Kornimate/medical-research-clean huggingface dataset:
evaluate the long-term safety and efficacy of evinacumab in patients with homozygous familial hypercholesterolemia

Conditions: Homozygous Familial Hypercholesterolemia

Summary: the primary objectives of the study are: * to evaluate the long-term safety and tolerability of evinacumab in patients with homozygous familial hypercholesterolemia (hofh) * to evaluate the long-term safety and tolerability of evinacumab in adolescent patients with hofh the secondary objectives of the study are: * to evaluate the effect of evinacumab on lipid parameters in patients with hofh * to evaluate the effect of evinacumab on lipid parameters in adolescent patients with hofh * to evaluate the potential development of anti-evinacumab antibodies


Eligibility criteria:
key inclusion criteria: 1. completion of the parent study in which they participated 2. able to understand and complete study-related questionnaires key exclusion criteria: 1. significant protocol deviation in the parent study based on the investigator's judgment, such as non-compliance by the patient 2. concomitant medications that have not been stable prior to the baseline visit 3. adverse event leading to permanent discontinuation from parent study 4. any new condition or worsening of an existing condition, which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in or completing the study 5. member of the clinical site study team and/or his/her immediate family 6. pregnant or breastfeeding women 7. women of childbearing potential who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 24 weeks after the last dose of study drug 8. men who are sexually active with women of childbearing potential and are unwilling to use the following forms of medically acceptable birth control during the study drug treatment period and for 24 weeks after the last injection of study drug: vasectomy with medical assessment of surgical success or consistent use of a condom. note: other protocol defined inclusion/exclusion criteria apply

Keywords: hofh
study to measure relaxation from different types of focused breathing exercises

Conditions: Breathing; Mind-body Practices; Yoga; Meditation

Summary: mind-body practices, such as yoga, ta'i chi, mindfulness and biofeedback, commonly use slow breathing techniques to induce physiological and mental relaxation. medical research suggests that slow breathing techniques induce physiological relaxation. this 6 week study will compare the effects of different types of breathing. the hypothesis is that different breathing techniques produce different physiological and mental changes.


Eligibility criteria:
inclusion criteria: * age 30 to 50 years * english speaking exclusion criteria: * hypertension * heart disease: history of coronary artery disease, myocardial infarction, significant valvular disease, or congestive heart failure * diabetes * renal disease * anxiety disorder * depression * other psychiatric conditions including schizophrenia or bipolar disorder * attention-deficit-disorder or attention-deficit-hyperactivity disorder * musculoskeletal condition limiting capacity to perform yoga such as chronic lower back pain, chronic neck pain * asthma * chronic obstructive lung disease * obstructive sleep apnea * smoker * currently taking blood pressure medications, oral diabetic medication or insulin * current participation in a mind-body practice/program * current cancer other than non-melanoma skin cancer * regular swimmer * plays wind or brass musical instruments

Keywords: breathing mind-body practices yoga meditation
pruritus and melanoma and cutaneous carcinomas treated with immunotherapy

Conditions: Pruritus

Summary: immune checkpoint inhibitors (icis) are commonly used in the therapeutic arsenal of metastatic melanoma, merkel cell carcinoma and cutaneous squamous cell carcinoma, thanks to their inhibiting effects on cytotoxic t-lymphocyte-associated protein 4 (anti-ctla4) and anti-programmed death-1 (anti-pd1) respectively. these treatments can induce numerous cutaneous and non-cutaneous adverse effects that are mainly due to their immunological action. their most frequent adverse effects are dysthyroidism, autoimmune hepatitis, colitis and skin disorders. among those, pruritus is frequently reported as a side effect of these treatments. its incidence has been estimated between 11% and 47%. pruritus can deeply affect the patient's quality of life and may lead to treatment discontinuation. until now, ici-related pruritus has been poorly studied and it is not understood. in the literature, data on the presence and characteristics of pruritus in patients treated by icis were provided, without analyzing the causes of this pruritus. indeed, it is not known if the occurrence of pruritus is related to direct or indirect effects of icis. some authors reported a correlation between the occurrence of cutaneous adverse events under icis and the survival. the principal aim of our study was to analyze the putative causes of pruritus occurring in patients treated with icis for melanomas and cutaneous carcinomas. the other objectives were to assess the association between the occurrence of pruritus and survival, and between the other adverse events and pruritus.


Eligibility criteria:
inclusion criteria: * age 18 years and older, * treated with icis (nivolumab, pembrolizumab, ipilimumab, cemiplimab) for melanoma, squamous cell carcinoma or merkel cell carcinoma * not having formulated any opposition exclusion criteria: * age under 18 years, * adults not legally competent, * presence of pruritus at the inclusion, * participation refusal
early diagnosis of small pulmonary nodules by multi-omics sequencing

Conditions: Carcinoma; Non-small-cell Lung Cancer; Lung Neoplasm

Summary: analyse immune repertoire and genetic mutations of benign and malignant pulmonary nodule，and evaluate peripheral blood detection for identifying nature of pulmonary nodule.

early diagnosis of lung cancer is of vital importance in lung cancer treatment. this research will first analyse the features of immune repertoire and genetic mutations from tissue of benign and malignant pulmonary nodule，then explore the feasibility of detecting these features from peripheral blood sample, and finally evaluate peripheral blood detection of lung cancer related immune repertoire and genetic mutations for identifying nature of pulmonary nodule.

Eligibility criteria:
inclusion criteria: 1. sign informed consent and consent to participate in this study; 2. found small nodules in pulmonary by ct and prepare for surgery; exclusion criteria: 1. malignant tumor history within the past 5 years; 2. receiving chemotherapy, radiotherapy or targeted therapy before surgery; 3. histology confirmed not non-small cell lung cancer 4. no matching tissue or blood samplesunqualified blood samples

Keywords: circulating tumor dna lung cancer surgery early diagnosis immuno-sequencing
study of ly2181308 in combination with docetaxel versus docetaxel in patients with non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the anti-tumor activity of ly2181308 in combination with docetaxel compared to docetaxel alone in participants with non-small cell lung cancer who were previously treated with first line chemotherapy.


Eligibility criteria:
inclusion criteria: * participants with non-small cell lung cancer with locally or advanced metastatic disease(stage iiib or iv at entry) not amenable to curative therapy and who have progressed after 1 line of chemotherapy * measureable disease as defined by response evaluation criteria in solid tumors (recist) version 1.1 * eastern cooperative oncology group (ecog) performance status of 0 to 1 * must make available any existing tumor tissue from the primary biopsy * participants with prior radiation may be eligible if they meet certain criteria * adequate bone marrow reserve and organ functioning * women must have a negative pregnancy test and must comply with a highly reliable contraceptive method during and for 6 months after the treatment period and must not be breastfeeding * men must comply with a contraceptive regimen during and for 6 months after the treatment period exclusion criteria: * currently enrolled in or discontinued a clinical trial involving an investigational drug/device within the last 30 days. participants may be permitted to enter treatment before the 30 day waiting period in special circumstances * pregnant or breastfeeding * serious concomitant systemic disorders that would compromise the safety of the participant or the participant's ability to complete the study * second primary malignancy that could affect compliance with the protocol or interpretation of the study results * known allergy or hypersensitivity to docetaxel, taxanes, ly2181308, oligonucleotides, or any component of the formulations * participants with documented central nervous system or brain metastasis at the time of study entry * pre-existing neuropathy equivalent to a common terminology criteria for adverse events(ctcae)code greater than or equal to 2
behavioral activation for depression through virtual reality

Conditions: Depression

Summary: evaluate the effectiveness of a brief, virtual reality intervention for depressed mood


Eligibility criteria:
inclusion criteria: * patient health questionnaire - 9 (measure of depression) over 9 * positive and negative affect schedule (measure of positive and negative affect): positive affect score below 24 * age over 18 years * signs informed consent exclusion criteria: * completes more than 20% of evaluations retrospectively (not the day they are assigned) * has a severe mental health disorder as evaluated with the mini international neuropsychiatric interview * does not sign the informed consent
effect of selected rehabilitation program in patients with plantar fasciitis

Conditions: Plantar Fascitis; Plantar Fasciitis, Chronic; Heel Pain Syndrome

Summary: this study will be done to investigate the effect of the selected rehabilitation program for pf on plantar fascia thickness, clinical outcomes such as pain, foot function, dorsiflexion rom and pressure pain threshold and alignment such as rearfoot eversion angle and foot posture index in patients with pf.

plantar fasciitis (pf), which constitutes approximately 15% of all foot disorders, is the most prevalent cause of heel pain. it is a long-term degenerative process that is impacted by subtalar pronation and pes planus. one million us patients saw primary care physicians with pf between 1995 and 2000. there is not enough data to determine the best physical therapy management techniques for individuals with heel pain, despite the existence of multiple successful treatment approaches. this study investigated at how a mechanically based rehabilitation program affected patients with pf in terms of foot alignment, plantar fascia thickness, pain, pressure pain threshold, rom and foot function. the approach included strengthening the plantar intrinsic muscles of the foot, plantar fascia specific stretching and achilles tendon stretching, and passively correcting the pathomechanics of the foot by low dye tapping and high load resistance exercise for achilles tendon and windlass mechanism

Eligibility criteria:
inclusion criteria: * plantar medial heel pain: most noticeable with initial steps after a period of inactivity, but also worse following prolonged weight-bearing * pain with palpation of the proximal insertion of the plantar fascia * positive windlass test * flat foot posture utilizing the foot posture index * age range from 40 to 60 years exclusion criteria: * tarsal tunnel syndrome * atrophy of the fat pad. * diabetic patients or patients with rheumatoid arthritis * corticosteroid injection over the last sex months
the modum bad complex posttraumatic stress disorder study

Conditions: Post-Traumatic Stress Disorder

Summary: this study compares three established, manual based psychotherapies for complex post-traumatic stress disorder (cptsd) in patients with childhood trauma (e.g. sexual abuse, violence). the primary aim of the study is to compare phase-oriented treatment (stabilization + exposure) with two non-phased treatments, exposure and stabilization.

available treatment procedures for ptsd are largely developed within the context of adult trauma (e.g. accidents, natural disasters, rape or combat). the need for additional treatment options targeting dysfunctional affect regulation and interpersonal problems in patients suffering after childhood trauma is debated in research and clinical settings. 96 patients will be recruited from referrals to an in-patient clinic in norway called modum bad. after assessment, patients will be randomly assigned to one of three treatment arms. one-third will receive 10 weeks of prolonged exposure, one-third 10 weeks of skills training in affect and interpersonal regulation (stair), and the last third a phase-based treatment lasting 16 weeks (stair + narrative therapy).

Eligibility criteria:
inclusion criteria: * childhood trauma (e.g. sexual abuse, violence prior to age 18), * a diagnosis of posttraumatic stress disorder ptsd according to dsm-5 * a diagnosis of complex ptsd according to the suggested additional criteria for complex ptsd in international classification of diseases (icd-11) exclusion criteria: * severe psychotic disorder * dissociative identity disorder (did) * active phase substance dependence * acute suicidality * major current life crisis * severely disturbed group functioning * mental disability
safety, tolerability, and pharmacokinetics study of human monoclonal antibody brii-198

Conditions: COVID-19

Summary: this is a phase 1 study in which healthy adult volunteers will receive brii-198 or placebo and will be assessed for safety, tolerability, and pharmacokinetics.


Eligibility criteria:
inclusion criteria: * subject must be 18 to 49 years of age inclusive; * body weight ≤100 kg and body mass index (bmi) within the range of 19.0-24.0kg/m2 (inclusive); * male or female; exclusion criteria: * any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation; * a history of significant hypersensitivity, intolerance, or allergy to any drug compound; * history of alcohol or other substance abuse;

Keywords: covid-19 phase i monoclonal antibody
treatment of early ra: minocycline in combination with methotrexate vs methotrexate alone

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to determine if a combination of methotrexate and minocycline works better than methotrexate alone in early rheumatoid arthritis

the purpose of this study is to determine if a combination of methotrexate and minocycline works better than methotrexate alone in early rheumatoid arthritis (ra). specific aims of this study are: a. to demonstrate that the combination of minocycline and methotrexate is well tolerated when used in the first year of ra. b. to compare the efficacy of the combination of minocycline and methotrexate with methotrexate and placebo therapy in early sero-positive ra patients.

Eligibility criteria:
inclusion criteria: * age over or equal to 19 years old and less than or equal to 75 years old * diagnosis of ra as determined by fulfilling 4 of 7 acr criteria * positive rheumatoid factor * duration of disease: greater than six weeks and less than one year exclusion criteria: * allergy to tetracycline or methotrexate * previous dmard treatment * doses of oral steroids greater than 7.5 mg/day * intra-articular injections within the last four weeks * significant liver or renal disease or active peptic ulcer disease * patients who are not willing to abstain from alcohol consumption * women of childbearing potential who are not practicing a successful method of contraception
melatonin as a neuroprotective therapy in neonates with hie undergoing hypothermia

Conditions: Hypoxic Ischemic Encephalopathy

Summary: hypoxic-ischemic encephalopathy (hie) occurs in 20 per 1000 births. only 47% of neonates treated with the state of the art therapy (induced systemic hypothermia) have normal outcomes. therefore, other promising therapies that potentially work in synergy with hypothermia to improve neurologic outcomes need to be tested. one potential agent is melatonin. melatonin is a naturally occurring substance produced mainly from the pineal gland. melatonin is widely known for its role in regulating the circadian rhythm, but it has many other effects that may benefit infants with hi injury. melatonin serves as a free radical scavenger, decreases inflammatory cytokines, and stimulates anti-oxidant enzymes. therefore, melatonin may interrupt several key components in the pathophysiology of hie, in turn minimizing cell death and improving outcomes. the research study will evaluate the neuroprotective properties and appropriate dose of melatonin to give to infants undergoing therapeutic hypothermia for hypoxic ischemic encephalopathy.

thirty subjects will be enrolled in a dose escalation study. subjects 1-10 will receive melatonin (0.5 mg/kg). if that dose proves to be safe, subjects 11-20 will receive an increased dose of melatonin (3 mg/kg). subjects 21-30 will receive a dose increased to the targeted projected therapeutic dose (5 mg/kg). the serum concentration of melatonin and capture adverse event reports during this dose escalation study in neonates undergoing hypothermia and the long-term safety and potential efficacy via developmental follow-up performed at 18-22 months of age. in addition, this study will determine the effect of melatonin on the inflammatory cascade, oxidative stress, free radical production, and serum biomarkers of brain injury in neonates undergoing hypothermia.

Eligibility criteria:
inclusion criteria: * eligible infants are \>36 0/7th weeks gestation, * ph (cord or neonatal) \<7.0, * base deficit \>16 meq/l, * no available blood gas, * a cord blood/first hour of life blood gas with ph \> 7.0 and \< 7.15, * base deficit between 10 and 15.9 meq/l, * infants must have a history of an acute perinatal event, * either a 10-minute apgar \< 5 or a continued need for ventilation, * all infants must have signs of encephalopathy within 6 hours of age using the modified sarnat scoring system, * neonates cooled within 6 hours of birth will be included in the study. exclusion criteria: * suspected inborn errors of metabolism (elevated ammonia) and hypoglycemia, * clinical signs and symptoms consistent with meningitis detected upon sepsis evaluation, * a diagnosis of congenital abdominal surgical problems along with multiple congenital anomalies and/or chromosomal abnormalities.
effectiveness of percutaneous foraminotomy

Conditions: Spinal Stenosis

Summary: percutaneous extraforaminotomy using bs extraforamonotomy kit(biospine co.,ltd, seoul, south korea), was performed in patients who did not show improvement lasting more than 1 month after diagnostic conventional fluoroscopically guided transforaminal epidural block with local anesthetic and steroid. numeric rating scale(nrs) pain score, oswestry disability index (odi), roland-morris disability questionnaire (rdq), claudication distance(cd) was checked before and after the procedure.

percutaneous extraforaminotomy with transforaminal adhesiolysis may be an effective minimal invasive technique in patients not responsive to conventional epidural steroid injection.

Eligibility criteria:
inclusion criteria: * radicular pain with positive provocation factors \> 3 months * radicular pain at l4 or l5 * presence of dominant side when bilateral symptom present * positive provocation factors: leg symptoms elicited or aggravated by walking but relieved by sitting down * not appropriate relief of pain routinely conservative treatment (physiotherapy, exercise, analgesic medication, epidural steroid injection) \> 3 months * magnetic resonance imaging(mri) : foraminal stenosis of grade 1-3 (foraminal herniated intervertebral disc(hivd) with mild to severe degree of foraminal stenosis according to ajr:194, april 2010 by lee, et. al) * subjects who signed for the consent form exclusion criteria: 1. acute back or leg pain 2. sings of progressive neurologic deficits, including muscle atrophy and abnormal tendon reflexes 3. patients with a history of prior spine surgery 4. allergic response to steroid or contrast dye 5. bleeding diathesis or over coagulopathy 6. patients with bilateral radiculopathy or spinal stenosis at more than 3 levels

Keywords: lumbar foraminal stenosis
randomized controlled trials of electro-acupuncture effects on perioperative anxiety in patients treated with pci

Conditions: Percutaneous Coronary Intervention

Summary: randomized controlled trials of electro-acupuncture effects on perioperative anxiety in patients treated with pci


Eligibility criteria:
inclusion criteria: * the main inclusion criteria were patients who underwent coronary angiography. patients suffer from generalized anxiety disorder(god). exclusion criteria: * the exclusion criteria were as follows: patients with chronic renal failure, chronic liver disease, bone disorders, and/or thyroid disorders.

Keywords: acupuncture, pci
port will be flushed every 3 months instead of every 4-6 wks, as recommended by port manufacturer.

Conditions: Complication of Catheter

Summary: the purpose of this study is to evaluate the safety and effectiveness of port (pac) flushes every 3 months rather than every four to six weeks. it is routine practice to flush ports every four to six weeks, according to the manufacturer's recommendations, using salt solution followed heparin if needed. this study examines the effectiveness of port flushes at an alternative interval of 3 months, reducing the number of visits to the health-care provider.

this is a phase ii, non-blinded, non-inferiority prospective cohort trial of patients with ports (pac) after a systemic therapy to evaluate the safety and effectiveness of pac flushes in 3 months intervals. patients with any type of cancer are eligible. the study will extend 1 year from enrollment of the last patient. each enrolled patient will have his or her port flushed five times in 3 month intervals. patients will be enrolled after the completion of systemic therapy and after completion of the restaging follow up, which is the time period from 4 weeks to 3 months after discontinuation of the chemotherapy. once patients are enrolled to extended interval pac flushes, they will be followed for one year. at the end of the year patients will return to standard pac flushes. if patients experience any pac malfunction, it would be considered a pac failure and the flushing will reverted back to the schedule recommended by the manufacturer.

Eligibility criteria:
inclusion criteria: 1. all patients 18 years and older with solid or hematological tumor who have a pac after completion of curative intent treatment (chemotherapy/biotherapy) 2. without active disease 3. able to give informed consent exclusion criteria: 1. minors, prisoners 2. previous pac failure 3. disease recurrence 4. patients who had their pac removed immediately following therapy.

Keywords: port catheter infusion flush cleanse chemotherapy