cyrilzakka/clinical-trials huggingface dataset:
A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

The purpose of the MycarinGstudy is to demonstrate the clinical efficacy and to assess safety and tolerability of rozanolixizumab in patients with generalized myasthenia gravis (MG).


Eligibility Criteria:
Inclusion Criteria:

* Study participant must be ≥18 years of age, at the time of signing the informed consent
* Study participant has documented diagnosis of generalized myasthenia gravis (gMG) at Visit 1, based on study participant's history and supported by previous evaluations
* Study participant has a confirmed positive record of autoantibodies against acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) at Screening (Visit 1).The presence of autoantibodies may be confirmed with repeat testing at Visit 1
* Study participant has Myasthenia Gravis Foundation of America (MGFA) Class II to IVa at Visit 1
* Study participant with a Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of at least 3 (with ≥3 points from non-ocular symptom) AND a quantitative myasthenia gravis (QMG) score of at least 11 at Visit 1 and at Baseline (Visit 2)
* Study participant is considered for additional treatment such as intravenous immunoglobulin g (IVIg) or plasma exchange (PEX) by the Investigator

Exclusion Criteria:

* Study participant has a known history of hyperprolinemia
* Study participant has a clinically relevant active infection (eg, sepsis, pneumonia, or abscess) in the opinion of the Investigator, or had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to the first dose of investigational medicinal product (IMP)
* Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent tuberculosis infection (LTBI), or current/history of nontuberculous mycobacterial infection (NTMBI) will be excluded
* Study participant has experienced hypersensitivity reaction after exposure to other anti-neonatal Fc receptor (FcRn) drugs
* Study participant with severe (defined as Grade 3 on the Myasthenia Gravis-Activities of Daily Living (MG-ADL) scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis at Visit 1 or Visit 2
* Study participant has a history of a solid organ transplant or hematopoietic stem cell/marrow transplant
Laparoscopic vs Abdominal Radical Hysterectomy In Patients With Early Cervical Cancer

The purpose of this study is to determine whether laparoscopic radical hysterectomy for early cervical cancer will has decreased postoperative pain intensity compared to abdominal radical hysterectomy with similar postoperative complications and survival rates.

Background: Radical hysterectomy with pelvic lymphadenectomy is one of the FIGO (International Federation of Gynecology and Obstetrics) recommended treatments for early cervical cancer. The objective of this study was to compare radical hysterectomy by laparoscopic approach and open radical hysterectomy in a single center randomized clinical trial. Nevertheless, there are no finished randomized controlled trials comparing laparoscopic radical hysterectomy and abdominal radical hysterectomy although there is an ongoing trial.

Methods: Were enrolled 30 IA2 with lymph vascular space invasion and IB cervical cancer patients. Postoperative pain intensity was defined as primary endpoint and pain intensity was measured by a 10-point numeric rating scale. Secondary outcomes were: intraoperative and other postoperative outcomes, histopathological outcomes and 5-year follow-up. Data analysis is being done at this moment

Eligibility Criteria:
Inclusion Criteria:

* Women of 18 years or older referred to our service with histologically confirmed primary squamous, adenocarcinoma or adenosquamous cervical cancer diagnosed by biopsy or cervical conization, clinically FIGO (International Federation of Gynecologic and Obstetrics) staged IA2 with lymph vascular invasion, IB and II A.

Exclusion Criteria:

* Patients with clinically advanced disease (IIB-IV), previous pelvic or abdominal radiotherapy, pregnancy, clinical diseases that would preclude one or both surgical approaches.
Effect of a Synbiotic on Symptoms of Patients With STC

To evaluate the efficacy of synbiotic (BIFICOPEC) containing Enterococci, Bifidobacteria, Lactobacilli triple viable bacteria and pectin in patients with slow transit constipation.

Chronic constipation has become a common, often chronic, functional gastrointestinal disease which influences the quality of life all over the world. A total of 100 patients diagnosed as slow transit constipation (STC) using Rome III criteria were randomized to receive either synbiotic or placebo twice daily for 12 weeks. The primary efficacy endpoint was the clinical remission and improvement rate at week 4 and 12. Stool frequency and consistency, colonic transit time (CTT), evacuation and abdominal symptoms, Patient Assessment of Constipation Symptoms (PAC-SYM scores), Gastrointestinal Quality-of-Life Index (GIQLI), Satisfaction scores and adverse events were also monitored.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18 years;
2. BMI: 18.5-25kg/m2;
3. chronic constipation was diagnosed according to RomeⅢ criteria;
4. colonic transit time (CTT) \>48 hours;
5. mild-to-moderate constipation with wexner constipation scale between 16 and 25.

Exclusion Criteria:

1. megacolon, intestinal obstruction, inflammatory bowel disease, and cancer;
2. secondary constipation (i.e. drugs, endocrine disorders, neurological disorders, metabolic disorders, psychological disorders or abdominal surgery);
3. severe anterior rectocele or full thickness rectorectal intussusception according to defecography;
4. pregnant or lactating women;
5. infection with enteric pathogen;
6. usage of antibiotics or proton pump inhibitors (PPIs);
7. hepatic, renal, cardiovascular, respiratory or psychiatric disease;
8. other diseases or factors evaluated by the investigator which could influence intestinal transit or intestinal microbiota.
Using Interventional Informatics to Address Social Determinants of Health During Clinical Care Visits to Promote Behavior Change and PREVENT Cardiovascular Disease

Healthcare providers recognize the need for behavior change and the influence of social determinants on youth at risk for poor cardiovascular health (CVH), especially among those of low-socioeconomic status (SES). Yet, providers lack the time and community data necessary to provide tailored, evidence-based care within routine practice. This project will use an Interventional Informatics approach to help providers prescribe patient-centered, evidence-based physical activity and nutrition prescriptions and link patients to community resources to account for social determinants at the point-of-care. This project will integrate our existing, novel, Patient-centered Real-timE interVENTion (PREVENT) tool into the BJC electronic health record (EHR) and test it with providers and adolescent patients at-risk for poor CVH. EHR integration of PREVENT will enable a cyclical, synergistic and data-centric approach to impact modifiable risk factors (physical activity and food intake) and prevent cardiovascular disease. This approach uses health informatics technology (HIT) to deliver data-driven, patient-centered care and generate evidence to support the use of HIT as a way to prevent cardiovascular disease across diverse patients and communities.


Eligibility Criteria:
Inclusion Criteria:

* Aged 12-17 years at baseline
* at risk for poor CVH (body mass index \>= 85th percentile)
* Receiving care from the Healthy Start Clinic at Barnes Jewish Hospital.
Robotic Endomicroscopy to Better Define Resection Strategies Applied to Hepatic Surgery

This study aims at assessing the feasibility of Probe-based Confocal Laser Endomicroscopy (pCLE) during laparoscopic hepatic masses resection for intra-operative characterisation of hepatic masses and surgical margins assessment.

Colorectal cancer is the third most common cancer and third leading cause of cancer deaths in the Western countries. In France, 45.000 new patients develop colorectal cancer every year. The liver is the most common organ targeted by CRLM, representing 50%. Approximately, 15-25% of colorectal cancer patients have synchronous CRLM at initial workup, and 20-30% patients sustain subsequent liver metastases within few years following diagnosis.

The strategy for colorectal cancer liver metastasis resection and liver cancer has evolved to a parenchymatic sparing procedure. This technic aims to minimize surgical margins width while removing the tumor. Therefore, the current standard for resection margins is a margin width superior to 1mm. However, there is still a debate concerning the margin width. Indeed, with modern chemotherapy, several studies reported no statistical differences in the overall survival between R0 patients and R1 patients treated with chemotherapy. However, in order to preserve patients from chemotherapy treatments' adverse effects an intra-operative microscopic assessment of surgical margins should be set up in order to reduce R1 margins occurrence.

Ex vivo study:

Surgical specimens obtained during hepatectomy will be imaged to generate an atlas of pCLE images.

In vivo study:

Intraoperative characterization of sub-capsular hepatic masses and surgical margins will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years
* Scheduled for a surgical resection of hepatic masses
* Provided signed informed consent

Exclusion Criteria:

* Allergy to Indocyanine green (ICG)
* Kidney failure
* Pregnancy or breastfeeding
Post Discharge Human Milk Fortifier in Preterm Infants

The purpose of this study is to determine whether low birth weight (LBW) infants fed human milk (HM)supplemented with a specially designed powdered human milk fortifier until 12 weeks after hospital discharge will have better growth and neurodevelopment than infants fed HM alone.

Consensus exists in the literature that a significant proportion of low birth weight (LBW, \<1800 g) infants leave hospital with overt signs of under-nutrition (eg. growth retardation). Recent evidence from randomized control trials suggest that provision of nutrient-enriched feeding to formula-fed premature infants after hospital discharge improves their growth, accretion of lean body mass and bone mineral content compared to infants fed a standard term formula. While available data suggest an advantage of human milk feeding after hospital discharge, experimental evidence on which to base guidelines to enrich, or not to enrich, human milk (HM) are notably absent.

Eligibility Criteria:
Inclusion Criteria:

* Birth Weight between 750-1800 g
* Gestational Age at birth between 26 and 32 weeks
* Singleton or twin birth (for twins to be eligible, both must meet eligibility criteria)
* Small for Gestational age or appropriate for gestational age
* ≥ 80% energy received from human milk in the previous three days
* ≥ 25% of human milk consumed orally in the previous three days
* Mother agrees to exclusively feed her infant human nilk after discharge
* If so randomized, parents agree to supplement \~1/2 or the human milk provided to her infant as powdered human milk fortifier for 12 weeks after hospital discharge
* Subject's parents have voluntarily signed an informed consent form

Exclusion Criteria:

* Serious congenital or chromosomal anomalies that will affect growth
* Grade III or IV periventricular/intraventricular hemorrhage
* Received steroids within 14 days o randomization
* Asphyxia (hypoxia or ischemia) es evident by severe and permanent neurological data
* Maternal incapacity, including maternal cocaine or alcohol abuse dring pregnancy, or concurrent, or mother or infant has tested positive for HIV
* Principal residence of study family outside GTA
* Mother unable to verbally communicate in English
* A single feeding must be fortified \> 24 kcal/oz or \>50% of feeds need to be fortified
Phenylbutyrate in Proteinuric Nephropathies

The purpose of this study is to determine whether sodium phenylbutyrate can reduce Lcn2 urinary expression in proteinuric patients.

Proteinuria is a major prognosis factor of chronic kidney disease (CKD) progression. Convergent evidences from clinical and experimental studies indicate that albuminuria and proteinuria are not simply a marker of CKD progression, but an active player in the evolution of the disease. Mechanistically, it has been shown that proteinuria induces endoplasmic reticulum stress in tubular cells, leading to induction of lipocalin 2/NGAL, a critical element of CKD progression. Moreover, proteinuric mice treated with phenylbutyrate are protected from CKD progression.

The aim of this study is to evaluate the efficacy of phenybutyrate, a molecular chaperone which inhibits ER stress, on the proteinuria-induced NGAL expression. Urinary NGAL/creatinine ratio will be evaluated in proteinuric patients before and under treatment with phenylbutyrate.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Kidney disease for ore than 3 months
* Proteinuria \> 1g/d or 0,1g/mmmol creatinine
* eGFR \>30ml/mn/1,73m2
* written informed consent
* affiliated with social security health insurance

Exclusion Criteria:

* Women with childbearing potential
* Recent (\<3 months) modification of ACE inhibitors or ARB
* Acute renal failure
* eGFR \<30ml/mn/1,73m2
* Nephrotic syndrome (albuminélia \<30g/l)
* Infection with HIV, HCV, HBV
* Liver insufficiency
* No affiliated with social security health insurance
* inclusion in another protocol of biomedical research
* risk of non-adherence to protocol and visits
* patients having a cardiac insufficiency of grade 3 or 4
* patient requiring of a strict salt-free diet
* patients under corticoids or immunosuppresseurs
* clinical intolerance in the treatment
* intolerance in the fructose, the syndrome of malabsorption glucose and galactose or a deficit in sucrase / isomaltase
* patients treated by Probenecide
Prospective Study for the Application of Cytosorb® in Critically Ill Patients

The mortality of critically ill patients is persistently high and requires targeted therapy of pathophysiological disorders. One approach to optimize therapy is the use of the cytokine adsorber Cytosorb®, which has a CE certification for the indications hyperinflammation, rhabdomyolysis and liver failure and is therefore frequently used in patients with sepsis, polytrauma and acute liver failure. Although few clinical data describe the efficiency mostly retrospectively, there are no data on real-time elimination performance and saturation kinetics during the course of treatment. These questions should be answered by the present study.


Eligibility Criteria:
Inclusion Criteria:

* intensive care therapy
* hyperinflammation or acute liver dysfunction or rhabdomyolysis
* need of continuous renal replacement therapy
* treatment with Cytosorb (decision of the attending physician)

Exclusion Criteria:

- other reasons for Cytosorb application
Determination of Liver Stiffness in Chronic Liver Disease Patients by Acoustic Radiation Force Imaging (ARFI) Ultrasound

A prospective, pilot study using acoustic radiation force imaging (ARFI) ultrasound (US) to quantify liver stiffness in children and young adults with chronic liver disease. ARFI results will be compared to the current clinical standard of Magnetic Resonance Elastography (MRE) and to liver biopsy when available.

ARFI US is a novel technique, recently FDA approved for use in children and adults, which provides an alternative method for quantifying liver stiffness. ARFI US has been shown in a small pilot investigation in Europe in children to be reliable and rapid in estimating moderate to severe liver stiffness using histology as a reference gold standard. ARFI measures the speed of a shear wave in the examined tissue, expressed in m/s. This shear wave velocity can be mathematically converted into a liver stiffness value, which can then be used to estimate degree of liver fibrosis. The technique is non-invasive, uses no ionizing radiation, and is fast (several minutes to complete). It is possible that ARFI US will be more accurate than MRE in quantifying liver stiffness. In addition, ARFI US will ultimately be a less expensive clinical test, shorter in duration, and will not require sedation/anesthesia in younger children as MRE requires.

Eligibility Criteria:
Inclusion Criteria:

* Less than 25 years old with chronic liver disease

Exclusion Criteria:

* Subjects without clinically ordered MRE
* Subjects who cannot cooperate with performance of the short ARFI exam
Treatment Approaches to Preeclampsia

This pilot study will document the efficacy and acceptability of administration of magnesium sulfate with the Springfusor pump for patients and staff at two sites where treatment or preeclampsia with magnesium sulfate is limited or not available. Currently, both sites refer patients to tertiary care facilities for further treatment.

Women diagnosed with preeclampsia that the clinic care team deem would benefit from treatment with magnesium sulfate will be given the option of participating in the study. Those who choose to take part in the study and meet study inclusion and exclusion criteria will receive full information about the study and be required to give their written or signed informed consent.

Women agreeing to participate in the study will receive a loading dose and maintenance therapy using an IV infusion administered by the Springfusor® pump. Women will receive a 8 mL loading dose containing 4g magnesium sulfate heptahydrate (MgSO4\*7H2O) 50% solution, which is approximately 2 mmoL magnesium/mL. The loading dose of 8mL with 4 g MgSO4 will be administered using the Springfusor® pump. The administration of the loading dose will be immediately followed by a maintenance infusion. The maintenance dose of 4 g (8 cc, 50% MgSO4) will be administered with the Springfusor® pump continuously over four hours. Clinical monitoring will occur once every hour during the treatment period. Clinical monitoring will occur throughout the treatment, with reflexes, urine output and respiration to be checked at least every hour (or, if more frequent, as per standard practice at the study site). The pump will be checked at each monitoring visit. Prior to discharge from the study, patients will be asked to assess their opinions about the acceptability and ease of use of the mode of administration. All requests or inquiries about termination of treatment will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Exhibit systolic blood pressure \> 140mm Hg OR a diastolic pressure \> 100 mm Hg
* Exhibit proteinuria \> 1+
* Have not given birth, or be 24h or less postpartum
* Exhibit urine output \>100 ml or more during the previous 4h or greater than 25 mL/h
* Agree to comply with study procedures
* Be \> 18 years of age
* Give informed consent for study participation

Exclusion Criteria:

* Eclamptic or seizing at the time of enrollment
* Received magnesium sulfate therapy 24h prior to study enrollment
A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Short Stature Children Due to Chronic Kidney Disease Before Transplantation

This study aims to evaluate the efficacy and safety of recombinant human growth hormone injection in short stature children due to chronic kidney disease before transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent of the subjects or the legal guardian.
* Subjects and guardian are willing and able to cooperate to complete scheduled visits,treatment plans and laboratory tests and other procedures.
* Diagnosed as chronic kidney disease.
* Glomerular filtration rate (GFR) \<75ml/per min/1.73m2.
* After the treatment and adjustment of hypertension, anemia, metabolic acidosis, malnutrition, renal osteopathy, hypothyroidism, etc..
* Chronological age: ≥2years and ≤14years.
* Height Standard Deviation Score(HtSDS) ≤-2SD for chronological age.
* Bone age: girls≤10 years; boys≤11years.
* Pre-pubertal (Tanner Stage I ) patients.
* No history of growth hormone treatment.

Exclusion Criteria:

* Subjects with abnormal liver functions.
* Subjects positive for anti-HBc, HbsAg or HbeAg in Hepatitis B virus tests.
* After adjustment heart function,Cardiac ejection fraction(EF) \<50%.
* Subjects with highly allergic constitution or allergy to proteins or investigational product or its excipient.
* Subjects with systemic chronic disease or general infection or mental disease.
* Subjects with diabetes or impaired fasting glucose.
* Subjects with tumor or potential tumor.
* Subjects who are using glucocorticoid or immunosuppressant.
* Other causes for growth retardation.
* Inability to obtain accurate height measurements.
* Subjects who took part in other clinical trials within 3 months.
* Concomitant administration of other treatment that may have an effect on growth within 3 months.
* Other conditions which are unsuitable for this study in the opinion of the investigator.
Therapeutic Exercise on the Psychological Well-being of Women Victims of Gender Violence.

The scientific literature shows that women subjected to gender violence suffer a deterioration in mental health (anxiety, stress and depression). In particular, a recent study carried out in Galicia found a high incidence of post-traumatic stress, depression and low self-esteem in women victims of gender violence.

The efficacy of therapeutic exercise in depression and anxiety has been widely demonstrated, as has the link between gender violence and deterioration of mental health, with a high incidence of post-traumatic stress. However, research on the effect of therapeutic exercise in battered women is very limited.

For this reason, the aim of the present project is to evaluate the effect of a therapeutic exercise program on mental health in women who have suffered gender violence.


Eligibility Criteria:
Inclusion Criteria:

* Women of legal age with a history of gender-based violence who come to the women's center or are included in the women's center's programs.

Exclusion Criteria:

* Consumption of alcohol or other drugs.
* Musculoskeletal disorders, recent surgery, as well as any physical problem that prevents exercise.
* Any medical contraindication to exercise.
* Pregnancy.
* Having any affirmative answer in the PARQ questionnaire (Physical Activity Readiness Questionnaire).
* Participants who do not have the capacity to consent to participate will be excluded.