cyrilzakka/clinical-trials huggingface dataset:
Serial Screening and Treatment of Bacterial Vaginosis Trial

The purpose of this investigator-initiated randomized control trial is to determine if bacterial vaginosis infection increases the likelihood of preterm delivery in women with history of preterm delivery. Subjects will be randomized in a two-arm study to undergo predetermined intervals of testing for bacterial vaginosis or control.

Preterm delivery affects 10% of all pregnancies in the United States. This risk is further increased in pregnant women with a history of preterm delivery. There are multiple etiology contributing of preterm labor. Of these, the presence of inflammation and infection have been a well-established cause. Bacterial vaginosis (BV), a common vaginal infection in pregnancy, may often be asymptomatic. Studies demonstrate a strong association between BV and preterm labor. Therefore it is recommended that women at high risk for preterm delivery are treated for this infection irregardless of symptoms. In this study the investigators hypothesize that increased testing for bacterial vaginosis, with subsequent timely treatment, may decrease the risk of preterm delivery in patients who are at high risk. The investigators suspect that the increase in monitoring will help diagnose asymptomatic bacterial vaginosis infections allowing for prompt treatment and avoidance of preterm labor.

Subjects will be randomized in a two-arm study to undergo predetermined intervals of testing for bacterial vaginosis or control. No experimental drugs or devices will be used.

* The intervention-arm will have a pelvic exam performed with vaginal swab collection at their initial obstetric visit. The women undergoing the intervention will then subsequently undergo additional vaginal swab collections in 2 week intervals starting at 16 weeks gestational age until 34 weeks gestational age.
* The control arm will undergo the standard of care. There will be no placebo for the control group.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age greater than or equal to 18 years old
* Pregnancy at less than 32 weeks gestational age at initial obstetric visit with Loma Linda Maternal Fetal Medicine (MFM) Clinic
* History of at least one prior preterm delivery \>16 and \<37 weeks not due to iatrogenic indications, or short cervical length \<2.5cm
* Willing to receive prenatal standard of care and comply with treatment plan and other study procedures at Loma Linda

Exclusion Criteria:

* Patients not deemed to be high risk for preterm delivery
* Patient with cervical dilation ≥1cm on initial exam or with protruding membranes
* Current pregnancy is multigestation
* Medical indications for iatrogenic preterm delivery during this pregnancy (e.g. preeclampsia with severe features)
* Desires termination during this pregnancy
A Study to Test How Well Different Doses of BI 3031185 Are Tolerated by Healthy Men

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3031185 in healthy male subjects following administration of multiple rising doses.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 50 years (inclusive)
* Body Mass Index (BMI) of 20.0 to 29.9 kg/m (inclusive) and body weight of at least 60 kg
* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial

Exclusion Criteria:

* Any finding in the medical examination (including BP, Pulse rate (PR) or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement at screening of systolic blood pressure outside the range of 90 to 139 mmHg, diastolic blood pressure outside the range of 50 to 89 mmHg, or pulse rate outside the range of 50 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Further exclusion criteria apply
Prophylactic Cerclage for Twin Pregnancy With Shortened Cervix

This randomized controlled trial is aimed to evaluate pregnancy and neonatal outcomes in twin pregnancies, in which a cervical cerclage is placed due to the shortening of the cervix with or without visible fetal membranes.

Introduction Multiple pregnancies are high-risk pregnancies and usually associated with an increased risk of neonatal morbidity and mortality, mainly due to preterm births. Preterm births occur in 50% of twin pregnancies and the mean gestational age for delivery is 35.3 weeks. Ten percent of all twin births take place before 32 weeks of gestation.1 Preterm births are responsible for more than 70% of all neonatal and infant mortality.2 Prematurity can have serious consequences for the child, such as hearing difficulties, vision impairment, learning disabilities, reduced IQ, and cerebral palsy. A cervical length of ≤25 mm in twin pregnancies is a good predictor of a spontaneous preterm birth when measured around 24 weeks of gestation.3,4 Numerous interventions have been attempted in order to prevent preterm births in twin gestations, but until now, no intervention has been effective. Use of cerclage in twin pregnancies is controversial. Some experts claim that placing a cervical cerclage could increase the risk of preterm births.5 However, there is growing evidence of beneficial effect of applying cervical cerclage. Based on a few, small, controlled trials, cervical cerclage may extend the pregnancy, if it is applied to a cervix of less than 15 mm.6,7 Such practice is still in need for further validation by well-structured and powered randomized controlled trials.

Rationale:

Pregnant in twins with history suggesting cervical weakness and evidence of shortened cervix in the current pregnancy might get benefit from mechanical support by cervical cerclage in trial to reduce the risk of preterm birth.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-45 years.
* Dichorionic twins.
* Transvaginal sonographic cervical length is \<25 mm with or without internal os dilatation ≥10 mm at 14-20 weeks gestational age.
* Asymptomatic.

Exclusion Criteria:

* Triplets and quadruplets.
* Monochorionic twins.
* Threatened/ inevitable miscarriage
* Bulging membranes through the external os.
* Extremes of age.
* Major fetal anomalies.
* Known cases with uterine anomalies e.g. bicornuate uterus, uterus didelphis... etc.
* Fetal demise.
* Fetal reduction in the current pregnancy.
Brain Connectivity Measured With High-density Electroencephalography

Emerging scientific results show that disrupted functional connectivity in stroke can explain behavioral impairments and predict their recovery over time. However, no technique is yet available for widespread use in clinics to examine how neural synchronization in brain networks is altered in stroke patients. This is crucial to determine favorable prognostic factors and to define individualized rehabilitation protocols. Importantly, the investigators have successfully used high-density electroencephalography (hdEEG) in healthy individuals to measure neural synchronization in brain networks. In this project, the investigators will develop methods and tools based on hdEEG for assessing functional connectivity in stroke patients. These methods and tools will be employed to examine how neural changes occurring after brain lesions explain behavioral impairments. The project will open the way for the use of hdEEG at the patient's bedside, as a neurodiagnostic tool for stroke as well as other brain disorders.


Eligibility Criteria:
In this study 125 stroke patients and 45 healthy participants will be recruited at the Institute for Research and Healthcare with a Scientific Character (IRCCS) San Camillo hospital.

Inclusion Criteria (patients):

* right or left hemisphere damage
* unilateral stroke
* compliance with magnetic resonance imaging (e.g., no claustrophobia)

Inclusion Criteria (healthy participants):

• compliance with magnetic resonance imaging (e.g., no claustrophobia)

Exclusion Criteria (both patients and healthy participants):

• no comorbidities with psychiatric disorders
A Study to Evaluate the Combination of Pegylated Interferon Alfa Plus Valopicitabine in Patients With Hepatitis C

This Phase II study is being conducted in treatment-naive patients (no previous antiviral therapy for Hepatitis C infection) with genotype-1 chronic hepatitis C to evaluate the safety and effectiveness of valopicitabine alone and together with Pegylated Interferon (a drug approved by the Food and Drug Administration for the treatment of Hepatitis C infection).


Eligibility Criteria:
Inclusion Criteria:

* Documented clinical history of genotype-1 chronic Hepatitis C and compensated liver disease
* Treatment Naive (patient has received no previous treatment for chronic hepatitis C infection)
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Patient is pregnant or breastfeeding
* Patient is co-infected with HIV or Hepatitis B
* Other protocol-defined exclusion criteria may apply.
Long-term Follow-up Study in Subjects Who Received Voretigene Neparvovec-rzyl (AAV2-hRPE65v2)

Multi-site, non-randomized, observational study, for up to 15 years after subretinal AAV2-hRPE65v2 administration for each subject. The study is a non-interventional, follow-up study of subjects who participated in previous AAV2-hRPE65v2 gene therapy clinical trials.

This is an observational follow-up study of subjects who participated in previous Phase 1 and Phase 3 clinical trials of AAV2-hRPE65v2 gene therapy (voretigene neparvovec-rzyl) to evaluate long term durability and safety for 15 years after subretinal administration.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who participated in prior subretinal AAV2-hRPE65v2 gene therapy clinical studies

Exclusion Criteria:

1. Subjects who will not consent for study.
2. Subjects who the investigators believe are not capable of performing study assessments
How do Super Lean Subjects Keep Resistant to Body Weight Gain?

Obesity is the 5th leading cause of global death, and is major risk factors for many chronic diseases, such as type 2 diabetes, cardiovascular diseases, hypertension and cancer. Obesity is caused by an imbalance between energy intake and energy expenditure, and it is widely agreed to be a consequence of a gene by environment interaction. Although on average obesity rates are increasing, the shape of the distribution of adiposity is changing: it is becoming more right skewed. This is because there is a population of very lean subjects that has remained almost unchanged by the epidemic. The investigators have called these very lean individuals that are resistant to the epidemic and sustain a BMI \< 18.5 kg/m2 'super lean' subjects. We have very little understanding of the lifestyles of these individuals and how they are able to maintain their super lean phenotype, and whether the basis of their leanness is primarily genetics.

In this study, the investigators will recruit a sample of 150 super lean healthy volunteers with a BMI \>15 and \< 18.5 kg/m2 aged 20-40 years, in parallel with an age matched group of 150 healthy subjects with a BMI ≥22 and \< 25 kg/m2 as the control group. The investigators will screen out any individuals with eating disorders. In both groups, the investigators will study their lifestyles in particular focusing on their physical activity patterns and their food intake choices (monitored via food intake diaries and supported by metabolomics analyses of their urine to detect biomarkers of different food groups). Saliva samples will be collected for genotyping. The investigators will SNP genotype the individuals for 30 known polymorphic loci previously linked to obesity to establish if they have a particular genetic profile linked to their lean phenotype.

Eligibility Criteria:
Inclusion Criteria:

* control: BMI 20-25 kg/m2, healthy, age 20-40 years old superlean: BMI 15-18 kg/m2, healthy, with no eating disorders and diabetes, age 20-40 years old

Exclusion Criteria:

* Pregnant women and women in lactation Subjects are suffering from eating disorders or diabetes.
Incretin-based Therapy in Late Preclinical Type 1 Diabetes

The objective of the trial is to study whether daily treatment with liraglutide improves endogenous insulin secretion, postpones progression to overt Type 1 diabetes, and is tolerable and safe in subjects aged 10-30 years, who are positive for multiple islet autoantibodies and have dysglycemia.


Eligibility Criteria:
Inclusion Criteria:

* 10-30 years of age
* positive for at least 2 islet autoantibodies
* glucose intolerance or dysglycemia: impaired glucose tolerance (IGT, 2-hour p-gluc 7.8-11.0mmol/l), or impaired fasting glucose (IFG, fp-gluc 6.1-6.9mmol/l), and/or 10% rise in HbA1c since the last measurement (2 - 12 mo ago), and/or p-gluc at least 11.1mmol/l at 30, 60 or 90 min during OGTT
* not pregnant

Exclusion Criteria:

* allergic to liraglutide or other ingredients of Victoza
* type 1 diabetes
* diabetic ketoacidosis
* previous treatment in the last three months with any antidiabetic medication
* impaired liver or kidney function or on dialysis
* severe heart failure
* severe stomach or gut problem resulting in gastroparesis, or inflammatory bowel disease
* past or current history of pancreatitis
* serum calcitonin value above normal (\>50 ng/l or at least 3.4pmol/l)
* presence of any chronic metabolic, hematologic or malignant disease
* obesity BMI at least 30
* pregnant females and females of childbearing potential who are not using adequate contraceptive methods.
* breast-feeding
Characterization of Sympathetic Nerve Activity in Stress Cardiomyopathy

Stress (Takotsubo) cardiomyopathy (SC) is a peculiar form of acute, reversible myocardial dysfunction predominantly affecting the apical and mid left ventricular segments.

In this institution over the last two to three years the investigators have identified more than a dozen patients with stress cardiomyopathy. The investigators' overarching goal is to characterize these individuals with the hope of identifying risk factors and developing strategies to prevent the occurrence of SC in situations where the likelihood in susceptible individuals may be high.

Stress (Takotsubo) cardiomyopathy (SC) is a peculiar form of acute, reversible myocardial dysfunction predominantly affecting the apical and mid left ventricular segments. This was originally described in Japan but is increasingly recognized all over the world especially in older women. There is evidence to support that excess sympathetic activation and catecholamine surges are potential mechanisms that cause this temporary myocardial 'stunning'. The amount of catecholamines in circulation of patients with SC was 2 to 3-fold higher when compared to subjects with acute myocardial infarction related equivalent cardiac dysfunction \[Wittstein, et al. NEJM, 2005\].

In this institution over the last two to three years the investigators have identified more than a dozen patients with stress cardiomyopathy. This diagnosis has been confirmed by echocardiographic documentation of normalization of left ventricular function over a course of few days to weeks. The investigators' overarching goal is to further characterize these individuals with the hope of identifying risk factors and developing strategies to prevent the occurrence of SC in situations where the likelihood in susceptible individuals may be high.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stress cardiomyopathy in the past

Exclusion Criteria:

* Coronary artery disease (CAD), primary coronary intervention (PCI) or coronary artery bypass graft (CABG)
* Cardiac dysfunction
* Heart failure
* Significant arrhythmias
* Severe chronic obstructive pulmonary disease (COPD)
* Diabetic neuropathy
* Pregnancy
Comparison of a Novel Non-diffractive Extended Depth of Focus Intraocular Lens (IOL) and a Trifocal IOL

The purpose of this study is to compare visual performance and quality of life (QOL) following bilateral implantation of a novel non-diffractive extended depth-of-focus (EDOF) intraocular lens (IOL) (AcrySof® IQ Vivity, Alcon, TX, USA) and a trifocal IOL (Acrysof® IQ PanOptix, Alcon, Fort Worth, TX) in a prospective comparative interventional case series.

Developments in cataract surgical devices and intraocular lenses (IOL) increased patient expectations and changed the practice patterns in ophthalmology. Nowadays, cataract surgery is considered as a refractive surgery. With multifocal IOLs, spectacle independence can be achieved with a good distance, intermediate and near visual acuity. This is associated with increased quality of life after cataract surgery.The most important disadvantages of multifocal IOLs are loss of contrast sensitivity and photic phenomena such as glare and halo. Although multifocal IOLs are more frequently associated with photic disturbances than monofocal IOLs, the trifocal IOLs have improved performance in photic phenomena when compared to bifocal IOLs. Recently, a new technology known as extended depth of focus (EDOF) IOLs have been developed. These lenses create a single elongated focal point to enhance the depth of focus, improving intermediate vision without compromising distance vision. Although EDOF IOLs provide better intermediate distance vision when compared to monofocal IOLs, near vision is not as good as trifocal IOLs. The most important advantage provided by the EDOF technology is lower rate of photic disturbances than trifocal IOL designs. The aim of this study was to compare the visual performance and patient-reported quality of life (QOL) outcomes following bilateral implantation of a novel non-diffractive wavefront shaping EDOF IOL (AcrySof® IQ Vivity, Alcon Research, TX, USA) and a trifocal IOL (AcrySof® IQ PanOptix, Alcon Laboratories, Fort Worth, TX).

Eligibility Criteria:
Inclusion Criteria:

* Cataract patients scheduled for surgery who are interested in spectacle independence.
* Bilateral cataract with plan of bilateral sequential cataract surgery.
* Adult patients older than 18 years of age
* Normal cognitive function, able to understand advantages and disadvantages associated with different types of IOLs.

Exclusion Criteria:

* Ocular diseases other than cataract including irregular astigmatism, diabetic retinopathy, age-related macular degeneration or any other retinal diseases, severe dry eye, glaucoma, amblyopia, uveitis, pseudoexfoliation syndrome, abnormal pupillary function, history of intraocular or corneal surgery, congenital eye abnormalities, or eye trauma.
* Patients with high myopia with axial length (AL) ≥ 26,5 mm and high hyperopia (AL ≤ 21.5 mm)
* Lifestyle and work-related factors requiring sharp near or distance vision
* Patients with unrealistic visual expectations.
Efficacy Study of Subcutaneous Methyl-B12 in Children With Autism

We will be testing a specific dietary supplement, methylcobalamin (vitamin B12). Follow-up assessments with our clinical team will take place over the 12-week study period so that we can record any changes in development. The main goal of this study is to determine if subcutaneous injections of vitamin B12 given every three days can positively affect behavior and development in children with autism.

Hypothesis: Methylcobalamin injections will improve measures of executive function, speech, and socialization in children with autism, and will be associated with metabolic improvement.

Autism is a complex neurodevelopmental disorder that is thought to involve an interaction between multiple and variable susceptibility genes (Keller \& Persico, 2003), epigenetic effects (Beaudet, 2002), and environmental factors (London, 2000). The increase in the prevalence of autistic spectrum disorders from 4-5/10,000 in the 1980s to 30-60/10,000 in the last decade has raised great concern (Bertrand et al., 2001; DeStefano et al., 2004; Steinhausen et al., 1986; Yeargin-Allsopp et al., 2003). Research into potential therapeutic interventions designed to ameliorate the metabolic and clinical symptoms of autism is urgently needed to reduce the enormous public health burden of this disorder and to improve the quality of life for affected children and their families. Nutritional supplementation through subcutaneous injections of methyl B12 is a current treatment for children with autism that has anecdotal reports of remarkable clinical improvements and few side effects. However there are no published studies to support its clinical benefit.

Comparison: Injections of methylcobalamin compared to injections of sterile saline over a six week period.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of DSM IV defined autism and meets cut off on Autism Diagnostic Inventory-Revised (ADI-R) and the Autism Diagnostic Observation Scale (ADOS).
* Age 3 to 8 years
* IQ of 50 or above
* Willingness of parents to administer subcutaneous methyl B12.
* Parental agreement to continue present dietary, behavioral or psychotropic drug treatment but not change treatment during 12 week intervention or wait list.

Exclusion Criteria:

* Clinical evidence of seizure disorder
* Cancer
* Recent surgery
* Active infection with fever
* Fragile X or other known genetic cause of autism
* Bleeding disorder
* Perinatal brain injury (e.g. cerebral palsy)
* Current use of any methyl B12 product
* Evidence for malnutrition seen in abnormal albumin level
Lifestyle Modification for Weight Loss in Schizophrenia

The purpose of this study is to find out how effective lifestyle modification group therapy is on reducing body weight when compared to usual care in individuals with schizophrenia and/or schizoaffective disorder.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects will be between 18 and 65 years of age.
2. Have a BMI of 28 or greater.
3. Meet DSM-IV criteria for schizophrenia or schizoaffective disorder.
4. Be on a stable dose of antipsychotic medication for at least one month, with positive symptoms stability as judged by the clinical team and investigator.

Exclusion Criteria:

1. A history of dementia or mental retardation.
2. Not capable of giving informed consent for participation in this study.
3. Ongoing pregnancy.
4. Living in a structured environment where the meals are provided as part of the program, e.g., a group home, nursing home, etc.