cyrilzakka/clinical-trials huggingface dataset:
Role of TMEM219 Marker in Type 1 Diabetes

Type 1 diabetes (T1D) is a chronic metabolic disease characterized by autoimmune destruction of β cells of the insulin producing pancreatic islets. The different immunological approaches implemented to date to treat T1D have obtained a negligible number of insulin-independent individuals. The initial stages of diabetic disease are characterized by the massive and progressive infiltration of T cells and autoantibodies within the tissue with the consequent development of insulitis and subsequently, the destruction of pancreatic beta cells. The onset of T1D has been mainly associated to a dysregulation of the immune response. However, data are emerging on the importance of non-immunological factors responsible for the damage to pancreatic beta cells. The investigators have recently shown that the expression of the TMEM219 death factor is an essential factor in controlling the fate of stem cells in diabetes.

The aim of the study is to identify new markers in the mechanism of damage to pancreatic beta cells in the onset of type 1 diabetes, with particular reference to apoptotic factors such as TMEM219.

METHODS OF RECRUITING THE SUBJECTS Healthy subjects, individuals with type 1 and type 2 diabetes and those who are at risk of developing diabetes will be enrolled. Enrollment was approved by the University of Florida Ethics Committee within the NPOD project, Network for the Pancreatic Organ Donors with Diabetes.

Duration of the study: 5 years.

EXPERIMENTAL PROCEDURE:

The following analyses will be performed on the collected and received samples:

* Study of TMEM219 expression and of other TMEM219-related markers by immunohistochemistry and immunofluorescence and western blot
* Study of TMEM219 expression and of other TMEM219-related markers by molecular biology analysis
* Analysis of the proteomic profile on collected biological liquids The above analyses will be performed at the Pediatric Clinical Research Center Romeo ed Enrica Invernizzi at the Sacco Hospital - University of Milan.

PREVIOUS EXPERIENCES The investigatore expertise in manipulating / studying the signaling involved in the pathogenesis of type 1 diabetes has been widely recognized in several publications in recent years (Diabetes 2013, Diabetes 2014, Diabetes 2015, Science Translational Medicine 2017) as well as the characterization of marker expression including TMEM219 (Cell Stem Cell 2015).

RELEVANCE OF THE STUDY The study offers the possibility to acquire new information on the pathogenesis of diabetes and to identify new target mechanisms for designing innovative therapeutic strategies in the treatment of diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Reported in the NPOD protocol

Exclusion Criteria:

* Reported in the NPOD protocol
Effects of Ivabradine in Patients With Stable Coronary Artery Disease Without Clinical Heart Failure

The purpose of this study is to evaluate the effect of ivabradine on cardiovascular events in patients with coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

* Evidence of coronary artery disease
* Sinus rhythm and resting heart rate equal or higher than 70 bpm

Exclusion Criteria:

* Unstable cardiovascular condition
* Known hypersensitivity to ivabradine or current treatment with marketed ivabradine
A Study of IBI362 9 mg in Chinese Adults With Obesity

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical study evaluating the efficacy and safety of IBI362 9 mg in obese subjects. Subjects will be randomly assigned to IBI362 9 mg and placebo groups. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 2-week screening period, a 60-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18 years or older at the time of signing informed consent
* Have a BMI ≥30 kg/m2
* Have a history of at least one self-reported unsuccessful dietary effort to lose body weight

For subjects with T2D at screening:

* Have a diagnosis of T2D according to the WHO classification above or equal to 3 months prior to the day of screening
* Treated with either diet and excercise alone or on stable treatment with up to 3 oral antidiabetic medications alone or in any combination (EXCEPT GLP-1R agonists or DPP-4 inhibitors) for at least 2 months prior to the day of screening
* HbA1c 7.0-10.0% (both inclusive) at screening
* Fasting blood glucose ≤11.1 mmol/L at screening

Exclusion Criteria:

• A self-reported change in body weight above 5% within 3 months before screening

For subjects without T2D at screening:

• HbA1c ≥6.5% as measured by local laboratory at screening

For subjects with T2D at screening:

* Have history of proliferative diabetic retinopathy, diabetic macular edema or non-proliferative diabetic retinopathy that required acute treatment
* Have had 2 or more episodes of ketoacidosis, hyperosmolar state or lactic acidosis within 6 months before screening;
Examination of B Cell Responses in Human Blood

The aim of this study is the assessment B-cell immune responses in HIV-infected individuals.

Groups of patients with different immune competencies will be examined. The impact of HIV infection on immune response will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected individuals
* controls

Exclusion Criteria:

- none
The BALANCE Study: A Study in Spain to Find Out Whether a Patient Support Program Helps People With Pulmonary Fibrosis Who Take Nintedanib

The aim of this study is to describe patients' satisfaction with Patient Support Program (Balance Program), Quality of Life and depression symptoms, dosing pattern, disease symptoms, adverse events and nintedanib discontinuation (both permanent and non-permanent) from study inclusion to 12 months of follow-up.


Eligibility Criteria:
Inclusion criteria

* Adults (≥18 years old at baseline).
* Patients included in the Patient Support Program (PSP) Balance Program.
* Ability to read and speak Spanish correctly according to the investigator criteria.
* Agree to participate and signing informed consent at baseline.

Exclusion criteria

- Suspicion or diagnosis of any relevant cognitive impairment at the discretion of the investigator.
Crossover Trial of AD036 in Obstructive Sleep Apnea

This is a randomized, 3-Period, Placebo-Controlled, Crossover, phase 2 clinical study to examine the efficacy and safety of AD036 versus placebo or atomoxetine in patients with obstructive sleep apnea.

The study is designed to examine the efficacy and safety of AD036 to treat obstructive sleep apnea. The study is a three-period single-dose randomized crossover design in which patients will undergo overnight Home Sleep Apnea Testing (HSAT) with dosing of one of the following 3 treatments: AD036, Atomoxetine, or Placebo. Participants will return 1 week after their final crossover HSAT for an end of study (EOS) Visit.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female, between 25 to 65 years of age, inclusive, at the Screening Visit.
* AHI 10 to \<20, or AHI ≥20 if meets PSG criteria

Exclusion Criteria:

* History of narcolepsy.
* Clinically significant craniofacial malformation.
* Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. A medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication
* CPAP should not be used for at least 2 weeks prior to first study PSG
* History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.
OCT Reference Database

To collect data for a reference database.

Collection of multiple subjects to create a reference database.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects 18 years of age or older on the date of informed consent
2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
3. Subjects presenting at the site with normal eyes (eyes without pathology)
4. IOP ≤ 21 mmHg bilaterally
5. BCVA 20/40 or better (each eye)
6. Both eyes must be free of eye disease

Exclusion Criteria:

1. Subjects unable to tolerate ophthalmic imaging
2. Subject with ocular media not sufficiently clear to obtain acceptable OCT images
3. HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD \< 5%
4. HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses \> 33% or false positives \> 25%, or false negatives \> 25%
5. Presence of any ocular pathology except for cataract
6. Previous ocular surgery or laser treatment, other than uncomplicated refractive procedure or cataract surgery, performed within six months prior to study scanning
7. Narrow angle
8. History of leukemia, dementia or multiple sclerosis
9. Concomitant use of hydroxychloroquine and chloroquine
Effect of a GnRH Injection on Ghrelin Concentrations in Girls With Suspected Premature Puberty

The purposes of the study is to investigate whether circulating levels of ghrelin decreases after an iv injection of GnRH in girls with suspected central premature puberty and to investigate the effects of different post sampling handling on the preservation of acylated ghrelin.

Patients with clinically suspected central premature puberty undergo a GnRH stimulation test to have an appropriate diagnosis. 20 such girls will be recruited to this study and a modified GnRH stimulation test will be done. The modification includes prolonged blood sampling time (0, 30, 60, 90, 120, and 150 min after the GnRH injection instead of the usual 0, 30, 60, and 90 min). The girls will also be investigated twice. In randomised order they will be given either GnRH or placebo (isotone saline), on different days. One week to one month will separate the different investigation days.

The proteinase inhibitor 4-(2-aminoethyl) benzene-sulfonyl fluoride hydrochlorid (AEBSF) will be added to some of the blood tubes, and hydrochloric acid will be added to some of the plasma. All plasma samples will be frozen and all analyses will be done at the same time. Acylated ghrelin will be analyzed by Millipore's specific ELISA kit and deacylated ghrelin will be analyzed by Cayman's specific ELISA kit.

Anthropometric data as well as pubertal state will be collected. P-glucose, S-insulin, S-follicle stimulating hormone (FSH), S-luteinizing hormone (LH), and S-estradiol will also be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Female gender.
* Clinical suspicion of central precocious puberty.
* A GnRH stimulation test is to be performed to make appropriate diagnosis.

Exclusion Criteria:

* Age \< 1 year.
* Weight \< 10 kg.
* Untreated hypo- or hyperthyroidism.
* Diabetes of any kind.
* BMI \> 3 z-score.
* Growth hormone treatment.
* Syndrome or suspected syndrome.
* Tumour or congenital malformation of the hypothalamus or the pituitary gland. (Neuroradiology does not have to be performed only because of the study.)
* On going ulcus ventriculi or the patient has gone through surgery that removed part of the ventricle or changed it markedly in any other way.
Functional Outcome After Arthroplasty

Bipolar hemiarthroplasty (BA) has long been the preferred treatment and is performed in most fracture neck of femur (FNF) cases. It is justified by the reasonable operative time, low blood loss and acceptable functional outcomes. The dual mobility cup total hip replacement (DMTHA) has emerged as a relevant alternative to BA. Since then, there is an on-going debate on the best implant to use. Age, co-morbidities, patient independence and potential surgical complications must be considered when deciding between implants. The risk of dislocation is a crucial factor because of its important consequences. The investigators evaluated the functional and mechanical outcomes of BA versus DMTHA in FNF in active elderly patients.


Eligibility Criteria:
Inclusion Criteria:

* active patients
* displaced fracture neck of femur
* age from 60 to 80

Exclusion Criteria:

* ipsilateral previous hip surgery
* grade 3 hip osteoarthritis according to tonnis classifiction
* dysplastic acetabulum
Pharmacologically Active Constituents of Chocolate and Their Symptomatic Effects in Patients With Idiopathic Parkinson's Disease

This study evaluates plasma concentrations of pharmacologically active constituents of chocolate and their effects on motor and non-motor symptoms of Parkinson's disease. Following one week of abstinence from cocoa-containing products, patients with Parkinson's disease will be randomized to receive either dark or white chocolate. After one week of chocolate consumption, patients will then cross over to white or dark chocolate, respectively, and take the corresponding chocolate product for another week. Blood samples will be taken at baseline, week 1 and week 2 to examine plasma concentrations of pharmacologically active constituents of chocolate at all three timepoints. Moreover, patients will be clinically examined for motor and non-motor symptoms at all visits.


Eligibility Criteria:
Inclusion Criteria:

* Female or male individuals aged 40 years and above
* Parkinson's Disease according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria
* Hoehn and Yahr stage I-III
* Minimum score of 16 points in the motor part of the Unified Parkinson Disease Rating Scale (UPDRS part III)
* Stable antiparkinsonian medication for at least 4 weeks prior to study inclusion
* Ability to provide informed consent

Exclusion Criteria:

* Clinical signs for a secondary or atypical Parkinsonian syndrome
* Treatment with any investigational medical product within 30 days prior to study inclusion
* Intake of chocolate or other cocoa-containing products within the last 7 days prior to study inclusion (patients can be re-screened after 7 days of abstinence from chocolate and other cocoa-containing products)
* Known intolerance or allergies against chocolate or other cocoa-containing products
* Diabetes mellitus and/or impaired glucose tolerance in the medical history
* Alcohol or drug abuse in the medical history
* Presence of levodopa-induced motor complications
* Other neurological, psychiatric or miscellaneous conditions that would significantly impair study participation, medical assessments or the consenting process
Systematic Withdrawal of Neurohumoral Blocker Therapy in Optimally Responding CRT Patients

The primary objective of this study is to demonstrate that in patients with recuperated/normalized left ventricular function, defined as an ejection fraction (EF) ≥ 50%, after implantation of cardiac resynchronization therapy, device treatment is sufficient and neurohumoral blocker therapy can safely be withdrawn


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years
* CRT implantation

  * based on class I recommendations of ESC (European society of CArdiology) guidelines:
  * Left bundle branch block (LBBB) with QRS duration \>150 ms and left ventricular ejection fraction (LVEF) ≤35% who remained NYHA functional class II, III and ambulatory IV despite adequate medical treatment
  * LBBB with QRS duration 120-150 ms and LVEF ≤ 35% who remain in NYHA functional class II, III and ambulatory IV despite adequate medical treatment
* At the moment of inclusion: ≥ 6 months after implantation
* At the moment of inclusion: normalised LVEF (≥ 50%), LVIDD/BSA (left ventricular internal diastolic diameter indexed to body surface area) ≤3.2 cm/m²(woman) en ≤3.1 cm/m² (men) or LVDV/BSA (left ventricular diastolic volume indexed to body surface area) ≤75 ml/m² (women) or ≤75 ml/m² (men)
* euvolemic clinical state and functioning in NYHA class I

Exclusion Criteria:

* contraindication for withdrawal of ACE-I/ARB such as diabetic nephropathy and proteinuria \> 1g / 24 h
* severe ventricular arrythmia (sustained VT or ventricular fibrillation) occuring at the time LV function was normalized
* ischemic cardiomyopathy with evidence of scarring (scarring on MRI or severe hypokinesia/akinesia in \>1 LV wall segment on echocardiography)
* known severe coronary atherosclerosis (stenosis ≥ 80%)
Combined Treatment of Cetuximab and Paclitaxel in Basal Like Breast Carcinoma

Basal like breast carcinoma is a Her2, estrogen receptor (ER) progesterone receptor (PR) negative breast cancer. It is notable for the high level of epidermal growth factor receptor (EGFR) expression in this tumor subtype .

Thus the investigators wanted to combine the use of anti EGFR therapy in the form of Erbitux (cetuximab) with the widely used weekly taxol chemotherapy for the treatment of these women. This is a small phase I/II study.

Basal like breast carcinoma is a Her2, ER PR negative breast cancer. It is notable for the high percentage of EGFR expression in this tumor subtype.Weekly taxol (paclitaxel) is widely used in breast cancer patients with metastatic disease. Erbitux (cetuximab) is a monoclonal antibody that shown its ability to enhance activity of chemotherapy in colon carcinoma. Thus we wanted to combine the use of anti EGFR therapy in the form of Erbitux (cetuximab) with the widely used weekly taxol chemotherapy for the treatment of women with basal like breast carcinoma. This is a small phase II study that will hopefully provide initial data as to the general tolerability and response rate of this combination in this disease. Furthermore, pathologic analysis will be used to try and assess relation of response with the presence of immunohistochemical markers such as EGFR expression.

Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic breast carcinoma of the basal like subtype with available biopsy for analysis and ECOG PS of 2 or less

Exclusion Criteria:

* Pregnancy
* BUN, blood creatinine, AST, ALT \> X3 of upper limits of normal
* More than previous 2 chemotherapy lines in the metastatic settings or the use of previous inhibitors of EGFR
The Crnic Institute Human Trisome Project Biobank

The Human Trisome Project will significantly increase the speed of Down syndrome research and the understanding of associated medical conditions. Its biobank will provide de-identified samples to research.

The purpose of this study is to provide qualified and approved researchers with access to biological samples and health information to answer specific research questions. This project will significantly increase the speed of Down syndrome research and the understanding of associated medical conditions such as Alzheimer's disease, congenital heart defects, autoimmune disorders, autism, and some forms of leukemia.

Participation includes a blood draw, a mouth swab, and allowing researchers to look at your health information yearly for the next 5 years. Optional procedures include providing a urine and/or stool sample and taking part in the study for a longer time frame.

Eligibility Criteria:
Inclusion Criteria:

Anyone 6 months to 89 years old who:

1. has Down syndrome (any type)
2. does not have Down syndrome

Exclusion Criteria:

1. Prisoners
2. Wards of the state
Drug Interaction Study of Simvastatin and Dabigatran

The aim of the study is to evaluate the effect of simvastatin on the pharmacokinetics and pharmacodynamics of dabigatran in healthy male adults

Pharmacokinetics and pharmacodynamics of dabigatran without coadministration of simvastatin will be compared with those after multiple administration of simvastatin.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 19 and 50 years
* Subjects with body mass index (BMI) between 18.5 and 29.9 kg/m2 and weight more than 50 kg
* Subjects who agree with performing contraception during the study
* Subjects who agreed with written informed consent

Exclusion Criteria

* Subjects who have a current or prior history of cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, skin, psychiatric, or neurological diseases that is clinically significant
* Subjects who have clinically significant allergic history or allergy to simvastatin, dabigatran, or other components of drug
* Creatinine clearance is below 60 ml/min
* Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) is more than 2-fold of upper limit or normal range
* Subjects who have clinically significant bleeding
* Subjects at risk of bleeding
* Subjects who took drugs which significantly interact with simvastatin or dabigatran prior to dosing
* Whole blood donation within 60 days prior to dosing, or apheresis donation within 20 days prior to dosing
* Participated in a previous clinical trial within 90 days prior to dosing
* Subjects with a history of alcohol abuse
* Subjects who are determined by investigator's decision as unsuitable for clinical trial participation
Novel Laboratory Methods in Nutrition Studies

This prospective, nonrandomized, feasibility study will compare laboratory measures at the beginning and end of the study period in adults consuming a nutritional study product.


Eligibility Criteria:
Inclusion Criteria:

* Participant must agree to refrain from taking supplements other than study product.
* Participant states willingness to follow protocol as described, including consumption of study product per protocol, performing finger stick/DBS on Day 60 and completing any forms needed throughout the study.

Exclusion Criteria:

* Body Mass Index (BMI) \> or equal to 35 kg/m2
* Has planned elective surgery requiring 2 or more days of hospitalization during the entire study
* Has stated active malignant disease
* Has a known history of chronic renal parenchymal disease
* Has a known history of severe liver disease/liver failure
* Has any psychiatric disorders that would interfere with study product consumption or compliance with the study procedures
* Known allergy or intolerance to any study product ingredient
* Participation in another study that has not been approved as a concomitant study
Impact of a Low Carbohydrate Breakfast on Glucose Control in Type 2 Diabetes

Large glucose excursions at breakfast are prevalent in type 2 diabetes and can contribute to sustained hyperglycaemia across the day. Lowering consumption of dietary carbohydrate is known to reduce post-meal glucose excursions but it is unknown whether lowering the carbohydrate at breakfast only will impact subsequent post meal glucose excursions throughout the day. The aim of this study is to examine, under free living conditions and using typical dietary patterns, whether eating a breakfast low in carbohydrate can lower daily post-meal glycemia when compared to consuming a low-fat breakfast (per the current diabetes guidelines).


Eligibility Criteria:
Inclusion Criteria:

* Physician-diagnosed Type 2 Diabetes (\>6 months)

Exclusion Criteria:

* Exogenous Insulin
* A1c \> 9%
* Cardiovascular, liver, or renal other disease
* Breakfast and meal skippers
Surgery for Intravenous Leiomyomatosis

Intravenous leiomyomatosis (IVL) with intracardiac extension is a rare benign smooth muscle tumor. Reviewing literature, intracardiac extension of the IVL has been reported in at least 70 cases. Most are individual case reports. Surgical experience is not much. However, different opinion of surgical strategies remain controversial. The purpose of this report is to describe our experience of surgical management for the IVL with intracardiac extension.

All patients underwent surgical management. Clinical data were obtained from medical reports. Following-up was made through email and telephone.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years.
* Tumor markers were all within normal limits.
* Patients underwent surgical management.
* Patients were followed-up for more than 12 months.

Exclusion Criteria:

-Tumor markers were all within abnormal limits