cyrilzakka/clinical-trials huggingface dataset:
Intervention on New Onset-T1D Children

A pilot proof of concept clinical trial will be performed to demonstrate the restoration of gut barrier integrity by administration of beneficial anti-inflammatory gut microbial strains (Lactobacilli-enriched Vivomixx® probiotic) to new onset Type 1 Diabetes Children.

This is an interventional randomized, 2-arm, single-blind, single-center, placebo-controlled mechanistic clinical trial (1:1).

One sachet of probiotic for children \< 10 years old or two sachets for subjects \> 10 years old dissolved into water or noncarbonated drinks will be administered every day for 90 consecutive days.The primary end point of the study will be the preservation of the residual insulin-producing beta-cell mass measured as the change in C-peptide values at 12 months after the beginning of treatment. Moreover, the investigators will collect blood samples for serological analysis (autoantibodies detection, measurement of biomarkers of gut barrier integrity) and immunological profiling; fecal samples for microbiome and metabolomic analysis. Finally the investigators will assess whether the response to Vivomixx® probiotic remains stable over a long-term period, that is in the absence of active treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of insulin-dependent type 1 diabetes
* Positive for at least one islet autoantibody (ICA, GADA, IA-2, IAA, ZnT8)
* No more than 3 months from first insulin injection
* ≥ 7 to \< 18 year old

Exclusion Criteria:

* Diagnosed with celiac disease, IBD or other intestinal inflammatory pathologies
* Diagnosed with tuberculosis, hepatitis B or C, HIV, or active EBV or CMV infection; significant cardiac disease; conditions associated with immune dysfunction or hematologic dyscrasia (including malignancy, lymphopenia, thrombocytopenia, or anemia); liver or renal dysfunction.
* Ongoing use of systemic medications other than insulin.
* Recent administration of antibiotics (1 months prior to treatment)
* Deemed unlikely or unable to comply with the protocol or have any complicating medical issues or abnormal clinical laboratory results that interfere with study conduct or cause increased risk.
Sialic Acid Supplementation in N-Acetylneuraminic Acid Synthase (NANS) Deficiency

This study is aimed at assessing the impact of short-term (3 days) exogenous sialic acid supplementation on endogenous biomarkers of sialic acid metabolism in NANS deficient patients.

NANS deficiency is a genetic disorder presenting clinically with intellectual development disorder, skeletal dysplasia and dysmorphic features. It has recently been described in 9 patients (4 children and 5 adults). Biallelic mutations in the NANS (N-Acetylneuraminic acid synthase) gene cause a block in the endogenous synthesis of sialic acid and accumulation of the precursor, N-acetyl mannosamine (ManNAc). In a cell culture model, this block results in hyposialylation of glycoproteins and glycolipids. It seems likely that in human, this enzyme deficiency impairs the sialylation of glycolipids and glycoproteins, known to be essential for brain development. Exogenously added sialic acid partially rescued the phenotype of NANS-deficient zebra fish. Currently there is no approved treatment for patients with NANS deficiency. The investigators concluded that exogenous sialic acid supplementation might be useful for NANS patients. Given that sialic acid is found as both, a free sugar and in a bound form in standard nutrition as well as in high quantities in breast milk, it can be considered as a safe nutritional ingredient; this notion is fully supported by animal toxicity studies.

The use of sialic acid in NANS deficiency is in line with oral supplementation of specific sugars for treatment of other glycosylation and sialylation defects such as congenital disorders of glycosylation (CDG) and myopathy with mutation in the gene GNE. This novel monosaccharide therapy represents an opportunity to address fundamental biochemical questions about the relative contribution of endogenous and dietary sources on sialic acid metabolism and its potential role as a future therapy for NANS patients.

Eligibility Criteria:
Inclusion Criteria for controls:

* 4 healthy adults aged 18 to 60 years (inclusion in Switzerland)

Inclusion Criteria for subjects with NANS deficiency:

* 4 adults aged 18 to 60 years with genetically proven NANS deficiency (inclusion in Italy)
* 2 children aged 1 to 18 years with genetically proven NANS deficiency (inclusion in Switzerland)

Exclusion Criteria for controls:

* Medication, Restrictive diet (e.g. lactose free diet), obesity or other co-morbidities (e.g. neurological disease, developmental delay)

No exclusion Criteria for subjects
The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss

In this clinical cohort study, the investigators are going to observe the efficacy of anti-coagulation and immune therapy in the treatment of recurrent pregnancy loss with a prospective randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

- Woman who had 2 miscarriage before 12(th) week of gestation.The patient who is diagnosed as thrombophilia with recurrent pregnancy loss. Signed consent form.

Exclusion Criteria:

1. having experienced severe allergies, trauma history and/or operation history within 3 months.
2. with a history of mental illness and/or family history of mental illness limb disabled.
3. taking medicine within one month.
4. suffering major events or having mood swings.
5. having internal and surgical disease(after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine routine)
6. chromosome aberrations in anyone of the couple.
7. patients who have drugs contraindications
IL-6 as a Biomarker for Personalized Treatment of PR

Several studies have shown the relevance of the IL6 level before treatment or after 6 months, as a predictive biomarker for the persistence of remission. The IL6 assay is now routinely available using the instruments available at the Montpellier University Hospital and with reagents provided by the ROCHE Laboratory. Moreover medical practices should incorporate this parameter. However, relevant threshold shlould be defined before being able to integrate biomarkers such as IL6 for monitoring bDMARDs in an algorithm.

The medical staff of Clinical Immunology Unit has decided to include the dosage of IL-6 during a routine biological assessment during patient visit to follow the new EULAR recommendations . This measument will be perfom in addition to the CRP and biochemical parameters on subjects with active RA or in remission upon the introduction of biological treatments or JAKi or during remission after at least 6 months of treatment. From March to July 2021, 200 patients will beenrolled and will benefit of this assessement. The investigators will retrospectively define clinical correlations with serum IL6 levels in order to define a threshold. In the second stage, a decisional algorithm based on the results of this project will be create. This will allow an improvement of the medical practices thanks to the integrationof of serum IL6 dosage as a standard during patients visits. The IL-6 assay will be performed on the e801 module of the Cobas lines (Roche Diagnostics) currently in place in the Biochemistry and Hormonology laboratory. The Elecsys® IL-6 - Roche Diagnostics test, high sensitivity, is an electrochemiluminescence immunoassay.


Eligibility Criteria:
Inclusion criteria:

* 18 to 65 years old
* patients with rheumatoid arthritis according to 2010 ACR/EULAR criteria who have one of the following conditions:

  * Subjects with active RA (DAS28\> 3.6) who have failed methotrexate treatement and with a standard medical care for which an indication for biotherapy is retained or
  * Subjects with remission of RA (DAS28\<2.6) for which a biotherapy delay (anti-TNF or anti-IL6R or JAKi) is proposed.

Exclusion criteria:

- Age under 18 years old
An Exploration of Genetic Testing for Prostate Cancer Susceptibility

Study of the factors that affect interest in - and uptake of - genetic testing for variants that predispose to prostate cancer from the perspective of the patient.

This study will use a mixed methods approach to follow men as they move through the genetic testing process, from initial contact through to receiving their genetic testing results. A questionnaire will be used to measure variables at both baseline and after proceeding through the testing process. A small cohort of men will be invited to be interviewed to gather some in depth qualitative data about the issues that have arisen during the study process.

Eligibility Criteria:
Inclusion Criteria:

* Men with a positive family history of prostate cancer. The definition of a positive family history will be: Men with a first degree relative with prostate cancer diagnosed at \<70 years; Men with two relatives with prostate cancer where at least on is diagnosed at \<70 years; Men with three relatives with prostate cancer diagnosed at any age
* Age 40-69 years
* No previous biopsy for raised PSA
* Absence of any psychological, familial, sociological or geographic situation potentially hampering compliance with the study protocol and follow-up schedule.

Exclusion Criteria:

* Previous prostate cancer
* Men from families where there is known to be a mutation in a high-risk prostate cancer gene
* Men who have had a prostate biopsy within the last 12 months.
Effects of Beef Protein Consumption on Energy Intake

The purpose of this study is to determine ad libitum daily energy intake, body weight changes and appetite profile in response to protein/carbohydrate and fat ratio over 12 consecutive days, and in relation to age, gender, body mass index (BMI) and fat mass and obesity-associated (FTO) gene alleles.

The protein leverage hypothesis requires specific evidence whether energy intake would depend on a possible protein intake target in humans. Meat protein as complete protein may show most beneficial effects on variables regarding food intake regulation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Age 18-70 years
* BMI 18-35 kg/m2
* Non-smoking
* Weight stable

Exclusion Criteria:

* Smoking
* Use of medication
* More than moderate alcohol consumption
* Vegetarian
Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration

This study will evaluate which procedure is the best for patients referred for biopsy of a lung nodule (growth in the lung) meeting the size and location requirements of the protocol. Two different procedures are available for lung nodule biopsy:

1. a computed tomography guided biopsy ("CT-guided biopsy") which consists of sampling the nodule from the "outside-in", through the chest wall with CT guidance, and
2. navigation bronchoscopy, which is a procedure using technology designed to guide a catheter through the natural airway route (wind-pipe and bronchi) to access the nodule.

Endpoints:

Primary:

• To evaluate diagnostic accuracy through 12 months of clinical follow-up

Secondary:

* To evaluate rate of pneumothorax.
* To evaluate rate of pneumothorax requiring chest tube placement.
* To evaluate clinically significant bleeding (defined by bleeding requiring intervention).
* To evaluate need for hospitalization after procedure.
* To evaluate duration of the procedure.
* To evaluate procedural factors associated with improved yield (type of biopsy, number of biopsies, use of radial ultrasound, presence of a bronchus sign, biopsy site).
* To evaluate need for additional nodule biopsy.
* To evaluate need for additional procedure for staging.
* To evaluate radiation exposure from fluoroscopy-guided bronchoscopy and CT for CT-guided biopsy.
* To evaluate need for F-Nav (digital tomosynthesis) during navigation bronchoscopy.
* To evaluate diagnostic yield
* To evaluate the rate at which the biopsy procedure yields a confident clinical diagnosis (including any added yield from endobronchial ultrasound-guided mediastinal and/or hilar lymph node biopsies or microbiologic studies which yield an explanation for a nodule despite non-diagnostic biopsy specimens).

Eligibility Criteria:
Inclusion Criteria:

* Patient is referred for biopsy of a single indeterminate pulmonary nodule, with the following characteristics regarding size, location, accessibility, and probability of malignancy:

  * Intermediate pre-test probability of malignancy as defined by a pre-test probability of malignancy between 10% and 100%, using a validated clinical prediction model, which is either:

    * The Brock model14 if no PET scan data are available, or
    * The Herder model15 if PET-CT data are available.
  * Size between 10 and 30 mm (long diameter).
  * Location peripheral, here defined as occupying the middle or outer third lung zones.
  * Accessible via navigation bronchoscopy and also accessible via CT-guided biopsy (i.e. the nodule is clinically suited to equal access by either procedure), as confirmed by an independent interventional panel.

Exclusion Criteria:

* Patients with proximal nodules, as defined by nodules present in the proximal 1/3 of the lung by dedicated software analysis (described below) will not be eligible for the study.
* Patients with multiple nodules requiring biopsy (patients may have other nodules not considered for biopsy).
Somatostatin Receptor PET/CT in SSTR-Related Disease Patients

To evaluate the potential usefulness of 68Ga/18F-TATE/JR11/LM3 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various SSTR-related disease patients.

Subjects with various SSTR-related disease patients underwent 68Ga/18F-TATE/JR11/ LM3 PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga/18F-TATE/JR11/LM3 PET/CT were calculated.

Eligibility Criteria:
Inclusion Criteria:

- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled SSTR PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

- (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Starting Early to Prevent Obesity Using Telehealth (StEP OUT): Intervention Development Trial

The goal of this intervention development study is to optimize the Starting Early to Prevent Obesity Using Telehealth (StEP OUT) intervention for feasibility and acceptability, using human-centered design and community-engaged research methods.

This intervention development study will enroll three to four consecutive cohorts to receive Starting Early to Prevent Obesity Using Telehealth (StEP OUT), an online, group-based nutrition education and parenting support program beginning in the third trimester of pregnancy and continuing through the first four to six months of infancy. It is tailored to Hispanic/Latinx families. StEP OUT will be delivered by a registered dietician/certified lactation counselor in coordination with the Long Island Jewish Medical Center Special Supplemental Nutrition Program for Women, Infants, and Children (LIJ WIC). The StEP OUT curriculum is based on the Starting Early Program (StEP), which uses didactic instruction, reflective discussion, interactive demonstrations, and hands-on practicing of skills to support prenatal nutrition and healthy early infant feeding practices. The details of program structure and content will evolve as the study progresses based on feedback from participants, interventionists, and our Community Advisory Board. Initially, we will plan to have 5 formal sessions structured as groups with multiple participants receiving the session simultaneously, primarily via remote videoconference, though sessions may occur individually, based on participant schedule and preference. Each session will conclude with a structured feedback discussion designed to elicit targets and strategies for further program adaptation. We will collect feasibility and acceptability data after each session and at the end of the five-session program for each cohort. The iterative intervention adaptation process will be complete once all participants rate the intervention as "acceptable" or higher and fidelity is 90% or higher. We anticipate meeting this benchmark after 3 cohorts but may need to recruit an additional cohort to test subsequent adaptations, if necessary.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant with at least 14 weeks estimated gestational age
* Self-identify as Hispanic/Latinx
* Speak fluent English or Spanish
* At least 18 years of age
* Has a phone or device to participate in video calls
* Receiving or eligible to receive WIC benefits

Exclusion Criteria:

* Diminished mental capacity
* Serious medical or psychiatric illness
* Serious fetal illness
A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique

This is a single-center, open-label, Phase Ib/II study aiming to assess the perioperative safety and postoperative outcomes of a novel surgical technique in treating primary adenocarcinoma located in the upper 1/3 of the stomach or gastroesophageal junction (Siewert II or III).

The study will enroll 30 patients who will undergo totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique. Clinical data will be collected to evaluate perioperative safety. Patients will be followed for at least 3 months, during which endoscopy will be performed to analyze occurrences and reasons for anastomotic-related complications. Additionally, the quality of life after surgery will be evaluated by QLQ-C30 and QLQ-STO22.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 75 years old;
2. Pathologically confirmed as adenocarcinoma;
3. Primary tumor located in the upper 1/3 of the stomach or the gastroesophageal junction (Siewert II or III);
4. If it is adenocarcinoma of the upper 1/3 of the stomach, cT1N0M0 should be met.
5. For gastroesophageal junction adenocarcinoma, cT1-2N0M0 should be met, and clinical judgment should indicate no distant lymph node metastasis around the stomach.
6. Bilateral resection margins should be greater than 2 cm, and more than half of the residual stomach should be preserved.
7. No history of upper abdominal surgery (excluding laparoscopic cholecystectomy).
8. No preoperative comprehensive treatments such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.
9. Preoperative ECOG (Eastern Cooperative Oncology Group) score of 0/1.
10. Preoperative ASA (American Society of Anesthesiologists) score I-III.
11. Good function of important organs.
12. Signed informed consent.

Exclusion Criteria:

1. Preoperative assessment indicating cT4b or Bulky lymph nodes enlargement or distant lymph nodes metastasis;
2. Pregnant or lactating women;
3. Patients with severe mental illness;
4. Preoperative temperature ≥38°C or infectious diseases requiring systemic treatment;
5. Severe respiratory diseases, with FEV1 \< 50% of predicted value;
6. History of other malignant tumors in the past 5 years;
7. Severe liver or kidney dysfunction;
8. Unstable angina or myocardial infarction within the last 6 months;
9. History of stroke or cerebral hemorrhage within the last 6 months (excluding old infarcts);
10. Systemic use of glucocorticoids within the last 1 month;
11. Emergency surgery required due to complications of gastric cancer (bleeding, perforation, obstruction);
12. Patient has participated in or is currently participating in other clinical trials (within the last 6 months).
Application of Magnetic Fields as Adjunctive Treatment for Type II Diabetes

The purpose of this study is to see if using a device called the Resonator, that puts out a very low electromagnetic field, effects blood glucose and A1c levels in people with Type 2 Diabetes.

The purpose of this pilot study is to determine whether application of magnetic fields generated by the Resonator result in statistically significant reductions in finger stick blood glucose levels, serum glucose and hemoglobin A1c levels. The study will also investigate any induced changes in serum lipids and liver function tests as indirect markers of insulin resistance.

Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of Type II Diabetes Mellitus with A1c level above the upper limit of normal
* Subject currently performs routine finger stick blood sugar testing
* Subject is ambulatory
* None or stable medication regimen without significant side effects for at least 6 months, willingness and ability to maintain the stable medication regimen throughout the course of the study.
* Hemoglobin A1c levels within a 0.8% range of patient mean A1c level for the last two documented determinations, that must be within 2 years of the baseline testing date.
* Willingness to test finger stick blood sugars according to protocol.
* Willingness to have lab test blood draws performed according to protocol
* Willingness to maintain stable diet and activity regimen for the duration of the study.
* Willing and able to abstain from partaking in any non-essential existing or new treatments to improve serum blood sugar levels.
* Adequate contraceptive measures for female subjects
* Male or female
* Any ethnic group
* Between 21 and 80 years of age

Exclusion Criteria:

* Change in medical regimen within 6 months prior to initiation of study
* Any signs of Type I diabetes
* Active infectious process within 3 weeks of study initiation causing wide fluctuations in finger stick blood sugar level.
* Change in BMI of greater than 6% within a 6 month period prior to study initiation
* Any planned revascularization procedure
* Symptomatic congestive heart failure
* Leg or foot ulceration or open wounds
* Gangrene
* History of intermittent claudication
* Hemodialysis
* Currently being treated for malignancy
* Currently being treated with oral or intravenous catabolic steroids.
* Reported consumption of more than 14 alcoholic drinks per week.
* Pregnant, breast feeding,or planning pregnancy prior to the end of participation.
* Developmental disability or cognitive impairment that would make it difficult for the subject to partake in the clinical study, including adequate comprehension of the informed consent form and ability to record the necessary measurements.
* Uncontrolled hypertension
* Uncontrolled atrial fibrillation or other uncontrolled arrythmias, e.g. tachycardia, bradycardia
* Uncontrolled seizure disorder
* Uncontrolled, unstable, or untreated medical conditions which may significantly impact the subjects health or ability to complete the entire study, in the opinion of the investigator
An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer

Phase 1 study to evaluate the safety and effect of Gedatolisib and PTK7-ADC for the treatment of triple negative breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Metastatic Triple-negative Breast Cancer
* Willingness to undergo tumor biopsy
* Patients must have received at least 1 prior chemotherapy regimen for metastatic disease

Exclusion Criteria:

* Previous treatment with mTOR inhibitor
* Untreated brain metastases