cyrilzakka/clinical-trials huggingface dataset:
Gene Modulation of NLRP3, IL-1β and TNF-α in Peripheral Blood of Patients With Exogenous Obesity Treated With Berberine

The patients will be invited to participate in a research study aimed at determining the Gene Modulation of NLRP3, IL-1β and TNFα in peripheral blood of patients with exogenous obesity treated with berberine.

The study will take 6 months in total, in this study will participate patients with exogenous obesity, which is defined as an abnormal accumulation of fat that can be detrimental to health. After the evaluation it will be determined if you meet the section criteria to be able to participate in the study. The patients will be randomly assigned to a group which may be:

Group I. The investigator will give a nutritional plan according to your caloric requirements for lifestyle change and the patients will be scheduled biweekly for 3 months to assess your weight, height, body mass index and percentages of fat or muscle.

Group 2. The investigator will be given a nutritional plan and controlled moderate aerobic exercise that will consist of a goal of 10,000 steps or 150 minutes per week.

The patient will be given a lifestyle change plan in accordance with their nutritional requirements.

Group 3. The investigator will give a nutritional plan, moderate aerobic exercise with a goal of 10,000 steps or 150 min per week; and the phytopharmaceutical Berberine will take 3 tablets every 8 hours for 3 months.

Biweekly sessions will be carried out for 3 months, then monthly for 6 months; blood samples will be taken at the beginning of the study, that is, after the informed consent, at 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* • Patients with BMI ≥ 30kg/m2

  * With risk factors for type 2 diabetes (history of diabetic parents or siblings, sedentary habits)
  * Fasting blood glucose ≤ 126 mg/dL or glycosylated hemoglobin \< 6.5%
  * Controlled arterial hypertension
  * \>18 years of age
  * Accept and sign the informed consent

Exclusion Criteria:

* • Pregnancy patients

  * Diabetics patients
  * Presenting any serious adverse effect
  * Patients who decide to withdraw from the protocol
AVE8062 in Combination With Platinum-taxane Doublet in Advanced Solid Tumor

The purpose of this study is to determine the recommended dose of the combination of AVE8062 with platinum salts (cisplatin or carboplatin) and taxanes (docetaxel or paclitaxel) in patients with advanced solid tumors for which platinum-taxane doublet constitutes mainstay of care.


Eligibility Criteria:
Inclusion Criteria:

* Advanced neoplastic disease (i.e. metastatic or locally advanced disease) for which platinum-taxane doublet regimens are approved or constitutes the mainstay of care such as non small cell lung cancer, epithelial ovary cancer, gastric cancer, transitional cell and bladder cancer and head and neck cancer.
* Eastern cooperative oncology group (ECOG) performance status of 0 to 1.

Exclusion Criteria:

* Concurrent treatment with any other anticancer therapy, including chemotherapy, immunotherapy, radiotherapy (excluding radiotherapy with palliative intent on non-target lesions), targeted therapy, gene therapy, or patients planning to receive these treatments during the study.
* Absence of histologically or cytologically proven cancer at the first diagnosis.
* Negative serum/urinary pregnancy test
* Washout period of 3 weeks for prior anti-tumor therapy or any investigational treatment

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder

The objective of this study is to assess the efficacy, safety and tolerability of 12-weeks treatment with darifenacin in patients aged \>Ý 65 years with OAB.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of OAB for at least six months prior to Visit 3
* Symptoms of OAB during the 7 day diary period immediately preceding Visit 3:
* ≥ 1 UUIE on average per day and
* ≥ 10 episodes of micturition on average per day

Exclusion Criteria:

* A total daily urinary volume \> 3000 ml or a mean volume voided per micturition of \> 300 ml as verified in the micturition diary before randomization
* Post-void residual (PVR) urinary volume \> 100 ml
* Clinically significant stress urinary incontinence as determined by the investigator
* Clinically significant bladder outlet obstruction as determined by the investigator
* Concomitant diseases in which the use of anticholinergic drugs is contraindicated, e.g. urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh B and C), severe ulcerative colitis, toxic megacolon.

Other protocol inclusion / exclusion criteria may apply
Mycophenolate vs Azathioprin in Autoimmune Hepatitis

A study with 20 de novo patients with autoimmune hepatitis, 10 receiving azathioprin and 10 receiving mycophenolat mofetil.


Eligibility Criteria:
Inclusion Criteria:

* De novo autoimmune hepatitis
* Consent

Exclusion Criteria:

* age below 18
* pregnancy
Single Dose Antibiotic Treatment of Acute Watery Diarrhea, Rifaximin Versus Azithromycin, with Loperamide Adjunct

The purpose of this study is to compare a single dose of rifaximin with loperamide to the current standard approach of single dose azithromycin with loperamide for the treatment of acute watery traveler's diarrhea (TD).

The study requires 1) taking a single dose antibiotic plus loperamide to treat TD, 2) providing blood and stool samples at different time points to evaluate infection and immune responses, 3) completing a daily symptom diary following treatment, 4) being seen by the study doctor to monitor illness and recovery, and 5) completing a brief electronic questionnaire at 3 months.

Participants will be randomly assigned to one of the two treatment groups. The two groups are 1) rifaximin 550 mg as a single dose with loperamide 4 mg initially followed by 2 mg after each unformed stool or 2) azithromycin 500 mg as a single dose with loperamide 4 mg initially followed by 2 mg after each unformed stool. Both groups will take the antibiotic dose and 4 mg of loperamide.


Eligibility Criteria:
Inclusion Criteria:

1. Active duty military, 18-60 years old
2. Presence of acute watery diarrhea (3 or more loose/liquid stools in 24 hours or 2 loose/liquid stools in 24 hours and associated symptoms such as nausea, vomiting, abdominal cramps or tenesmus) lasting \<96 hours in duration that impacts function in activities and/or performance of primary duties. Refer to recruitment decision tree below.
3. Eligible for ambulatory management. (Note: Ambulatory management in this study means that the patient can be treated on an outpatient basis to include up to 23 hours of medical observation and IV therapies.)
4. Able to comply with follow-up procedures.
5. Will remain in country for at least 7 days or an assurance that follow-up can be arranged elsewhere.

Exclusion Criteria:

1. Allergy to rifamycins, macrolides, or loperamide (not including mild gastrointestinal upset).
2. Antibiotic therapy in the 72 hours prior to presentation (excluding malaria prophylaxis with mefloquine, malarone, chloroquine/proguanil, tafenoquine, or doxycycline).
3. Concomitant medications with known drug-drug interactions with any of the study drugs (includes theophylline, digoxin, warfarin, chloroquine and hydroxychloroquine).
4. Current or history of liver disease or other serious health conditions based on review by study physician.
5. Acute dysentery and/or febrile illness (temperature \> 100.4°F \[38.1°C\]).
6. Presence of symptoms \>96 hours prior to initiating treatment.
7. Use of \>4 mg loperamide or use of any amount of loperamide for greater than 24 hours prior to enrollment. Prior use of bismuth subsalicylate or other anti-diarrheal, non-antibiotic therapy in the 48 hours prior to enrollment.
8. Positive pregnancy test at presentation (unknown effects with rifaximin). All female participants will be administered a urine pregnancy test prior to enrollment.
9. Previously screened or randomized in this study.
GI-Reasons- A Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS)

This study investigates if Celebrex has a lower incident of Gastrointestinal Events than other NSAIDS in subjects with osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients of at least 55 years of age with a clinical diagnosis of OA who are expected to require daily prescription anti-inflammatory analgesic therapy for arthritis symptom management and for whom either celecoxib or a nsNSAID is an appropriate treatment option.

Exclusion Criteria:

* GI ulcer hemorrhage or active GD ulceration less than 90 days prior to screening visit.
* Patients with a history of myocardial infarction, unstable angina, ischemic or hemorrhagic stroke, transient ischemic attack, previous revascularization procedure to coronary, carotid, cerebral, renal, aortic or peripheral arterial vasculature.
Ovulation Induction in Women With Clomiphene Citrate Resistant PCOS

Polycystic ovary syndrome (PCOS) affects 5-10% of women in childbearing age. Hyperinsulinemia contributes to chronic anovulation commonly encountered in women with PCOS. The first choice therapy is clomiphene citrate (CC). In CC resistant cases, the American College of Obstetrics and Gynecology (ACOG) recommends the use of insulin sensitizer metformin. Other insulin sensitizing agents include rosiglitazone and pioglitazone. Pioglitazone is said to improve fertility and ovulation in patients with PCOS.CC may be associated with poor endometrial thickening due to its antiestrogenic effect. Letrozole may improve this condition. In this study we will compare the effect of combined letrozole-metformin-pioglitazone with that of combined CC-metformin-pioglitazone in ovulation induction in CC-resistant PCOS women.

Polycystic ovary syndrome (PCOS) affects 5-10% of women in childbearing age. Hyperinsulinemia contributes to chronic anovulation commonly encountered in women with PCOS. The first choice therapy is clomiphene citrate (CC). In CC resistant cases, the ACOG recommends the use of insulin sensitizer metformin. Other insulin sensitizing agents include rosiglitazone and pioglitazone. Pioglitazone is said to improve fertility and ovulation in patients with PCOS.CC has a long half-life (2 weeks), and this may have a negative effect on the cervical mucus and endometrium, leading to discrepancy between ovulation and conception rates. There has been a search for a compound capable of inducing ovulation but devoid of the adverse antiestrogenic effects of CC. recent studies have suggested that letrozole, an aromatase inhibitor, does not possess the adverse antiestrogenic effects of CC and is associated with higher pregnancy rates than CC treatment in patients with PCOS.

In this study we shall compare the effect of combined letrozole-metformin-pioglitazone with that of combined CC-metformin-pioglitazone in ovulation induction in CC-resistant PCOS women.This will be a prospective comparative clinical trial in which 2 groups of women will be generated (groups A and B) using the sealed envelopes randomization method.Group A (40 women) will receive: letrozole 2.5 mg/day from 3rd day of the cycle for 5 days and (pioglitazone 15 mg + metformin 850 mg) once daily from 1st day of the cycle for 10 days. Group B (40 women) will receive clomiphene citrate 100 mg/day from 3rd day of the cycle for 5 days and (pioglitazone 15 mg + metformin 850 mg) once daily from 1st day of the cycle for 10 days. Ovulation will be monitored by vaginal ultrasound and serum estrogen and progesterone.

Eligibility Criteria:
Inclusion Criteria:

* 20-40 years old
* PCOS infertile women resistant to CC for3 cycles

Exclusion Criteria:

* presence of medical disorders as diabetes, hypertension, cardiac problems, liver or kidney diseases, hyperprolactinemia or thyroid dysfunction.
* use of gonadotropins before
* previous ovarian drilling
* presence of urinary symptoms especially bloody urine
Effects of Segmental and Pursed Lip Breathing Exercises on Upper Cross Syndrome

Upper cross syndrome is relative prevalent 67% musculoskeletal disorder among general population due to increased usage of smart gadgets and poor postural habits. Upper cross syndrome is known for initiating malfunction of cervical and upper back muscles also associated with respiration. Individuals with upper cross syndrome may present with relaxed supine positioning, they may having normal respiratory mechanics but might be converted to accessory muscles activated pattern. Neck pain is the most common type of pain in non-traumatic conditions, affecting about 75.7% of people. The aim of this study is to compare the effects of segmental and pursed lip breathing exercises on pain, functional disability and quality of life in population with upper cross syndrome.

Current study will be randomized controlled trial conducted at Ismail Medicare Jhang, 40 patients according to inclusion criteria will be included in the study. They will be allocated into 2 groups by non-probability purposive sampling technique. Group A (control group) will receive conventional physical therapy treatment (hot pack, electrical stimulation, myofascial release, ROM and strengthening exercises) while Group B (experimental group) receive conventional physical therapy treatment with segmental and pursed lip breathing exercises. Outcome measures are Pain Numeric Scale, Quality of life (SF 36) and Functional disability (neck disability index). These tools will measure neck function and neck pain intensity. Treatment time will be 4 weeks, 3 sessions per week, each session will be 45 minutes long, and measurements will be taken after 4 weeks. Data will be analyzed by SPSS version 25. After assessing normality of data by Shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups analysis.

Key Words: Breathing Exercises, Cervical Pain, Disability, Upper Cross


Eligibility Criteria:
Inclusion Criteria:

* Both Gender \>25-40 years
* Diagnosed with Upper Cross Syndrome, having neck pain intensity more than 5 on numeric pain rating scale and having pain from more than 3 months
* Positive Janda cervical flexion Test

Exclusion Criteria:

* Patient with other musculoskeletal disorder e.g cervicogenic headache excluded
* Neck pain with whiplash or headache disorder were not included
* Patients had any history of previous head and neck surgery excluded
* Any history of Infection in the cervical spine were not included
* Trigger points of trapezius were excluded
Gas Exchange and Cardiovascular Kinetics of Regulation - Effects of Short Term Changes in Gravity

The regulation of the cardiovascular respiratory system after changing environmental conditions or changes in work rates are essential for cognitive as well as physical functioning. For decades, it is known that high level of headward acceleration (+Gz) impairs cardiovascular function that may cause loss of consciousness. Some "anti-g" maneuvers, such as muscle contraction of the lower extremities and buttocks or intermittent exhalation on exertion (i.e., exhalation against a closed airway) have been proved to increase tolerance to high +Gz.

Main objective of this experiment is to investigate the effects of anti-g maneuvers on cardiovascular and respiratory tolerance to the push-pull-effect.

Cardiovascular and respiratory functions will be evaluated with the following parameters: heart rate, stroke volume, cardiac output, blood pressure, oxygen uptake, carbon dioxide output, ventilation, breathing frequency, body core temperature.

Electromyography (EMG) will not be a judgment criteria but will be used to check the quality of 'muscle contraction' anti-g maneuver.

The main hypothesis is that anti-g maneuvers will increase cardiovascular and respiratory tolerance to the push-pull effect, especially when they are combined.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers (men or women)
* Aged from 20 to 65
* Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
* Who accepted to take part in the study
* Who have given their written stated consent
* Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection.

Subjects will be staff member of the team or of other teams participating in the parabolic flight campaign.

Exclusion Criteria:

* Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
* Treated or non-treated arterial hypertension
* Smoker
* Asthma
* Respiratory bacterial or viral infection
* Pregnant women
A Study to Assess Dystrophin Levels in Participants With Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD)

This study is designed to evaluate the ability of ataluren to increase dystrophin protein levels in muscle cells of participants with nmDMD. The study will evaluate the levels of dystrophin before and after 40 weeks of ataluren therapy using muscle biopsies and 2 validated assay methods, electrochemiluminescence (ECL) and immunohistochemistry.


Eligibility Criteria:
Inclusion Criteria:

* Evidence of signed and dated informed consent/assent document(s) indicating that the participant (and/or his parent/legal guardian) has been informed of all pertinent aspects of the trial.
* Phenotypic evidence of duchenne muscular dystrophy (DMD) based on the onset of characteristic clinical symptoms or signs (for example, proximal muscle weakness, waddling gait, and Gowers' maneuver) and an elevated serum creatine kinase (CK). Medical documentation of phenotypic evidence of DMD needs to be provided upon request by the Sponsor's medical monitor.
* Documentation of the presence of a nonsense point mutation in the dystrophin gene as determined by gene sequencing. Review and approval of documentation by sponsor or designee is required prior to enrollment.
* Willing to undergo muscle biopsy.

Exclusion Criteria:

* Ongoing intravenous (IV) aminoglycoside or IV vancomycin therapy.
* Known contra-indication to muscle biopsy (such as bleeding or clotting disorders).
* Prior or ongoing therapy with ataluren.
* Known hypersensitivity to any of the ingredients or excipients of the study drug (for example, refined polydextrose, polyethylene glycol 3350, poloxamer 407, mannitol 25C, crospovidone XL10, hydroxyethyl cellulose, colloidal silica, magnesium stearate).
* Exposure to another investigational drug within 2 months prior to start of study treatment, or ongoing participation in any interventional clinical trial.
* Requirement for daytime ventilator assistance or any use of invasive mechanical ventilation via tracheostomy. Evening non-invasive mechanical ventilation such as use of bilevel positive airway pressure (Bi-PAP) therapy is allowed.
* Elevated serum creatinine or cystatin C levels at screening.
* Prior or ongoing medical condition (for example, concomitant illness, psychiatric condition, behavioral disorder), medical history, physical findings or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the participant, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results.
Restructuring Body Experience in Anorexia Nervosa: Virtual Reality Functionality-Focused Mirror Exposure

Background: Body image disturbance remains a core therapeutic challenge in Anorexia Nervosa (AN) treatment, necessitating innovative intervention approaches. This study protocol describes a randomized controlled trial investigating Virtual Reality Functionality-Focused Mirror Exposure (VR-FME), a novel intervention targeting the perceptual, affective, and cognitive dimensions of body image disturbance in AN patients.

Methods: This single-blind, parallel-group randomized controlled trial will evaluate the efficacy of VR-FME as an adjunct to treatment as usual (TAU). Participants with AN will be randomly allocated to receive either VR-FME combined with TAU or TAU alone. The intervention specifically addresses altered body image through immersive virtual reality technology, providing controlled exposure and cognitive restructuring opportunities.

Primary Outcome: The primary outcome measure will assess changes in body image disturbance severity and core eating disorder symptomatology. We hypothesize that the integration of VR-FME with TAU will demonstrate superior therapeutic outcomes compared to TAU alone.

Significance: This protocol represents an innovative approach to addressing body image disturbance in AN, potentially enhancing current therapeutic strategies through the integration of immersive virtual reality technology. The findings will contribute to the evolving landscape of technology-enhanced interventions for eating disorders.


Eligibility Criteria:
Inclusion Criteria:

* Age: between 16-24.
* Primary diagnosis of Anorexia Nervosa
* BMI \> 14.5
* No current diagnosis or previous diagnosis for neurological disorders
* Females
* Fluency in Italian
* Ability to provide informed consent (and parental consent for minors)

Exclusion Criteria:

* Anorexia Nervosa is not a primary diagnosis
* Age \< 16
* BMI \< 14.5
* Conditions that could interfere with VR use (e.g., neurological conditions, severe visual impairments, vestibular disorders)
* Males
* Substance abuse, active suicidal ideation, severe psychiatric comorbidities
* Pregrancy
* Ongoing participation in other clinical trials
* Inability to commit to the full duration of the study
Evaluation of Birdshot Retine Choroidopathy Treatment by Either Steroid or Interferon alpha2a

Birdshot Retine choroidopathy (BRC) is a sight threatening posterior uveitis. The long term visual outcome has recently be studied showing a legal blindness to 14% at 5 years. Visual acuity is threatened by macular edema (80%), macular atrophy, and choroidal neovascularization.

Birdshot Retine choroidopathy (BRC) is a sight threatening posterior uveitis. The long term visual outcome has recently be studied showing a legal blindness to 14% at 5 years. Visual acuity is threatened by macular edema (80%), macular atrophy, and choroidal neovascularization.

The conventional therapy includes in first line steroid therapy of which side effects are well known. If the daily steroid dose necessary to control the intra ocular inflammation is superior to 0.3 mg/kg/d a combined therapy to immunosuppressive drug is suggested in order to do a steroid sparing effect. Immunosuppressive drugs include increased infectious risks, hematologic and sterility troubles, and secondary malignancies. Moreover immunosuppressive drugs have a own toxic effect and The classical immunosuppressive drug used in BRC the cyclosporineA has a high level of nephrotoxicity.

That is the reason why immunomodulatory drugs as interferons have been suggested in BRC.

Interferon alpha2 a has been shown efficient in uveitis in Behcet's disease. We propose to analyse the potential therapeutic effect of Interferon alpha2 a versus Steroid therapy with a control group for a 4 months period. This short period could not make the disease worse because of the slow pathologic processus.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Birdshot Retine choroidopathy with macular edema
* HLA A29 positive
* Work up of infection or sarcoidosis disease negative

Exclusion Criteria:

* Pregnancy
* Alcohol addiction
* Mood disturbance
* Medullar, hepatic, renal deficiency