cyrilzakka/clinical-trials huggingface dataset:
Effect of a Probiotic on Visceral Fat Accumulation

The study's main objective is to investigate if an extract containing the probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) has a positive effect on the accumulation of abdominal visceral fat in people with abdominal obesity.

The study's main objective is to investigate if an extract containing the probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) has a positive effect on the accumulation of abdominal visceral fat in people with abdominal obesity.

Participants: 129 men and women with a waist circumference ≥102 cm (men) or ≥88 cm (women), randomly assigned to one of 3 treatment groups in parallel: one group (43 members) with active probiotic, another one with the probiotic inactivated by heat, and the last group with the placebo.

Treatment consists of product consumption study for 12 weeks, taking 1 capsule per day. 4 visits during the study, a pre-inclusion visit and 3 study visits (weeks 1, 6, and 12) will be scheduled.

Secondary objectives are to asses the probiotic's effects on:

* the accumulation of subcutaneous body fat and body weight, body mass index (BMI) and waist circumference.
* glucose metabolism and insulin resistance.
* blood lipid profile.
* blood pressure.
* inflammation.
* circulating levels of adiponectin and leptin.
* changes in the intestinal microbiome

The statistical analysis will follow the principles specified in the guidelines of the ICHE9 and CPMP/EWP/908/99 ICHE9 Points to Consider on Multiplicity Issues in Clinical Trials.

Eligibility Criteria:
Inclusion Criteria:

* Adults men or women (\>18 years old)
* Waist circumference ≥102 cm (men) or ≥88 cm (women) and \<150cm
* Written informed consent provided before the initial screening visit.

Exclusion Criteria:

* Use of antibiotics within 30-days period before the study
* Waist circumference other than those specified in inclusion criteria
* Body mass index (BMI) ≥ 40 kg/m2
* Glucose (fasting state) ≥ 126 mg/dL
* Anemia (hemoglobin ≤13 g/dL in men and ≤12 g/dL in women)
* Suffer from claustrophobia (to the extent that precludes NMR).
* Wear pacemakers, electrical stimulators or cochlear implants (NMR contraindications)
* Following a hypocaloric diet and/or receiving pharmacologic treatment for weight loss
* Having eating disorders.
* Use of medication, antioxidant, or multi-vitamin supplements interfering with the study
* Chronic gastrointestinal pathology
* Being intolerant or suffer from allergy to any of the products of the study.
* Pregnant or intending to become pregnant
* Being in breastfeeding period.
* Chronic alcoholism
* Current or past participation in a clinical trial or consumption of a research product in the 30 days prior to inclusion in the study.
* Failing to follow study guidelines.
Physical Fitness, Cardiovascular and Brain Health

The goal of this study is to determine if aerobic exercise or progressive muscle relaxation is associated with changes in cardiovascular health, brain function, and cognition.

Cognition is the most important determinant of health status, quality of life and functional ability in older age. Therefore, early interventions that preserve and enhance cognitive function are crucial for ensuring successful aging. The most common treatable risk factor for late-life cognitive impairment is midlife hypertension (HTN). One highly promising intervention strategy is aerobic exercise as it has been associated cognitive benefits in non-demented older adults. However, it is still unclear whether this benefit is due simply to prevention of other risk factors (e.g., reductions in blood pressure) or if exercise can reverse the negative effects of HTN on the brain. The goals of the current study are to employ sensitive measures of neuroimaging and cognition in order to 1).Compare cerebral health in endurance trained versus sedentary middle aged adults with normal or borderline to stage 1 hypertension, 2). measure the effects of exercise training in previously sedentary middle aged adults adults with normal or borderline to stage 1 hypertension, and 3). examine if exercise-related differences and changes in neural integrity and cognition are mediated by systemic vascular health.

Eligibility Criteria:
Inclusion Criteria:

* Sedentary adults Participants will be classified as sedentary if they have not engaged in regular physical exercise for at least one year prior to study enrollment.
* Ages 45-65
* Normal blood pressure or Borderline or stage 1 hypertension Borderline hypertension will be defined as systolic blood pressure between 120-139 mmHg and/or diastolic blood pressure between 80-89 mmHg. Stage 1 hypertension will be defined as systolic blood pressure between 140-159 mmHg and/or diastolic blood pressure between 90-99 mmHg.

Exclusion Criteria:

* Signs or symptoms of chronic heart disease
* Smoking (current or within the past 6 months)
* Peripheral artery disease (ankle-brachial index\<0.9)
* Diabetes (fasting blood glucose\>126 mg/L)
* Orthopedic problems that would prohibit participants from participating in exercise.
* Axis I psychiatric disorder
* Magnetic resonance contraindications
* Baseline Intellectual Quotient \< 70
* Below chance performance on the practice items of the cognitive tasks
* Evidence of large vessel stroke on magnetic resonance imaging
Artificial Intelligence for Screening of Multiple Corneal Diseases

This study developed a deep learning algorithm based on anterior segment images and prospectively validated its ability to identify corneal diseases.The effectiveness and accuracy of this algorithm was evaluated by sensitivity, specificity, positive predictive value, negative predictive value, and area under curve.


Eligibility Criteria:
Inclusion Criteria:

1. The quality of slit-lamp images should clinical acceptable.
2. More than 90% of the slit-lamp image area including three main regions (sclera, pupil, and lens) are easy to read and discriminate.

Exclusion Criteria:

1）Insufficient information for diagnosis.
Colorectal Metastasis to Liver Extraction with Auxiliary Transplant and Delayed Resection

Liver transplantation (LT) has become an accepted treatment for selected patients with unresectable liver metastases due to colorectal cancer (CRLM). The goal of this study is to look at and compare the clinical results of all the different approved methods (living vs. Deceased, whole organ vs. Split, one staged vs. Two staged) used to perform a standard liver transplant procedure for recipients with CRLM. Investigators will look at things like different procedure results, recovery in the hospital, and survival rates one year after the transplant. Investigators will also take blood samples from participants to be used in future research. All the transplant methods the investigators are comparing are standard practices approved by the United Network of Organ Sharing (UNOS).


Eligibility Criteria:
Inclusion:

1. All Patients of either gender ≥ 18 years of age who are listed for Liver transplant candidates at Northwestern with liver metastases due to colorectal cancer (CRLM).
2. Subjects must be able to provide informed consent themselves and without the use of a legally authorized representative (LAR), to be determined by the PI or Sub-I at the time of Consent.

Exclusion:

1. Adults unable to consent
2. Pregnant Women
3. Certain clinical/surgical/anatomical parameters, at the discretion of the PI.
Prediction Value of the BreathID 13C-Methacetin Breath Test for Hepatic Decompensation

The objectives of this study are:

* To evaluate the ability of the Methacetin Breath Test (MBT) to detect hepatic decompensation events
* To evaluate the relationship between liver Biopsy and clinical outcome and show that the MBT has a better predictive ability of clinical outcome than liver biopsy.
* To evaluate the ability of the MBT to predict each of the individual liver related complications.

Exalenz has previously gathered information in a previous study on patients with chronic liver disease including the methacetin breath test. Several years later, the company wishes to investigate this group of subjects and see retrospectively if the breath test was a predictor of complications related to their liver disease.

Eligibility Criteria:
Inclusion Criteria:

All subjects that aere enrolled in the previous Exalenz trial HIS-EX-408 or PLT-BID-1108

Exclusion Criteria:

None
Genetic Testing in Upper Tract Urothelial Carcinoma (UTUC): the Epicheck Study

Background:

Upper tract urothelial carcinoma (UTUC) is a rare tumor associated with bladder cancer in up to 50% of cases. Its incidence is rising due to improved detection and bladder cancer survival. The diagnosis of UTUC is challenging because more than 35% of the standard biopsies can result inconclusive. The grading of UTUC cells, which delivers the most important data for the choice between a kidney-sparing surgery (KSS) and a radical treatment, is upgraded in 30% of radical nephroureterectomies. The follow-up of UTUC after KSS requires an invasive procedure as a diagnostic ureteroscopy for a minimum of 5 years, and urinary cytology has low diagnostic power.

Objective:

The aim of the study is to evaluate the accuracy (overall and stratified for grade) of a DNA methylation urine biomarker test (Bladder EpiCheckTM) in UTUC, and to compare it with current standard (urinary cytology). The secondary objective is to show its applicability in the specific clinical scenario of UTUC surveillance after kidney-sparing surgery and related cost-effectiveness.

Design, Setting, and Participants:

From February 2019 to February 2021, 80 consecutive patients candidates to ureteroscopy for suspicion of primary, recurrent or metachronous UTUC in one tertiary Referral Centers (Fundaciò Puigvert) giving written informed consent will be included in the study.

Intervention:

Bladder urine samples (\> 10 ml) will be collected for cytology and for the methylation test before cystoscopy. Prior to semirigid and flexible ureteroscopy, urine specimens from the upper urinary tract will be obtained via a ureteral catheter.


Eligibility Criteria:
Inclusion Criteria:

* Patients suspected for primary or recurrent upper tract urothelial cancer requiring ureteroscopy

Exclusion Criteria:

* Metastatic disease with patient unfit for ureteroscopy
* Positive cystoscopy (concomitant presence of bladder cancer)
* Macroscopic hematuria not self-limiting requiring upfront nephroureterectomy
Chronic Heart Failure - COngestion eValuation

Heart failure (HF) is a significant cause of death and the leading cause of hospitalization in patients over 65 years of age. Congestion is the main source of symptoms and the leading cause of hospitalization for HF. Furthermore, congestive signs identified in asymptomatic patients are associated with the risk of developing symptomatic HF. The literature supports a multi-modality / integrative evaluation of congestion, combining clinical examination, laboratory results and ultrasound evaluation.

The main objective of the CHF-COV study is to identify congestion markers (clinical, biological and ultrasound) quantified during a consultation or day hospitalization for the monitoring of chronic HF that are associated with the risk of all-cause death or hospitalization for acute HF within 24 months after day hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic acute heart failure admitted in hospital for scheduled day hospitalization or consultation
* Age ≥18 years
* Patients having received complete information regarding the study design and having signed their informed consent form.
* Patient affiliated to or beneficiary of a social security scheme.

Exclusion Criteria:

* Comorbidity for which the life expectancy is ≤ 3 months
* Dialysis patient (peritoneal dialysis or hemodialysis) or patients with glomerular filtration rate \<15 ml/min/m2 at inclusion.
* History of lobectomy or pneumonectomy lung surgery
* Severe pulmonary or pleural pathology preventing reliable acquisition of lung ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis, etc.
* Pregnant woman, parturient or nursing mother
* Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
* Adult person who is unable to give consent
* Person deprived of liberty by a judicial or administrative decision,
* Person subject to psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 of the Public Health Code.
Cabazitaxel in Patients With Recurrent Ovarian Cancer After Failure of Standard Therapy.

Many ovarian cancer patients have been offered different standard cytostatics and gradually develop chemo-resistance. However, a considerable fraction of these patients are still in good general health and have a strong wish for further treatment.

Cabazitaxel (Jevtana®) is a new taxane with effect in breast and prostatic cancer. In both tumors it has shown effect in patients refractory to docetaxel. Therefore, it could be anticipated that cabazitaxel may also have an effect in chemo-resistant ovarian cancer.

The aim of the study is to investigate whether cabazitaxel could be a reasonable treatment option in patients with chemo-resistant and refractory ovarian cancer with regard to effect and toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer.
* Platinum resistant ovarian cancer with at least two previous cytostatic regimens or platinum-refractory disease defined as progression while receiving the last line of platinum based therapy or within 4 weeks of last platinum dose
* Progression on previous treatment.
* Measurable disease by RECIST 1.1 or evaluable by GCIG CA-125 criteria
* Age ≥ 18 years.
* Performance status 0-2.
* Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):

  * Neutrophils (ANC) ≥ 1.5 \* 10\^9/l
  * Platelet count ≥ 100 \* 10\^9/l
  * Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/l
  * Serum bilirubin ≤ 1.0 \* ULN
  * Serum transaminase ≤ 2.5 \* ULN
  * Serum creatinine ≤ 1.5 ULN (at creatinine above 1.5 x ULN measured GFR must be at least 50 ml / min)
* Remaining life expectancy of at least 3 months
* Written informed consent

Exclusion Criteria:

* History of severe hypersensitivity reaction (≥grade 3) to taxol.
* History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs.
* Allergy to the active substance or any of the auxiliary agents.
* Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a 2-week wash-out period is necessary for patients who are already on these treatments)
* Neuropathy grade ≥ 2.
* Pregnant or breast-feeding patients. For fertile women a negative pregnancy test at screening is mandatory.
* Fertile patients not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment.
* Other malignant diseases within 5 years prior to inclusion in the study, except basal cell or squamous cell carcinoma of the skin and cervical carcinoma-in-situ.
* Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation.
* History of any chronic medical or psychiatric condition or laboratory abnormality that is not medically controlled or in the opinion of the investigator may increase the risks associated with study drug administration. (e.g. diabetes, cardiac diseases, hypertension, renal, thyroid or liver disease).
* Vaccination with yellow fever vaccine or any live attenuated vaccine during the treatment.
Levator Hiatal Dimensions and Mode of Delivery

The aim of this observational study is to learn about how muscle dimensions of the pelvic floor measured during pregnancy in primigravida impact birth mecanics and mode of delivery. Tha main aims are to 1. Explore associations between mode of delivery and hiatal dimensions measured by transperineal ultrasound antenatally and 2. Explore the association between duration of 2nd stage of labour and hiatal dimensions.

A pelvic floor ultrasound examination will be performed between pregnancy week 12 and 20 and levator ani muscle hiatal dimensions will be compared between women having a normal vaginal delivery and women with emergency cesarean or operative vaginal deliveries.

The women will be enrolled and examined at the 12-week routine ultrasound examination after informed consent and examined again at the 18 weeks gestation examination. The women will be examined in the supine position on a bed with knees and hips semi-flexed and abducted. Bladder and bowel should be emptied prior to the examination. They will be instructed in how to perform pelvic floor contraction and maximal Valsalva maneuver.

First, a 2D scan will be performed of one experienced clinician. The average of 3 2D levator hiatal anteroposterior measurements will be stored. Then, a 3D/4D ultrasound examination of the pelvic floor will be performed using a Voluson S10, E8 or E10 (GE healthcare, Zipf, Austria) device with a RAB 4-8 MHz curved array transducer with the acquisition angle set at 85 degrees. Offline analysis of the ultrasound volumes will be performed using the 4D view (GE Healthcare, Austria) software, blinded to all clinical data. Hiatal anteroposterior diameter will be measured in both 2D and 3D. Hiatal area and hiatal transverse diameter will be measured in the 3D volume. These measures have previously been demonstrated to have high interrater and intrarater reliability in women in this study population.

Details regarding maternal height, weight, age, ethnicity, marital status, employment, induction of labour, duration of active 2nd stage of labour, gestational length, use of epidural analgesia, indication for operative delivery (slow progress or fetal distress), mode of delivery (forceps, vacuum, cesarean section), infant birthweight, head circumference, Presentation (occiput anterior/ posterior), head station at intervention, infant gender, Apgar score, perineal trauma, postpartum hemorrhage, will be collected from electronic patient journals after delivery. The women will be informed that they may be contacted within 2 years after delivery for a follow up, but separate consent will be needed.

Participants will have a unique study number and the coupling list will be stored on a safe area at St. Olav's server.

Eligibility Criteria:
Inclusion Criteria

* Age over 18 years
* Ability to consent
* Singleton pregnancy

Exclusion criteria

* Previous deliveries \> 16 weeks gestation
* Previous pelvic floor surgery
* Anomalies affecting the pelvic floor function (such as myelomeningocele)
* Epilepsy, since this might influence intervention during delivery
* Women with elective cesarean
Monroe County Inflammatory Bowel Disease (IBD) Registry

This phase is to register all subjects in Monroe County, New York with Inflammatory Bowel Disease (IBD) not already included to update the database for years 1990-2003. This will give us a truly population based study which will add to our knowledge of IBD epidemiology, allowing us to compare our rates with the rest of the world. We will be able to provide accurate incidence data from 1980 to 2000, and point prevalence from 12/31/2000. It will have special significance because of the relatively stable Monroe County population prior to 2000 (population in 1970=711,917; population in 2000 = 735,343).


Eligibility Criteria:
Inclusion Criteria:

* Patients with IBD who sign consent from 1995-2001

Exclusion Criteria:

* Patients without IBD
Efficacy of rTMS Treatment After Spinal Cord Injury

There is accumulating evidence that neuromodulation by repetitive transcranial magnetic stimulation (rTMS) of the motor cortex holds promise as a treatment for rehabilitation of motor function following a spinal cord injury. This study is designed to assess the clinical potential of non-invasive stimulation of the primary motor cortex to improve motor functions.The results will help to evaluate the clinical relevance of motor cortex stimulation for motor functions in patients with spinal cord injury. The outcomes of this study could potentially support the initiation of a larger clinical trial and the development of a new routine treatment.

The investigators will recruit 20 patients with low cervical or thoracic ASIA C or D spinal cord injuries based on specific inclusion and exclusion criteria. The patients will be randomized into 2 groups. Each group will receive either the theta burst stimulation or the placebo stimulation. rTMS will be delivered using a figure-of-eight coil positioned on the patient's head, targeting the leg area of the primary motor cortex. After the motor threshold (MT) is determined patients will receive a unilateral 90% subthreshold theta burst stimulation for 3 minutes The protocol includes 15 stimulation sessions over a 3-week period. The 12-week follow up consist of a series of electrophysiological and functional tests to assess upper and lower limb function bilaterally. Secondary outcomes include pain using the NRS scale, and self-reported evaluation of autonomic functions before, during, and after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years and less than 80 years
* Chronic patients with an incomplete cervical and/or thoracic spinal cord injury (traumatic and non-traumatic) affecting upper and/or lower extremities (i.e., C4-T12 and classified as ASIA C or D) (Figure 138).
* Capable and willing to provide informed consent and able to adhere to the treatment schedule
* Patients who can be followed for the whole duration of the study

6.3 Exclusion criteria

* Contraindication to rTMS:

  * past severe head trauma
  * history of epilepsy or ongoing epilepsy
  * active cerebral tumor
  * intracranial hypertension
  * implanted ferromagnetic devices such as cardiac pacemaker and neurostimulator and cochlear implants
  * pregnancy or lactation.
* Any clinically significant or unstable medical or psychiatric disorder
* Other ongoing research protocol or recent past protocol within two months before the inclusion
* History of treatment with Deep Brain Stimulation (DBS)
* Subjects protected by law (guardianship or tutelage measure)
* History of substance abuse (alcohol, drugs)
* Pending litigation
* Impossibility to understand the protocol or to fill out the forms
* Chronic use of sedative medication
* Participation in another clinical trial evaluating spinal cord injury
Narrow-Band UVB-Therapy in Psoriasis

Study on two different irradiation schemes in UVB phototherapy for psoriasis. Previous studies demonstrated a similar clinical effect in erythematogenic and suberythematogenic irradiation, with less complications in suberythematogenic irradiation. Most of these studies used both irradiation schemes within the same patient. UVB has a systemic effect on the body. Our hypothesis is that previous conclusions are incorrect and that the erythematogenic scheme will result in earlier clearance of the psoriasis.

109 psoriasis patients, referred for UVB phototherapy, participated in our study after given their written informed consent. After determining the minimal erythema dose (MED) patients were randomised in either group 1, erythematogenic scheme, or group 2, suberythematogenic scheme. Group 1 started with 70% of MED and every following irradiation with an increase of 40%. Group 2 started with 30% of MED and every next visit an increase of 20%. The study protocol was adjusted in case of erythema (sunburn) according to a standard erythema-phototherapy protocol, varying from skip one irradiation to lowering the percentage of increase. In case of clearance the study stopped. Clearance was defined as less than 10% of baseline body area of psoriasis.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for UVB phototherapy
* Older than 18 years

Exclusion Criteria:

* No topical medication for 2 weeks
* No systemic medication for 4 weeks
* No medication (betablocker, lithium) interfering with psoriasis