Kornimate/medical-research-clean huggingface dataset:
expanded access program (eap): allow patients in the us with idiopathic pulmonary fibrosis access to pirfenidone

Conditions: Idiopathic Pulmonary Fibrosis

Summary: this is an open label multi-center program to allow patients in the us with ipf access to treatment with pirfenidone.


Eligibility criteria:
inclusion criteria: * 1. clinical and radiographic diagnosis of ipf including the presence of usual interstitial pneumonia (uip) pattern or possible uip pattern on historical hrct (ats 2011). 2. %fvc ≥ 50% and %dlco ≥ 30% based either on historical pulmonary function tests obtained in the 30 days prior to screening or on tests obtained during screening. 3. able to understand the importance of adherence to program treatment (pirfenidone) and protocol, and willing to follow all program requirements, including the concomitant medication restrictions, throughout the program. 4. able to understand and sign a written informed consent form. exclusion criteria: a patient who meets any of the following criteria will be excluded from the program: 1. is receiving an investigational agent (defined as any drug that has not been approved for marketing for any indication in the us); prior use of pirfenidone is permitted. 2. has received fluvoxamine therapy ≤ 28 days prior to the first dose of program treatment (pirfenidone) in pipf-031, or is unable or unwilling to avoid fluvoxamine for the duration of the program. 3. has any known contraindication for the use of pirfenidone, specifically: * hypersensitivity to the active substance or to any of the drug product excipients * severe hepatic impairment including end stage liver disease * severe renal impairment (crcl \< 30 ml/min) including end stage renal disease requiring dialysis 4. history of cigarette smoking within 3 months prior to the completion of screening or is unwilling to avoid tobacco products throughout program. 5. known explanation for interstitial lung disease other than ipf, including but not limited to radiation, drug toxicity, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, human immunodeficiency virus (hiv) infection, viral hepatitis, and cancer. 6. history of clinically significant environmental exposure known to cause pulmonary fibrosis (pf), including but not limited to drugs (such as amiodarone), asbestos, beryllium, radiation, and domestic birds. 7. pregnancy or lactation. women of childbearing capacity are required to have a negative serum pregnancy test before treatment and must agree to maintain highly effective contraception by practicing abstinence or by using at least two methods of birth control from the date of consent through the end of participation in the program. if abstinence is not practiced, one of the two methods of birth control should be a hormonal contraceptive (e.g., oral contraceptive and a spermicide).
shortened antibiotic treatment of 5 days in community-acquired pneumonia

Conditions: Community-acquired Pneumonia

Summary: cap5 is an investigator-initiated multicentre non-inferiority randomized controlled trial which aims to assess the efficacy and safety of shortened antibiotic treatment duration of community-acquired pneumonia (cap) in hospitalized adult patients based on clinical stability criteria. three to five days after initiation of antimicrobial therapy for cap, participants are randomized 1:1 to parallel treatment arms: 5 days (intervention) or minimum 7 days (control) of antibiotic treatment. the intervention group discontinues antibiotics at day 5 if clinically stable and afebrile for at least 48 hours. the control group receives antibiotics for a duration of 7 days or longer at the discretion of the treating physician. the primary outcome is 90-day survival which will be tested with a non-inferiority margin of 6%.


Eligibility criteria:
inclusion criteria: * hospitalized with community-acquired pneumonia; defined as new pulmonary infiltrate on chest x-ray and/or ct scan and at least one symptom compatible with pneumonia (cough, fever, dyspnoea and/or chest pain) * initiation of antibiotics within 12 hours of the time of the chest x-ray with an infiltrate * age ≥ 18 years * afebrile (temperature ≤ 37.8 °c) for 48 hours at randomization * clinically stable at randomization (systolic blood pressure ≥ 90 mm hg, heart rate ≤ 100/min., respiratory rate ≤ 24/min., peripheral oxygen saturation ≥ 90%) exclusion criteria: * immunosuppression (hiv-positive, neutropenia, corticosteroid treatment (≥10 mg/day of prednisone or the equivalent for \>30 days), chemotherapy, immunosuppressive agents, immunosuppressed after solid organ transplantation, asplenia) * hospitalization during the previous 14 days * antibiotic treatment (\>2 days) within the past 30 days, directed at lower respiratory tract pathogens * uncommon cause requiring longer duration of antimicrobial therapy (pseudomonas aeruginosa, staphylococcus aureus, mycobacterium spp., fungi) * extrapulmonary infection (e.g. endocarditis, meningitis, or abscess) * pleural empyema or lung abscess * pleural effusion requiring drainage tube * intensive care unit (icu) admittance * pregnancy and breastfeeding

Keywords: community-acquired pneumonia treatment duration pneumonia lung diseases respiratory tract diseases respiratory tract infections bacterial infections pneumonia, bacterial anti-infective agents anti-bacterial agents
hiv-related stigma intervention for malaysian clinicians

Conditions: Hiv

Summary: key populations at risk of hiv (including men who have sex with men, people who inject drugs, transgender women, and female sex workers) are more likely to be infected with hiv but less likely than members of the general population to know of their hiv status, receive hiv prevention counseling, or be linked to hiv care services. clinician stigma towards these groups remains a potent and persistent driver of these hiv disparities in many places of the world. the investigators propose to incorporate evidence-based stigma reduction tools into a popular teletraining platform for clinicians and pilot test the resulting intervention (project echo® for hiv prevention and stigma reduction) with clinicians in malaysia, a context wherein clinician stigma and hiv disparities are substantial.


Eligibility criteria:
inclusion criteria: * practicing general practitioner or family medicine specialist in malaysia exclusion criteria: -
effect of oral vitamin d3 and calcium supplementation on muscle and bone health among rural post-menopausal women

Conditions: Sarcopenia; Osteoporosis

Summary: this will be three-arm parallel group trial. the goal of this intervention study is to observe the effect of vitamin d3 and calcium supplementation for the period of 6 months on improving the sarcopenia indices such as appendicular muscle mass, muscle strength and muscle function as well as bone density among rural post-menopausal women between age 40 to 65 years. the main questions it aims to answer are: 1. does the vitamin d3 supplementation alone help in improving sarcopenia measures or the addition of calcium supplement along with vitamin d3 will be more effective in improvement of muscle mass, muscle strength and muscle function. 2. does vitamin d3 and calcium supplementation improve the bone density on supplementation for the period of 6 months among post-menopausal women. participants will be given supplementation in three groups in which first group will receive vitamin d3 and calcium supplementation, second group will receive only vitamin d3 supplementation and third group will receive placebo in the form of vitamin b-complex tablet. calcium tablet of 500 mg was given daily for the period of 1 month and compliance was checked by collecting empty blisters of tablets from the participants. vitamin d3 (60,000iu) tablet was given once a month and compliance were checked by observing direct consumption of tablet in front of the care provider/trained social worker. participants will be measured at the baseline for their muscle and bone parameters and they will visit after 6 months on completion of their supplementation. researcher will compare both the supplementation arms (calcium and vitamin d3 with vitamin d3 alone) with each other and with the third arm of placebo group (supplemented with vitamin b-complex tablet).


Eligibility criteria:
inclusion criteria: 1. healthy post-menopausal women 2. age between 40-65 years. exclusion criteria: 1. women with co-morbidities such as diabetes, thyroid conditions, heart disease, chronic liver/kidney disease, present acute illness 2. presence of any metal implants in bones 3. women who have undergone hysterectomy.

Keywords: sarcopenia intervention study sarcopenia
tacrolimus in children with henoch-schönlein purpura nephritis

Conditions: Henoch-Schönlein Purpura Nephritis

Summary: henoch-schönlein purpura (hsp) is the most common vasculitis in children, with an incidence of approximately 10:100 000 children and a slight male predominance (male-to-female ratio of 1.5:1). henoch-schönlein purpura nephritis (hspn) is the principal cause of morbidity for hsp and 1%-7% of hspn patients may progress to renal failure or end-stage renal disease. immunosuppressive therapy has become the standard treatment in children with hspn, however the use of these drugs are still mainly in an off-label manner in clinical practice. tacrolimus, a calcineurin inhibitor, has been recently suggested in the treatment of hspn in children. however, the evidence-based clinical data are still limited. given the potential benefits and unmet need in clinical practice, the purposes of this pilot study were to assess effectiveness and safety of tacrolimus in hspn children and evaluate the potential impact of cyp3a5.


Eligibility criteria:
inclusion criteria: hspn children aged less than 18 years; receiving tacrolimus as initial immunosuppressive therapy - exclusion criteria: children received other immunosuppressive drug before the trial or other systemic trial drug therapy; children had a concomitant medical condition, whose participation, in the opinion of the investigator and/or medical advisor, may create an unacceptable additional risk. -

Keywords: tacrolimus, henoch-schönlein purpura nephritis, children
a dose finding study of vn-0200

Conditions: Respiratory Syncytial Virus Infections

Summary: this study will assess the immunogenicity, safety and tolerability of vn-0200 after intramuscular injections in japanese healthy elderly subjects.


Eligibility criteria:
inclusion criteria: * japanese healthy elderly aged \>=60 and =\<80 years (at the time of informed consent). * subjects who can follow the compliance requirements during clinical trials, undergo medical examinations and tests specified by the protocol, and report symptoms, etc. exclusion criteria: * serious cardiovascular, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatric disorders. * serious acute illness. * has been diagnosed with congenital or acquired immunodeficiency. * previous vaccination with an rsv vaccine (including the investigational drugs). * having a history of anaphylaxis or severe allergies due to medicines, or vaccination. * administration of gamma globulins, systemic immunosuppressants (including drugs for the treatment of autoimmune diseases), hematopoietics (excluding iron and vitamins), and corticosteroids (excluding topical preparations, inhalants, and small-dose short-term oral administration\*) or planned administration of them in the period starting 28 days prior to informed consent and ending 28 days after the second vaccination. \* \<14 days, 20 mg/day on a prednisolone basis. * planned or actual administration of other vaccine in the period starting 14 days prior to informed consent and ending 14 days after the second vaccination.

Keywords: respiratory syncytial virus infections
what is the optimal cycle regimen for frozen- thawed embryo transfer cycles

Conditions: Infertility; Female Infertility; Pregnancy Early

Summary: investigators will be comparing artificial (hrt) frozen-thawed embryo transfer cycles to correctly conducted spontaneous natural cycles after the transfer of a chromosomally normal embryo.

the most common treatment protocols for frozen embryo transfers include natural cycles with or without human chorionic gonadotrophin (hcg) trigger or endometrial preparation with hormonal treatment (artificial cycles), with or without gonadotrophin - releasing hormone agonist suppression. recent studies comparing artificial and natural cycles concluded that the optimal means of endometrial preparation for frozen- thawed cycle remains unclear and both options may be offered to women with regular ovulatory cycles. correctly identified spontaneous natural cycles are the preferred option for frozen-thawed embryo transfer in women with regular menstrual cycles. investigators will be comparing artificial (hrt) frozen-thawed embryo transfer cycles to correctly conducted spontaneous natural cycles after the transfer of a chromosomally normal embryo.

Eligibility criteria:
inclusion criteria include the following: 1. women aged 18 years to 42 years with regular menses (26-34 days) 2. having 1 or 2 chromosomally normal cryopreserved blastocysts available for transfer. 3. first frozen-thawed transfer cycle 4. progesterone level \< 1.5 ng/ml day of trigger injection in stimulation cycle from which embryos to be transferred were created. exclusion criteria include the following: 1. polycystic ovarian syndrome 2. poor ovarian responder in accordance with bologna criteria 3. uterine abnormality us / saline infusion sonohysterogram 4. previous dilatation \& curettage (d\&c) 5. hydrosalpinx 6. asherman syndrome 7. history of endometriosis 8. icsi due to severe male factor with testicular sperm 9. any known contraindications or allergy to oral estradiol or progesterone. 10. discontinuation of hrt medication ( medication error in research hrt cycle ) 11. failure to detect ovulation in the research natural cycle 12. duration of estradiol exposure ≥ 17 days and endometrium \< 6mm 13. spontaneous ovulation in hrt artificial cycle

Keywords: hormone replacement therapy frozen thawed embryos frozen embryo cycle
evaluation of the efficacy and safety of indigo naturalis oil extract on psoriatic nails

Conditions: Nail Psoriasis

Summary: the purpose of this study is to evaluate efficacy and safety of indigo naturalis oil extract in treating nail psoriasis.

nail psoriasis treatment is notoriously difficult. while indigo naturalis has been demonstrated safe and effective in treating skin psoriasis, its effect on nail psoriasis remains unverified.

Eligibility criteria:
inclusion criteria: 1. adults aged between 20 and 65 years 2. received a diagnosis of nail psoriasis with at least one year history based on clinical assessment by two dermatologists and failure of topical systemic chinese herbal anti-psoriasis therapy for fingernail psoriasis. 3. female patients of childbearing age agreed to continue using birth control measures for the duration of the study. exclusion criteria: 1. patients had non-plaque (i.e., pustular, guttate, or erythrodermic) or drug-induced forms of psoriasis, total body surface involvement of more than 60% 2. a history of allergy to indigo naturalis, or with onychomycosis or any fingernail infection. 3. patients have received systemic therapy within four weeks before enrollment 4. patients have received phototherapy within three weeks, or topical psoriasis agents within two weeks. 5. using medications which affect psoriasis during the study and unwillingness to comply with study protocol.

Keywords: nail psoriasis indigo naturalis
the effects of different gastric residual volume thresholds for holding feeding in internal medicine.

Conditions: Critical Illness

Summary: this is a randomized control trial with a parallel design. eligible patients will be randomly assigned into two groups: a control group which will be holding tube feeding when the grv reaches 200 ml, and an experimental group will hold tube feeding when the grv reaches 300 ml. enteral feeding will be administered according to the study flow chart.

background: malnutrition is a common issue among critically ill patients. which increases hospital stays, costs, and mortality rate. according to the study, the primary reason for nurses to hold enteral nutrition is elevated gastric residual volume (grv). however, there is still no consensus on the definition of high residual gastric volume, there is currently no consensus among experts and scholars regarding the threshold for holding enteral nutrition. clinical nurses may prematurely hold enteral nutrition due to concerns regarding potential side effects such as vomiting and choking. the aim of this study is to increase the threshold for holding enteral feeding based on the results of the study, in order to improve nutritional intake in critically ill patients in internal medicine. objective: increase the nutritional intake of critically ill patients in the department of internal medicine by increasing the threshold for holding tube feeding. methods: this is a randomized control trial with a parallel design. eligible patients will be randomly assigned into two groups: a control group which will be holding tube feeding when the grv reaches 200 ml, and an experimental group will hold tube feeding when the grv reaches 300 ml. enteral feeding will be administered according to the study flow chart. the outcome data will collected based on the medical chart including frequency of diet volume ratio (diet received/diet prescribed), incidence of gastrointestinal complications, ventilator days, ventilator-associated pneumonia, length of intensive care unit(icu) stay, changes in nutritional indicators, apache ⅱ and duration of parenteral nutrition use. expected result: the results of this study will provide evidence regarding the improved effectiveness and safety of increasing the threshold of grv in medical icu and inform future evidence-based practice.

Eligibility criteria:
inclusion criteria: * adult patients admitted to the internal medicine intensive care unit. * patients receive enteral nutrition through a nasogastric tube. * patients receiving continuous enteral feeding. exclusion criteria: * patients post-abdominal surgery. * patients admitted to the intensive care unit due to gastrointestinal disorders (e.g., gastrointestinal bleeding, bowel obstruction). * patients receiving palliative care with reduced enteral nutrition.

Keywords: enteral nutrition gastric residual volume
spherical gelfoam versus tri-acryl microsphere for uterine artery embolization for symptomatic fibroids

Conditions: Symptomatic Uterine Fibroids

Summary: the primary purpose of this study is to compare pain after uterine artery embolization using spherical gelfoam or tris-acryl gelatin microsphere in patients with symptomatic fibroids

uterine artery embolization(uae) is a minimally invasive treatment alternative to hysterectomy and myomectomy in symptomatic fibroids. however, post-procedural pain after uae remains a major problem. the spherical gelfoam and tri-acryl gelatin microsphere are two embolic materials used for uae. therefore, the aim of study is to compare pain intensity and inflammation after uterine artery embolization using the two embolic agents with symptomatic fibroids.

Eligibility criteria:
inclusion criteria: 1. women with symptomatic fibroids (age: 20 - 60 years old) exclusion criteria: 1. bradycardia (\<45 bpm) 2. conduction abnormalities 3. liver failure 4. renal failure 5. uncontrolled hypertension 6. high grade obesity (bmi ≥ 30 kg/m2) 7. drug allergy 8. illiteracy 9. pregnancy

Keywords: fibroid embolization pain inflammation
longitudinal assessment of traumatic microvascular injury-2

Conditions: Traumatic Brain Injury

Summary: the goal of this observational study is to learn about changes in the brain of patients over the first 3 years following a traumatic brain injury (tbi). the main question it aims to answer are: - how tbi effect the rate of brain tissue loss compare to healthy brain participants will give blood samples, complete mri scans, and neuropsychological assessment measures. researchers will compare results between healthy control group and tbi group to determine changes in injured brains.


Eligibility criteria:
inclusion criteria: 1. age 18-65, inclusive 2. history of non-penetrating tbi of at least moderate severity (defined by evidence of trauma-related neuroimaging abnormality on cranial computerized tomography (ct) scan. 3. high-velocity, high-impact injury mechanism consistent with diffuse axonal injury (e.g., motor vehicle accident, fall from height, etc.) 4. immediate loss of consciousness (cases with delayed loss of consciousness due to expanding lesions will be excluded) exclusion criteria: 1. history of premorbid disabling neurological or psychiatric disease (such as epilepsy, brain tumors, meningitis, cerebral palsy, encephalitis, brain abscesses, vascular malformations, cerebrovascular disease, alzheimer's disease, multiple sclerosis, hiv-encephalitis) 2. history of premorbid disability condition that would interfere with outcome assessments 3. bilaterally absent pupillary reponses 4. penetrating tbi 5. elevated intracranial pressure (≥ 17 mmhg) 6 contradictions to contrast-enhanced mri (e.g., ferromagnetic implants, pregnancy, allergy to gadolinium contrast, renal impairment \[gfr \< 60ml/g/m3\], claustrophobia, hemodynamic instability) 7. prisoners, patients in police custody 8. objective lung disease (paco2 at rest \> 50 mmhg or venous serum bicarbonate \> 26 meg/l) based on any labs available for review from patient's clinical care. note that these will not be checked solely for study purposes 9.requiring portable oxygen at enrollment 10. chronic heart failure, severe pulmonary disease 11. current substance abuse that precludes participation and follow-up in the study, as determined by the study investigators 12. if there is medical or other disability that precludes completion of the study procedures as determined by the study investigators
simvastatin effect on radiation therapy of brain metastases

Conditions: Brain Metastases

Summary: the purpose of the study is to evaluate the effect of simvastatin in combination with radiotherapy on the clinical outcomes of patients with brain metastases.

despite current advances in therapies, the outcome for patients with brain metastases is fatal. new therapeutic approaches, such as radiosensitizing agents, are needed to provide a significant survival advantage for those patients. statins have been reported to enhance the efficacy of radiotherapy in addition to a neuroprotective effect. the aim of the study is to evaluate the effect of simvastatin on the efficacy and safety of radiation therapy in patients with brain metastases and on improving patients' quality of life.

Eligibility criteria:
inclusion criteria: * patients with measurable brain metastases * age more than 18 years old * patients should be planned for radiation therapy exclusion criteria: * renal dysfunction (more than 1 upper normal level) * hepatic dysfunction (alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) \>3 times the upper normal level ) * pregnancy or lactation. * known hypersensitivity to simvastatin

Keywords: brain metastases simvastatin radiation therapy