cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of AlphaNine Versus BeneFIX in Patients With Severe Hereditary Haemophilia B

The goal of this non-randomized, multi-center study in subjects with severe hereditary haemophilia B was to determine and compare the pharmacokinetic and safety profiles of BeneFIX in subjects having had 2 prior pharmacokinetic assessments with AlphaNine.

Two pharmacokinetic assessments (studies) were carried out in the same subjects during a previous clinical trial. The first pharmacokinetic study (PK1) was performed after a single dose of AlphaNine. The second pharmacokinetic study (PK2) was performed following 26 Weeks of AlphaNine treatment after PK1. To compare AlphaNine with BeneFIX, a third pharmacokinetic study (PK3) (current study) was performed after a single dose of BeneFIX administered following a 7- to 15-day wash-out period.

The main objective of the PK3 study was to assess the pharmacokinetic profile of BeneFIX and compare to the pharmacokinetic profile of AlphaNine from the PK2 study.

Eligibility Criteria:
Key Inclusion Criteria:

* Participated in the previous study "Efficacy and safety of factor IX (FIX) contained in Alphananine in patients with severe hereditary haemophilia B":
* Congenital deficiency in Factor IX (FIX)
* FIX residual activity of ≤2% of normal
* Had required FIX-containing products in the past and in clinical records that were collected data to assess a reliable estimation of at least 150 treatment exposure days to previous products
* Was able to receive treatment for more than 10 days for a 6-month period

Key Exclusion Criteria:

* Received a dose of FIX in the 7 days prior to the infusion
* FIX inhibitor level of \>0.5 Bethesda units (BU) or clinically relevant presence in the past (≥5 BU)
* Active bleeding at the moment of infusion
* Had a known allergic reaction to any BeneFIX component
* Exhibited symptoms of any intercurrent infection (ie, fever, chills, nausea) at the time of the first infusion
* Had any disease that might affect the distribution or metabolism of FIX and which could affect interpretation of the study (such as non-controlled diabetes mellitus)
* Had non-controlled arterial hypertension
* Had abnormal renal function (creatinine \>1.5 mg/dL)
* Had documented liver cirrhosis or any hepatic disorder with alanine aminotransferase (ALT) levels 2.5x upper limit of normal (ULN )
* Prevision to be concomitantly treated with other FIX-containing products
* Had conditions that might affect subject compliance (survival-limiting \[in 2 year time\] diseases, alcohol or other drug abuse, etc.)
* Unable to provide a storage plasma sample before the first dose of BeneFIX
SENSIMED Triggerfish® in Sitting and Supine Position

The purpose of the study is to evaluate changes in intraocular pressure (IOP) between sitting and supine body positions and correlate the values obtained with conventional tonometers to the output provided by the investigational device.

20 subjects will be enrolled in the investigation. Eligible subjects will receive one session of 22-hour continuous IOP monitoring with SENSIMED Triggerfish® in ambulatory mode, with body position transitions carried out in-hospital. SENSIMED Triggerfish® will be installed randomly on right or left eyes and the IOP recording will be initiated as soon as the adaptation of the device on the subject's eye is satisfying. Subjects will then go home. The next morning, subjects will return to the hospital and during SENSIMED Triggerfish® monitoring on one eye, IOP measurements will be taken in the fellow eye in sitting position using Goldmann, tonopen and pneuma-tonometers. Then subjects will lie down on a flat bed. After 15 ± 5 minutes and again after 45 ± 5 minutes IOP will be measured in supine position, using Goldmann, tonopen, pneuma-tonometer and Perkins tonometers. Then subjects will sit up again. After 30 ± 5 minutes IOP will be measured with the Goldmann tonometer.

Eligibility Criteria:
Inclusion Criteria:

* Subject is able to provide informed consent
* Healthy subject, with no previous ocular medical history, with the exception of spectacle vision correction for myopia, hyperopia and astigmatism
* No more than 4 diopters spherical equivalent
* No more than 2 diopters cylinder equivalent
* GAT IOP of less than or equal to 21 mmHg at inclusion and open iridocorneal angles, no history of any IOP \> 21 mmHg
* GAT IOP difference between eyes within 1 mmHg during initial exam
* GAT IOP differences between initial sitting and supine positions, between left and right eyes, within 2 mmHg during initial exam
* ≥ 18 years
* For women with childbearing potential, adequate contraception

Exclusion Criteria:

* Subjects with contraindications for wearing contact lenses
* Severe dry eye syndrome
* Keratoconus or other corneal abnormality
* Conjunctival or intraocular inflammation
* History of eye surgery
* Full frame metal glasses during SENSIMED Triggerfish® recording
* Known hypersensitivity to silicone, plaster or ocular anesthesia
* Pregnancy and lactation
* Simultaneous participation in other clinical studies
Internet-Based Intervention for Occupational Stress Among Medical Professionals

The aim of this study is to assess the efficacy of internet intervention for reduction of occupational stress and its negative consequences (job burnout, depression) among medical professionals through the enhancement of the resources that are critical for coping with stress: self-efficacy and perceived social support.

Medical professionals are at high risk for job stress and burnout. Research show that the negative effects of stress can be reduced through strengthening personal resources such as self-efficacy and perceived social support. In line with cultivation and enabling hypotheses (Schwarzer \& Knoll, 2007; Benight \& Bandura, 2004) either self-efficacy cultivates perceived support, or rather perceived support enables self-efficacy. This study aims at testing both hypotheses in experimental design by applying them as a theoretical framework for the Med-Stress: evidence-based, CBT-framed internet intervention to foster resource accumulation among medical professionals.

The effectiveness of intervention will be tested in a four-arm randomized controlled trial comparing the effects of: 1) self-efficacy and perceived support sequential enhancement (cultivation hypothesis), 2) perceived support and self-efficacy sequential enhancement (enabling hypothesis), 3) only self-efficacy, and 4) only social support enhancement (controls). Primary outcomes are job stress and burnout, secondary outcomes include work engagement, depression, and secondary traumatic stress. Self-efficacy and perceived support are expected to mediate the relationships between condition assignment and outcomes. Assessments include baseline (T1), three- or six-weeks post-test (depending on the condition, T2), as well as six- and twelve-months follow-ups (T3, T4). Intervention effect sizes and between-groups comparisons at post-test and follow-ups will be calculated.

This study will contribute to the findings on the role of personal resources in the development of job stress and burnout by demonstrating the cultivation vs enabling effects of self-efficacy and perceived social support.

Eligibility Criteria:
Inclusion Criteria:

* Age of at least 18 years
* Professionally active medical providers
* Internet connection

Exclusion Criteria:

* No access to a device with Internet connection
A Multicenter Real World Study of Kanglaite for Cancer Cachexia

A prospective, multi-center real-world study of the effectiveness and safety of Kanglaita Injection/Capsule in Chinese patients with cancer cachexia

This is a large national-based prospective, multi-center real-world observational study. Cancer cachexia patients scheduled for sequential treatment with Kanglaite injection and capsule between August 2018 and March 2020 at 640 participating hospitals will be recruited to evaluate the effectiveness and safety of Kanglaite.

Eligibility Criteria:
Inclusion Criteria:

Patients with pathological or cytological diagnosis of lung, liver, pancreatic or stomach cancer; Patients scheduled to receive Kanglaite injection for 7 or more days, followed by Kanglaite capsule for 14 or more days; Patients willing to participate in this study and provide written informed consent.

Exclusion Criteria:

None
Ureagenesis Analysis in Healthy Subjects and in Urea Cycle Disorder Patients

Urea cycle disorders (UCDs) are dramatic congenital inherited metabolic disorders. There is no cure. Many novel therapeutic approaches are currently being developed, which hopefully will change the current situation. Testing the efficacy of such new therapies in patients is a challenge, because many clinical parameters are influenced by several disturbances and biochemical parameters are often not very specific.

The measurement of ureagenesis is a tool to analyze the entire function of the urea cycle in a single test. This is more meaningful for the characterization of UCD patients than the analysis of single metabolites or enzymes. Therefore, the test will be important to evaluate current and future novel therapies.

The term "ureagenesis" means "production of urea", which is the main task of the urea cycle. This total urea production can be measured with a "tracer" (in this case a stable ammonium chloride isotope). This tracer is non-radioactive and non-toxic. It is for example used as an unmarked substance in cough syrup, diuretic drugs and as food additive. Thus, the tracer does not pose a risk to the participant, especially since only a very low dose is applied.

The investigators will analyze specific substances from the urea cycle (namely \[15N, 14N\] urea and several \[15N\] amino acids) that are produced during the test and compare them with results from healthy people. The maximum test duration is 5 hours.

This project is being carried out at one site, namely the University Children's Hospital in Zurich.

This project is being carried out under Swiss law. The responsible Ethics Committee has reviewed and approved the study.


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects at any age and given written informed consent
* subjects with a UCD confirmed by genetic or enzymatic diagnostics at any age and given written informed consent

Exclusion Criteria:

* healthy subjects with acute and chronic disease requiring treatment of any kind
* pregnant or lactating women.
* UCD patients with acute and chronic (other than her/his UCD) disease requiring treatment
* UCD patients in which intake of carglumic acid cannot be stopped for 24 hours prior to the test
Radiofrequency Ablation of Genicular Nerves for Advanced Osteoarthrosis of the Knee Joint 1 Year Follow-up.

Pharmacological treatment of pain due to osteoarthritis of the knee often proves to be inadequate and/or cause intolerable side effects. Arthroplasty of the knee may offer a solution, but waiting lists may be long or certain patients may not be apt for a surgical intervention. Therefore an alternative pain treatment that is effective and has little side effects allowing to offer pain relief to those difficult to manage patients would be an added value in the therapeutic options.

We studies the short and long-term effects of radio frequency treatment of the genicular nerves in patients with severe pain due to osteoarthritis of the knee.

Radio frequency treatment (RF) of the genicular nerves was found to be effective in a randomized controlled trial. Because of the blinding patients were allowed to continue pre-intervention pharmacological treatment, which may have interfered with the outcome. The short follow-up (12 weeks) does not allow drawing conclusion on the duration of the effect.

We aimed at assessing the pain reducing effect of RF of the genicular nerves and the duration of the effect.

Eligibility Criteria:
Inclusion Criteria:

* patients suffering from pain caused by osteoarthrosis of the knee joint
* osteoarthrosis of the knee joint (grade 3-4 according to the Kellgren Lawrence classification)
* pain of moderate to severe intensity (VAS≥5, on a 10-point scale) during \>3 months
* pain resistant to conservative treatments

Exclusion Criteria:

* acute knee pain associated with radicular neuropathy or intermittent claudication, connective tissue diseases affecting the knee, serious neurologic or psychiatric disorders, mental deterioration impeding adequate communication or collaboration, injection with steroids or hyaluronic acids during the previous 3 months, anticoagulant medications, pacemakers, and prior electro-acupuncture treatment
Biomarkers to Predict Response to Interferon Therapy in Patients With Melanoma

RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer, and may help doctors learn how well patients will respond to treatment.

PURPOSE: This laboratory study is looking at biomarkers to predict the response to interferon therapy in patients with melanoma.

OBJECTIVES:

* Generate a comprehensive multiplexed array of melanoma-associated serological markers and validate it using serum samples from patients with melanoma and healthy control participants.
* Determine changes in the profile of serological markers induced by interferon-alfa 2b (IFN-α2b) therapy.
* Define panels of serological markers with prognostic and predictive power for IFN-α2b therapy responses in patients with melanoma.

OUTLINE: This is a multicenter study.

Serum samples are used for multiplex analyses. Biomarkers to be assessed include cytokines, chemokines, growth factors, angiogenic and antiangiogenic molecules, matrix metalloproteases (MMPs), tissue inhibitors of MMPs (TIMPs), melanoma-associated antigens, basic fibroblast growth factor, insulin-like growth factor I and II, thrombospondin, endostatin, angiostatin, vasostatin, and vascular endothelial growth factor inhibitor.

PROJECTED ACCRUAL: A total of 1,716 samples will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of melanoma OR healthy volunteer (control)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Pharmacokinetics, Safety and Tolerability of Rising Doses of Buscopan® in Healthy Male Volunteers

Study to investigate pharmacokinetics, safety and tolerability of Buscopan® after single rising dose and after multiple rising doses


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease.
2. Age ≥21 and age ≤50 years
3. BMI ≥18.5 and BMI \<30 kg/m2 (Body Mass Index)
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria:

1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
2. Evidence of a clinically relevant concomitant disease
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
5. History of relevant orthostatic hypotension, fainting spells or blackouts
6. Chronic or relevant acute infections
7. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) as judged clinically relevant by the investigator
8. Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to randomization
9. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to enrolment in the study or during the study
10. Participation in another trial with an investigational drug within two months prior to randomization
11. Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
12. Inability to refrain from smoking on trial days as judged by the investigator
13. Alcohol abuse (more than 40 g/day for males)
14. Drug abuse
15. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
16. Excessive physical activities within one week prior to administration or during the trial
17. Any laboratory value outside the reference range that is of clinical relevance
18. Inability to comply with dietary regimen of trial site
19. Hypersensitivity to hyoscine butylbromide and/or related drugs of these classes
20. History of megacolon
21. History of prostatic hyperplasia
22. History of mechanical stenosis of the gastrointestinal (e.g. after surgery of the gastrointestinal tract)
23. History of narrow-angle glaucoma
24. History of tachycardic arrhythmias
25. History of myasthenia gravis
26. Bladder-neck obstruction
Prosthetic Outcomes and Clinical Performance of Implant Supported Zirconia Crowns

To compare biological, technical, radiographic, and patient-reported outcomes of two types of monolithic zirconia crowns screw-retained to implant.

To assess whether the new form of multilayered zirconia crowns will show similar survival and success rate to conventional monolithic Zirconia screw-retained to implants in molar and premolar regions.

First Null Hypothesis: Multilayered monolithic zirconia crowns would have similar survival, success rate compared to conventional monolithic zirconia implant supported crowns.

Second Null hypothesis: There would be no difference in clinical and patients related outcomes between multilayered and conventional monolithic zirconia implant supported crowns.

Study design:

A short-randomized controlled trial study, the (PICO) study design: population will be patients from Jordan University Hospital with implants planned for single screw-retained zirconia crowns in the posterior site (premolar or molar), intervention will be the multilayer monolithic screw-retained zirconia crowns over implants, the comparator is the conventional monolithic zirconia crowns over implants, and the main outcomes will be the prosthetic/technical outcomes, survival and success rates in addition to radiographic, patient-reported outcomes, and biological parameters.

Methodology The patients who fulfilled the inclusion/exclusion criteria and entered the study will have a fully digital workflow starting from data acquisition using an intraoral scanner (3Shape TRIOS® 5) , Ti-base abutment design and CAD/CAM milling of the two types of monolithic zirconia blanks (IPS e.max® ZirCAD Prime and IPS e.max® ZirCAD LT).

The fabricated zirconia crowns in both groups will have the same treatment and will be cemented to the Ti-base abutment according to the (APC) concept; alumina airborne-particle abrasion 50-μm at 1 bar for 15-20 seconds, intaglio surface primed using MDP for 60 seconds and air blown for 5 seconds, and finally cemented to the abutment by phosphate monomer resin cement PANAVIA™ V5(Blatz-Alvarez-Compendium-APC-2016, n.d.).

On the other hand, the Ti-base abutment: height will be standardized at 4mm, and the base abutment surface will have blasting with alumina particles of 50 μm at 2-bar pressure for 15-20 seconds at a 10-mm step-over distance at an angle of 45 degrees.

Eligibility Criteria:
Inclusion Criteria:

* Partially edentulous area with suitable restorative space more than 5.5 mm
* At least 18 years of age
* Opposing natural teeth or fixed restorations supported by teeth or implants.
* Generally good health (ASA I, ASA II)
* Participant complies with good oral hygiene practices (BOP and PI less than 20%)
* Healthy integrated implant/s without signs of periimplantitis in the posterior site planned for single tooth replacement (in premolar or molar areas)
* Patients received bone-level implants, RC Straumann Implants.

Exclusion Criteria:

* Inability to provide consent.
* Temporomandibular disorders
* Smoking of more than 10 cigarettes per day
* Untreated caries or periodontal disease of remaining dentition
Probiotic-enriched Artichoke in Functional Constipation

The aim of the present randomized double-blind controlled crossover study is to compare the effects of the 15-day consumption of artichokes enriched with the probiotic Lactobacillus paracasei LMGP22043 with those of ordinary artichokes on treatment preference, satisfactory relief of symptoms, bowel habit and the modulation of SCFA production in a group of patients suffering from functional constipation.

Functional constipation is a common problem in westernized societies and is characterized by different gastrointestinal symptoms.Different therapeutic strategies have been proposed, but a new therapeutic approach for constipation could be based on the modulation of intestinal microflora by administering prebiotics and/or probiotics. Currently, probiotic products are mainly incorporated in fermented milk-based products or concentrated probiotic preparations. To enlarge the range of choice and to exploit the nutritional qualities of plant matrices, an innovative line of probiotic vegetable products such as artichokes has been developed. The use of these vegetables containing live probiotic strains can take advantage of some their peculiar features for growth and improved bacterial survival. Artichokes can, therefore, work as valid "active" vehicles for the transport and release of adequate amounts of bacterial populations.

Eligibility Criteria:
Inclusion Criteria:

* fulfilment of the Rome Criteria III for constipation
* availability of at least one GI imaging study during the last five years(colonoscopy, sigmoidoscopy, abdominal ultrasound, barium enema)
* commitment to availability for the whole study period

Exclusion Criteria:

* major abdominal surgery
* the presence of any concomitant diseases such as organic GI diseases including lactose and gluten intolerance; medical or psychiatric illness
* alarming symptoms (rectal bleeding, weight loss, etc)
* family history of peptic ulcer, colorectal cancer, or IBD;
* abnormal laboratory data or thyroid function.