cyrilzakka/clinical-trials huggingface dataset:
High-Dose Influenza Vaccine in Nursing Homes

The purpose of this study is to prospectively evaluate relative effectiveness of high dose influenza vaccine in preventing influenza mortality, hospitalization, and functional decline in a nursing home population in the U.S., compared to the standard dose trivalent seasonal influenza vaccine.

SUMMARY: This nationally representative study samples from estimated 6782 Medicare-certified nursing homes co-located within 50 miles of the 122 cities reporting to Center for Disease Control and Prevention (CDC) weekly influenza surveillance. In total, 1000 facilities will be enrolled for random assignment to either: 1) the licensed high dose (HD) trivalent influenza vaccine (High-Dose Fluzone \[HD vaccine\]), or 2) the standard dose (SD) trivalent influenza vaccine (Fluzone \[SD vaccine\]) for their residents. Additionally, half the facilities will receive free SD vaccine for their staff and the remaining facilities will practice usual care (no free vaccine) for staff.

BACKGROUND: Influenza and pneumonia (P\&I) are leading infectious causes of hospitalization and mortality in community-dwelling older adults and residents of long-term custodial care facilities or nursing homes (NH), and produce substantial annual health care costs. The elderly incur over 90% of this disease burden and NH residents are especially vulnerable given immune senescence, multimorbidity, and close living quarters. While hospitalization rates for NH residents vary considerably between facilities, most occur during the sixteen weeks of peak influenza activity annually. Influenza vaccination, a mainstay in prevention, is recommended in the U.S. for all individuals six months of age and older. Vaccination associates with reduced rates of stroke, heart attack, hospitalization, and death in non-institutional older adult populations. However, the benefit of influenza vaccine for the elderly in general has been questioned, a salient concern for frail elderly, such as NH residents. Influenza vaccination rates vary substantially between nursing homes. Influenza vaccine response declines with advancing age, indicating the need for a better vaccine.

OBJECTIVES: The primary objective is to estimate the differences in all-cause hospitalization rates during influenza season experienced by long-stay nursing home residents, between facilities using HD vaccine vs. SD vaccine. The secondary objective is to estimate the differences in the likelihood of Activities of Daily Living (ADL) functional decline and mortality rates in the study nursing homes.

Eligibility Criteria:
Inclusion Criteria:

* Long-term care facilities within 50 miles of one of the 122 cities that serve as CDC surveillance sites

Exclusion Criteria:

* Facilities already systematically administering HD vaccine to their residents
* Facilities having fewer than 50 long-stay residents
* Hospital-based facilities
* Facilities with more than 20% of the population under age 65
* Facilities not submitting Minimum Data Set (MDS) data
A Study of the Effect and Safety of HS-10390 in the Treatment of Patients with Primary IgA Nephropathy

This study will evaluate the efficacy and safety of HS-10390 in subjects with primary IgA nephropathy, and explore the optimal dose for the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, between 18 and 65 years age.
* Biopsy-proven primary IgA nephropathy.
* Currently on stable dose of ACEI and/or ARB therapy, for at least 12 weeks prior to screening (the patient's maximum tolerated dose and is at least one-half of the maximum labeled dose).
* Average 24-hour urine total protein ≥ 0.75 g/24 h at screening.
* Estimated GFR (using the CKD-EPI 2009) ≥ 30 mL/min per 1.73 m\^2 at screening.
* Systolic BP between 100 and 150 mmHg and diastolic BP between 60 and 100 mmHg.

Exclusion Criteria:

* IgA nephropathy secondary to another condition
* IgA nephropathy with rapid decline of renal function; Kidney pathology indicated that more than 50% of the glomerulus had large crescent body formation, which may affect the study results; Tubule atrophy - interstitial fibrosis of more than 50%;
* Chronic kidney disease (CKD) in addition to IgAN
* Patients treated with any systemic non-biologic immunosuppressive drugs (including systemic corticosteroids) within 12 weeks prior to randomizing；
* Require any prohibited medications prior to randomizing;
* Exposure to an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening
* History of organ transplantation, with exception of corneal transplants
* Platelet\< 100×109/L or hemoglobin value \< 90 g/L) or Hematocrit value \< 27% (0.27 V/V) at Screening
* Elevations of transaminases (ALT and/or AST) \>2 times upper limit of normal or total bilirubin and/or direct bilirubin exceeding 1.5 times the upper limit of normal (ULN) at screening
* Potassium \>5.5 mmol/L at Screening
A Trial of Custom Foot Orthoses for the Treatment of Plantar Heel Pain

This is a study investigating treatment of plantar fasciitis (heel pain). Physicians commonly prescribe specialized orthoses (shoe inserts) to treat heel pain. This study will evaluate the reduction in heel pain associated with three types of orthoses. It is hypothesized that custom made orthoses will significantly decrease pain and improve foot function in comparison to prefabricated insoles and sham insoles.


Eligibility Criteria:
Inclusion Criteria:

Patients will be included if they present for each of the following:

* Pain at plantar fascial attachment to calcaneal tubercle and/or pain distal from tubercle along plantar fascial band
* Typical post-static dyskinesia. Pain first steps in morning or when getting up after being seated for a period of time
* Patients will be ambulatory with an age range of 18-75 with plantar heel pain present for no more than one year.
* They will not have previous injection within 6 months or currently use prescription custom foot orthoses.
* Patient history, exam, x-rays, and ultrasound will rule out other etiologies of heel pain including proximal or local nerve entrapment, arthritis, bone cyst or tumor, or stress fracture. Since most patients will likely self-treat this condition prior to seeking care, the investigators will allow a washout period (appendix) and acetaminophen rescue analgesia provision.

Exclusion Criteria:

* Proximal musculoskeletal pathology (i.e., knee or hip arthritis, sciatica secondary to back pathology, significant limb length discrepancy.
* Use of gait assistive devices (crutches, canes, walkers).
* Inability to wear supportive closed toed shoes.
* Lack of range motion at the first metatarsophalangeal joint or subtalar joint.
Effects of Compound Probiotics-Polygonatum Sibiricum on Liver Health and Metabolism in Middle-aged and Elderly People

The purpose of this study was to evaluate the regulatory effects of Huangqian-biobacteria compound preparation on liver health and related metabolic disorders in middle-aged and elderly people, observe its effects on liver function indexes, basal metabolic rate, markers of oxidative stress, inflammatory factors and intestinal microecology, and evaluate the incidence of adverse reactions in subjects during the 3-month intervention period.


Eligibility Criteria:
Inclusion Criteria:

1. The age of the subjects is 40-80 years old; 2. The subject meets one of the following metabolic disease components: ① abdominal B - ultrasound shows fatty liver or fat infiltration; ② arterial blood pressure is higher than 130/85mmHg, or the subject is on antihypertensive treatment; ③ prediabetes or type 2 diabetes, with fasting blood glucose above 6.1mmol/L; ④ overweight or obesity, with BMI of 24.0kg/m² or more, or male waist circumference of 90cm or more, female waist circumference of 85cm or more, or excessive body fat content and percentage.

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Exclusion Criteria:

1. People who are allergic to any of the pharmaceutical ingredients used in this study; A history of alcohol abuse (drinking more than 14 units of alcohol per week :1 unit = 285mL for beer, 25mL for spirits, 100mL for wine);
2. Patients who received probiotics within 1 month before taking the experimental drug;
3. Recent history of gastrointestinal bleeding, obstruction, perforation, tumor and other serious organic diseases;
4. Aminotransferase index \> 3 times the normal value;
5. Kidney disease (creatinine index higher than normal);
6. Patients with serious psychological and mental diseases, resulting in the inability to express themselves normally;
7. Patients with infectious liver diseases, such as hepatitis B and C;
8. The female subject is breastfeeding or has a positive pregnancy test result during the screening period or during the test -
Animal Allergy in Korean Veterinary Researcher

The investigators will evaluate sensitization to animal allergens and allergic symptom during contacting animal allergens in Korean veterinary researchers who attend their annual conference.

The investigators will compare sensitization to animal allergen and other clinical and occupational factors between subjects who suffer from allergic symptom during contacting animal and those who do not.

The investigators will visit annual conference of Korean veterinary researchers.

After informed consent, Korean veterinary researchers who attend their conference and agree to enrollment into this study will be asked to respond to questionnaires regarding their gender, age, underlying allergic diseases, family history of allergic diseases, occupation and it's duration, contact animal and contact duration. Subjects will also be requested to report allergic symptom, causal animal and situation of contact including veterinary service, animal experiment, pet ownership, and ingestion if subjects suffer from allergic symptom when subjects contact animal.

Then, subjects will also be asked to undergo skin prick test for animal allergens including chicken feather and ten mammal epithelia as well as cow's milk, and hen's egg, four fish flesh and seven animal meats.

subjects will be divided into two group, subjects who suffer from allergic symptom during contacting animal and those who do not. Between two groups, sensitization to animal allergens as well as other demographic and occupational factors including gender, age, underlying allergic diseases, family history of allergic diseases, occupation and it's duration, contact animal and contact duration will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Veterinary researchers attending their annual conference

Exclusion Criteria:

* Veterinary researchers who receive medication including antihistamine (H1 and H2 blocker), systemic glucocorticosteroid which can effect on the result of skin prick test
* Veterinary researchers who do not want to participate in this study
A Study of People With Multiple Myeloma (MM) in Portugal (CharisMMa-Portugal)

The main aim of this study is to see how people with MM respond to previous or current treatment.

Participants will be treated according to their clinic's standard practice. Each participant will fill out a study questionnaire during a routine doctor visit. Information collected from past medical records will also be used.

This is a non- interventional, retrospective epidemiological study of participants with MM. The study will characterize MM participants with symptomatic relapse and/or refractory (R/R) disease.

The study will enroll approximately 151 participants. The study will have a retrospective data collection referring to previous 5 years from participants' records and medical charts regarding diagnosis, disease activity, treatment patterns, and healthcare resources while quality of life (QoL) will be obtained from European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 and EORTC QLQ-MY20 questionnaires. All participants will be enrolled in one observational group.

This multi-center trial will be conducted in Portugal. The overall time to participate in this study is limited to completion of a questionnaire at the time of joining the study.

Eligibility Criteria:
Inclusion Criteria:

1. At least one previous treatment line.
2. Symptomatic R/R disease in the previous 6 months to study enrolment.
3. Receiving treatment with an accurate and thorough data fulfilled in their participant's medical records available at the study site.
4. On regular follow-up for relapse and/or refractory disease during the recruitment period at the study site.
5. Capable of understanding and completing both QoL questionnaires (EORTC QLQ-C30 and EORTC QLQ-MY20).

Exclusion Criteria:

1. Diagnosed with MM more than 5 years previous to inclusion in this study.
2. Diagnosed with any malignancy other than MM or its complications within the past 5 years.
3. Currently participating in a clinical trial for his MM or having participated in a clinical trial within 5 years before inclusion.
4. Diagnosed with any hematological disease other than MM or its complications.
In-vitro Study to Assess the Coagulation Effects of Exogenous Oxytocin Using Thromboelastography.

Oxytocin is normally administered following delivery in pregnant patients to reduce postpartum bleeding by increasing uterine tone. It is unclear whether the use of intravenous oxytocin alters coagulation in pregnant patients. The purpose of the in-vitro study is to assess the coagulation changes of oxytocin in blood samples from pregnant patients using thromboelastrography (TEG). TEG is a point-of-care device which measures the viscoelastic properties of clot formation, and can provide rapid and detailed information about coagulation changes. We aim to collect blood samples from pregnant patients to assess the in-vitro effects of synthetic oxytocin on coagulation using TEG.

All obstetric patients presenting for elective induction of labor or elective Cesarean delivery will be informed about the study prior to and on admission to the labor and delivery unit. Admission blood sampling will take place by venepuncture for the following analysis:TEG, PT, PTT, INR, Hct, Platelet count.The results of oxytocin influence on thromboelastogram parameters will be compared to a control. The control is an aliquot of parturient blood with no added oxytocin. Thromboelastography will be used to assess coagulation changes between control samples and blood samples with added oxytocin. The results will not be used to influence clinical management of any case.

Eligibility Criteria:
Inclusion Criteria:All obstetric patients with singleton pregnancies admitted to the labor and delivery unit at Lucile Packard Childrens Hospital awaiting elective induction of labor or elective Cesarean delivery. We will select 25 healthy ASA 1 patients with singleton pregnancies who are scheduled for uncomplicated elective induction of labor. Gestational age equal to or greater than 37 weeks.

Exclusion Criteria:Patients with underlying coagulation disorders. Patients with thrombocytopenia. Patients with pregnancy-induced hypertension, pre-eclampsia. Patients admitted for non-elective cesarean section. Patients in active labor. Patients requiring the following medications prior to surgery: NSAIDS, aspirin, anticoagulants.

Patients with significant obstetric or medical disease. No patients \<18 years of age will be recruited.
Tick-borne Encephalitis and Possible Borrelial Serology

In Europe, tick-borne encephalitis (TBE) virus causing TBE is transmitted by the bite of Ixodes ricinus tick, which can also transmit Lyme borreliae , the causative agent of Lyme borreliosis (LB). Since TBE and LB are both endemic with high incidence rates in Slovenia, we should be attentive to the possibility of double infections. Double infections with TBE virus and Lyme borreliae were reported to occur rarely even in endemic countries, however reliable data on coinfection rates are rather limited. Microbiological diagnosis of TBE virus infection is quite straightforward, and there is no specific therapy for TBE available so far. This markedly differs from borrelial infection, in which case interpretation of serological test results demands more caution, but there is highly efficient antibiotic treatment available for LB. This may lead to over prescribing of antibiotics to TBE patients with documented borrelial antibodies in serum indicating possible coinfection with Lyme borreliae, but missing clinical or microbiological criteria for proven borrelial coinfection. Approximately 10% of patients who had been treated appropriately for LB and about one third of patients after TBE report nonspecific subjective complaints, such as fatigue, headache, arthralgia, and myalgia, termed post-Lyme and post-encephalitic symptoms, respectively. These may not be differentiated clearly from nonspecific symptoms occurring with a rather substantial incidence also in the general population. A trend of ascribing medically unexplained nonspecific subjective symptoms to LB in subjects with positive borrelial antibodies in serum puzzles the situation further.

The aim of this prospective observational study was to assess the proportion and clinical implication of proven and possible coinfection with Lyme borreliae in patients with TBE, and to evaluate the association between anti-borrelial antibiotic therapy and clinical outcome in the subgroup of patients with possible coinfection.


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* admitted between January 2007 and December 2013 at the University Medical Centre Ljubljana, Slovenia
* tick-borne encephalitis defined according to European criteria (febrile illness with symptoms and/or signs of meningitis or meningoencephalitis, cerebrospinal fluid (CSF) pleocytosis (\>5 × 106 cells/L), and demonstration of acute TBE virus infection (the presence of specific tick-borne encephalitis virus IgM and IgG antibodies in serum or demonstration of intrathecal production of specific TBE virus IgM and/or IgG antibodies in patients previously vaccinated against tick-borne encephalitis)

Exclusion Criteria:

* Lyme borreliosis in the past
Evaluation of an Osteoporosis Prevention Strategy in Women With Osteoporotic Fracture of the Upper Limb

Osteoporosis is a disease characterized by reduced bone mass and increased skeletal fragility, predisposing to an increased fracture risk. The presence of a low trauma fracture is a powerful predictor of future fractures and about 50% of patients with a fragility fracture will suffer a subsequent fracture in the next 10 years (Center Jacqueline R, 2007). Osteoporotic fractures are associated with an increased morbidity and mortality but also high financial costs. However, less than 20% of patients presenting a low trauma fracture receive an appropriate post-fracture osteoporosis management (Little and Eccles, 2010). The hypothesis of a lack of information and an under assessment of consequences by both patients and physicians has been raised to explain this gap between recommended care and usual practices.

The aim of the PREVOST program is to assess the efficiency of patient-centered osteoporosis prevention program, after a fragility fracture of the upper limb, to improve post-fracture management of osteoporosis (ie BMD test and / or osteoporosis treatment) in women over 50 years old.

This open randomized controlled trial aims to compare the BMD or osteoporosis treatment prescription rate at 6 months after inclusion between two groups: "intervention" receiving information on fracture and osteoporosis (oral and written), phone call reminders and written information to give to their family physician, and "control" receiving usual care without information.


Eligibility Criteria:
Inclusion Criteria:

* Women aged over 50 years
* with a fragility fracture of wrist or humerus that occurred in the past 6 months
* treated in an emergency department or orthopedic department
* who signed the consent form

Exclusion Criteria:

* no signed consent
* previous history of femoral neck fracture
* poly-trauma or accident
* patients under osteoporosis treatment
* patients who performed a BMD test in the past 6 months
* patients with severe renal impairment, hyperthyroidism, bone primary or secondary malignancy.
* legal disability
* difficulty in understanding French
* psychiatric disorder
Evaluation of Intervention on Impaired Glucose Tolerance(IGT) in Patients With Coronary Heart Disease.

The purpose of this study is to determine whether therapeutic intervention on impaired glucose tolerance in patients with coronary heart disease can decrease the incidence of new onset DM.


Eligibility Criteria:
Inclusion Criteria:

* Patients with coronary heart disease
* Impaired Glucose Tolerance

Exclusion Criteria:

* Age \< 40yr or \> 75yr
* Diabetes Mellitus
* Scr \> 2.0 mg/dL（176 μmol/L）
* ALT or AST \> 2.5 ULN
* Hb \< 90g/L
* Heart Failure
* Infection
* Undergo other interventional clinical trial
Pharmacokinetics of Extended-Release Test- and Reference Formulations of AZD0837

The aims of this study are to evaluate the pharmacokinetics, safety and tolerability of the oral doses of the extended-release test- and reference formulations of AZD0837 in healthy volunteers both in fasting and fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subject aged between 18 to 45 years inclusive
* Body mass index (BMI) between 19 to 30 kg/m2 inclusive
* Body weight between 50 to 100 kg inclusive
* Women must be either post-menopausal, permanently sterilised or, if of childbearing potential, must have a negative pregnancy test before intake of study medication and use a reliable form of contraception before and during participation in the study.

Exclusion Criteria:

* Significant illness (including ongoing or history of liver disease), trauma or surgical procedures from 2 weeks before the pre-entry visit until the first administration of Investigational Product
* Clinical significant abnormalities in clinical chemistry, haematology or urinalysis result including positive result on screening tests for serum hepatitis B surface antigen, hepatitis C antibody or HIV or positive F-Hb result pre-entry
* History of bleeding disturbance (including extensive menstrual bleedings) or thrombotic disorder
* Clinically significant medical history, as judged by the investigator, including psychiatric disorders or severe allergies.
Project to Update the Study of Congenital Haemophilia in Spain

This study is conducted in Europe. The aim of the study is to update the knowledge about the prevalence and severity of congenital haemophilia (A and B) in Spain.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol)
* Male patients of any age diagnosed with congenital haemophilia A or B who visited their HTC at least once during the period of January 2013 to December 2013

Exclusion Criteria:

* Previous participation in this study
* Female patients
* Acquired haemophilia