cyrilzakka/clinical-trials huggingface dataset:
16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis

This study assessed the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who were tolerant to or had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-lactating female patients
* Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray) fulfilling the Modified New York criteria for AS (1984)
* Patients should have been on NSAIDs with an inadequate response
* Patients who were regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose
* Patients who had been on an anti-TNFα agent (not more than one) must have experienced an inadequate response

Exclusion Criteria:

* Chest X-ray (or MRI) with evidence of ongoing infectious or malignant process
* Patients with total ankylosis of the spine
* Patients previously treated with any biological immunomodulating agents except for those targeting TNFα
* Previous treatment with any cell-depleting therapies
Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)

The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.

Teduglutide is an analog of naturally occurring human glucagon-like peptide-2 (GLP-2), a peptide secreted by L-cells of the distal intestine. GLP-2 is known to increase intestinal and portal blood flow, and inhibit gastric acid secretion. Teduglutide binds to the glucagon-like peptide-2 receptors located in intestinal subpopulations of enteroendocrine cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus. Activation of these receptors results in the local release of multiple mediators including insulin-like growth factor (IGF)-1, nitric oxide and keratinocyte growth factor (KGF).

This multicenter, double-blind, international, Phase III trial will have a treatment period of 28 weeks. Subjects in this study are those who received teduglutide or placebo in protocol CL0600-004 (NCT00081458). These subjects will receive daily subcutaneous injections of 0.05 milligrams or 0.10 milligrams of teduglutide per kilogram of body weight. Subjects will have visits every 4 to 6 weeks and will be assessed for parenteral nutrition (PN) reduction with a follow-up period of 4 weeks duration for those subjects who do not complete this protocol, or do not enter into the long-term safety extension protocol CL0600-010.

Eligibility Criteria:
Inclusion Criteria:

At dosing week 24 of protocol CL0600-004 (NCT00081458), subjects will be reviewed for their participation in this study.

Subjects who meet all of the following criteria can be enrolled in this study:

* Signed and dated informed consent form (ICF) to participate before any study-related procedures are performed
* Completion of protocol CL0600-004 (NCT00081458)

Exclusion Criteria:

* History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state
* History of alcohol or drug abuse (within previous year)
* Prior use of native glucagon-like peptide 2 (GLP-2) within 3 months of screening visit
* Pregnant or lactating women
* Any condition or circumstance, which in the investigator's opinion would put the subject at any undue risk, prevent completion of the study, or interfere with analysis of the study results
To Investigate the Multiple Dose Safety, Tolerability and Pharmacokinetics of WCK 4282 (FEP-TAZ)

To evaluate the safety, tolerability and pharmacokinetics (PK) of multiple IV doses of FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) administered every 8 hours (q8h) in healthy adult volunteers for 10 days.


Eligibility Criteria:
Inclusion Criteria:

* Have a body Mass Index (BMI) between 18 to 32 kg/m2 (both inclusive).
* Medical history without any major pathology.
* A sustained supine systolic blood pressure \<150 mm Hg or \>90 mm Hg or a supine diastolic blood pressure \<95 mm Hg or \>50 mm Hg at Screening or Check-in (Day -1). Blood pressure may be retested once in the supine position.
* Glomerular filtration rate (GFR) \> 80 mL/min, estimated by the Cockcroft-Gault equation.

Exclusion Criteria:

* Use of cefepime and/or tazobactam within 60 days prior to study drug administration.
* History or evidence of clinically relevant pathology which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
The Effects of Mother-infant Skin-to-skin Contact on Stress Response of Preterm Infants

This study will evaluate the effect of maternal-infant skin-to-skin contact (SSC) versus routine care on general stress in preterm infants in the neonatal intensive care unit (NICU).

Primary outcome of this trial to investigate the effects daily skin-to-skin contact on cumulative stress through measures salivary cortisol. The intervention group will receive mother-infant skin-to-skin contact at least 1 continuous hour everyday from infant 3 days of life until discharge. The control group will receive routine neonatal care during hospitalization except skin-to-skin contact. The concentration of salivary cortisol and other infant and parental outcomes will be measured in both groups.

Eligibility Criteria:
Inclusion Criteria:

* 31 weeks≤gestational age\<37 weeks;
* Birth weight ≥ 1500g;
* Admission age \< 24h;
* No congenital malformations;
* Vital signs are stable and does not use ventilator and other auxiliary life support systems.

Exclusion Criteria:

* Severe periventricular / intraventricular hemorrhage (grade III);
* Receiving sedation or vasopressor or analgesics opiodis and corticosteroids;
* Mother unable to communicate and communicate normally; Mother has a history of depression.
Effect of Exercise as Non-surgical Treatments on Time to Total Hip Replacement Surgery

The aim of this trial is to test the hypothesis that patients with severe hip osteoarthritis postpone time to hip replacement surgery following participation in a patient education and supervised exercise program when compared to patients receiving patient education alone.

Hip replacements are performed at an increasing rate, also in younger and less disabled patients. Recent studies indicate non-surgical interventions being effective in reducing pain and disability also at later stages of disease when hip replacement is considered. Possible, non-surgical treatments can be used to postpone hip replacement. The effect of education and supervised exercise on time to hip replacement is largely unknown

Eligibility Criteria:
Inclusion Criteria:

* 40 years and older
* Indication for total hip arthroplasty
* Residency within local municipal or willing to commute

Exclusion Criteria:

* Inflammatory joint disease
* Earlier ipsilateral proximal femur fracture
* Hip pain \< 3 months
* Neuropathy or neuromuscular disease
* Malignant disease
* Diseases where a moderate level of physical exercise is contraindicated
* Unable to speak or read Danish
* Unable to participate for other reasons
* Refuse to participate
Development of Cocktail for Measuring the Activity of Important Cytochrome P450 Enzymes

The Cytochrome P450 enzymes are responsible for the metabolism of a wide range of drugs and other xenobiotics. Genetic variants of the encoding P450 genes have shown to influence the rate of metabolism of many clinically used drugs.

The drugs tramadol, omeprazole, losartan, quinidine and caffeine reflect the activity of CYP2D6 (tramadol), CYP2C19 (omeprazole), CYP2C9 (losartan), CYP1A2 (caffeine) and CYP3A4/5 (quinidine).

The aim of the study is to investigate if the cocktail of tramadol, omeprazole, losartan and caffeine can be used to simultaneously determine the activity of CYP2D6, CYP2C19, CYP2C9 and CYP1A2. Furthermore, will the natural occurring 4-beta-hydroxy-cholesterol in the blood be measured as a metric for CYP3A4/5.

The study is divided in two. First part will include 12 healthy volunteers and consists of three arms separated by at least one week. In the first arm 50 mg of tramadol will be ingested and urine will be collected for 8 hours. In the second arm 20 mg omeprazole, 25 mg losartan and 200 mg caffeine will be ingested followed by 8 hours urine collection and a blood sample 4 hours after administration of the drugs. In the last arm 50 mg of tramadol, 20 mg omeprazole, 25 mg losartan and 200 mg caffeine will be ingested followed by 8 hours urine collection and a blood sample 4 hours after administration of the drugs.

Metabolic ratios will be calculated based on urine and plasma concentrations of the drugs and the relevant metabolites. Relevant genetic variants of the cytochrome P450 encoding genes will be determined.

If the metabolic ratios of the drugs are not significantly different between the arms, Second part of the study will be conducted.

This part is identical with the last arm and will include a maximum of 400 healthy volunteers: 50 mg of tramadol, 20 mg omeprazole, 25 mg losartan and 200 mg caffeine will be ingested followed by 8 hours urine collection and a blood sample 4 hours after administration of the drugs.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers,
* Written consent, AND
* Age 18-65 years old.

Exclusion Criteria:

* Daily medication,
* Alcohol abuse,
* Pregnancy, OR
* Breastfeeding.
Comparative Study of Human Immunodeficiency Virus Negative Host Talaromyces Between Voriconazole and Amphotericin Sequential Itraconazole Therapy

Through a multi-center large-sample non-randomized controlled study, the effect of voriconazole, amphotericin B sequential itraconazole therapy on Talaromyces in Human Immunodeficiency Virus（HIV）negative hosts were compared to clarify whether the two therapies were equivalent; A comprehensive efficacy evaluation system and standard treatment program was established to provide a basis for standardized treatment of Talaromyces in Human Immunodeficiency Virus negative hosts.The observational indicators included: 2-week all-cause mortality; 24-week all-cause mortality; clinical improvement time; level of decrease of fungus in the blood culture medium two weeks before treatment; recurrence; appearance of adverse drug reaction at the level 3 and above. Dynamically monitor the immune cells and factors like anti-Interferon-γ autoantibodies, Interferon-γ, Th1/Th2, and Th17/Treg in the HIV-negative Talaromyces host microenvironment, and observe the host's immune status and its change. 3. study the effect of absence of Interferon-γ and Interferon-γ Receptor (IFN-γR）on the activation and function of anti-Interferon-γ autoantibodies, Th1/Th2, and Th17/Treg by establishing a Talaromyces mouse model that knocks out the Interferon-γ and IFN-γR gene and a IFN-γ silenced cell model; Study the effect of anti-IFN-γ autoantibody on the activation and function of IFN-γ、Th1/Th2、Th17/Treg by increasing its titer in vitro and vivo; determine by which path the anti-IFN-γ autoantibody of HIV-negative host influences its immune regulation mechanism; finally, the intervention effect of IFN-γ on high titer anti-IFN-γ autoantibodies is studied, providing a new idea for immunotargeted therapy.


Eligibility Criteria:
Inclusion Criteria:

1. HIV-negative adults (≥18 years of age) who diagnosis of talaromyces that was confirmed by either microscopy or culture
2. Must be able to swallow tablets

Exclusion Criteria:

1. Pregnancy, central nervous system involvement assessed either clinically or by analyses of cerebrospinal fluid
2. An allergy to voriconazole, itraconazole or amphotericin
3. The concomitant use of certain medications that interact with voriconazole, itraconazole or amphotericin
4. An alanine aminotransferase or aspartate aminotransferase level of more than 400 U per liter
5. An absolute neutrophil count of less than 500 per cubic millimeter
6. A creatinine clearance of less than 30 ml per minute (calculated by the method of Cockcroft and Gault)
7. a concurrent diagnosis of cryptococcal meningitis
8. concurrent treatment with rifampicin
9. previous treatment for talaromyces for more than 48 hours
10. HIV positive who diagnosis of talaromyces.
Improvement of Care of Patients Undergoing Pancreaticoduodenectomy

The study is a randomised controlled trial comparing the effectivity and impact of epidural analgesia and wound catheter analgesia in patients undergoing pancreaticoduodenectomy. The aim of the study is to examine whether there are a difference in perioperative fluid therapy and complication rates between the patients in epidural and wound catheter groups.

All patients undergoing pancreaticoduodenectomy in Helsinki University Hospital are recruited in the study. Patients meeting the inclusion criteria and giving consent to participate the study will be randomised to whether epidural analgesia group or wound catheter analgesia group. Both groups receive additional analgesia with intravenous PCA-oxycodone (patient controlled analgesia).

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or over
* patients who undergo pancreaticoduodenectomy

Exclusion Criteria:

* patients to whom are made a major vascular reconstruction
* patients with significant comorbidities and inability to use PCA
* regural use of strong opioids or drugs preoperatively
* patients with severe chronic pain issues
* chronic atrial fibrillation
* patients who refuse to take part to the study
The Impact of an 8-week Supported Exercise Program on Fitness and Symptoms in Adolescents With Down Syndrome

This study explores the effects of an eight-week exercise intervention for adolescents with Down syndrome on home exercise compliance. As well, to observe changes in fitness including muscular strength, endurance and aerobic capacity. Finally to observe any changes in mood, behavior and quality of life.

Adolescents with Down syndrome will participate in an eight-week, center-based exercise intervention. Participants will undergo an hour of exercise intervention each week. During this time, participants will be working with a team consisting of a physician, physical therapy student volunteers, and clinical research coordinators. Exercises will focus on strength and endurance of all major muscle groups, while ensuring proper technique and form is used. They will also receive instruction on how to continue the exercise program at home.

Prior to starting, and at the end of eight sessions, all exercise participants will undergo testing procedures for anthropometric, strength and flexibility measurements. This data will be collected as part of clinically evaluating the impact of the program on each participant. In addition to the exercise program (and clinical assessments of fitness), DSFit participants will complete study measures of behavioral functioning as well as scales of depression and anxiety. Participants in the DSFit study will also complete a weekly exercise log during the intervention and for a follow-up period afterwards.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* 10 to 17 years old (until 18th birthday)
* Diagnosed with Down syndrome by a physician
* Medically cleared to exercise

Exclusion Criteria:

* Requires consistent one-on-one care
* History of behavioral issues (outbursts, aggressive/self-injurious, bolting)
* Pre-existing cardiovascular, respiratory or orthopedic conditions that could place participant at risk for injury or illness resulting from exercise. For example:
* Untreated significant atlantoaxial instability
* Severe pulmonary hypertension
Connected Yorkshire: A Data-linkage Study of Pre-hospital, Emergency Department and Out of Hours Service Data

There is increased demand on emergency departments (ED) across the UK. The services are becoming stretched and as a result waiting times are increasing and patient care is suffering.

By linking together patient data from different hospitals and services across Yorkshire, researchers are able to build a more complete picture of how emergency and urgent care (UEC) services in the region function.

This picture will help researchers understand the flow of patients through EUC services, to understand what the most common health issues are and to better plan community services in the future. The anonymous data can help scientists understand EUC services across an entire region and suggest improvements in a much more synchronised way.

Health service managers will also be able to understand how one ED in Yorkshire compares to another. By re-using existing data researchers will also allow hospitals to learn lessons from each other so that each local service can improve and deliver better care for its patients.

In the future, this information will help researchers to plan ahead and forecast disease outbreaks. The data used will, over time, tell a story that will help deliver better and more targeted care.

The aim of the research project is to build a unique dataset based on expertise already being developed across the Yorkshire and Humber region. We will collect routine NHS data from a number of providers of EUC and link the data to provide a coherent picture of EUC demand. This rich data source will allow the EUC services to be viewed as a whole system, enabling demand on the system by patients to be analysed as well as the flow of patients through the system.


Eligibility Criteria:
Inclusion Criteria:

* access urgent and emergency care services in Yorkshire and the Humber region between 2011 and 2017

Exclusion Criteria:

* None
Advanced Heart Care At Home

End-of-life (EOL) care for heart failure (HF) patients includes high healthcare utilization and costs, in part due to the lack of integration of optimal HF management and home-based palliative care. In a pilot quality improvement project of clinician "nudges" to enroll seriously ill HF patients in a home-based, integrated HF and palliative care platform, the investigators demonstrated decreased healthcare utilization and costs and increased hospice utilization among seriously ill HF patients. The investigators propose a pragmatic randomized trial for clinicians of seriously ill HF patients admitted to three University of Pennsylvania Health System Hospitals, randomly assigning an opt-in approach (usual care) versus a "nudge" or opt-out approach of a visit from an Advanced Heart Care at Home (AHCAH) liaison to clinicians of eligible patients to discuss and enroll in the AHCAH program, to rigorously and scientifically evaluate clinical, utilization, and cost outcomes among high-risk HF patients at the EOL, and to promote physician uptake of best practices.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age
2. Reside within Caring Way's geographic catchment
3. Heart Failure ICD code from any previous healthcare encounter (inpatient or outpatient) in the 12 months prior to index hospitalization
4. Admitted to a cardiology or hospitalist service
5. Palliative Connect score greater than 0.3
6. Index hospitalization during study period

Exclusion Criteria:

1. Less than 18 years of age
2. Pregnant women
3. Incarcerated patients
4. Homeless patients
5. Reside outside of Caring Way's geographic catchment
6. Patients without an identifiable primary physician for AHCAH staff to communicate with as determined by the AHCAH liaison via EPIC
7. Prior hospitalization during study period
Immersive Virtual Reality Treatment for Unilateral Spatial Neglect

Unilateral Spatial Neglect (USN) is a relatively common neuropsychological syndrome following stroke. It is characterized by difficulties in detecting, orienting and identifying events located in the hemispace contralateral to a brain lesion, unrelated to a primary motor or sensory disorder. Numerous methods have been developed for the rehabilitation of this syndrome. However, limitations in terms of efficacy are highlighted. These limitations may be linked to the fact that these methods are restricted to certain sensory modalities, thus failing to take into account the heterogeneity of the syndrome. Moreover, some patients' adherence to rehabilitation programs can also be complicated by motivational difficulties. Immersive Virtual Reality could help overcome these limitations. Indeed, it enables the introduction of new sensory modalities, notably auditory, to support a better apprehension of space.

The main objective of this study is to determine the efficacy of an immersive virtual reality rehabilitation protocol based on musical practice in patients suffering from USN. This study also aims to explore the benefits of this rehabilitation protocol on patients' daily lives, as well as to explore the influence of patients' mood and motivation on the benefits of the immersive virtual reality rehabilitation protocol.

To achieve these goals, patients will benefit from immersive virtual reality rehabilitation based on music practice. This rehabilitation will be compared to conventional USN rehabilitation. To this end, patients will be divided into two groups: classical rehabilitation only or classical rehabilitation and immersive virtual reality in parallel. Each patient will be randomly assigned to one of the two groups for a period of 2 weeks. Pre- and post-rehabilitation assessments will be provided.


Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 years
* Free and informed written consent
* Enrolled in the French social security system
* Cerebral lesion of vascular origin
* Unilateral spatial neglect syndrome

Exclusion Criteria:

* Epilepsy or migraine
* Major vision problems
* Major hearing impairment
* Pre-existing cognitive impairment (MMSE \< 20)
* Major disorders of verbal comprehension preventing the protocol
* Refusal to sign consent form