cyrilzakka/clinical-trials huggingface dataset:
Impact of Dairy Products on Postprandial Inflammation

The study will quantitatively evaluate the systemic, postprandial inflammatory and metabolic response to the ingestion of three different meals in obese subjects. The administered meals will differ in the proportion of dairy products. Postprandial response will be monitored during 6 hours after meal consumption.


Eligibility Criteria:
Inclusion Criteria:

* male
* BMI ≥ 20 kg/m2
* age 25-55 y
* informed consent

Exclusion Criteria:

* Physiological or psychological diseases
* Allergies to food or intolerance to high-fat meal
* Vegetarians
* Chronic intake of drugs
* Smokers
* Diabetes mellitus Type I and II
* Debilitating kidney diseases
* Debilitating liver diseases
* Clinically established coronary heart diseases
* Ingestion of vitamins or dietary supplements during the course of the study
State Dependent Resonance in the BG-cortical Loops

Neuronal activity in circuits between the basal ganglia (BG) and motor cortical areas is abnormally synchronized and rhythmic. The oscillatory activity prevails at 8-30 Hz in untreated Parkinson's Disease (PD) and its amplitude at both subthalamic and cortical levels inversely correlates with motor impairment. Moreover, these different levels in BG-cortical loops are coherent in this frequency band. The 8-30 Hz activity is suppressed by treatment following treatment with dopaminergic drugs and is partially suppressed prior to and during voluntary movements. An unanswered question is how do BG-cortical loops become so prominently engaged in this oscillatory activity? One possible explanation is that the resonance frequencies of the loops fall in the 8-30 Hz band in the untreated state, so that oscillations in this band are transmitted particularly well. So we hypothesize loop resonances in the 8-30 Hz frequency band at rest, which should be suppressed during movement and following dopaminergic therapy.

Stimulate STN (at 0, 5, 10, 15, 20, 25, 30, 40, 70 and 130 Hz) in chronically implanted patients at rest and during simple and complex motor tasks while recording the steady state evoked potential over the cortex using EEG over the 19 sites of the classical 10/20 system and a channel to record artifact over the stimulator. Experiments will be carried out both in the OFF medication and ON medication condition.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease idiopathic evolving for more than 5 years
* Electrodes of stimulation implanted in 2 nuclei under - thalamic in the service of functional and stereotaxic neurosurgery of the CHU La timone for at least 6 months
* Doped sensibility superior to 50 % (estimated by the section III of the score UPDRS)
* Efficiency of the stimulation superior to 30 % (estimated by the section III of the score UPDRS)

Exclusion Criteria:

* Patients not verifying the criteria of inclusion
* Absence of data concerning the location of electrodes
Vestibulectomy Surgical Techniques Comparison Study

Vestibulectomy Surgical Techniques Comparison Study

Vestibulectomy: A Prospective Comparison of Two Surgical Techniques for the treatment of Provoked Localized Vulvodynia (PVD)

Eligibility Criteria:
Inclusion Criteria:

1. Reported provoked tenderness to the vestibule for at least 3 months in non-pregnant, estrogen-replete healthy subjects aged 18 years or over meeting Friedrich's criteria for PVD44-45 and supported by the ISSVD Terminology Consensus Definition45 for vulvar pain. Subjects who are \>45years of age must have either have a maturation index52 of \< 10% parabasal cells or willingness to participate in local estrogen replacement until achieving this same clinical result.
2. Cotton swab Test30-31 mean verbal rating score of ≥4/10 in 4 of 6 defined points of the vestibule (2, 4, 6, 8, 10, 12 o'clock) and cotton swab test verbal score ≤ 2/10 for the labia majora and minora, intra labial sulcus, and perineum
3. Ability to insert a regular Tampax® tampon
4. Baseline Tampon Test verbal pain score ≥430

f. Phone and internet access e. Willingness to engage in pelvic floor physical therapy (PT)

Exclusion Criteria:

1. Pregnancy
2. Any other clinical reason for dyspareunia (endometriosis pain, chronic pelvic pain, vulvar dermatoses such as psoriasis, lichen sclerosus)
3. Unable or unwilling to complete baseline assessments
4. Prior vestibulectomy or hymen surgery
5. Prior or current use of testosterone dosed for gender affirmation
Comparison Of Isometric And Isokinetic Strength Training Effects On Physical Performance In Athletes With Knee Pain

Frequent sports events causing more injuries in athletes causing decline in their performance. Injuries around knee joint are common. Strength training of hamstring and quadriceps are effective tool in rehabilitation. The multi-speeds and multi-angles strength training plans were used to see the effects on symptoms and performance in athletes.

A total of 69 athletes with knee pain were recruited and randomly divided into two groups. 50 athletes completed the training programs, 25 in each group. Data was also collected from healthy athletes for normative values. International Knee Documentation Committee subjective knee evaluation form was used to report the athlete's knee condition and severity of symptoms including pain. Biodex isokinetic system was used for isokinetic and isometric strength trainings and kinetic data collection. Physical performance of an athlete was assessed by components of fitness through two commonly used tests: Illinois agility run test and vertical jump test. The athletic single leg stability test was used to assess the stability of athletes on Biodex Balance System.

Eligibility Criteria:
Inclusion Criteria:

* The adult athletes between ages 18 to 35 years.
* Athletes with unilateral knee pain.
* Both male and female.

Exclusion Criteria:

* Athletes with bilateral knee pain and any deformity around knee were excluded from this study.
* Any other joint involvement of lower limb while assessment were also excluded from study.
* Athletes with recent history of surgeries for fractures or ligamentous reconstruction were excluded from this study.
* Patients who were medically unstable.
Safety Profile of a New Berberine Formulation with Improved Bioavailability

This study aims to evaluate important safety markers related to liver- and kidney function in healthy individuals after treatment with a new formulation, LipoMicel Berberine. The main question this research aims to answer is:

Is the new formulation of Berberine (LipoMicel) with improved bioavailability safe and well tolerated in healthy individuals?

Participants will:

1. Take 1000 mg (2 capsules/d) of LipoMicel Berberine orally for a maximum period of 30 days.
2. Return to study site weekly for blood tests.
3. Keep a diary of their symptoms (collection of adverse events).


Eligibility Criteria:
Inclusion Criteria:

* Healthy men or women between 21-65 years of age.
* Completed an online health questionnaire on their medical history
* A voluntarily signed informed consent form.

Exclusion Criteria:

* Use of anti-inflammatory or non-steroidal anti-inflammatory medication
* Presence of cardiovascular disease and/or other acute or chronic diseases (e.g., liver, kidney or gastrointestinal diseases).
* Use of cannabis, nicotine or tobacco
* Drinking of excess alcohol (\>20 g/day)
* Those who are or plan to become pregnant
* Use of antioxidant supplements
* Use of cholesterol-lowering agents
* Participation in another investigational study
Establishment and Characterization of Meningioma Patient-derived Organoids

In this study, meningioma organoids will be established from patients' tissues and the characterization of the organoid will be performed.

Aims and Hypothesis to be tested:

The investigators hypothesized that the derived organoid should have a similar morphological and genetic mutation signatures to the patient primary tissue.

Study period: 1 year for patient recruitment and organoid generation from patient tumor

Study population: 30

Study samples:

Patient's meningioma tumor sample are collected from patients with surgical needs. Sample collected are used for organoid culture. Morphological and genetic characteristics will be compared between the patient tumor sample and the corresponding derived organoids

Primary outcome measures:

Whole exome sequencing data of patient tumor tissue and patients-derived organoids

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (aged \>18 years) with meningioma
2. Admission into Prince Wales hospitals neurosurgical services
3. Patients with surgical needs of meningioma removal

Exclusion Criteria:

1. Patients (or next-of-kin as appropriate) refuse to participate into the study
Phase III Clinical Trial of NPB-01 in Patients With Guillain-Barré Syndrome

Patients diagnosed with Guillain-Barré syndrome were confirmed based on the diagnostic criteria for Guillain-Barré syndrome. Patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days.

Patients evaluate the Functional Grade（FG） and Arm Grade（AG） et al.

As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by the start of the study treatment.


Eligibility Criteria:
Inclusion Criteria:

1. In principle, patients are able to receive study drug within 2weeks(with limits of 4weeks) from the start of symptoms.
2. Patients with predominant motor neuropathy and Hughes's Functional Grade(FG) is grade4 or grade5(in this regard, if symptoms is progressive, patients with FG is grade3 involve in this study).
3. Patients with plasmapheresis, steroids(in prednisolone equivalent, more than 100mg/day) and immune globulin therapy is no operation for this onset.
4. Patients with greater than or equal to 18 years old at informed consent.

Exclusion Criteria:

1. Patients with history of shock for NPB-01.
2. Patients with history of hypersensitivity for NPB-01.
3. Patients with history of volatile organic solvent abuse, abnormal porphyrin metabolism, history of pharynx or cutaneous diphtheria, plumbism, tephromyelitis, botulism, hysterical paralysis, toxic neuropathy(nitrofurantoin, dapsone, organophosphorous compound), serious diabetic neuropathy,peripheral neuropathy due to HIV,impaired peripheral neuropathy except Guillain-Barré syndrome.
4. Patients with malignancy at informed consent.
5. Patients treated with immune globulin at 8 weeks before informed consent.
6. Patients with IgA deficiency.
7. Patients with impaired liver function.
8. Patients with impaired renal function.
9. Patients with cerebro- or cardiovascular disorders.
10. Patients with high risk of thromboembolism.
11. Patients with hemolytic/hemorrhagic anemia.
12. Patients with decreased cardiac function.
13. Patients with decreased platelet.
Association of Leucocyte Telomere Length With DPAS Score in Skin Aging

The goal is to know the profile of photoaging based on clinical examination, Dermoscopic Photoaging Scale and leucocyte telomere length

The main questions of Research are:

* what is the profile of photoaging based on clinical examination results in skin aging
* what is the profile of photoaging based on DPAS Score in skin aging
* what is the profile of leucocyte telomere length in skin aging

Participants are female and male with the age of 29-31 years old and 59-61 years old. They will be examined by dermatovenereologist and will be photographed in 5 positions, they will get dermocopy on forehead, right cheek , left cheek, and chin, and their blood will be drawn about 10 mL in order to get the profile of leucocyte telomere length

Skin aging is a process of deterioration in the physiological structure and function of the skin that significantly increases in the 4th and 5th decades of life. Skin aging is a combination of physiological and pathological aging. Physiological change cannot be avoided and mandatory for everyone, pathological aging ir extrinsic aging is an abnormal skin condition caused by cigarettes, pollution and ultraviolet (UV). In general, the clinical characteristics of skin aging consist of pigmentation changes, hydration disorders, the appearance of wrinkles and skin tumors. The photoaging assessment was first proposed in 1996 by Dr. Richard Glogau, The Glogau scale assesses photoaging based on clinical assessment grouped into 4 categories, namely types I, II, III, and IV,where each type is graded by the severity of wrinkles, namely from mild, moderate, advanced, and severe. Isik et al. developed an instrument for quantitative skin aging assessment using dermoscopy. This examination is non-invasive and is expected to provide a more objective assessment. There are four facial regions assessed in the DPAS score calculation: forehead, right cheek, left cheek, and chin. The sum of the scores of the four regions is assessed based on 11 parameters, with a maximum final score of 44. Telomeres are repetitive DNA-Protein complexes located at the ends of chromosomes of eukarotic cells, and their function is to maintain chromosome stability during cell division, by protecting chromosomes from degradation and fusion. Many factors affect telomere length, such as body mass index, hormonal therapy, antioxidant intake, chronic diseases, and gender. Research by son et al. found that telomere length shortening was validated to increase the odds of skin aging (OR=0.96, 95% CI: 0.9332-0.99566, P= 0.03) Telomeres are closely linked to cellular aging, especially in dermal cells and telomere shortening in skin fibroblasts may lead to epidermal aging and barrier function defectcs.

Eligibility Criteria:
Inclusion Criteria:

* Female and Male (age 29-31 years old and 59-61 years old
* signs of aging

Exclusion Criteria:

* pregnant or breastfeeding
* have disease or genetic problem
A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Synchrony Dual Optic Intraocular Lens in Patients Undergoing Cataract Extraction

The purpose of the study is to determine if the Synchrony Dual Optic Accommodating Intraocular Lens can be used safely and effectively in post cataract extraction subjects


Eligibility Criteria:
Inclusion Criteria:

1. Patients must be scheduled to undergo primary intraocular lens implantation for the correction of aphakia following extraction of a senile cataract.
2. Patients must have a cataract causing reduction in visual acuity to a level of 20/40 or worse with BAT on medium setting.
3. Patients must require Synchrony® Lens correction of 16D - 28D or, if participating in the control study, patients must require a Clariflex® (AMO®), Phacoflex® II models SI30NB (AMO®) or a SI40NB (AMO®).
4. Patients must have ≤ 1.0 D of preoperative keratometric astigmatism.
5. Patients must have clear intraocular media other than cataract(s).
6. Patients must be age 50 or older at the time of implantation.
7. Patient must be willing and able to return for all scheduled follow-up examinations and have signed a written informed consent form.

Exclusion Criteria:

1. Patients with any anterior segment pathology (anterior segment or corneal abnormalities, chronic uveitis, iritis, corneal dystrophy, pseudoexfoliation, etc.).
2. Patients with glaucoma, glaucoma suspect or ocular hypertension, i.e., IOP \> 22 mmHg.
3. Patients with previous retinal detachment or retinal pathology including age- related macular degeneration.
4. Patients with diabetes, currently being treated systemically.
5. Patients with systemic or ocular disease that may prevent the patient from achieving uncorrected distance visual acuity of 20/32 or better post operatively.
6. Patients with congenital bilateral cataract.
7. Patients who require chronic administration of any topical ophthalmic or systemic medication that may affect accommodation such as mydriatic, cycloplegic and myotic agents; tricyclic antidepressants, phenothiazines, benzodiazepines, first generation antihistamines, anticholinergic agents. The use of tamsulosin hydrochloride (Flomax®) is also excluded preoperatively due to floppy iris syndrome.
8. Patients with best corrected visual acuity of 20/80 or worse in the fellow eye not attributable to cataract.
9. Patients who are currently participating or have participated in an investigational study, other than this study, within the past 60 days.
10. Patients who have had previous ocular surgery in the operative eye, including refractive surgery.
A Phase III Study of the Efficacy and Safety of Remimazolam Compared to Placebo and Midazolam in Colonoscopy Patients

A prospective, double-blind, randomized, placebo and active controlled, multi-center, parallel group study comparing remimazolam to placebo, with an additional open-label arm for midazolam, in patients undergoing a colonoscopy for diagnostic or therapeutic reasons.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, aged ≥18, scheduled to undergo a diagnostic or therapeutic colonoscopy (therapeutic procedures could include hemostasis, resection, ablation decompression, foreign body extraction, for example).
* American Society of Anesthesiologists Score 1 through 3
* Body mass index ≤40 kg/m2.
* For female patients with child-bearing potential, negative result of pregnancy test (serum or urine) as well as use of birth control during the study period (from the time of consent until all specified observations were completed).
* Patient voluntarily signed and dated an informed consent form that was approved by an Independent Review Board prior to the conduct of any study procedure.
* Patient was willing and able to comply with study requirements and return for a Follow-up Visit on Day 4 (+3/-1 days) after the colonoscopy.

Exclusion Criteria:

* Patients with a known sensitivity to benzodiazepines, flumazenil, opioids, naloxone, or a medical condition such that these agents were contraindicated.
* Chronic use of benzodiazepines for any indication (eg, insomnia, anxiety, spasticity).
* Chronic use of opioids for any indication.
* Female patients with a positive serum human chorionic gonadotropin pregnancy test at screening or baseline.
* Lactating female patients.
* Patients with positive drugs of abuse screen or a positive serum ethanol at baseline.
* Patient with a history of drug or ethanol abuse within the past 2 years.
* Patients in receipt of any investigational drug within 30 days or less than seven half-lives (whichever was longer) before screening, or scheduled to receive one during the study period.
* Participation in any previous clinical trial with remimazolam.
* Patients with an inability to communicate well in English with the investigator, or deemed unsuitable according to the investigator (in each case providing a reason).
Elizabeth Glaser Pediatric AIDS Foundation Maternal Events and Pregnancy Outcomes (MEP Project)A Multi-site Protocol

The purpose of this study is to find out if antiretroviral drugs are safe and well tolerated by HIV-positive pregnant women and their infants in South Africa and Zambia.

Although the use of HAART in pregnancy has significantly reduced rates of vertical transmission of HIV-1, some questions remain regarding the safety of these therapies and their potential impact on the uninfected infant.

The overall goal of the project is to establish a voluntary exposure-registry and perform observational surveillance on HIV - positive pregnant women who are exposed to antiretroviral products during the prenatal period, in order to evaluate the outcome of the pregnancy and safety of the products in HIV-positive pregnant women, and their infants.

Eligibility Criteria:
Inclusion Criteria:

* HIV positive pregnant woman on antiretroviral treatment
* Able and willing to participate and provide informed consent
* Be at least 18 years of age or older than legal age to provide consent
* If under legal age, must have legal guardian who is able to give consent
* Be an emancipated minor

Exclusion Criteria:

* History of mental illness
* History of condition that would preclude provision of consent
* Inability to provide consent
Clavipectoral Fascia Plane Block Versus Interscalen Brachial Plexus Block for Clavicle Surgery

The pain after clavicle fracture surgery may be managed with combined superficial cervical plexus-interscalene block and recently clavipectoral fascia plane block (CPB). CPB was defined by Valdes in 2017 firstly. It may be used for postoperative analgesia after clavicle surgery. CPB may be an alternative to interscalene brachial plexus block.

The aim of this study is to compare the efficacy of the US-guided CPB and ISCB for postoperative analgesia management after clavicle surgery. The primary aim is to compare perioperative and postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting).

Clavicle fracture is common in men and children after a direct fall on shoulder during sport activity such as cycling or an injury during a traffic accident. The pain after clavicle fracture surgery may be managed with combined superficial cervical plexus-interscalene block (ISCB) and recently clavipectoral fascia plane block (CPB). CPB was defined by Valdes in 2017 firstly. It may be used for postoperative analgesia after clavicle surgery. The clavipectoral fascia covers the clavicular site of the pectoralis major muscle. It provides the potential interfascial space between the clavicle and the pectoralis major muscle. CPB provide effective analgesia after clavicle surgery. It is also easy to perform. With this advantage and its analgesic effectiveness for clavicle surgery, CPB may be an alternative to interscalene brachial plexus block. However, randomized clinical efficacy trials are needed to investigate the effectiveness of CPB for clavicle fractures. In the literature, data about CPB is so limited, however it seems a good alternative to brachial plexus block for pain management after clavicle fracture.

The aim of this study is to compare the efficacy of the US-guided CPB and ISCB for postoperative analgesia management after clavicle surgery. The primary aim is to compare perioperative and postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting).

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) classification I-II
* Scheduled for clavicle surgery under general anesthesia

Exclusion Criteria:

* history of bleeding diathesis,
* receiving anticoagulant treatment,
* known local anesthetics and opioid allergy,
* infection of the skin at the site of the needle puncture,
* pregnancy or lactation,
* patients who do not accept the procedure