cyrilzakka/clinical-trials huggingface dataset:
Microbiome, Antibiotics, and Growth Infant Cohort

This cross-disciplinary study will assemble and longitudinally follow a large, diverse birth cohort to determine the relationships between early life antibiotic exposure, microbiome development, growth, antibodies, and immunostimulation.

Perinatal and infant antibiotic exposures are common and have been linked to changes in the gut microbiome, which plays a central role in health and disease. Childhood obesity is an epidemic and animal models have linked antibiotic induced changes in the microbiome with increased adiposity. Infants become colonized with trillions of bacteria in the first few hours of life. During this time period, their nascent immune system develops tolerance to commensal microbes

The primary objectives are to measure the impact of common perinatal and early childhood antibiotic exposures on the structure and function of the developing gut microbiome. To determine the association between common perinatal and early childhood antibiotic exposures and weight/adiposity gain in a large birth cohort of children. To determine mechanisms for the association between microbiome changes over time and the rate of weight/adiposity gain in a large birth cohort of children. To determine the normal developmental pattern by which healthy children develop antibodies in their blood against the microbes that naturally colonize their intestines. To determine the association between immunostimulation and protection from persistent colonization in humans.

Eligibility Criteria:
Inclusion Criteria (if not specified, applies to child):

* Born at Pennsylvania Hospital
* Recruited at \<120 hours of age
* Born at ≥36 0/7 weeks gestation
* Birth weight ≥2000 grams
* Parents plan to receive well-child care in the Children's Hospital of Philadelphia (CHOP) network, Society Hill Pediatrics, Center City Pediatrics, Penn Medicine or South Philly Pediatrics
* Biological mother is the legal guardian, or the child is born from a surrogacy with guardianship immediately transferred in hospital

Exclusion Criteria (if not specified, applies to child):

* Child in neonatal intensive care unit (NICU) for \>120 cumulative hours
* Biological mother NOT legal guardian, except surrogacy where guardianship is transferred at birth
* Biological mother NOT primary caretaker, except surrogacy where guardianship is transferred at birth
* Biological mother \< 18 years of age
* Child has culture confirmed (blood or cerebrospinal fluid cultures) infection
* Biological mother is non-English speaking
An Observational Study in Patients With HER2 Positive Metastatic Breast Cancer (SystHERs Registry)

This multi-center, prospective observational study will evaluate the treatment patterns, and the safety in patients with HER2-positive (HER2+) metastatic breast cancer (MBC). Eligible patients will have an initial metastatic breast cancer diagnosis that has not been previously treated with systemic therapy; patients may be enrolled up to 6 months after the diagnosis. Data will be collected for up to 8 years.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Initial diagnosis of HER2+ MBC, as diagnosed by the treating physician, no more than 6 months prior to study enrollment
* Availability of cancer-specific historical data points in the patient's medical records

Exclusion Criteria:

* Any inability to provide informed consent
Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis C

The purpose of the study is to evaluate if continuous subcutaneous delivery of interferon alfa-2b using an external drug pump in combination with the use of oral ribavirin provides a safe and effective treatment for patients with chronic hepatitis C infection as compared to patients who receive standard treatment.

The study will include patients who are diagnosed with chronic hepatitis C genotype 1 infection and who have received no previous interferon or other anti-HCV treatment.

Eligibility Criteria:
Inclusion Criteria:

* Signed patient consent form
* Genotype 1 chronic HCV with detectable HCV RNA
* No previous treatment for HCV infection
* Hepatitis B and human immunodeficiency virus negative at screening visit
* Able and willing to follow contraception requirements
* Screening laboratory values, test, and physical exam within acceptable ranges
* Weight between 40 kg and 125 kg
* Proficiency in the use of the external pump infusion system

Exclusion Criteria:

* Current or planned enrollment in another investigational device or drug study
* Anticipated inability to complete all clinic visits and comply with study procedures
* History of, or any current medical condition, which could impact the safety of the subject during the study
* Autoimmune hepatitis, suspected hepatocellular carcinoma, decompensated liver disease, or other known liver disease other than HCV
* Alcoholism or substance abuse with \<6 documented months of sobriety
* Known allergy or sensitivity to interferons or ribavirin
* Any other condition that, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study
Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma

The prognosis of patients with unresectable, locally advanced non-small cell lung cancer (NSCLC) is poor. Chemoradiotherapy is the main treatment modality for this disease. The newer drug regimens can be expected to improve survival in this subset of NSCLC patients. Modern targeted therapies have enhanced the outcomes of lung cancer treatment, especially for advanced NSCLC. Among the targeted approaches for the inhibition of angiogenesis is bevacizumab, a monoclonal antibody that represses vascular endothelial growth factor (VEGF). Bevacizumab in combination with platinum-based chemotherapy used as neoadjuvant chemotherapy may change the previous treatment modality. It allows some lung cancer patients to be downstaged to surgery rather than radiotherapy. Thus, survival of these patients may be improved.

This trial investigates the role of neoadjuvant pemetrexed, carboplatin and bevacizumab in unresectable, locally advanced lung adenocarcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed unresectable, locally advanced (III A (bulky N2), III B) lung adenocarcinoma
* No previous chemotherapy, radiotherapy, surgery or biological therapy for lung cancer
* Adequate organ and bone marrow function

Exclusion Criteria:

* Prior chemotherapy or radiation therapy for NSCLC
* Prior treatment with bevacizumab or other agents specifically targeting vascular endothelial growth factor (VEGF)
* Patients with known hypersensitivity to other recombinant human antibodies
* History of stroke or transient ischemic attack (TIA).
* History of myocardial infarction or unstable angina within the past 12 months.
* Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), symptomatic diverticulitis, or active uncontrolled infection.
* Women who are pregnant or breast-feeding
Use of Predictive Modeling to Improve Operating Room Scheduling Efficiency

This study compares two different methodologies of scheduling cases in the operating room.

The goal of the proposed study is to address the efficacy of a scheduling methodology that uses a regression-based predictive modeling system (PMS) to calculate operative and anesthetic time length. The investigators hypothesize that compared to the traditional scheduling system (TSS) that calculate operative length using historic means, case allocation in an operating room using the PMS will improve scheduling precision, increase operative volume and increase Operative Suite (OS) personnel satisfaction, without having adverse impact on patient outcomes. The investigators will evaluate this hypothesis using a randomized block design in two operating rooms of a single surgical specialty for a total of 100 operative days per arm.

Eligibility Criteria:
Inclusion Criteria:

* The only requirement for including a day in the study will be that all the procedures performed in that specific day have been previously performed in our hospital at least 5 times a year for each of the last three years. This rule will encompass the vast majority of the performed vascular procedures in our facility. Setting the threshold at a minimum of 5 cases per year is essential to assure that some data will be available to calculate the expected length of the case with either the traditional or the predictive modeling system. If a case is performed in a day when the scheduling imprecision is supposed to be calculated using the PMS but modeling data do not exist, then the anticipated length of this case will be calculated using the historic means.
* Surgery cancellation after the first case will not disqualify that day from inclusion in the study. If the cancellation occurs in the last case of the sequence for the specific day then no particular intervention will be taken. The anticipated end of the surgical day will reset to the end of the last case that took place, and all the imprecision calculations will be performed as described below. If the cancellation occurs in one of the intermediate cases, then the end of the operative day will reset to reflect the removal of the cancelled case.

Exclusion Criteria:

A day will be excluded from the study when any of the following occur (based on historical data the investigators anticipate 10-15% of the operative days to meet the exclusion criteria):

* Only one or no cases have been scheduled for the entire operative day
* An emergency case is added as first case, or in between the scheduled cases.
* The operative day falls during a major holiday week (Thanksgiving, Christmas, New Year). The schedule during these time periods tends to be fragmented, cancellation rates are high, and cases are frequently performed with back-up teams only. All these factors may distort the findings.
* There is an unusual case in the schedule that does not meet the minimum requirement of 5 previous operations on a yearly basis for the last three years.
* The first case of the day is cancelled
Study of Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of the Alzheimer's Type

The purpose of this study is to learn if aripiprazole is safe and effective in the treatment of psychosis associated with dementia of the Alzheimer's type.


Eligibility Criteria:
Inclusion Criteria:

* Institutionalized patients with Alzheimer's Disease
Clinical Evaluation of "Snow-plow"Technique Versus Bulk Fill Technique in Restorations of Class II Cavities

The aim of the study is to assess the performance of " snow-plow" technique as compared to Bulk Fill technique in restoration of class II cavities.

1. With limited evidence-based information about the clinical performance of resin composite in class II cavities. it is beneficial to compare the newly introduced "snow-plow' technique using a randomized clinical trial to test the null hypothesis that this new technique has the same clinical performance.
2. The comparator will be the bulk fill technique as an alternative to the conventional layering technique. This is because it has shown lower polymerization shrinkage when comparing it to the conventional composite. Bulk fill has reduced the chair time for the patient. It is done by the application of 4mm increment and cured at once.
3. Patients are selected according to the eligibility criteria discussed in the following section.
4. local anesthesia will be administered and the operative field will be isolated before starting the restorative procedure. A standard class II cavity will be prepared at the two-surface cavities.
5. The preparation will be performed using rotary instrumentation for cavity preparation by a water-cooled high-speed hand-piece by the same operator.
6. The teeth are then restored using one of the two techniques according to their allocation with the same steps discussed in the different arms.
7. The restorations are assessed using the modified USPHS criteria at the time intervals stated in the outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* class II carious lesions in premolars and molars.
* Vital upper or lower teeth with no signs of irreversible pulpitis.
* Presence of favorable occlusion and teeth are in normal contact with the adjacent teeth.

Exclusion Criteria:

* Deep carious defects (close to pulp, less than 1 mm distance).
* Periapical pathology or signs of pulpal pathology.
* Endodontically treated teeth
* Tooth hypersensitivity.
* Possible prosthodontic restoration of teeth.
* Heavy occlusion or occlusal contacts or history of bruxism.
* Severe periodontal affection.
Bioavailability of Maqui Berry Extract (MBE) in Healthy Subjects

The aim of the present study is to describe the bioavailability for the proprietary standardized maqui berry extracts Delphinol® and MaquiBright® enriched in anthocyanins and in particular delphinidins. The analyses are based on two selected key substances namely delphinidin-3-glucoside and cyanidin-3-sambubioside and their metabolism to phenolic acids.

The bioavailability of anthocyanins specific for Delphinol®/MaquiBright® was analyzed in plasma sample kinetics (at 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h and 8h after intake of 1000mg standardized maqui berry extract in capsules) in 12 healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
2. Sex: female and male
3. Age: 18- 50 years
4. BMI ≥19 or ≤30 kg/m²
5. Non-smoker
6. Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, haematology

Exclusion Criteria:

Subjects who met one or more of the following criteria are not eligible:

1. Relevant history or presence of any medical disorder, potentially interfering with this study (e.g. mal absorption, chronic gastro-intestinal diseases, etc.)
2. For this study clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening
3. Coffee consumption \>3 cups / day
4. Consumption of more than 5 portions fruits and vegetables per day
5. Blood donation within 1 month prior to study start or during study
6. Regular intake of drugs or supplements possibly interfering with this study (e.g. Vitamin C, E, OPC etc.) within 2 weeks prior to study start or during study (Vitamin D with highest dosage of 1000 I.E. per day will be allowed)
7. Vegetarians / vegans
8. Drug-, alcohol- and medication abuses
9. Known HIV-infection
10. Known acute or chronic hepatitis B and C infection
11. Relevant allergy or known hypersensitivity against compounds of the study preparations
12. Known pregnancy, breast feeding or intention to become pregnant during the study
13. Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study
14. Anticipating any planned changes in lifestyle for the duration of the study
Topical ASP-1001 (Contrast Media Formulation) and the Acute Response to Nasal Allergen Challenge (NAC)

The purpose of this study is to see whether ASP-1001 when given as a nasal spray is safe and can reduce the signs and symptoms of allergic rhinitis (hayfever) following nasal challenge with antigen.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females between 18 and 55 years of age.
2. History of grass and/or ragweed allergic rhinitis.
3. Positive skin test to grass and/or ragweed antigen.
4. Positive response to screening nasal challenge.

Exclusion Criteria:

1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
2. Pregnant or lactating women.
3. Upper respiratory infection or sinusitis within 14 days of study start.
4. Use of nasal steroids, antihistamines in the last 2 weeks.
5. FEV1\<80% of predicted at screening for subjects with history of mild asthma
6. current smokers or recent ex-smokers
7. Any social or medical condition that, in the opinion of the investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Integrative Cognitive-Affective Therapy for Adolescent Eating Disorders

Recently, Integrative Cognitive-Affective Therapy (ICAT), a novel intervention for bulimia nervosa (BN) and binge eating disorder (BED) that targets emotion regulation deficits, has shown promise in reducing eating disorder symptoms as well as improving emotion regulation capacities in adults. However, this treatment has not been investigated in an adolescent sample. Given the contributing role of emotion regulation in adolescent eating disorder symptoms and limited treatment options for adolescents with BN and BED, the aim of this study is to adapt the existing adult ICAT treatment for adolescents with clinically significant binge eating (ICAT-A) and to evaluate the extent to which ICAT-A is helpful in reducing binge eating and associated eating disorder symptoms in a younger sample.


Eligibility Criteria:
Inclusion Criteria:

* Subject with full and sub-threshold bulimia nervosa and binge eating disorder (that is binge eating weekly)
* No major weight loss (defined as a reduction of 10% baseline body weight or more)
* Subject who meet criteria for any Diagnostic and Statistical Manual of Mental Disorders (DSM-5) eating disorder characterized by binge eating with or without compensatory behavior
* Subjects who take medications that do not directly impact weight or appetite (including Selective serotonin reuptake inhibitors (SSRI) antidepressants) will be included if their dose has been stable for at least six weeks
* Subject must be living at home
* At least one parent/guardian is willing to participate in the treatment.

Exclusion Criteria:

* Subject on medications that influence weight or appetite (including antipsychotic medications)
* Subject who is medically or psychiatrically unstable (defined as requiring hospitalization within the past 3 months)
* Acutely suicidal requiring current hospitalization or who meet criteria for substance use disorder in the past month
* Subjects who become or psychiatrically unstable during the study will be re-evaluated, removed from the study, and referred for appropriate treatment.
ROLE of PLATELETS in the PATHOPHYSIOLOGY of SYSTEMIC LUPUS

Blood platelets, well known for their role in hemostasis, are abnormally activated in patients suffering from systemic lupus erythematosus (SLE), but also from other immunomediated diseases (scleroderma, vasculitis, myositis, Gougerot-Sjögren's and rheumatoid arthritis) in cases of high disease activity. Once activated, platelets express adhesion molecules such as P-selectin on their surface, enabling them to interact physically with immune cells. In a recent work, we identified that activated platelets from lupus patients interact with regulatory T cells and block their regulatory function, thus participating in the deregulated activation of the immune system in SLE. In addition, inhibition of platelet-immune cell interactions by an anti-P-selectin antibody improved LES symptoms in two mouse models.

The aim of this work is to investigate other potential platelet-immune cell interactions in patients with SLE, in comparison with other autoimmune diseases (systemic scleroderma, ANCA vasculitides, inflammatory myositis, Gougerot-Sjögren syndrome and rheumatoid arthritis).

This study could lead to a better understanding of the role of platelets in the pathophysiology of autoimmune diseases, identify new biomarkers of activity, and assess the potential of new therapeutic avenues in these diseases, such as platelet targeting.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 70 years of age
* Patient affiliated to a health insurance scheme (beneficiary or beneficiary's beneficiary)
* Patient able to understand the aims and risks of research
* Patient having signed and dated an informed consent form
* Patient for whom the diagnosis of at least one of the following pathologies has been confirmed:
* Systemic lupus erythematosus meeting ACR/EULAR 20195 classification criteria.
* Systemic scleroderma meeting ACR/EULAR 20136 classification criteria.
* ANCA vasculitis according to EULAR/ACR 2022.7-9 classification criteria.
* Inflammatory myositis according to EULAR/ACR 201710 classification criteria.
* Gougerot-Sjögren syndrome according to EULAR/ACR 2016 classification criteria11.
* Rheumatoid arthritis according to ACR/EULAR 201012 classification criteria.

Exclusion Criteria:

* Patient in exclusion period (determined by a previous or current study)
* Inability to give patient informed consent (patient in emergency or immediate life-threatening situation)
* Patient under court protection
* Patient under guardianship or curatorship
Effect of Counseling on Psychological Stress Amongst Women Felt to be at High Risk for Breast Cancer Development

To evaluate 1) the extent of patient overestimation of breast cancer development risk in subjects referred to a physician-based high-risk breast clinic; 2) the ability of physician counseling to improve patient risk perception and reduce psychological distress; 3) to identify factors relevant in clinical practice associated with increased distress and risk perception.

Patients referred to the Baystate Comprehensive Breast Center High-Risk Clinic wil, after giving consent, complete an intake evaluation of breast cancer risk, the patient's perceptions of breast cancer development risk, and the Brief Symptom Inventory-18. Physician history, physical and counseling then takes place, with sharing of risk estimates based on modified Gail model and Myriad tables regarding breast cancer risk and probability of BRCA1/2 mutation. After counseling, patients complete another assessment of risk perception and BSI-18, and again 2 months and 1 year post counseling. Recommendations for hormonal management and referral for formal genetic evaluation and testing will be tracked.

Eligibility Criteria:
Inclusion Criteria:

* Attendance at High-risk Clinic
* Ability to complete BSI-18 and risk perception questionnaire

Exclusion Criteria:

* Diagnosis of invasive breast cancer
* Diagnosis of ductal carcinoma in situ.
Retrospective Chart Review to Evaluate Safety and Tolerability of ADVATE Among Previously Untreated Patients in China With Moderate to Severe Hemophilia A

The purpose of this post-marketing safety study is to evaluate the safety, immunogenicity, and effectiveness of ADVATE in previously untreated patients (PUPs) in China with moderate to severe hemophilia A.


Eligibility Criteria:
Inclusion Criteria:

1. Previously untreated patient (PUP) in China with moderate to severe hemophilia A.
2. Investigator prescribed ADVATE as the predominant therapeutic agent for the management of hemophilia A
3. Informed consent form from patient and/or legal representative will need to be signed per local regulation

Exclusion Criteria:

1. Presence of an inherited or acquired hemostatic defect other than hemophilia A, and any other clinically significant chronic disease
2. Participants who participated in another investigational FVIII drug study, or had participated in any clinical study involving an investigational FVIII drug during the course of the observation period
Trial of Vitamin D3 Supplementation in Paediatric Autism

To build on a recent case study and open label trial, the investigators want to find out if vitamin D supplementation can influence behavioural and core symptoms of autism.

The investigators will assess behavioural and core symptoms of autism before and after 20 weeks of vitamin D supplementation in a double-blind, placebo-controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Positive autism diagnostic observation schedule
* Stable medication regimen
* Tolerate phlebotomy

Exclusion Criteria:

* Unstable or very severe autism
* Epilepsy
* Renal/liver/gastrointestinal disease