cyrilzakka/clinical-trials huggingface dataset:
Cognitive and Memory Function in Patients With Fibromyalgia

Patients suffering from Fibromyalgia will be examined for the presence of memory and/or cognitive impairment using specific psychological tests.

Their results will be compared to those with active RA associated with pain and with a normal control group.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from fibromyalgia patients suffering from active RA

Exclusion Criteria:

* Patients with depressive disorders Patients treated with SSRI
Safety And Efficacy Of Tofacitinib In Patients With Refractory Myasthenia Gravis: A Pilot Study

This is a 6 month study that will evaluate the efficacy of 5mg tofacitinib tablet taken twice a day in patients with refractory myasthenia gravis. Twenty adult participants will receive a four month treatment of tofacitinib followed by elution for one month.


Eligibility Criteria:
Inclusion Criteria:

* fluctuating muscle weakness and fatigability classified as the Myasthenia Gravis Foundation of America (MGFA) clinical classification Type IIa-IVa;
* more than 10% amplitude decrement in low frequency repetitive nerve stimulation, and less than 10% amplitude increment in high frequency repetitive nerve stimulation;
* understanding and assigning the informed consent form, and having a good compliance with treatment.

meet all of the criteria in above as well as at least one of the below:

* refractory: insufficient response to full dose- and course- steroids treatment (0.75-1mg per kg per day for at least 3-6 months), failure to respond adequately to tacrolimus (no less than 3mg per day) for 3 months;
* severe or intolerable adverse effects from conventional immunosuppressive therapy.

Exclusion Criteria:

* positive for muscle-specific kinase (MuSK) antibodies;
* a tumor history except for thymoma;
* a history of Type B and Type C hepatitis;
* a history of tuberculosis or T-SPOT.TB tset positivity;
* hepatic, renal and cardial insufficiency (baseline: ALT/AST\>50U/L;BNP\>200pg/ml）;
* severe allergy or infection, or chronic or recurrent infection;
* pregnancy;
* hyperlipidemia;
* participating other clinical trials
Accuracy of the Drager Dual-sensor Temperature Measurement System

Our primary hypothesis is that the Draeger dual-sensor temperature monitoring system, used at the forehead, is sufficiently accurate compared to tympanic, bladder or esophageal temperature and oral temperature for routine clinical use during hypothermic conditions, as well as during fever.

We will include patients undergoing general anesthesia or regional anesthesia. The temperature recorded by Draeger dual-sensor monitoring system will be obtained at 5-minute interval.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing trauma surgery with general anesthesia
* Patients undergoing orthopedic surgery with regional anesthesia

Exclusion Criteria:

* Younger than 18 or older than 80 years of age
* Have a pre-existing nasogastric tube
* Require bispectral index monitoring
* Upper esophageal disease
* Forehead rash or infection
* Oral infection or trauma
* Ear infection or drainage
A Study Investigating the Predictive Value of Philadelphia Positive Stem Cell Properties in Newly Diagnosed Patients With Chronic Myeloid Leukemia in Chronic Phase Receiving Treatment With Imatinib

Imatinib (IM) is first-line treatment for patients with newly diagnosed CML in chronic phase. The drug is associated with high rates of cytogenetic responses with minimal toxicity in approximately 80% of patients. In 20% of patients however, the disease is either initially unresponsive to IM (Imatinib), resistance develops within a few months, or blast crisis occurs early and unexpectedly following an initial response. An increasing body of clinical evidence indicates that single agent molecularly targeted therapy (as in Gleevec/Imatinib) will not cure most patients with CML, as molecular remissions are rare. There is currently no clinically useful predictive tests to identify AT DIAGNOSIS those patients who are destined to be IM failures. The authors of this study have recently demonstrated that CML stem/progenitor cells are biologically insensitive to IM and are also genetically unstable and rapidly generate IM-resistant mutants in vitro and in vivo. The team recently discovered that the CD34 stem/progenitor cells of newly diagnosed CML patients who subsequently fail to respond to IM treatment show a reduced response to IM and a higher frequency of BCR-ABL mutations by comparison of 14 IM non-responders with 11 IM-responders. If this finding can be validated in a larger prospective cohort of patients, this predictive test could be used to more rationally design treatment plans with early addition of alternative therapies ie: Dasatinib or combination therapies for patients according to their individual risk profiles.

Hypothesis:

The clinical response of newly diagnosed chronic phase CML patients to IM can be predicted by certain biological properties of their CD34 stem/progenitor cells which are variable among patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CML in chronic phase.
* ECOG \<2.
* Normal organ function and ULN Total bili, AST and ALT.
* Must have the ability to understand and sign a written consent form

Exclusion Criteria:

* Patients may not be receiving any other investigational agents.
* May not have prior treatment with Imatinib, Dasatinib, Nilotinib or other tyrosine kinase inhibitors.
* Patients must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant or nursing mothers
* Patients must have no prior malignancies except for; adequately treated non-melanoma skin cancer, cervical carcinoma-in-situ, adequately treated Stage I or II cancer from which the patient is in complete remission, or any other cancer from which the patient has been disease free for 5 years
Safety and Feasibility of Remote Ischemic Conditioning on Prehypertension and Early-stage Hypertension

Nowadays, the incidence of stroke in China has reached 1.6‰, and this disease has become a primary cause of death in China. One of its major risk factors is hypertension. As shown in the researches, the risk of stroke grows remarkably when the blood pressure increases and there exists a log-linear relationship between them. Systolic pressure and diastolic pressure relate to the risk of stroke independently. Systolic pressure decreasing 10mmHg will reduce the stroke risk by 31% and a decrease of 1\~3mmHg will reduce the stroke risk by20\~30%. As to diastolic pressure, a 5mmHg decrease will reduce the stroke risk by 34% and a 10mmHg decrease will reduce the stroke risk by 56%.In addition, patients with isolated systolic hypertension (SPB≥160mmHg, DPB≤90mmHg) or critical isolated systolic hypertension (SPB=140\~159mmHg, DPB\< 90mmHg) will suffer a higher risk of stroke than people with normal blood pressure. The ACC has already revised its Hypertension ManagementGuidelines of the standard of diagnosis for hypertension and the timing of starting medical treatment in hypertensive patients. Because more and more researches shown that people with blood pressure between 120-139/80-89mmHg have higher risk of ASCVSD compared to those with blood pressure lower than120/80mmHg; However, in China, the diagnostic criteria for hypertension has not been revised yet. Therefore, we still have a blind spot in treating such patients who suffer from borderline systolic hypertension at 130\~140 mmHg of blood-pressure with or without ASCVD or those with the first stage hypertension but refusing to take anti-hypertension drugs. What is more, most of them are middle-aged adults, once they have a stroke, it would lead to terrible and costly consequences to both their family and society. Thus, it is necessary to explore new non-pharmacological methods to control blood pressure for reducing the risk of stroke


Eligibility Criteria:
Inclusion Criteria:

* systolic blood pressure between 160 and 125 mmHg or diastolic blood pressure between 80 and 100 mmHg
* age≥18
* essential hypertension
* patient did not take anti-hypertensive medicine regularly

Exclusion Criteria:

* patients with severe uncontrolled diabetes
* contraindication for remote ischemic preconditioning
* life expectancy less than 1 year
* patients with atrial fibrillation or other kind of arrhythmia
* unwilling to be followed up or poor compliance.
Stem Cell Ophthalmology Treatment Study

This study will evaluate the use of autologous bone marrow derived stem cells (BMSC) for the treatment of retinal and optic nerve damage or disease. http://mdstemcells.com/scots-ii/

Eyes with loss of vision from retinal or optic nerve conditions generally considered irreversible will be treated with a combination of injections of autologous bone marrow derived stem cells isolated from the bone marrow using standard medical and surgical practices. Retinal conditions may include degenerative, ischemic or physical damage ( examples may include macular degeneration, hereditary retinal dystrophies such as retinitis pigmentosa, stargardt, non-perfusion retinopathies, post retinal detachment. Optic Nerve conditions may include degenerative, ischemic or physical damage ( examples may include optic nerve damage from glaucoma, compression, ischemic optic neuropathy, optic atrophy ). Injections may include retrobulbar, subtenon, intravitreal, intraocular, subretinal and intravenous. Patients will be followed for 12 months with serial comprehensive eye examinations including relevant imaging and diagnostic ophthalmic testing.

Eligibility Criteria:
Inclusion Criteria:

* Have objective, documented damage to the retina or optic nerve unlikely to improve OR
* Have objective, documented damage to the retina or optic nerve that is progressive
* AND have less than or equal to 20/40 best corrected central visual acuity in one or both eyes AND/OR an abnormal visual field in one or both eyes.
* Be at least 3 months post-surgical treatment intended to treat any ophthalmologic disease and stable.
* If under current medical therapy ( pharmacologic treatment) for a retinal or optic nerve disease be considered stable on that treatment and unlikely to have visual function improvement ( for example, glaucoma with intraocular pressure stable on topical medications but visual field damage ).
* Have the potential for improvement with BMSC treatment and be at minimal risk of any potential harm from the procedure.
* Be over the age of 18
* Be medically stable and able to be medically cleared by their primary care physician or a licensed primary care practitioner for the procedure. Medical clearance means that in the estimation of the primary care practitioner, the patient can reasonably be expected to undergo the procedure without significant medical risk to health.

Exclusion Criteria:

* Patients who are not capable of an adequate ophthalmologic examination or evaluation to document the pathology.
* Patients who are not capable or not willing to undergo follow up eye exams with the principle investigator or their ophthalmologist or optometrist as outlined in the protocol.
* Patients who are not capable of providing informed consent.
* Patients who may be at significant risk to general health or to the eyes and visual function should they undergo the procedure.
The Effects of Methadone and Buprenorphine on Fetal Neurobehavior and Infant Neonatal Abstinence Syndrome - 1

The purpose of this study is to evaluate the effects of drugs used by treatment providers on the fetuses and infants of opiate dependent women. The subjects in this study are women enrolled in a large, multi-site, double blind study that looks at the effects of methadone and buprenorphine treatment during pregnancy. This study will evaluate fetal and maternal biophysiologic data longitudinally during pregnancy to determine how these substances may affect fetal neurobehavior. Additionally, infant neurobehavioral assessments and measurements of infant vagal tone will be collected to see how methadone and buprenorphine differentially affect the neonatal abstinence syndrome, or "withdrawal" in exposed neonates.

Previous research by this group has found that methadone treatment during pregnancy directly impacts fetal neurophysiology independently of maternal physiology. Buprenorphine is a new therapy for opiate dependent individuals, and its use during pregnancy is currently being evaluated. Some research has shown that buprenorphine lessens the neonatal abstinence syndrome when compared to methadone. Thirty methadone and 30 buprenorphine maintained women will be evaluated at 24, 28, 32 and 36 weeks gestation using a state-of-the-art computerized fetal actocardiograph and data analysis program to simultaneously evaluate fetal movement and heart rate and maternal physiologic parameters. Investigators will be blinded to treatment group. Longitudinal neurodevelopment of the fetuses in each group will be explored. The differential effects of methadone and buprenorphine on the neonatal abstinence syndrome will also be explored.

Eligibility Criteria:
Inclusion Criteria:

* generally healthy opiate dependent women
* currently enrolled in the study "Maternal Opioid Treatment, Human Experimental Research study
* uncomplicated singleton pregnancies

Exclusion Criteria:

* complications of pregnancy, including HIV, diabetes, polyhydramnios, hypertension, preterm labor or placenta previa
* evidence of fetal malformation
* significant maternal health problems, including HIV infection
* significant maternal psychopathology that would preclude informed consent, including schizophrenia
* alcohol dependency per DSM IV criteria
Efficacy and Safety of a 'Graft/Prosthesis, Biomaterial (DKM410)' in the Treatment of Both Nasolabial Folds

The purpose of the study is to assess the efficacy and safety of a 'Graft/prosthesis, biomaterial (DKM410)' in the treatment of both nasolabial folds.


Eligibility Criteria:
Inclusion Criteria:

1. Age 19 years and older
2. Wrinkle Severity Rating Scale (WSRS) 3 or 4
3. Visually symmetrical bilateral nasolabial folds
4. Agreed not to use any dermatological treatment and wrinkle-improving functional cosmetics.
5. Voluntarily decided to participate in the study and signed the informed consent form
6. Willing to follow the protocol

Exclusion Criteria:

1. History of undergoing a permanent or semi-permanent filler treatment on the face
2. Received soft tissue augmentation using HA filler or collagen for nasolabial folds within 18 months from screening.
3. Received any surgery or laser treatment, chemical filling, heart attack, or Botox injection within 24 weeks from the screening
4. History of allergic reactions to Hyaluronic Acid or Gram-positive bacteria protein
5. Hypersensitivity to Lidocaine or amide local anesthetic
6. Positive for the intradermal response test
7. History of severe or plurality of allergies
8. Having skin inflammation or infection in nasolabial folds
9. History of keloid formation, hyperpigmentation, or hypertrophic scars on the face.
10. History of streptococcal disease
11. Uncontrolled epilepsy
12. Porphyria
13. Having or being currently suffering from autoimmune diseases
14. History of immunodeficiency or immunosuppressive drugs
15. History of herpetic eruption
16. Having bleeding disorder or blood clotting disorder
17. Having anticoagulant drugs or components within 72 hours from the application of medical advice
18. Received antiplatelet drugs within 2 weeks from the application of medical advice
19. Having high dose vitamin E or nonsteroidal anti-inflammatory drugs (NSAIDs) and high dose vitamin C within one week from the application of medical advice
20. Received drugs that inhibit or decrease liver metabolism
21. Clinically significant abnormalities on electrocardiogram
22. Pregnant or breast-feeding or who planning to conceive
23. Clinically severe cardiovascular, digestive, respiratory, endocrine, central nervous system disorders or mental illness
24. Other investigational products or procedures within 3 months from screening
25. Not eligible due to other reasons at the investigator's discretion
The Effect of Inferior Alveolar Nerve Block in Fracture Mandibular Surgeries

The aim of the study is to assess the efficacy of adding of pre-emptive inferior alveolar nerve block compared to the conventional systemic intravenous analgesia in controlling perioperative pain in fracture mandibular surgeries.

Opioid drug administration is a common technique to reduce pain from surgical trauma. However, the use of large doses of opioid drugs during and after surgery can be associated with an increased incidence of multiple side effects such as; ventilatory depression, sedation, nausea, vomiting, pruritus, difficult voiding and ileus.

In maxillofacial surgeries in which patients often receive maxillomandibular fixation these side effects are troublesome to the patient and at worst case scenario can cause a life-threatening complications. Ventilatory depression and vomiting are the most serious side effects especially in early postoperative hours. Various methods have been proposed to minimize these side effects. Nerve block with long-acting local anesthesia is a proposed technique in this regard.

In maxillofacial operations, bupivacaine is a highly efficient long-acting local anesthetic and has been used as a safe local anesthetic for neuroanalgesia after cleft lip operation or third molar surgery alone or in combination with low-power laser and diclofenac.

Inferior alveolar nerve block is considered as gold standard for sensory block of the hemi mandible. It can provide adequate anesthesia and analgesia for one side of the mandibular teeth and gingival mucosa, the body and inferior ramus of the mandible, the anterior two-thirds of the tongue and floor of the mouth cavity.

The inferior alveolar nerve (IAN) block is a widely used regional anaesthetic nerve block for the mandible. The most commonly used technique for IAN block is called the direct approach which include inserting the needle into the pterygomandibular raphae by penetrating the buccinators muscle. Once in this space, the aim is to inject the local anaesthetic solution besides the inferior alveolar nerve before it enters the mandibular foramen.

Eligibility Criteria:
Inclusion Criteria:

1. Age group: 18 - 65 years old.
2. American Society of Anesthesiologists (ASA) Physical Status Class I to III
3. Scheduled for fracture mandible fixation.

Exclusion Criteria:

1. Refusing to participate in the study.
2. History of allergy to the medications used in the study.
3. Contraindications to regional anesthesia (including coagulopathy and local infection).
4. Psychiatric disorders.
5. Pregnancy.
Bioavailability of Phenolic Compounds in Bread

The consumption of wholemeal cereals has been associated with the reduction of several chronic diseases. The mechanisms behind these protective effects may be linked, besides dietary fiber and micronutrients, to an increased intake of phenolic compounds, mainly, hydroxycinnamates contained in the bran. Among bran fractions, aleurone usually contains the highest concentration of ferulic acid, principally contained as monomeric form and diferulic acid esters linked to arabinoxylans, representing the most relevant subclasses. The aim of the study was to evaluate the absorption of hydroxycinnamates by measuring the urinary excretion of phenolic metabolites in humans fed with two different kind of a commercial bread, as wholegrain bread and a white bread enriched with aleurone fraction. Moreover, the pharmacokinetics of the main phenolic compounds was also evaluated by measuring the circulating metabolites in plasma samples.


Eligibility Criteria:
Inclusion Criteria:

* BMI 18-25 kg/m2

Exclusion Criteria:

* Pregnancy and breastfeeding
* diagnosis of celiac disease
* diagnosed methabolic diseases (diabetes and disorders of glycaemic control, hypertension, dyslipidemia)
* sustained use of nutritional supplements of vitamins, in particular E and C, at the recruitment step
* chronic pharmacological therapy
* antibiotic therapy during the last 40 days
Pharmacokinetic, Safety and Tolerability Study of Aclidinium/Formoterol Fixed Dose Combination and Formoterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this Phase II study is to evaluate the pharmacokinetics, safety, and tolerability of aclidinium/formoterol fixed dose combination (FDC 400/12 μg via the Almirall Inhaler and formoterol 12 μg via the Foradil® Aerolizer®, both administered twice daily for five days to patients with moderate to severe COPD.


Eligibility Criteria:
Inclusion Criteria:

* Current or former cigarette smokers with a cigarette smoking history of at least 10 pack-years
* A diagnosis of stable moderate to severe COPD and stable airway obstruction as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines and stable airway obstruction.

Exclusion Criteria:

* Patients who have been hospitalized for an acute COPD exacerbation within three months prior to Screening
* Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks before Screening
* Patients with any clinically significant respiratory conditions other than COPD
* Clinical history that suggests that the patient has asthma as opposed to COPD
* Chronic use of oxygen therapy ≥ 15 hours/day
* Patients with clinically significant cardiovascular conditions
* Patients with a history of hypersensitivity reaction to inhaled anticholinergics, beta-2 agonists, sympathomimetic amines, or inhaled medications