cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of QAX576 in Patients With Eosinophilic Esophagitis

This study is designed to investigate the effects of a 12 week course of intravenous QAX576 6mg/kg every 4 weeks in reducing the number of eosinophils in the esophagus of EoE patients by 75% or greater when compared with baseline.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18-50 with symptomatic eosinophilic esophagitis
* Female subjects must be women of non child bearing potential.
* Elimination diet must have been tried.
* Treatment for at least two months prior to enrollment on a protocol pump inhibitor .
* Appropriate contraception must be used by males, (e.g., spermicidal gel plus condom)
* Must be able to communicate well with the investigator, to understand and comply with the requirements of the study.
* Understand and sign the written informed consent.

Exclusion criteria:

* Have received corticosteroids within 3 months before starting the study for any symptoms.
* Any other eosinophilic disorders.
* History of clinical schistosomiasis, or having travelled within the preceding 6 months to an area with endemic schistosomiasis, including but not limited to Southeast and Southwest Asia, South America and Africa. Travel to these areas must not be planned for at least 6 months after the last dose.
* Donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial dosing.
* History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
* History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening.

Other protocol-defined inclusion/exclusion criteria may apply
Investigating Public Enthusiasm for Mammography Screening in Denmark

Based on an American study by Scherer et al., it is hypothesized that some women will make irrational choices regarding their participation in mammography screening. Therefore, the aim is to estimate the prevalence of Danish women having an irrational preference for mammography screening even when it confers no benefits, but only harms.

The prevalence of women making an irrational decision will be compared to the participation rate in the Danish screening program. The study population will consist of a random sample of women aged 44-49. Similar to the American study, two types of information will be compared (detailed vs. non-detailed information about the harms of screening). Participants will be randomised to one of two information groups. Based on the American study, it is assumed that the willingness to participate in the hypothetical screening program will be 40 percent. To achieve the desired precision in this study, a standard error of 2.5 percent is required corresponding to a confidence interval spanning approximately 35-45 percent. This will require 384 women in each group, corresponding to a total study population of 768. The survey will be sent electronically (using "e-Boks") with a link to access the online survey trial. The survey will consist of screening and cancer related questions as well as questions on age, education, and health literacy. Five questions on appraisal of health information from the Health Literacy Questionnaire will also be included. After the data collection, data will be linked to data on income, residence, civil status, education, breast cancer diagnosis, and information on whether a participant is immigrant, descendent or of Danish origin.

The original plan for the main analysis was to compare the two groups of women randomized to different information groups (detailed vs. non-detailed information about the harms of screening). However, due to lower participation rate and therefore smaller sample size than expected, information group was disregarded in the main analysis. The two groups will still be compared in a secondary analysis. This decision was made before getting access to data from the questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Residence: Central Denmark Region

Exclusion Criteria:

-
The Role of Resistance Training in Non Alcoholic Fatty Liver Disease

The aim of the study is to evaluate the effect of RT on clinical and metabolic parameters in patients with NAFLD.

Background: Non Alcoholic Fatty Liver Disease (NAFLD) is the most prevalent liver disease in developed countries with a prevalence rate of 20-30 % of adults. About 10-25% of these individuals are estimated to meet the current diagnostic criteria for Non Alcoholic Steatohepatitis (NASH) and some may progress to Cirrhosis and liver failure. NAFLD is now recognized as the hepatic manifestation of the metabolic syndrome. Recent data shows that NAFLD might also predict the tendency to develop diabetes mellitus and coronary artery disease. The drug of choice for NAFLD is yet to be found. The recommended treatment of NAFLD includes weight reduction and Physical Activity (PA), but the data of the effect of Resistance Training (RT) PA on NAFLD is scant.

Aim of the study: To evaluate the effect of RT on clinical and metabolic parameters in patients with NAFLD. Study design: Randomized Clinical Trial. Patients will be randomly allocated to 2 arms (intervention and control). The intervention arm will perform RT, whereas control arm will be advised to perform home stretching. Medical examination will be performed at week 0 (baseline) and at week 13 using uniform protocols.

Eligibility Criteria:
Inclusion Criteria:

* Ultrasound diagnosed fatty liver.

Exclusion Criteria:

* Presence of HBsAg or anti-HCV antibodies (will be obtained from blood tests at the liver clinic).
* Patients with known diabetes treated with antidiabetic medications.
* Patients with known kidney disease, CHD, lung disease, inflammatory bowel disease.
* Excessive alcohol consumption ≥ 30 g/day in men or 20 g/ day in women.
Irrisept C.Acnes Study

A Prospective, Randomized, Controlled Trial Comparing An Irrisept Antiseptic Irrigation With 0.05% Chlorhexidine Gluconate versus Standard of Care Prophylaxis Chlorohexidine Wipes

The purpose of this prospective randomized control trial is to access outcomes of positive culture growth of C. acnes from specimens obtained from the shoulders of patients undergoing primary shoulder arthroplasty whose intraoperative management includes Irrisept antiseptic irrigation and compare it to patients whose management includes standard of care prophylaxis wipes.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has signed the IRB-approved informed consent form specific to this study prior to undergoing any research related procedures
2. Patient can read and understand English
3. Patient who will undergo a primary shoulder arthroplasty
4. Patient is over the age of 18

Exclusion Criteria:

1. Patient who has had a previous surgery on the ipsilateral shoulder
2. Patient has a known allergy to topical iodine or Chlorohexidine gluconate.
3. Patient has had non-surgical prophylaxis antibiotic treatment within 14 days of index surgery
4. Patient requires a revision procedure for a previous ipsilateral shoulder surgery
5. Patient has any significant pathology that, in the opinion of investigator, makes the patient unsuitable for study participation
6. Patient is a pregnant woman
Comparison of Femoral Nerve Catheter and Adductor Canal Block With Steroid Adjuvant in Total Knee Replacement (TKR)

We hypothesize continuous adductor canal block with steroid adjuvant would offer no inferior analgesics and rehabilitation ability than continuous femoral nerve block for postoperative patients receiving total knee arthroplasty.

A total of 80 patients who will undergo total knee arthroplasty will be randomized into two groups:

Treatment groups Treatment details Femoral Group (40 patients) Continuous femoral nerve block (bolus: 0.5% Ropivacaine 10-15 ml ; infusion of 0.15 % Ropivacaine 4-6ml/h) Adductor Group (40 patients) Adductor canal block with steroid adjuvant (bolus: 0.5% Ropivacaine 10-15ml; Dexamethasone 4mg) (Total 80 patients will be recruited)

* All patients will receive single shot tibial nerve block with local anaesthetics (0.5% Ropivacaine 5-8ml) before surgery for analgesia of posterior knee.
* All patients will receive the same preemptive and postoperative multimodal medications for perioperative analgesia.
* All groups will receive standardized method of spinal anaesthesia and standardized method of intraoperative sedation for the surgery.
* Intravenous patient controlled analgesia (PCA) with morphine will be given for 48h to patient as rescue analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary osteoarthritis
* Scheduled for elective total knee arthroplasty
* Signed written informed consent
* Planned use of spinal anaesthesia
* Cognitive sound to use assessment tools

Exclusion Criteria:

* Patients refusing to give consents
* Scheduled for revision total knee replacement
* Patient outside range of 30 to 80 yrs old
* Non-chinese population
* Cognitive impairment/ inability to use the outcome assessment tools
* Contraindications to regional anesthesia
* severe cardiovascular disease (unstable angina, second or third degree heart block)
* pre-existing neurologic disease including psychiatric disorder
* drug abuser
* Pre-operative history of neurological abnormality in the ipsilateral leg e.g. history of stroke, neurogenic pain or previous nerve injury.
* Allergy or contraindication to drugs used in this study: morphine, Non-steroidal anti-inflammatory drugs (NSAID) such as ketorolac , diclofenac, dihydrocodeine, local anaesthetics (lignocaine, ropivacaine, bupivacaine), epinephrine
* Moderate or severe renal impairment (serum creatinine \> 160 micromol/l)
Nocturnal Oxygen Therapy

To compare the efficacy of long-term use of nocturnal oxygen therapy (12 hours) with that of continuous, low-flow oxygen therapy (24 hours) in patients with chronic hypoxic lung disease.

BACKGROUND:

Chronic obstructive pulmonary disease is a major health problem in the United States. In 1975, it was the sixth leading cause of death. The economic impact of the disease in 1972 amounted to $803 million in the direct costs of disability treatment, $3.05 billion in disability costs, and $645 million in lost earnings due to premature death.

Motivated in part by the significant toll of this disease, a conference on the Scientific Basis of Respiratory Therapy, co-sponsored by the American Thoracic Society and the Division of Lung Diseases, examined the current status of the use of oxygen therapy in chronic lung disease. The proceedings of the conference, published in the American Review of Respiratory Disease (Vol. 110, No. 6, December 1974), included a recommendation for clinical studies that would provide a critical assessment of the role of nocturnal oxygen therapy in the treatment of patients with chronic obstructive pulmonary disease. Low-flow oxygen, administered continuously, was known to benefit some patients with chronic hypoxic lung disease. However, low-flow oxygen administration for long periods of time is cumbersome, confining, and expensive. If nocturnal oxygen administration could be unequivocally demonstrated to be efficacious, then the advantages of convenience and cost would have a favorable impact on treatment of patients, and a rationale could be developed for testing this therapy in a larger group of patients.

The Planning Phase of the trial was initiated in September 1976. Patient recruitment began in May 1977. The Recruitment Phase lasted 24 months. The 203 patients in the trial were assigned randomly to nocturnal oxygen therapy (home) or continuous low-flow oxygen therapy.

DESIGN NARRATIVE:

Randomized, fixed sample. Two hundred and three patients were randomly assigned to at-home treatments of continuous oxygen therapy or nocturnal oxygen therapy. Endpoints related to quality of life, neuropsychological function, and respiratory function and capacity. Intervention lasted for 6 months to 3 years, with an average intervention of 19.3 months.

Eligibility Criteria:
Men and women, ages 35 to 70, who had severe chronic obstructive lung disease requiring supplemental oxygen therapy.
Microbiome Effect of Omadacycline on Healthy Volunteers

The goal of this study is to assess microbiome changes associated with omadacycline vs. comparators (moxifloxacin or oral vancomycin). Using a phase I study design, healthy volunteers aged 18-40 years will be given a 10-day course of either omadacycline 450 mg days 1 and 2 followed by 300 mg PO once daily, moxifloxacin 400 mg once daily, or oral vancomycin 125 mg given four times daily. Stool will be collected at baseline, daily during therapy, and at two follow-up time periods (days 13-14 and days 30-32). DNA will be extracted from stool and used for qPCR biomass and microbial metagenomic experiments. Results from the study will provide definitive data on the microbiome effects of omadacycline versus comparator antibiotics.


Eligibility Criteria:
Inclusion. All volunteers will be considered healthy based on medical history

Exclusion. Patients will be excluded if they report any of the following:

* Cardiovascular disease
* Gastrointestinal disease
* Hepatic or renal disease
* Receipt of an antibiotic for at least three months prior to enrollment.
* Receipt of a probiotic for at least a month prior to enrollment and during the entire study period.
Effect of Psycho-Educational Interventions in Communication Partners of Older Adults With Hearing Impairment

Hearing impairment is a critical health problem throughout the world. In addition, having an impact on the biopsychosocial functioning of older adults, it places enormous stress and burden on communication partners who interact with older adults with hearing impairment every day. These communication partners generally have restrictions to their social lives and an increased communication burden, as well as symptoms of depression and adopting maladaptive coping and poorer quality of life. Therefore, group-based multi-component psycho-educational interventions are recommended. The purposes of this study are to examine the effects of group-based multi-component psycho-educational interventions (GMC-PEIs) on burden, depression, coping and quality of life in communication partners of older adults with hearing impairment. The single-blind, randomized control trial will include communication partners of older adults with hearing impairment. Participants will be randomized to either intervention groups or control groups.

The study will be an experimental design featuring repeated measures, with data collected from a pretest, a posttest and a follow-up test. An estimated total of 92 participants will be randomly assigned to experimental and control groups. The experimental group will participate in a 6-week group-based multi-component psycho-educational interventions (GMC-PEIs), including provide information on communication skills training, clear speech training, psychosocial support, stress management and successful person testimonial, consisting of 60-minute sessions once per week, while the control group will be put on a waiting-list group. Each group will be assessed of the outcomes at 3 time points: baseline (T0), three months following the intervention (T1) and again at six months following the intervention (T2). The investigators will use the Significant Other Scale for Hearing Disability (SOS-HEAR), the 10-item version of the Center for Epidemiological Studies Depression Scale (10-Item CES-D), the Brief Coping Orientation to Problems Experienced Scale (B-COPE), the Short Form Health Survey (SF-12) and the International Outcome Inventory for Hearing Aids-Significant Other (IOI-HA-SO) as the outcome indicators. The principle of intention-to-treat (ITT) analysis will be used, and the result will be analyzed mainly by generalized estimating equation (GEE).

Eligibility Criteria:
Inclusion Criteria:

* being18 or older
* living with older adults with hearing impairment
* they were indicated that as primary communication partner
* no known hearing loss
* having normal cognitive function
* articulate in the Mandarin Chinese language
* signing a consent form to participate

Exclusion Criteria:

* severe psychiatric disorders
* the communication partner who is hired as a caregiver
EuroPainClinicsStudy IX

Prospective comparison between epiduroscopy procedure, Racz catheter procedure and caudal epidural block in patients with FBSS

I. Epiduroscopy is an advanced proven diagnostic and therapeutic method for chronic radicular pain after spinal surgery. Moreover, this method is frequently used in patients with chronic low back pain conditions without previous spine surgery also known as "virgin back". Epiduroscopy allows by optical fiber technology and skiascopy imaging the exact examination of the epidural space and subsequently mechanical lysis (with advanced interventional options by laser, radiofrequency, balloon techniques etc.) and/or drug administration to the target point.

II. The Racz catheter procedure is based on epidural neurolysis. It is used to release some of the adhesions or scar tissue which surround entrapped nerves in the epidural space of the spine. This state could be caused by chronic inflammatory adhesions or by healing mechanisms after spine surgery - scars. Mechanical liberation of epidural space further allows better administration and targeting of drugs as corticoids or hyaluronidase. This technique is performed under fluoroscopy imaging. Suitable epidurogram and skiascopy confirm appropriate catheter position during procedure.

III. The caudal epidural block involves placing a needle through the sacral hiatus to deliver medications into the epidural space. This approach to the epidural space is popular in managing a wide variety of chronic pain conditions in adults, especially chronic low back pain syndromes. Fluoroscopy is considered as a gold standard of needle guidance during procedures in which caudal epidural injections are performed.

Eligibility Criteria:
Inclusion Criteria:

* patients aged between 20 and 80
* patients with FBSS (at least 1 - up to 2 lumbar laminectomies) who has radiating pain (VAS \>=5) on lower extremities
* those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form

Exclusion Criteria:

* more than 2 lumbar laminectomies
* patients without previous spine surgery
* patients with a history of other spinal diseases (compression fracture, spondylitis, tumor)
* women with a positive pregnancy test before the trial or who planned to become pregnant within the following 3 years
* other patients viewed as inappropriate by the staff
* disagreement with participation in the study
Early Postnatal Discharge in a French Perinatal Network

The purpose of this "before-after" study is to determine the effectiveness of a multidimensional intervention to increase the rate for early discharge of low-risk mothers and the healthy newborn in a perinatal network.

In March 2014, the French Health Authorities edited new guidelines about early discharge after delivery. Early discharge is defined as a discharge during the 72 hours following vaginal delivery of low-risk mothers and their healthy newborn. These guidelines defined the conditions of eligibility for early discharge for mothers and babies, and the different criteria of their follow-up at home by midwives .

The average length of stay following normal delivery is higher in France than in other European countries: eg : 4.3 days in France vs 2.2 days in Sweden (OECD indicators 2011) On the other hand, according to an investigation conducted by a patients association, 38% women declared that they felt that their hospitalization was too long after their baby's birth, but their request for a shorter stay had not been taken into account by hospital caregivers. The investigators hypothesis is that the rate of early discharge could be increased by a multi-pronged program coordinated in a perinatal network, and could improve quality of postpartum care, and women's satisfaction.

The "Réseau Périnatal Alpes Isère" is a perinatal network located in French Alps region. Its purpose is to coordinate 5 maternity services an organization of midwives providing pre and postnatal home care, for about 10000 births annually. In 2010, according to the hospital database provided by the Medical Information Systems Program, early discharge concerned only 4.1% of mothers between 0 and 48 hours after delivery . At the same time, 65% of women could be considered as at low risk, considering they gave birth to a healthy singleton, born after 38 weeks of gestation by vaginal delivery. This rate is not precise, in view of the lack of availability of documented rate of non-eligibility for early discharge such as non- eutrophic babies, or adverse events during postpartum and the neonatal period.

Eligibility Criteria:
Inclusion Criteria:

"1" low risk mothers ith uncomplicated pregnancy and birth defined as

* lack of mental disability
* lack of referred problems about mother to infant bonding
* lack of precarious state
* vaginal delivery without bleeding more than 500cc
* lack of postpartum complications during hospitalization

"2" low risk baby defined as

* singleton
* gestational age \>= 38 weeks
* apgar score \> 7 at 5 minutes life
* normal weight expected for gestational age
* lack of infection, or jaundice

Exclusion Criteria:

* person deprived of liberty
* person who does not speak French
* person not covered by health insurance
Assistive ExoSkeletons to Enable Wearable Rehabilitation Robotics

Study will evaluate the use of lower-limb assistive exo-skeletons worn on the ankle and foot. Participants will wear the exo-skeletons and walk in a safe environment. Measurements will be taken to determine how the exo-skeletons affect the pressure on the feet of people with diabetic foot ulcer and how they walk.

Study will evaluate the use of lower-limb assistive exo-skeletons worn on the ankle and foot. Participants will include those with self-described history of Diabetic Foot Ulcer and age-matched healthy volunteers. Participants will wear the exo-skeletons and will be asked to walk 32 feet, and to stand quietly for 30 seconds.

Measurements will be taken to evaluate how the exoskeletons affect how people walk, and will also evaluate the pressure on the bottom of their feet. These measurements will be repeated multiple times to evaluate four different exo-tendon spring rates, and two sets of control shoes.

Exo-skeletons have been shown to reduce the pressure on the bottoms of people's feet and to reduce the effort to walk. This study is necessary to understand the contribution of different levels of exo-skeleton spring force to these effects.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported history of diabetic foot ulcer

Exclusion Criteria:

* Unable to continuously ambulate/walk ≥ 40 feet without an assistive device, such as a cane or walker
* Signs/symptoms of an infected foot lesion/ulcer as determined by a basic foot exam
* Trans-metatarsal foot amputation or more significant amputation.
* Symptomatic for signs/symptoms of cardiovascular disease as determined from interpretation of the 2017 PAR-Q+ (predicated on participant responses of "yes" indicating symptomatic/unstable medical conditions to page 2 and page 3 of the 2017 PAR-Q)
* Participants will be excluded from this study if they demonstrate pre-participation, or chronic, signs/symptoms of hypoglycemia: Confusion, unusual headache, unusual visual disturbances, self-reported mental dullness, shakiness, self-reported weakness, abnormal sweating, undue nervousness/anxiety, and/or tingling of the mouth, toes, and/or fingers or if they answer yes to question 5b and 5c of the 2017 PAR-Q+ .
* Participants will be temporarily excluded from this study if they are symptomatic for acute illness such as cold or fever. If the participant is symptomatic for acute illness such as cold or fever, participation will be reconsidered upon illness resolution.
* If participants answer yes to question 4a of the 2017 PAR-Q+ and if they demonstrate pre-study participation resting blood pressure \< 90/60 mmHg and \>140/90 mmHg .