cyrilzakka/clinical-trials huggingface dataset:
Mauriac Syndrome: Isotopic Techniques and Genetic Analysis

Mauriac syndrome (MS) is an entity of individuals combining poorly controlled diabetes mellitus type 1, short stature and glycogenic hepatopathy. Thus, the functional significance of Mauriac syndrome for glucose metabolism remains disputed, and whether genetic defects in glycogen metabolism contribute to glycogenic hepatopathy in MS remains to be clarified.Coupling the genetic analysis of targeted genes involved in glucose regulation with a dynamic exploration will eventually determine if a genetic abnormality leads to the disease and explains the nature of the phenotype.

Investigation of glucose homeostasis in MS, after an oral glucose load followed by exercise, using a quantitative measurement of the substrate flux. This dynamic in vivo kinetics can be explored using stable, nonradioactive tracers with the help of gas or liquid chromatography.

Investigation of genetic factors associated with MS phenotype. Molecular analysis will be performed by next generation sequencing (exome or whole genome sequencing). In addition, a targeted analysis for pathogenic variants in genes implicated in homeostasis regulation will be done.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for controls:
* DT1
* \> 18 years old)
* Presence of at least one of the following auto-antibodies: anti-GAD65, anti-IAA, anti-ZnT8, anti-IA2 or ICA and/or low C-Peptide
* Insulin therapy by multiple daily injections or continuous subcutaneous insulin infusion by an insulin pump
* Informed consent as documented by signature

Inclusion criteria for subjects:

* Mauriac syndrome
* DT1
* \> 18 years old
* Presence of hepatomegaly in infancy (confirmed ≥ 1 abdominal US) at the time of diagnosis of Mauriac Syndrome
* Presence of short stature during infancy at the time of diagnosis of Mauriac Syndrome (\<P3; WHO growth curves on ≥ 2 different measures, at 2 different time-points)
* Presence of at least one of the following auto-antibodies: anti-GAD65, anti-IAA, anti-ZnT8, anti-IA2 or ICA and/or low C-Peptide
* Informed consent as documented by signature

Exclusion criteria for subjects and controls :

* Obesity (BMI ≥ 30 kg/m2 or \> 90th percentile)
* Illness that contraindicates physical activity
* Women who are pregnant or breast feeding
* Any clinically unstable disease
* Myocardial infarcts, syncope, heart rhythm disorder, unstable hypertension in the last 6 months
* Blood donation in the last 3 months for men and 4 months for women before the study
* Enrollment in a previous study less than 30 days before the start of the study
* Participation of the investigator, a family member, an employee or someone having a link with the investigator
PET-FDG in Myocarditis

This study evaluates the diagnostic performance of 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) with rest perfusion imaging for the diagnosis of myocarditis. Patients with clinical suspicion of myocarditis will be recruited and undergo a rest myocardial perfusion scan and a FDG PET/CT scan following a myocardial suppression protocol.

Myocarditis is characterized by myocardial inflammation, which can lead to fibrosis and heart failure.

FDG PET/CT, with appropriate suppression protocol including high-fat-low-carbohydrate diet, fasting, and IV heparin, can be use to detect myocardial inflammation. It is frequently used for the diagnosis of inflammation in cardiac sarcoidosis. After the initial inflammatory phase, inflammation resolves and fibrosis can seen. Resting perfusion imaging will allow identification of fibrosis. The combination of FDG PET/CT and rest perfusion imaging could allow detection of the various phases of myocarditis; inflammation and fibrosis.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Clinical suspicion of myocarditis due to findings such as:

   1. Symptoms and signs of myocarditis such as dyspnea, orthopnea, palpitation, and chest pain, without other identifiable cause
   2. New onset of cardiovascular symptoms with recent history of viral disease or previous myocarditis
   3. Unexplained new onset of left ventricular dysfunction
   4. Unexplained elevated troponin
   5. Magnetic resonance imaging findings suggestive of myocarditis, such as late gadolinium enhancement and edema
   6. Biopsy findings compatible with myocarditis
3. Women of childbearing potential must have a negative urine or blood pregnancy test
4. Capable of giving informed consent and the consent must be obtained prior to any study related procedures
5. Subject's with body mass index inferior or equal to 45 kg/m2

Exclusion Criteria:

1. Female subject who is pregnant or breastfeeding and unwilling to stop for 24h
2. Claustrophobia or inability to lie still in a supine position for imaging purposes
3. Unwillingness or inability to provide informed consent
A Research Study Looking at Similarity Between LY3437943 Versions for Different Injection Devices

The main purpose of this study is to look at the amount of the study drug, LY3437943, that gets into the blood stream and how long it takes the body to get rid of it when given using two different devices. The study will also evaluate the safety and tolerability of LY3437943 and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately 16 weeks, including screening.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or non-pregnant females as determined by medical history, physical examination, and other screening procedures
* Body mass index (BMI) between 18.5 and 32.0 kilograms per meter squared (kg/m²), inclusive
* Have clinical laboratory test results, blood pressure and pulse rate that are acceptable for the study
* Are agreeable to receiving study treatment by injections under the skin
* Males who agree to use highly effective/effective methods of contraception and women not of childbearing potential (postmenopausal or oophorectomized)

Exclusion Criteria:

* Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Smoke more than the equivalent of 10 cigarettes per day
* Is a known user of drugs of abuse
* Have known allergies to LY3437943 or related compounds
The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy

An extended pelvic lymph node dissection (ePLND) is the most accurate staging method to assess the presence of lymph node metastases in prostate cancer (PCa) patients. The therapeutic value, however remains unclear. Prospective randomized trials to address this void are lacking. Since in intermediate and a proportion of high risk PCa the risk of nodal metastases is generally below 25%, the vast majority of men undergo a procedure that has no oncological benefit, but is not without toxicity.

Therefore, the investigators aim to compare the oncologic outcomes of intermediate- and high-risk PCa patients with an estimated risk of lymph node invasion of 5-20% undergoing a radical prostatectomy (RP) with or without an ePLND.

The role of an extended pelvic lymph node dissection (ePLND) in patients undergoing radical prostatectomy (RP) remains controversial. An ePLND is the most accurate staging method to assess the presence of lymph node metastases. Lymph node involvement is associated with a significantly worse prognosis and may require immediate or delayed adjuvant therapy. However, an ePLND is associated with an increased risk of complications such as lymphoceles, thromboses and lymphedema, and prolongs surgery and patient recovery. Thus, the diagnostic advantage of PLND should be weighed against the potential morbidity.

The therapeutic value of an ePLND remains especially unclear in PCa patients with an estimated risk of lymph node invasion (LNI) ≤ 20%, where only a minority of patients will have nodes harbouring metastases. Prospective trials to address this issue are still lacking.

Eligibility Criteria:
Inclusion Criteria:

* Male, aged ≥ 18 years
* Prostate cancer patients with a Briganti calculated risk of LN metastases of 5-20% without evidence of metastases on Prostate-Specific Membrane Antigen (PSMA) PET/CT requiring an ePLND in the standard treatment
* Scheduled for a (robot-assisted) laparoscopic radical prostatectomy
* Written informed consent

Exclusion Criteria:

* American Society of Anaesthesiology (ASA) classification \> 3
* Patients with a contradiction for a lymphadenectomy
* Neoadjuvant hormone deprivation therapy
* Absence or withdrawal of an informed consent
* Evidence of metastases on pre-operative PSMA PET/CT
A Study of HSP90 Inhibitor AT13387 Alone or in Combination With Abiraterone Acetate

A 2-part, Phase 1-2, open-label, parallel group, randomized study in patients with Castration-Resistant Prostate Cancer (CRPC) who are no longer responding to treatment with abiraterone and steroids. In Part A (Phase 1), patients will continue to receive the same doses of abiraterone and steroids they were receiving prior to study entry and will be randomized to receive 1 of 2 different treatment regimens of AT13387 in combination with abiraterone. Once the best regimen is established in Part A, based on safety and antitumor activity, patients will be randomized to the selected treatment regimen and dose of AT13387 in combination with abiraterone or AT13387 alone in Part B (Phase 2).


Eligibility Criteria:
Inclusion:

1. Must have prostate cancer
2. Have received prior castration by orchiectomy and/or hormone therapy
3. Males \>18 years of age
4. Normal activity level for self care
5. Have been receiving abiraterone therapy with a steroid for ≥1 month
6. Have disease progression on abiraterone as defined by either PSA progression, radiographic or bone progression
7. Have adequate bone marrow, liver and kidney function
8. Must be willing to provide pre-existing tumor samples, if this material exists. If pre-existing samples are not available, a sample must be obtained during screening
9. Must be willing and able to provide written informed consent and comply with the protocol and study procedures

Exclusion:

1. Prior anti-cancer treatment with any Heat Shock Protein 90 (HSP90) inhibitor or histone deacetylase (HDAC) inhibitor compound
2. Have received chemotherapy within 4 weeks prior to receiving study drug
3. Prior prostate surgery or radiotherapy within 4 weeks from the first dose of study drug
4. Hypersensitivity to AT13387 or other components of the drug product
5. Treatment with any investigational drug within 4 weeks prior to the first dose of study drug
6. Severe systemic diseases or active uncontrolled infections
7. Presence of a life-threatening illness, medical condition, organ system dysfunction, or other factors
8. Abnormal heart function
9. Other cancer except for adequately treated basal cell or squamous cell carcinoma of the skin, or superficial bladder cancer, or other cancer from which the subject has been disease-free for at least 3 years;
10. No known brain or CNS involvement
11. Unable to receive corticosteroids or history of pituitary or adrenal dysfunction
12. Known history of human immunodeficiency virus (HIV) or seropositive test for hepatitis C virus or hepatitis B virus
Enhancing a High School Based Smoking Cessation Program

The purpose of this study is to examine the the efficacy of adjunctive nicotine replacement therapy when used in combination with the contingency management (CM) + cognitive behavioral therapy intervention. Subjects will be randomly assigned to receive either a nicotine transdermal patch or a placebo patch as well as being randomly assigned to receive either CM or no CM; all subjects will receive cognitive behavioral therapy. We hypothesize that that subjects receiving both active nicotine patch and CM will have higher rates of abstinence from tobacco than subjects in the other groups.


Eligibility Criteria:
Inclusion Criteria:

* High School aged
* Desire to quit smoking
* Smoking \>5 cigarettes per day
* Able to read and write in English

Exclusion Criteria:

* Current dependence on other substances
* Medical conditions that would contraindicate the use of a nicotine patch
Neural Correlates of Empathogenic and Affiliative Actions of Oxytocin

Mounting evidence indicates that the intranasal administration of the neuropeptide oxytocin has prosocial effects. However, the neural substrates of these effects are still unclear. The investigators hypothesized that a single dose administration of oxytocin should increase empathogenic and affiliative responses and that these effects are mediated by an increased insula activity.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers
* In a heterosexual relationship

Exclusion Criteria:

* Current or past psychiatric disease
* Current or past physical illness
* Psychoactive medication
* Tobacco smokers
Transtympanic Ringer's Lactate for the Prevention of Cisplatin Ototoxicity

Cisplatin and carboplatin induce ototoxicity manifested as sensorineural hearing loss, tinnitus, and/or vestibular disturbances. Ototoxicity is induced via damage to inner ear structures by reactive oxygen species. Previous animal studies demonstrated that transtympanic injection of Ringer's Lactate (RL) provided near complete otoprotective effect against cisplatin. The purpose of this study is to determine if transtympanic administration of Ringer's Lactate via a pressure equalising (PE) tube in patients undergoing platinum based chemotherapy treatment will prevent tinnitus, vestibular dysfunction and hearing loss especially at high frequencies. Pre- and post- chemotherapy treatment audiometry will be measured and statistically analysed for significance.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 14
* Patients undergoing platinum based chemotherapy
* Patients who agree to participate in the study

Exclusion Criteria:

* Patients unable to provide consent
* Patients with head and neck cancer
* Patients undergoing radiation of the head and neck
* Patients who develop a tympanic perforation
* Patients with persistent otorrhea
Perioperative Management of Preoperative Anemia in Colorectal Cancer

Both preoperative anemia (PA) and perioperative blood transfusion can contribute on poorer outcomes after colon cancer surgery. Anemia is known to be associated with a slower recovery after surgery thus often worsening short-term results, and allogenic red blood cells transfusion (ARBT) are known to promote systemic inflammatory response and affect overall and cancer-specific survival.

Patient Blood Management (PBM) systems are an evidence-based multimodal approach focused on safe and rational use of blood products, mainly through a proper PA assessment, a minimization of procedural blood loos and strict transfusion policies. Given the high prevalence of PA in patients with colorectal cancer (CRC), and its association with adverse events, it is expected that PBM implementation in said scenario carries a decrease in complications and an improved survival rate. Available literature to date supports preoperative anaemia screening and restrictive transfusion policies, nevertheless barriers exist that limit the expected implementation of PBM systems in colorectal surgery.

The present study aims to evaluate feasibility of a PBM pathway implementation in a high-volume CRC Surgery Unit based on completion of anemia screening and treatment before surgery and changes of allogenic products use along the years. The objective is to estimate the impact of a proper preoperative optimization with iron intravenous infusion (IVI) on PA measured from changes Hemoglobin (Hb) levels in comparison to those of non-anemic patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Colorectal Cancer
* Patients with an indication of elective radical surgery

Exclusion Criteria:

* treatment with red blood cells transfusion before assessment in the PBM Anemia Clinic
* non-iron deficient anemia
* treatment with Sucrose-based IVI or Oral Iron (OI) preparations not strictly controlled by the PBM clinic
A Bioequivalence Study of IMPLANON and Radiopaque IMPLANON (34528)(P05720)

The primary purpose of this study is to demonstrate the bioequivalence of IMPLANON and Radiopaque IMPLANON.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 but not older than 40 years of age at the time of screening
* Good physical and mental health
* Regular cycles with a usual length between 24 and 35 days
* Body mass index ≥ 18 and ≤ 29
* Willing to give informed consent in writing

Exclusion Criteria:

* Contraindications:

  * known or suspected pregnancy
  * active venous thromboembolic disorder (e.g. deep vein thrombosis,pulmonary embolism)
  * presence or history of severe hepatic disease as long as liver function values have not returned to normal
  * malignancy or pre-malignancy, if sex -steroid-influenced
  * undiagnosed vaginal bleeding
  * hypersensitivity to any of the components of Implanon/Radiopaque Implanon
* Hypertension, i.e. systolic blood pressure \>140 mmHg and/or diastolic blood pressure \> 90 mmHg.
* A history during pregnancy or during previous use of sex steroids of: jaundice and/or severe pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss
* Present use or use during 2 months prior to the start of Implanon/Radiopaque Implanon of one of the following drugs: phenytoin, phenobarbital, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, ritonavir, nelfinavir, griseofulvin or the herbal remedy St John's wort.
* Administration of investigational drugs within 2 months prior to the start of Implanon/Radiopaque Implanon
Non-interventional Study of Ocrelizumab in Participants With Relapsing or Primary Progressive Multiple Sclerosis

This is a multicentre non-interventional study aimed at evaluating the real-world effectiveness and safety of ocrelizumab treatment in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS), who have been prescribed ocrelizumab as per routine practice. This study will use a comprehensive combination of participant reported outcomes and conventional multiple sclerosis (MS) endpoints that measure clinical domains commonly affected by MS (e.g. fatigue, hand function, gait, cognition), and their impact on employment, activities of daily living, quality of life and healthcare resource utilization. The incidence, type, and pattern of serious adverse events (SAEs), and of adverse events (AEs) leading to treatment discontinuation will also be determined.


Eligibility Criteria:
Inclusion Criteria:

* Must have a definite diagnosis of RMS or PPMS and in whom a decision to initiate ocrelizumab has been taken as part of routine clinical practice
* Must be prescribed ocrelizumab in line with the SmPC
* Must have provided signed informed consent
* Must be able and willing to complete the PROs as per clinical practice

Exclusion Criteria:

* Previously treated with ocrelizumab (including phase II, phase III and phase IIIB clinical trials, local trials and investigator initiated study (IIS) as well as a pre-approval access or compassionate use programmes or local registries that are not compatible with the MuSicalE study design)
* Not receiving ocrelizumab in line with the SmPC
Agili-CTM Implant Performance Evaluation in the Treatment of Osteoarthritis of the Great Toe

The purpose of this study is to evaluate the performance of the Agili-CTM implant in the treatment of osteoarthritis of the Great Toe.

Agili-C™ implant is a CE marked. The Agili-CTM implant is a porous resorbable tissue regeneration scaffold for the treatment of articular cartilage and/or osteochondral defects.

The Agili-C™ implant will be implanted using the Agili-Kit™ surgical toolset which is designed for the precise preparation of sites in cartilage and osteochondral defects, for implanting the Agili-C™ implant.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Osteoarthritis of the First Metatarsophalangeal Joint
* Presence of good bone stock
* Physically and mentally willing and able to comply with post-operative
* rehabilitation and routinely scheduled clinical and radiographic visits

Exclusion Criteria:

* \< 18 years of age
* Any past or present evidence of infection of the treated joint
* Any known malignant tumor of the foot
* Known inflammatory arthropathy or crystal-deposition arthropathy
* Chemotherapy treatment in the past 12 months
* History of allergic reaction or intolerance to calcium carbonate or hyaluronate
* Patient who is pregnant or intends to become pregnant during the study
* History of any significant systemic disease, such as but not limited to, HIV infection, hepatitis infection or HTLV infection; known coagulopathies, that might compromise the subject's welfare
* Known substance abuse or alcohol abuse
* Participation in other clinical trials in parallel to this study
* Known insulin dependent diabetes mellitus
* Unable to undergo imaging studies
African-American Diabetes Intervention Project

A controlled trial to assess the potential benefit of a home based worker in improving control in African-American children with insulin dependent diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Insulin dependent diabetes mellitus