * height greater than 1,90 m * presence of barotrauma (pneumothorax) or pleural fistula * hemodynamic instability (map \ 0,5 µg /kg / min) * neurocritical patient * obstetric patient
study to evaluate biomarkers and clinical manifestations in individuals with glycogen storage disease type iii (gsd iii)

Conditions: Glycogen Storage Disease Type III

Summary: the primary objective of this study is to evaluate potential biomarkers of gsd iii.


Eligibility criteria:
inclusion criteria: * confirmed historical diagnosis of gsd iii based on pathogenic mutations in the agl gene on both alleles or gde deficiency based on biopsy of liver, muscle, or fibroblasts * willing to comply with all study procedures * willing and able to provide written informed consent. if a minor, willing and able to provide written assent and have a legally authorized representative willing and able to provide written informed consent exclusion criteria: * presence or history of any condition that, in the view of the investigator, places the subject at high risk of poor study compliance, interferes with study participation, or interferes with the subject's ability to safely or reliably complete the study assessments * use of any ip within 30 days prior to informed consent/assent or at the time of enrollment
supporting tailored and responsive prep in rural north carolina

Conditions: HIV Pre-Exposure Prophylaxis

Summary: this project consists of two phases to be completed over five years. phase 1 (aims 1 and 2) will be completed during years 1-3 (r61). the phase 1 study is a randomized trial of a multilevel hiv pre-exposure prophylaxis (prep) intervention strategy in rural and peri-urban north carolina sexually transmitted infection (sti) clinics, with primary outcome of prep uptake within 3 months of an index sti clinic visit.

participants will be randomized 1:1 to an intervention or control condition. participants enrolled in the intervention arm will receive a multilevel intervention with three components: a prep navigator to facilitate linkage to prep services and completion of applications for health insurance/drug assistance; a digital health intervention (dhi) platform (healthmpowerment) - a hipaa-compliant evidence-based dhi that provides interactive educational resources, social support, and tools for developing prep behavioral skills and self-efficacy; and referral to telehealth prep services as an option for linking to prep care. control arm participants will receive the standard prep referral services available at the sti clinic setting where they were recruited. they will also receive linkage to a limited version of the dhi, with basic prep resources and information.

Eligibility criteria:
inclusion criteria: * report sexual activity with a male in the past 12 months * received hiv testing within 90 days pre-enrollment and not known to be hiv-positive at screening/enrollment by self-report * age 18-39 years * have daily smartphone access * be english speaking * deny current prep use exclusion criteria: * confirmed prior hiv-positive diagnosis * prior prep use (oral prep or injectable prep) within the last 3 months.
nationwide results on chronic pain after bilateral transabdominal preperitoneal inguinal hernia repair (tapp)

Conditions: Hernia, Inguinal; Chronic Pain

Summary: danish male patients who had undergone bilateral tapp (july 2012 to june 2013) were recruited from the danish hernia database and cross-checked with hospital files and the national patient registry. a standardized postal questionnaire was sent out two years after the index surgery to investigate patients related outcome measures (proms) such as chronic post-operative pain.

the present study was primarily undertaken to provide evidence for the risk of activity-related chronic postoperative inguinal pain following bilateral tapp in an all-male danish setting. impaired sexual activity and sleep disturbance due to pain was also recorded. data based on nationwide consecutive patients undergoing bilateral tapp. data collected for the danish inguinal hernia database, hospital files and the national patient registry (denmark).

Eligibility criteria:
inclusion criteria: * danish males, * age\>18 years * elective, bilateral tapp due to inguinal hernia within the period from july 1, 2012 to june 30 2013 exclusion criteria: * age \<18 years * miss-classified surgical code * non-danish speaking * psychiatric anamneses * regarded and non-compliant patients who had either died, emigrated or were lost to follow-up emergency repair * femoral hernia repair

Keywords: inguinal hernia
ultrasound-guided vs non-guided prolotherapy for internal derangement of temporomandibular joint. a randomized clinical trial

Conditions: TMJ Disc Disorder; Ultrasound Therapy; Complications; TMJ; Prolotherapy; Internal Derangement; Clicking Tinnitus; Injection Site; Pain, Chronic; Anterior Disc Displacement; Myofascial Pain Syndrome; Masticatory Muscle

Summary: ultrasound guided versus non-guided prolotherapy for treatment of internal derangement of temporomandibular joint. rationale for conducting the research: the most critical cause for guided prolotherapy is to specify the accurate location of glenoid fossa and the disc space while prolotherapy procedure, and to adjust the needle insertion to according to articular eminence, mandibular condyle, and intra-articular space as anatomical variations. the vibration of ultrasound waves generates a heat so there is a thermal effective for prolotherapy effusion in the tmj space.


Eligibility criteria:
inclusion criteria: 1. patients with tmd - internal derangement with symptomatic clicking pain, according to rdc (research diagnostic criteria for tmjd) sheet . 2. muscles spasm causing tmds. 3. patients who failed to improve on conservative measures or highly hyperactivity patients. 4. female and male patients age range from 20 to 60 years old. exclusion criteria: 1. patients who refused to be included in the research. 2. patients with a systemically diseases or inflammation whether local or generalized. 3. patients with bleeding disorders. 4. patients with unknown dextrose allergy.
serratus plane block in preventing postoperative pain of mastectomy

Conditions: Serratus Plane Block; Chronic Pain; Breast Cancer

Summary: a prospective, double-blinded randomized controlled, 1-year follow-up study was designed to compare the analgesic effect of serratus plane block (spb) after breast cancer surgery. women undergoing radical mastectomy were divided into control group and spb group. the postoperative acute pain was evaluated by numerical rating scale (nrs) and the effect of preventing chronic pain was assessed at 3, 6, 12 months after surgery by nrs.


Eligibility criteria:
inclusion criteria: * women undergoing radical mastectomy with either sentinel lymph node dissection or axillary lymph node dissection or no axillary lymph node dissection * between the ages of 18 and 85 yr * with an american society of anesthesiology (asa) physical status i or ii * without any significant cardiopulmonary, renal and hepatic dysfunction exclusion criteria: * patients with any previous cancer other than breast cancer * occurrence of allergy to local anesthetics * occurrence of opioid-tolerant subjects * occurrence of consuming analgesics, sedatives, antidepressants or any history of substance abuse before surgery
structured comprehensive intervention to stimulate self- management and improve quality of life in copd patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study evaluates the effect of of a structured self-management intervention plan in patients with chronic obstructive pulmonary disease in primary care setting.half of the participants will receive the self-management plan while the other half will receive usual care.

chronic obstructive pulmonary disease (copd) is a great magnitude public health problem with an associated increased mortality and a high cost (consumption of health care resources and loss of health related quality of life (hrqol)). the comprehensive approach to this complex disease, focusing self-care promotion, improves hrqol and the patients" clinical status, as shown by several studies, although further investigation is needed to confirm these results in the field of primary care (pc) and to formulate clear recommendations on the more effective type of intervention. hypothesis: in (moderate-severe) copd patients, a structured self-management intervention plan in the setting of primary care, is more effective than usual treatment on the main outcomes associated with the disease: hrqol, lung function, exacerbations and hospital admissions, at 6, 12 and 24 months of follow-up. objectives: to evaluate the impact of a comprehensive intervention plan to promote self-care and improve hrqol in people with copd in pc. methods: multicenter randomized controlled trial, conducted at pc centers in barcelona. determinations: specific standardized and validated questionnaires, as the st george's respiratory for the hrqol. statistical analysis: intention to treat analysis. descriptive statistics of the variables of the intervention and the control group to assess their homogeneity at the beginning of the study. an analysis of variance (anova) will be used to assess differences among intervention groups. expected results: a significant improvement in hrqol attributable to the intervention performed in patients with copd applicability and relevance: to implement the intervention plan in clinical practice and to standardize its content.

Eligibility criteria:
inclusion criteria: * patients with at least one visit at the primary care physician during the past year * patients with a diagnosis of moderate (fev1 50% - 80%) or severe (fev1 30% - 50%) copd * patients treated with inhaled bronchodilators and accepting to participate in the study. exclusion criteria: * patients unable to come to the primary care centre * patients with cognitive impairment and/or a severe mental condition. * patients with a diagnosis of asthma, tuberculosis or other chronic respiratory disease. * patients needing chronic oxygen therapy. * patients with any terminal disease

Keywords: quality of life self-management, structured plan copd
intermediate-size expanded access program (eap), mesenchymal stromal cells (msc) for acute respiratory distress syndrome (ards) due to covid-19 infection

Conditions: Moderate to Severe Acute Respiratory Distress Syndrome Associated With COVID-19

Summary: the objectives of this intermediate-size expanded access protocol are to assess the safety and efficacy of remestemcel-l in participants with ards due to coronavirus infection 2019 (covid-19).

this intermediate-size expanded access protocol plans to treat approximately 50 adult participants, male and female, with moderate to severe ards due to covid-19 infection. participants who are 18 years of age or older will be enrolled at multiple clinical sites across the united states.

Eligibility criteria:
inclusion criteria: 1. 18 years or older 2. participant has coronavirus disease covid-19 confirmed by real-time reverse transcription polymerase chain reaction (rt-pcr) assay or another diagnostic test 3. moderate to severe ards as determined by the following criteria (adapted from the berlin criteria): * bilateral opacities must be present on a chest radiograph or computed tomographic (ct) scan. these opacities are not fully explained by pleural effusions, lobar collapse, lung collapse, or pulmonary nodules. * respiratory failure not fully explained by cardiac failure or fluid overload. an objective assessment (e.g., echocardiography) to exclude hydrostatic pulmonary edema is required if no risk factors for ards are present. * moderate to severe impairment of oxygenation must be present, as defined by the ratio of arterial oxygen tension to fraction of inspired oxygen (pao2/fio2). the severity of the hypoxemia defines the severity of the ards: * moderate ards: e pao2/fio2 \>100 millimeters of mercury (mmhg) and ≤200 mmhg, on ventilator settings that include positive end-expiratory pressure (peep) ≥5 centimeters (cm) of water or * severe ards: pao2/fio2 ≤100 mmhg on ventilator settings that include peep ≥5 cm of water 4. ≤72 hours post-initiation of ventilation 5. high sensitivity c-reactive protein (hs-crp) serum level ≥ 4.0 milligrams per deciliter (mg/dl) 6. acute physiologic and chronic health evaluation (apache ii) score ≥5 7. aspartate aminotransferase/alanine transaminase (ast/alt) \< 5x upper limit of normal (uln) 8. creatinine clearance ≥ 30 milliliters per minute (ml/min) 9. serum creatinine \<2 mg/dl exclusion criteria: 1. participant is receiving extracorporeal membrane oxygenation (ecmo) 2. females who are pregnant or lactating 3. known hypersensitivity to dimethyl sulfoxide (dmso) or to porcine or bovine proteins 4. severe chronic obstructive pulmonary disease (copd) requiring oxygen therapy prior to becoming ill with ards due to covid-19 infection 5. any end-stage organ disease which, in the opinion of the treating physician, may possibly affect the safety of the remestemcel-l treatment

Keywords: ards covid-19 coronavirus msc remestemcel-l mesoblast mesenchymal
bold mri as a surrogate of improved muscle oxygenation following endovascular therapy for the treatment of cli

Conditions: Peripheral Arterial Disease; Critical Limb Ischemia

Summary: the purpose of this study is to determine if an mri technique called blood oxygen level dependent, or bold, can be used to evaluate blood flow in the leg before and after treatment with standard endovascular therapy in patients with chronic lower limb ischemia.

this study is a prospective single arm, open label registry to evaluate the feasibility of blood oxygen level dependent (bold) magnetic resonance imaging for the assessment of a potentially new functional surrogate of altered lower limb skeletal muscle oxygenation after a successful percutaneous endovascular intervention. baseline mri assessment using the bold technique will be performed on qualified subjects prior to undergoing a standard of care endovascular therapy. post-procedure bold-mri assessment will also be performed at 30 days and either 90 or 180 days post-procedure. post-mr image acquisition processing and analysis will be performed, using pre-determined algorithms, by a core laboratory.

Eligibility criteria:
inclusion criteria: * age \> 18 and \< 90 years * subject has been informed of the nature of the study and agreed to participate and has signed an irb approved consent form * subject understands the duration of the study and its follow-up visit requirements and agrees to comply * subject has documented chronic limb ischemia in the target limb with rutherford category 2-5 and pulse plethysmography (ppg), pulse volume recording (pvrs), tcpo2, abis or toe pressures and symptoms that conform to the diagnosis of life-style limiting claudication or critical limb ischemia exclusion criteria: * adult subjects who lack the capacity to consent for themselves * women who are pregnant or wish to become pregnant during the course of the study. (women of child-bearing potential must undergo pregnancy testing at the time of enrollment, and be counseled in appropriate measures to avoid becoming pregnant for the duration of the study) * subjects with contraindications to mr imaging procedures (including the administration of gadolinium based contrast agents) * subjects suspected to be unable to withstand the reactive hyperemia protocol
interaction study slv337/simvastatin

Conditions: Type 2 Diabetes Mellitus

Summary: to investigate the effect of multiple doses of slv337 on the pharmacokinetics of simvastatin and simvastatin acid when co-administered in healthy male subjects


Eligibility criteria:
inclusion criteria: * volunteers with body mass index 18.0-28.0 kg/m2 exclusion criteria: * clinically relevant medical history

Keywords: interaction slv337 and simvastatin type 2 diabetes mellitus
treatment of meibomian gland dysfunction and evaporative dry eye

Conditions: Chalazion; Dry Eye Syndromes

Summary: the objective of this study is to evaluate the clinical utility, safety and effectiveness of the manual mini system compared to standardized warm compress therapy for application of controlled, localized heat therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye, and chalazia.


Eligibility criteria:
inclusion criteria: * at least 18 years of age. * meibomian gland obstruction * dry eye symptoms * willingness to comply with study procedures and return for all visits exclusion criteria: * ocular surgery, injury, or herpes infection within past 3 months * active ocular infection * active ocular inflammation or recurrent inflammation within past 3 months * moderate to severe allergic conjunctivitis * severe eyelid inflammation * eyelid abnormalities that affect lid function * ocular surface abnormalities that may compromise corneal integrity * macular disease * systemic disease condition or medication that causes dry eye * use of other treatments for meibomian gland dysfunction or dry eye * pregnant or nursing women * participation in another ophthalmic clinical trial within past 30 days