cyrilzakka/clinical-trials huggingface dataset:
The Role of TLR4 on Lipid-induced Insulin Resistance

The purpose of this study is to determine whether pharmacologic inhibition of Toll-like receptor 4 (TLR4) with eritoran for injection (E5564) prevents lipid-induced insulin resistance in lean, normal glucose tolerant (NGT) subjects.

E5564 = Eritoran

Eligibility Criteria:
Inclusion Criteria:

* Subjects capable of giving informed consent.
* lean (BMI \<26 kg/m2)
* normal glucose-tolerant subjects (completers) without a family history of Type 2 diabetes mellitus (DM)
* Both genders. (50% males)
* Age = 18-65 years. Older subjects are excluded because aging is a pro-inflammatory state.
* All ethnic groups
* Premenopausal women in the follicular phase, non-lactating, and with a negative pregnancy test. Postmenopausal women on stable dose of or not exposed to hormone replacement for \>=6 months.
* Lab: Hematocrit \>=34%, serum creatinine \<=1.4 mg/dL, normal electrolytes, urinalysis, and coagulation tests. Liver function tests up to 2x normal range.
* Stable body weight (+/-1%) for \>=3 months.
* One or less sessions of strenuous exercise/wk for last 6 months.

Exclusion Criteria:

* Presence of diabetes or impaired glucose tolerance based on ADA criteria;
* Current treatment with drugs known to affect glucose and lipid homeostasis. Subjects on a stable dose of statin (\>3months) are eligible.
* Non-steroidal anti-inflammatory drugs or systemic steroid use for more than 1 week within 3 months.
* Current treatment with anticoagulants (warfarin). Aspirin (up to 325 mg) and clopidogrel will be permitted if these can be held for seven days prior to the biopsies.
* History of heart disease (New York Heart Classification greater than class II; more than non-specific ST-T wave changes on the ECG), peripheral vascular disease, pulmonary disease, smokers.
* Poorly controlled blood pressure (systolic BP\>160, diastolic BP\>90 mmHg).
* Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and psychiatric disease.
Repeatability and Reproducibility of the ADC Map in Head and Neck Cancer. Prospective Multicenter Study

Evaluation of the repeatability and reproducibility of ADC maps in both primary and non-primary lesions lymph nodes in patients with head and neck cancer, using an acquisition protocol Standardized DWI

DWI imaging consists of a spin-echo echo-planar sequence (SE-EPI) that will be acquired with 1.5 T or 3 T tomographs according to the equipment of the individual centers involved, setting the acquisition parameters after the administration of any contrast medium.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 years;
* primary squamous cell carcinoma (SCC) of the hypopharynx, oropharynx, or oral cavity; confirmed by histology;
* a lesion visible on at least three consecutive DWI images, with a minimum diameter of 2 cm;
* specific written informed consent;

Exclusion Criteria:

* incomplete acquisition of DWI images;
* presence of artifacts that do not allow quantitative analysis of DWI images;
* performance status 2 or more according to Zubrod.
Ulipristal Acetate In Disease Charcot-Marie-Tooth Type of 1A

The disease Charcot-Marie-Tooth disease type 1A (CMT1A) is the most common inherited peripheral neuropathy, for which no treatment has proved its effectiveness. It is autosomal dominant, associated with a duplication of the chromosome 17p11.2 region which leads to overexpression of the gene and the protein-peripheral myelin protein-22 (PMP22), a major component of peripheral myelin.

In animals and humans, PMP22 mRNA level of glutathione S-transferase theta 2 and Cathepsin A (markers of oxidative stress), detected in a skin biopsy are markers that may play a role in the prognosis evolution of the disease. Furthermore, several studies have shown that the administration of progesterone increased the expression of PMP22 gene (measured in a skin biopsy) and worsening symptoms. In contrast, anti-progestins reduce the synthesis of PMP22 and improve symptoms in rat CMT1A.

The long-term safety of anti-progesterone was evaluated for mifepristone (RU486) ulipristal acetate and (EllaOne®). Few side effects have been reported including a few cases of endometrial hyperplasia reversible upon discontinuation of treatment. With the RU486, rare cases of adrenal androgen and failure have been observed. However, EllaOne® has low antagonistic action on the glucocorticoid receptor and no action on androgen receptors. The investigators therefore believe that it will be well tolerated in humans and will reduce the synthesis of PMP22 and the action of oxidative stress by improving disability of patients.


Eligibility Criteria:
Inclusion Criteria:

* Male 18-70 years
* CMT1A proven genetically (17p11.2 duplication)
* symptomatic CMT1A (MRC score \<5 in at least one muscle group)
* Non severe axonal impairment (amplitude of the motor evoked potential on the median nerve and / or ulnar than 50% of normal)
* Subject contacted with a valid phone number
* Subject affiliated to a social security scheme
* Subject has been informed of the results of the medical examination prior

Exclusion Criteria:

* Another cause of neuropathy: Chronic alcohol intoxication, chemotherapy, diabetes, kidney failure, monoclonal gammopathy, cryoglobulin, B12 deficiency, hepatitis B / C, HIV, Lyme or poliomyelitis
* Liver failure
* Lapp lactase deficiency, malabsoprtion syndrome glucose / galactose
* Support long-term drug interacting with the CYP3A4
* Patients with indication against xylocaine adrenaline
* In the biopsy site: surgery, skin disease or local infection
* Immunosuppression innate or acquired
* Hypersensitivity to the active substance / excipient
* uncontrolled severe asthma
* Treatment with vitamin C or vitamin B3 in the four weeks preceding randomization
* Orthopaedic surgery of the lower limbs in the 6 months prior to randomization or planned
* Against indication xylocaine adrenaline
* Malfunction of the innate or acquired coagulation
Effect of Calisthenic Exercise Training Combined With Aerobic Exercise in Patients With Dyslipidemia

Dyslipidemia is expressed as the serum concentration of lipid molecules with different structures outside the normal level. Deviation of serum lipid level from normal is accepted as the primary or most important factor in various cardiac and metabolic diseases, especially atherosclerosis. Dyslipidemia-related cardiovascular structure change is accepted as an important public health problem worldwide, and it is stated that the combined use of medical treatment, changes in diet and physical activity/structured exercise programs in the treatment of dyslipidemia is important in the success of treatment.

Lipid profile disorders (especially high total blood cholesterol level) are a major problem worldwide, and accepted as a important public health problem. It has been reported that approximately one out of every three people worldwide has been exposed to dyslipidemia risk factors. Prevalence studies showed that lipid profile disorders vary between 6.9% and 43.6% worldwide. Today, ischemic heart and central nervous system diseases are the most important causes of mortality and morbidity in adult population, globally. Especially, it is accepted that lipid profile disorders are the leading risk factors causing ischemic heart diseases.

Prevalence varies according to regions, lifestyle habits and individual factors, because of lipid profile disorders are caused by many different genetic and environmental factors. Apart from individual factors, there are other factors that lipid weight in diet, nutrient deficiencies which balancing lipid metabolism, physical activity level and inactivity, other comorbid diseases, and medical treatments change lipid metabolism in individuals and lead to deterioration in lipid profile. Especially lifestyle habits affect lipid metabolism most easily and they are the most easily modifiable factors.

It is recommended to apply a multi-dimensional approach when treating lipid profile disorders. It is recommended that, to include diet counseling and exercise therapy in these approaches. Exercise therapy is especially recognized as an important treatment option for the control and treatment of obesity, hypertension, hyperglycemia and metabolic syndrome symptoms that may accompany dyslipidemia.

It has been reported that aerobic exercise programs increase patients' quality of life and functionality which applied to dyslipidemia patients, but there is lack of information available in literature about the effects of calisthenic exercises in patients with dyslipidemia.

Eligibility Criteria:
Inclusion Criteria:

* Screening by the internal medicine clinic with the diagnosis of dyslipidemia
* Being between 18 to 65 years old
* Volunteering to participate in the research

Exclusion Criteria:

* Having any cardiac disease
* Having a co-existing psychiatric illness (like schizophrenia, bipolar disorder, etc.)
* Being infected with COVID-19 in the last 3 months
* Having any neurological problems that may affect cooperation
* Having pulmonary or orthopedic problem that may affect functional capacity
China Obstetrics and Gynecology Journal Club

The purpose of this study is to determine if an intensive journal club based on articles and materials provided on the journal Obstetrics and Gynecology Website improves written and spoken comprehension of medical English in a population of Chinese medical professionals.

This will be a randomized educational trial of an intensive journal club compared to a self study journal club (1:1 randomization). Randomization will take place after baseline.

The population will consist of 50 medical professionals at Heilongjiang University in Harbin China, who agree to participate in an 8 week educational intervention.

This study will assess the impact of applying English for Specific Purposes(ESP) pedagogy to foreign medical education and specifically evaluate learning in the field of obstetrics and gynecology(Ob-Gyn). ESP is a subdivision of a wider field, Language for Specific Purposes(LSP), defined as the area of inquiry and practice in the development of language programs for people who need a language to meet a predictable range of communicative needs. ESP emphasizes teaching language in context and designs a curriculum around the results of a needs assessment, to more accurately determine which language skills are of priority: listening, reading, speaking, and writing. Part of the theory behind ESP suggests that being able to use the vocabulary and structures that students learn in a meaningful context reinforces what is taught and increases motivation. Further, findings from a study by Okamura (2006) that examined how learners succeed in mastering scientific discourse in English showed that they focused on reading academic texts in their field to learn typical writing patterns. This is as opposed to junior learners who focused on mastering the English language by reading English texts written by authors from a breadth of fields. This application of ESP thus reflects how content-specific source articles could serve as rhetorical models and suggests that source articles are able to mediate scholarly writing and learning within the zone of proximal developmental; that is, learners are simultaneously gaining new content knowledge while increasing their skill base.

The proposed intervention is to design an ESP curriculum for medical professionals, specifically Ob-Gyn physicians and researchers at a Chinese Medical University, based on the journal club format and source articles. The study will quantitatively assess the impact of this model on student's ESP language comprehension as well as determine the necessity of the traditional "facilitator" role for a journal club whose purpose is to foster language literacy in non-English speaking universities.

Eligibility Criteria:
Inclusion Criteria:

* Chinese medical professional

Exclusion Criteria:

* English speaking fluency
* Non-Chinese speaking medical professional
Active Living Tool Kit for Chronic Conditions

The development and pilot testing of a self-management program that would be delivered in a one time mailing.

The mailing will consist of (1) A self-test that will help users know how he or she can best use the materials and where to start; (2) A copy of the 2012 Living Healthy Life with Chronic Conditions book. If people are visually impaired or have low literacy an audio CD of the book will be available in place of the print copy; (3)An exercise CD with flexibility and strengthening exercises at three different levels of intensity, designed for people with chronic conditions; (4) A relaxation CD with three different relaxation exercises; and (5) In addition, there will be tip sheets, one for each major tool such as managing pain, managing sleep, etc. It is expected that there will be 10-20 tip sheets in total.

The key content of the self-test and the tip sheets will be developed surveying master trainers of the existing small-group Chronic Disease Self Management Program (100 active trainers) and asking about 500 additional trainers to rank importance of key content items generated in initial survey. Pilot testing of the program will be by 250 people with chronic diseases. Participants will be surveyed by mailed questionnaires at baseline and six-months. A subgroup with diabetes (estimated 25-30%) will be asked to submit hemoglobin A1C blood test kits at baseline and six months.

Eligibility Criteria:
Inclusion Criteria:

* Have a chronic health condition
* 18 years of age
* Literate in English
* (for the blood test subset): have type 2 diabetes

Exclusion Criteria:

* Taken the small group or online Chronic Disease Self Management Program or related programs
* under 18
* active cancer treatment
* pregnant
Clinical Study on the Treatment of Mixed Component Cornea for High Risk Keratoplasty

Because of the immunologically privileged nature of the cornea, the graft rejection rate is less than 10% for low-risk keratoplasty. But when the cornea performed 2 or more quadrants of corneal neovascularization after ocular trauma or infection, the graft rejection rate is more than 65%, it is called high-risk keratoplasty.

This study will observe the graft survival of high-risk corneal transplantation using mixed component cornea from different donors.

Ocular trauma or infection lead to corneal limbal stem cell deficiency and central corneal opacification which could only be treated by central penetrating keratoplasty and limbal transplantation, but the rejection rate is very high. In clinical, we found that limbal transplantation combined with central penetrating keratoplasty from different donors can keep the graft transparent for a long time, this result also be found in organ transplantation, multiple donor organ transplantation could reduce rejection risk in liver and kidney transplantation. Therefore, it is speculated that there are different MHC antigens from different donors, which cause different reactions after transplantation. Because there are a large number of Langerhans cells， abundant blood vessels and lymphatic in the limbal, so the rejection occurs early and severely. Continuous and intense limbal rejection leads to the depletion of recipient T cells, lead to the immune tolerance of another donor's central corneal tissue. In this project, central penetrating keratoplasty and limbal transplantation from different donors will be carried out and the graft survival of high-risk corneal transplantation will be observed in clinical, to find a new method for high-risk corneal transplant patients.

Eligibility Criteria:
Inclusion Criteria:

* Central corneal opacity involving full layer
* Corneal neovascularization in two or more quadrants
* Patients must be willing and able to return for scheduled follow-up examinations for 12 months after surgery
* Ages：18 -70 Years

Exclusion Criteria:

* Central corneal opacity not involving the endothelial layer
* Less than two quadrants of corneal neovascularization
* History of Stevens-Johnson syndrome or Sjogren's syndrome
* Severe eyelid and conjunctival scar
* Loss of vision in contralateral eye
* Pregnant and lactating women
Assess Efficacy and Safety of TachoComb H vs. Standard Surgical Treatment (i.e. Suturing) in Patients Undergoing Prostatectomy (TC-017-AU)

The overall objective is to compare efficacy and safety of TachoComb H versus standard surgical treatment for the control of local bleeding in patients undergoing prostatectomy. Specific objectives include the comparison between test treatments for intraoperative haemostatic efficacy as well as for post-operative blood loss to be assessed by haemoglobin and haematocrit concentration of drainage fluid.


Eligibility Criteria:
Inclusion Criteria:

1. has the subject given informed consent according to local requirements before any trial related activies? A trial related activity is any procedure that would not have been performed during the routine management of the subject.
2. Is the subject 18 years of age or above ?
3. Is the subject planned for a radical prostatectomy for prostate cancer (cT3)?

   After prostate resection and primary haemostatic treatment
4. is only minor (i.e. oozing) or moderate haemorrhage persisting after primary surgical haemostatic procedures of the major vessels (no pulsating arterial haemorrhage and/or major venous bleeding)?

Exclusion:

At pre-operative screen

1. Is there anamnestic or laboratory evidence of coagulation disorders including haemophilia A or B and von Willebrand disease ?
2. Has the patient a history of allergic reactions after application of human fibrinogen, human thrombin, bovine aprotinin and/or collagen of any origin?
3. Is the patient undergoing an emergency operation?
4. Did the patient participate in a clinical trial less than 30 days prior to inclusion in present trial?
5. Does the patient participate in a clinical trial concomitantly with present trial?

   After tumour resection and primary haemostatic treatment
6. Has any serious surgical complication occurred?
7. Has any fibrin glue haemostatic (including any type of TachoComb) been used before randomisation?
A Pilot Study for Ginkgolides Meglumine Injection Skin Testing.

This pilot study is designed to explore the optimal concentration and method of Ginkgolides Meglumine Injection skin testing and to evaluate the value of skin test in predicting any possible allergic reactions to Ginkgolides Meglumine Injection.

Subjects will be enrolled in one of three groups with different doses to receive skin prick testing. Then they may be arranged to receive intradermal, subcutaneous injection or intravenous tests with different doses.

Eligibility Criteria:
Inclusion Criteria:

* Male and female between the ages of 18 and 70(inclusive)at the time of signing the Informed Consent Form （ICF）.
* Subjects meet any one of the following requirements

  * No history of using any dugs containing bilobalide, Ginkgolide A, Ginkgolide B, Ginkgolide K (including Ginkgolides Meglumine Injection).
  * History of using any dugs containing bilobalide, Ginkgolide A, Ginkgolide B, Ginkgolide K (including Ginkgolides Meglumine Injection), and no allergy.
  * History of allergy to any dugs contain bilobalide, Ginkgolide A, Ginkgolide B, Ginkgolide K (including Ginkgolides Meglumine Injection).
  * History of allergy to any other drugs.
* Willingness to participate in the study as evidenced by signing the informed consent form.

Exclusion Criteria:

* Women in breastfeeding,menstrual or pregnancy period.
* Subjects are in the infectious disease, eczema, dermatitis, trauma,etc.
* Subjects meet any one of the following conditions

  * Used β-blockers within 2 days prior to starting this study.
  * Used H1 anti-histamines, imipramine, phenothiazine, Beta adrenaline etc. within 1 week prior to starting this study.
  * Used short-acting glucocorticoids drugs within 1 week prior to starting this study.
  * Topical used glucocorticoids drugs within 2 weeks prior to starting this study.
  * Used long-acting glucocorticoids drugs within 4 weeks prior to starting this study
* Subjects are currently participating or have participated in any other clinical trials within the prior 1 month of signing the ICF.
* Subjects have a history of allergic shock.
* Subjects who are not suitable for this clinical trial at the discretion of the investigator.
The Effect of Sumatriptan and Placebo on CGRP Induced Headache

To develop a pragmatic migraine model the investigators will induce headache in healthy volunteers and in patients with migraine without aura with aCalcitonine Gene Related Peptide (CGRP). If the headache responds to sumatriptan, the model can be used to test new drug candidates.

There remains a great need for more effective anti-migraine drugs with fewer side effects. Human experimental models are valuable in early phase development of new anti-migraine drugs but useful models have not yet been developed. The investigators' group has shown that Calcitonine Gene Related Peptide (CGRP) induce headache/migraine in both healthy volunteers and in patients with migraine without aura (MO). To validate this model, the headache must respond to specific migraine treatment with sumatriptan.

Hypothesis: CGRP induces a migraine-like headache in both healthy subjects and in MO-patients and induced headache responds to a specific anti migraine drug; sumatriptan.

Aim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs.

Eligibility Criteria:
Inclusion criteria:

Healthy:

Healthy subjects of both sexes Age 18-60 years Weight 45-95 kg. Females were requested to use effective contraception.

Migraine patients:

Migraine patients who meet IHS criteria for migraine with or without aura of both sexes 18-60 years 45-95 kg.

Exclusion Criteria:

Healthy:

Any type of headache (except episodic tension-type headache \< 1 day per week) Serious somatic or psychiatric disease Pregnancy Intake of daily medication (except oral contraceptives).

Migraine patients:

Any other type of headache then migraine without aura (except episodic tension-type headache \< 1 day per week) Serious somatic or psychiatric disease Pregnancy Intake of daily medication (except oral contraceptives) Triptan non-responders
A Clinical Study to Investigate How Solifenacin Fluid is Taken up, How Long it Stays in the Body and How Effective and Safe it is in Treating Children Aged From 6 Months to Less Than 5 Years With Symptoms of Neurogenic Detrusor Overactivity (NDO)

The purpose of this study was to evaluate long term efficacy and safety of treatment with solifenacin succinate (the study drug) in children with neurogenic detrusor overactivity after multiple dose administration.

In some children with a severe form of spina bifida (which is the consequence of a spinal cord defect), the bladder muscle (detrusor) contracts strongly and without warning (also known as neurogenic detrusor overactivity) and the urethra (the passage connecting the bladder with outside) does not relax. Though these children cannot void, urine leakage can happen when the overactive contractions are strong, and/or the pressure in the bladder is so high that it overcomes the closed urethra (overflow at high filling bladder pressure). This high bladder pressure puts these children at risk for kidney damage and can decrease the quality of the bladder. Therapy was aimed to decrease the high filling bladder pressure and the overactive detrusor contractions.

Eligibility Criteria:
Inclusion Criteria:

* Myelomeningocoele
* Documented diagnosis of NDO, confirmed by urodynamics
* DSD (detrusor sphincter dyssynergia)
* Practicing clean intermittent catheterization (CIC)

Exclusion Criteria:

* Know genitourinary condition (other than NDO) that may cause incontinence
* Bladder augmentation surgery
* Current faecal impaction
* Electro-stimulation therapy within 2 weeks prior to visit
* Subjects with the following gastro-intestinal problems: partial or complete obstructions, decreased motility like paralytic ileus, subjects at risk of gastric retention
* Reflux grade 3 to 5
* Current urinary tract infection