cyrilzakka/clinical-trials huggingface dataset:
Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)

Evaluation of efficacy and safety of tofacitinib (CP-690,550) for the treatment of early rheumatoid arthritis in adult patients with moderate to severe disease who are methotrexate naïve. The efficacy will be evaluated by exploring the effects on joint structure assessed by magnetic resonance imaging, x-rays and by standard clinical assessment.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with moderate to severe early rheumatoid arthritis (\< 2 years) who are methotrexate and biologic disease modifying antirheumatic drug naive.

Exclusion Criteria:

* Pregnant or lactating patients;
* Patients with renal or hepatic impairment or other severe or progressing disease;
* Patients with contraindication to magnetic resonance imaging with gadolinium contrast.
Iressa and Radiotherapy in the Treatment of the Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck

The aim of the study is to determine if Iressa added to radiotherapy is effective and safe in shrinking tumour dimensions.


Eligibility Criteria:
Inclusion Criteria:

* Histologically Confirmed locally advanced Squamous Cell Carcinoma of Head and neck
* At least one measurable tumour lesion

Exclusion Criteria:

* No previous treatment such as chemotherapy, radiotherapy and/or surgery for Carcinoma Head and Neck
* No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
* Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
A Clinical Study Testing The Safety And Efficacy Of Crizotinib In East Asian Patients With Anaplastic Lymphoma Kinase (ALK) Positive Advanced Non-Small Cell Lung Cancer

This is an open-label multi-center Phase 2 efficacy and safety study of crizotinib in East Asian patients with advanced Non-Squamous NSCLC harboring a translocation or inversion event involving the ALK gene locus who have received only one prior chemotherapy regimen for advanced NSCLC and this regimen must have been platinum-based. Primary objective of this study is to assess the anti-tumor activity and safety profile of crizotinib. Secondary objectives are to evaluate clinical efficacy including median progression-free survival (PFS) and 1-year PFS rate, overall survival (OS), disease control rate (DCR) at 6 and 12 weeks, time to response (TTR), and duration of response (DR).


Eligibility Criteria:
Inclusion Criteria:

* Proven diagnosis of locally advanced or metastatic non-squamous cell carcinoma of the lung
* Positive for translocation or inversion events involving the ALK gene locus
* Patients must have had progressive disease after only one prior chemotherapy regimen. This regimen must have been platinum-based and may have included maintenance therapy.
* Evidence of personally signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.

Exclusion Criteria:

* Current treatment on another therapeutic clinical trial.
* Prior therapy directly targeting ALK.
* Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack.
* Ongoing cardiac dysrhythmias of NCI CTCAE Grade \>=2, uncontrolled atrial fibrillation of any grade, or QTc interval \>470 msec.
* Pregnancy or breastfeeding.
* Use of drugs or foods that are known potent CYP3A inducers/inhibitors/substrates with narrow therapeutic indices.
* Known HIV infection
* Known interstitial lung disease or interstitial fibrosis
* Other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study.
Bevacizumab, Dacarbazine and Interferon-Alfa to Treat Metastatic Melanoma

The purpose of this study is to determine whether combination therapy with bevacizumab (Avastin), dacarbazine and interferon-alfa-2a (Roferon-A) is effective in patients with locally advancing or metastatic melanoma.

Dacarbazine (DTIC) has been approved for treating metastatic melanoma in the 1970s, and after that numerous schedules and dacarbazine-based combinations have been studied in this disease. DTIC as a single agent gives a response rate of only 20%, but there have been efforts to improve this poor result by using DTIC in different combinations.Treatment of melanoma with combination chemotherapy and interferon-α (IFN-α) has given 50-60% response rates,but increase in the overall survival time has not been reached in controlled phase III studies. Thus, standard reference therapy in treatment of metastatic melanoma still is single dacarbazine or its combination with s.c. IFN-α. In addition, new studies with melanoma cells in vitro show that dacarbazine causes transcriptional up-regulation of vascular endothelial growth factor (VEGF), suggesting a potential clinical benefit of combination of DTIC and anti-VEGF therapy. IFN-α has been used in adjuvant therapy and in treatment of metastatic melanoma. IFN-α exerts its effects through antiproliferative, apoptosis-inducing and particularly antiangiogenic effects in addition to immunologic modulation.

The purpose of this study is to determine whether combination therapy with bevacizumab (Avastin), dacarbazine and interferon-alfa-2a (Roferon-A) can increase progression-free survival and overall survival in patients with locally advancing or metastatic melanoma.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed malignant melanoma either locally progressing inoperable or metastatic
* measurable/evaluable disease in accordance with RECIST criteria
* WHO performance status 0-2
* normal organ function
* signed written informed consent

Exclusion Criteria:

* unevaluable disease
* major surgery within 28 days prior to day 0
* uncompleted radiotherapy
* CNS metastases
* serious non-healing wound or ulcer
* bleeding diathesis or coagulopathy
* uncontrolled hypertension
* clinically significant cardiovascular disease
* depression or psychosis, which needs medication
* ongoing treatment with aspirin (\>325 mg/day)
* pregnancy
* any other serious or uncontrolled illness
* previous chemotherapy for metastatic melanoma
PCORI-CER-1306-03385 Lung Cancer Screening Readiness Study

Investigators will administer a brief, anonymous survey at the Texas Academy of Family Physicians (TAFP) annual Primary Care Summit to better understand the readiness of primary care physicians in Texas to implement lung cancer screening programs in their practice settings.

For this project there will be up to 1000 participants. Physicians attending the annual CME event at the Texas Academy of Family Physicians event will be asked to fill out an anonymous survey to better understand their readiness to implement lung cancer screening programs in their practice settings. The surveys will be administered to physicians attending the TAFP education events in Houston, Texas, October 17-19, 2014 and in Dallas, Texas, November 7-9, 2014.

Eligibility Criteria:
Inclusion Criteria:

1. Physicians attending the TAFP education events in Houston, Texas, October 17-19, 2014 and in Dallas, Texas, November 7-9, 2014.

Exclusion Criteria:

N/A
Early Oral Intake After Pancreaticoduodenectomy in the Age of ERAS

Early oral intake after Pancreaticoduodenectomy is recommended strongly according to the ERAS guideline, which was based on studies in patients with gastrointestinal cancer, mainly colorectal and gastric. Specific clinical study on early oral intake after PD is very limited. inadequate nutritional intake was significantly associated with a high incidence of postoperative complications. Therefore, the present study is aim to evaluate the tolerance, safety, and efficacy in the patients undergoing PD in the age of ERAS.

Enhanced Recovery After Surgery (ERAS) is an interdisciplinary, multimodal concept and has become an important focus of Pancreaticoduodenectomy procedures following universal accepted and practice in gastrointestinal and colorectal surgeries. Early oral diet without restrictions after operation is recommended strongly according to ERAS guideline. However, several studies demonstrated that only half validated the true practice of the postoperative oral diet. Furthermore, Oral intake tolerance after PD is controversial. Only 23% of patients were able to take solid food at day 3. It appears that adequate nutritional intake only via oral diet is a severe challenge. Besides, Studies showed that insufficient amount of dietary intake was significantly associated with extended duration of postoperative hospitalization and parenteral nutrition. Importantly, Specific clinical study on early oral intake after PD is very limited. Therefore, the present study is aim to evaluate the tolerance, safety, and efficacy in the patients undergoing PD in the age of ERAS.

Eligibility Criteria:
Inclusion Criteria:

* Periampullar carcinoma
* Pancreaticoduodenectomy
* ERAS protocol implemented

Exclusion Criteria:

* Preoperative Radiotherapy/chemotherapy
* Unresectable primary cancer
* Palliative surgery
* New York Heart Association class\>3
Postoperative Pain Course After Uvulopalatoplasty

The aim of this study is to determine the postoperative course including effects on the quality of life following soft palate surgery with radiofrequency knife (RAUP).

For the treatment of social snoring one common treatment modality is the surgical reconstruction of the soft palate. The procedure is a routine operation performed at nearly all Ear-Nose- and Throat departments in Norway. The surgery is done with local anaesthesia in an out-patient setting where the patients' postoperative observation at the hospital is limited to 1-2 hours. As the surgery is done in the sensitive mucosa and palatopharyngeal musculature the postoperative course might be unpleasant. The patients are therefore in the need of regular postoperative pain treatment extending into the 2 first weeks after surgery.

At hospitals the uvulopalatoplasty is performed using a radiofrequency knife (RAUP) after the soft palate has been infiltrated with local anaesthesia (1% xylocain/adrenaline). The incision is done paramedialy to the uvular base and up into the musculature of the soft palate then making a smooth arch toward the pharyngeal tonsil upper limit. The then elongated uvula is amputated to about ½ cm. Occasionally, a suture is placed laterally and medially to lift the palate and prevent postoperative scaring. Coagulation is done if necessary with light bipolar diathermy.

As the postoperative course might be unpleasant after RAUP it is of interest to study the time course and intensity of pain after surgery when using the standardised postoperative pain treatment at OmniaSykehuset. The result will be useful in future studies looking at ways to improve the pain treatment after uvulopalatoplasty.

Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex of Caucasian origin who are referred to the hospital for snoring that have been subjected to a sleep study indicating that uvulopalatoplasty might have a considerable affect on the snoring.

Exclusion Criteria:

* Chronic drug treatment (except birth control medication) with analgesics, anti-inflammatory treatment (both steroidal (SAIDs) and non-steroidal anti-inflammatory drugs (NSAIDs)) apart from standard postoperative analgesic treatment administered by the operator.
* Patients with diabetes.
* Patients who due to age or communication skills are considered unable to complete patient forms.
* Professional evaluation suggests an alteration of the planned surgical area or treatment form.
* Known or assumed intolerance or hyper sensibility to diclofenac, codeine or paracetamol (standard postoperative analgesic treatment).
* Consumption of alcohol in the period from 2 days before or until the end of the primary observation period (postoperative days 0-7
Investigation of Novel Immunological Biomarkers by Mass Cytometry in Patients With Early Multiple Sclerosis (CISCO)

The objective of CISCO is therefore to identify prognostic biomarkers of MS activity in early-stage patients.


Eligibility Criteria:
Patients :

Inclusion Criteria:

* Patients with clinically isolated syndrome (CIS) participating in the OFSEP cohort (French MS Observatory)
* At least 18 years of age
* Diagnosed with MS according to criteria 2017 at the time of their last visit.
* Non-opposition to participation in the study
* Having had at least one visit in the year following collection
* Follow-up for at least 1 year after collection.
* Having signed the OFSEP consent

Exclusion Criteria:

* CIS patients with progressive MS

Healthy volunteers :

Inclusion Criteria:

* Age 18 years or older
* Having participated in the ABCD-SEP clinical trial promoted by the Rennes University Hospital (NCT03744351).
* Matched on age and sex to patients of interest in the OFSEP cohort
* Not having objected to participation in the study

Exclusion Criteria:

* Persons of full age subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty
Organization in Acute Atrial Fibrillation Post Open Heart Surgery

A form of irregular heart rate called, Atrial Fibrillation (AF) is a major clinical problem. It afflicts about 2 million Americans and is the single largest heart related cause of stroke. However, despite 120 years of speculation and research, the mechanisms that cause AF are poorly understood. Acute AF is also the most common irregular heart rate after open-heart surgery in patients. This is seen in as many as 30% of such patients and often results in a longer hospital stay.

In this study we would like to study the pattern of atrial fibrosis (scar tissue in the heart) and an associated blood marker (a protein called pro-collagen-1) in those patients concurrently having open heart surgery.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age, Male or Female
2. Able to provide consent
3. Cardiac surgery, CABG of Valve replacement or repair.

Exclusion Criteria:

1. If AF terminates within 1 hour of initiation.
2. If the patient undergoes electrical cardioversion and/or receives digitalis within the first hour of inclusion.
3. If the patients and/or their family or the primary caregiver choose to be excluded from the study anytime, even after the initial 24-hour period.
4. If the patient expires within 1 hour of inclusion into the study. -
Assessment of a New Resin-based Composite Filling Material

Evaluation of a new resin-based composite material.

Amalgam and composite are the most commonly used restorative materials in dentistry. Due to the toxicity of mercury and the subsequent environmental problems, the search for alternatives continues and search into new composite restorative materials intensifies. The presently available composites have improved, but shrinkage of the composite during the curing procedure is still a clinical problem. A new composite restorative material has among other advantages demonstrated lower shrinkage in laboratory studies, due to a new formulation of the material.

This project aims to study the clinical performance of this new composite compared to a commonly used composite restoration material. 72 patients (158 teeth) are allocated to the project which is carried out at the School of dentistry, University of Aarhus, Denmark.

This project aims to study the clinical performance of a new composite restoration material (Filtek Silorane®) compared to a conventional composite restoration material (Ceram X®).

Amalgam and composite are the most commonly used restorative materials, with the number of composite restorations increasing over the past 20 years. Composite restorative materials have improved considerably over the years. They have almost reached the same resistance to wear as amalgam, and are as a consequence now also used for molar restorations.

The main reasons for replacing composite restorations are fractures and caries associated with the restorations.

To reduce the risk of caries a new composite material Filtek Silorane® with reduced polymerization shrinkage has been developed.

Extensive laboratory studies have been performed on the new material, but the clinical attributes have yet to be disclosed.

The study will be carried out as a randomized, double blinded, longitudinal study, with assessment of the restorations after one year.

The project includes 72 patients, 158 teeth. Most of the patients have been recruited from the Treatment Planning Clinic at the dental school in Aarhus. After giving their consent to take part in the study, the teeth are randomized into two treatment groups. Multi surface restorations of both upper and lower molars and premolars are performed

The treatment procedure is:

The patients are offered local anesthetic before treatment start. The cavity is excavated and filled according to the guidelines for composite restorations. An impression of the cavity is taken before and after it has been filled. After treatment bw-radiographs are taken.

The control procedure is:

The restoration is evaluated according to marginal adaptation, cavo surface marginal discoloration, approximal contact, fractures, caries associated with restorations and postoperative hypersensitivity. The controls will take place after three weeks and one year.

Eligibility Criteria:
Inclusion Criteria:

* Patients registered for treatment with a posterior multi surface composite restoration.

Exclusion Criteria:

* Poor oral hygiene or teeth needing endodontic treatment.
Subcision With PRP and Microneedling Versus Subcision With Saline and Micro-needling in Treatment of Posttraumatic Scars

Compare different minimally invasive approaches to reach optimum improvement by comparing the efficacy and safety of both combined subcision with platelet-rich plasma and microneedling versus combined subcision with saline and microneedling in the treatment of post-traumatic scars.

The scars at the level of the skin represent a normal and inevitable process of healing traumatic or surgical lesions, but except for the appearance of the skin, they also have a profound psychological impact . Thus, people with scars try to integrate them into their sense of self to gain psychological acceptance .

Many treatment options have been developed for the management of traumatic scars .Surgical intervention is an invasive technique, surgery has a high risk of inducing new scar formation .

Non-surgical approaches for the treatment of traumatic scars include topical treatments and minimally invasive approached as subcision,microneedling and laser.

Autologous platelet-rich plasma is plasma with a higher concentration of platelets than normally found, it can enhance wound healing which has been demonstrated in controlled studies for soft and hard tissues . The application of autologous platelet-rich plasma to surgical wounds has been shown to accelerate tissue repair and reduce postoperative pain .

Subcision is a procedure in which a needle is inserted under the skin and passed in multiple directions . Although subcision is adequate as a stand-alone treatment, improved results are achieved when it is combined with other modalities.

Microneedling is a percutaneous collagen induction therapy that causes skin resurfacing. It involves using fine needles to create controlled microdermal injuries starting a complex cascade of growth factors that end in collagen remodeling .

Because of the different treatment options available for this common problem, the current work aimed to combine and compare different minimally invasive approaches to reach optimum improvement.

Eligibility Criteria:
Inclusion Criteria:

* Patients with posttraumatic scars
* Age more than 12 years

Exclusion Criteria:

* Patients with platelet or blood clotting disorders, and chronic liver or autoimmune diseases.
* Patients with chronic debilitating diseases, uncontrolled systemic infection, or keloid tendency or with unrealistic expectations.
* Pregnant females.
* Patients who did not complete the treatment sessions or the follow-up period.
Usefulness of Exhaled NO in the Differential Diagnosis Acute Eosinophilic Pneumonia and Bacterial Pneumonia

Acute eosinophilic pneumonia (AEP) is diagnosed by cell count analysis of bronchoalveolar lavage fluid. However, the performance of bronchoscopy is not easy for patients with AEP, because they usually have hypoxia. Exhaled nitric oxide (FeNO) is usually elevated in the patients with eosinophilic inflammation such as asthma, but there is no previous studies FeNO in the patients with AEP. Investigators hypothesized that FeNO elevated significantly in patients with AEP, and FeNO can be used as non-invasive diagnostic method in patients who are clinically suspected with AEP, especially when the performance of bronchoscopy is difficult.


Eligibility Criteria:
Inclusion Criteria:

* All patients who visited the study hospital with bilateral pneumonic infiltration.

Exclusion Criteria:

* Patients who do not agree with our study protocol
Cognitive Effects of Mint Essential Oil

This study investigates the cognitive and mood effects of mint essential oils in a group of healthy, human adults. The investigational product will also be tested in vitro to ensure a number of biological mechanisms.

The volatile components of essential oils (e.g. sage, lemon balm and rosemary)are found to exert a number of psychotropic effects and the monoterpenes in particular seem to be responsible for the cognitive and mood effects attributed to them.

The current study aims to investigate the cognitive and mood effects of mint essential oil in humans and to ensure the efficacy of the investigational product by conducting in vitro analysis on central nervous system receptor binding properties.

This will be achieved by analysing gamma-Aminobutyric acid A (GABAA), neuronal nicotinic and N-methyl-D-aspartate receptor (NMDA) glutamate receptor binding efficacy, acetylcholinesterase (AChE) inhibition, and gas chromatography-mass spectrometry (GC-MS) analysis will quantify % Limonene, % Carvone, % Menthone and % Menthol levels in the investigational treatment.

Cognitive and mood assessment will be via a randomised, placebo controlled, crossover design in 24, healthy adults aged between 18-35 yrs which will involve x1 training and x3 testing visits to the lab (placebo, 50 (micro Litre) μL and 100 μL Mentha piperita essential oil).

Eligibility Criteria:
Inclusion Criteria:

* 18-35 yrs
* Free from illicit drugs, alcohol, prescription medication (apart from contraception in the case of women) and herbal extracts/food supplements at each assessment.

Exclusion Criteria:

* Head injury, neurological disorder or neuro-developmental disorder
* English not 1st language (or not equivalent to a native English speaker)
* Relevant food allergies/intolerances or digestive problems
* Smokes tobacco
* Drinks excessive amounts of caffeine (more than 600mg day as assessed by a caffeine consumption questionnaire)
* Takes illicit social drugs
* Pregnant, seeking to become so, or breast feeding