cyrilzakka/clinical-trials huggingface dataset:
Changes in the Hypotalamic-pituitary Region of Patients With Metabolic Syndrome and Obesity

This study aims to identify new morphological and quantitative magnetic imaging parameters of pituitary gland and sellar region in overweight and obese patient at baseline and after 3 years, dividing patients in 3 groups (weight loss through diet and lifestyle changes, weight loss through bariatric surgery, no weight loss)

This longitudinal prospective study in overweight and obese patients aims to identify and characterize new morphological and quantitative MRI parameters of pituitary gland and sellar region assessed by texture analysis with a specific software (ImageJ©). These parameters will be correlated them to hypothalamic-pituitary-peripheral axis function, metabolism and body composition.

Data will be detected at baseline and at 3 years follow-up to quantitatively identify the different pituitary MRI patterns in 3 groups:

1. patients without weight modifies
2. patients with weight loss obtain through diet and lifestyle changes
3. patients with weight loss obtained through bariatric surgery

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 25 Kg/m2

Exclusion Criteria:

* Malignant neoplasia;
* Current use of psychotropic drugs;
* Chronic renal failure;
* Pituitary macroadenomas and craniopharyngiomas;
* Contraindications to MRI execution (p. e. pace-maker, metal foreign bodies like slivers, non MRI compatible vascular clips or prosthesis)
Alpha Radiation Emitters Device for the Treatment of Squamous Cell Carcinoma (DaRT)

A unique approach for Skin Squamous Cell Carcinoma (SCC) treatment employing intratumoral diffusing alpha radiation emitter device

This will be a prospective study, assessing the safety and effectiveness of intratumoral alpha radiation mediated treatment with Alpha DaRT seeds for the treatment of Skin Squamous Cell Carcinoma (SCC) tumors.

Treatment will be delivered through radioactive sources (Alpha DaRT seeds) inserted into the tumors in the skin. This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.

Lesions with histopathological diagnosis of squamous cell carcinoma will be studied.

Reduction in tumor size 30-45 days after DaRT insertion will be assessed. Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).

Eligibility Criteria:
Inclusion Criteria:

* Subjects with histopathological confirmation of skin squamous cell carcinoma before surgical removal of the tumor.
* Subjects with a tumor size ≤ 5 centimeters in the longest diameter (lesions without nodal spread).
* Subjects' age is over 18 years old.
* Subjects' ECOG Performance Status Scale is ≤ 2.
* Subjects' life expectancy is more than 6 months.
* Female subjects of childbearing age will have evidence of negative pregnancy test.
* Subjects are willing to sign an informed consent form.

Exclusion Criteria:

* Subject has a tumor with a maximal diameter \> 5 centimeters.
* Subject has an ulcerative lesion.
* Subject has a tumor of Keratoacanthoma histology.
* Subjects' ECOG Performance Status Scale is ≥ 3.
* Patients with moribund diseases, e.g., autoimmune diseases, vasculitis, etc.
* Patients under immunosuppressive and/or corticosteroid treatment.
* Volunteers that participated in other studies in the past 30 days that might affect the evaluation of response or toxicity of DaRT.
* Pregnant women.
* Subjects not willing to sign an informed consent form.
Mini-flap BABA (Bilateral Axillo-breast Approach) Robotic Thyroidectomy is Safe

In this study, a randomized controlled study was conducted between two groups of 40 recipients of conventional flap during BABA robotic-thyroidectomy and 40 recipients of Mini-flap method during BABA robotic-thyroidectomy. In this study, we tried to determine whether the use of Mini-flap can reduce sensory loss and pain after BABA robotic-thyroidectomy.


Eligibility Criteria:
Inclusion Criteria:

* subjects who will have thyroid surgery
* subjects who has no evidence of lymph node metastasis on palpation and imaging (cN0)
* subjects who has thyroid nodule under 4cm (\<cT2)
* subjects who has no distant metastasis (M0)

Exclusion Criteria:

* subjects who has clinical evidence of lymph node metastasis (cN1a or cN1b)
* subjects who has both thyroid nodule
* subjects who underwent any radiotherapy on neck
* subjects who has primary hyperparathyroidism
* subjects who underwent head and neck surgery
* subjects who disagree to do this trial
Culturally-Responsive Curriculum for Caregivers With Children at Autism Likelihood

The goal of this clinical trial is to examine how helpful and relevant the Family Care Project workbook is for families from culturally and linguistically diverse backgrounds who have a young child at autism likelihood. The main questions this trial aims to answer are:

* Is the Family Care Project workbook useful for families?
* Is the Family Care Project workbook easy to use?
* Can the Family Care Project be implemented by non-profit workers who do not have health backgrounds?

Participants will complete surveys that elicit their feedback on their use of the workbook.

Access to early, evidence-based autism-specific treatment can profoundly improve long-term outcomes for children with Autism Spectrum Disorder (ASD). However, current estimates reveal an eight-month to three-year gap between caregiver first concerns about their child's ASD-related behaviors and receipt of ASD-specific services. This prolonged time-period between caregiver first concerns and receipt of ASD-specific services is characterized by elevated parenting stress, increased child behavioral challenges, and reduced quality of life, even compared to families of children with non-ASD developmental concerns. Unfortunately, culturally and linguistically diverse (CALD) communities experience lengthier time-periods between first concerns and receipt of services, report increased difficulty accessing timely diagnostic and treatment services, and ultimately experience worse health outcomes compared to White communities. The investigators will partner with Mother Africa, a local non-profit organization, to 1) co-design culturally-responsive caregiver-focused educational materials to support CALD families with young children who have social communication delays or ASD and 2) develop a novel route for dissemination of information and materials within non-profit organizations, which are often the preferred entry-point for accessing healthcare information and services for underserved populations, rather than traditional medical facilities. The educational materials will support caregiver and child well-being by increasing caregiver knowledge and use of ASD specific parenting strategies as well as increasing caregiver awareness and use of local ASD resources. This planned research has the potential to effect programmatic changes in the services and settings available to support CALD communities during the early years of a child's ASD condition and thereby improve child and caregiver outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Has a child who screens at likelihood on the Ages and Stages Questionnaire
* Speaks one of the following languages: Arabic, Mai Mai, Swahili, French, Tigrinya, Dari

Exclusion Criteria:

-
Study to Evaluate Progression Free Survival in Cancer Patients With Advanced Colorectal Carcinoma With AMT2003

The purpose of the study is to evaluate efficacy and safety of AMT2003 in cancer patients with advanced colorectal carcinoma.

The primary endpoint is progression free survival rate at 18 weeks after registration

The study will include patients with advanced colorectal carcinoma that is refractory to standard therapy or for which no effective standard therapy exists. Eligible patients must have had at least second-line chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Cancer confirmed by histology or cytology
* At least one measurable lesion
* Advanced disease refractory to standard therapy or for which no standard therapy exists
* Life expectancy of at least 3 months

Exclusion Criteria:

* Known secondary neoplasia or central nervous system (CNS) metastases; acute or chronic leukemia, lymphoma or multiple myeloma
* Body weight below 45 kg
* Female patients who are pregnant or breast feeding or adults of reproductive potential not employing effective method of birth control
* Confirmed diagnosis of HIV
* Insulin dependent diabetes mellitus / abnormal glucose tolerance test (GTT) / latent diabetes mellitus type I or II
* Chemotherapy or radiotherapy less than 4 weeks prior to entry
* Surgery less than 2 weeks prior to entry (or not recovered from effects of surgery)
* Participation in a clinical trial less than 30 days prior to entry in the study
Efficacy Study of RX-10100 to Treat Erectile Dysfunction (ED)

The primary objective of this Phase IIa trial is to determine the effective doses and treatment period for an upcoming RX-10100 Phase IIb trial in subjects with erectile dysfunction (ED). The secondary objectives of this trial are to evaluate the safety and the quality of life in subjects with ED receiving RX-10100 treatment.


Eligibility Criteria:
Inclusion Criteria:

* Have had ED for at least six months
* Stable, heterosexual relationship for at least 3 months
* Make at least one attempt of sexual intercourse per week during the untreated, 2-week screening period
* At least 50% of attempts of sexual intercourse during the untreated baseline period must be unsuccessful
* 'Moderate' or 'mild to moderate' ED, defined as an IIEF-EF domain score between 11 and 21 measured

Exclusion Criteria:

* Following previous or current medical conditions

  * Any unstable medical, psychiatric, or substance abuse disorder
  * Penile anatomical abnormalities
  * Primary hypoactive sexual desire
  * Spinal cord injury
  * Hypogonadism
  * Surgical prostatectomy
  * Stable or unstable angina pectoris
  * Myocardial infarction, stroke, or life-threatening arrhythmia
  * Uncontrolled atrial fibrillation/flutter at screening
  * Severe chronic or acute liver disease
  * Moderate or severe hepatic impairment
  * Clinically significant chronic hematological disease
  * Bleeding disorder
  * Significant active peptic ulcer disease
  * Resting hypotension or hypertension
  * Malignancy (cancers)
  * NYHA Class II to IV heart failures
  * Positive test for Hepatitis B surface antigen (HBsAg) or Hepatitis C
  * Symptomatic postural hypotension
* Following concomitant medication

  * Androgens or estrogens
  * Anti-androgens
  * Potent inhibitors of cytochrome P450 3A4
  * Any other investigational drug within 30 days before Visit 1
  * Any treatment for ED within 7 days before Visit 1 or during the study
  * Antibiotics in the penicillin class
* Following abnormal laboratory values

  * Serum total testosterone level (at least 25% lower)
  * Serum creatinine (\> 3.0 mg/dl)
  * Elevation of AST and/or ALT (\> 3 times the upper limit of normal)
  * Diabetic subjects with an HbAlc (\> 6.5%)
* Subjects with known hypersensitivity to amoxicillin
* Subjects with a history of unresponsiveness to any PDE5 Inhibitor treatment or a history of significant side effects leading to its treatment discontinuation
Adjustment Exploratory Protocols and Functional Evaluation of New Non Invasive Devices in Healthy Volunteers

Parameters, sequences or paradigms optimisation in view of data quality and relevancy improvement.

Various tests are needed for methodological optimization of the several devices (per-operative MRI, MEG, EEG, SPECT-CT, motor platform) of the technological platform.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Male or female aged over 18 years
* Registered in the French social security scheme
* Signed informed consent

Exclusion Criteria:

* Contraindication to Magnetoencephalography (MEG) and/or Electroencephalography (EEG)
* Contraindication to Magnetic resonance imaging (MRI)
* All categories of protected persons
Corneal Flap Transplantation for Macular Hole Repair of High Myopia

The goal of this clinical trial is to learn about an innovative surgical technique for macular hole repair. This technique is for patients with high myopia using pars plana vitrectomy (PPV) combined with corneal flap transplantation. The main questions it aims to answer are:

* Is the innovative surgical technique useful for patients?
* Is the surgical technique safe for patients?

Participants will:

* Undergo PPV combined with corneal flap transplantation to cover the macular hole.
* Maintain a prone position for 2 weeks postoperatively.
* Be observed by visual acuity, slit lamp, optical coherence tomography (OCT) and fundus photography for 1 year after surgery.

We describe an innovative surgical technique for macular hole repair using pars plana vitrectomy (PPV) combined with corneal flap transplantation. The corneal flap was sealed with autologous blood. The vitreous cavity was then filled with perfluoropropane (C3F8) or sterile air.

Eligibility Criteria:
Inclusion Criteria:

* Patients with macular hole and retinal detachment caused by pathologic myopia.

Exclusion Criteria:

* Patients with previous retinal surgery, trauma, other ocular diseases that could affect the vision, for example choroidal neovascularization, diabetic retinopathy, or opaque corneas were excluded.
Interstitial Lung Disease: a Study from Infancy to Elderly Including Relatives

The concerned patients are children and adults suffering from idiopathic interstitial pneumonias, other chronic fibrosing interstitial pneumonias with a progressive phenotype, and interstitial pneumonia associated with Scleroderma and related cases of patients carrying a mutation on one of the telomere-associated genes.

This is a national, observational, longitudinal, multicenter study that will be conducted retrospectively and prospectively. It aims to collect consistent and comparable clinical data for patients and their relatives, whether they carry a mutation or not, affected by diffuse idiopathic interstitial pneumopathy.

The expected duration of the study, including data analysis, is approximately 10 years (5 years for participant enrollment and 5 years of follow-up, in addition to the steps for data management and statistical analyses).

Each participating center will inform every participant by providing an information sheet, and their written consent will be obtained before including them in the study and commencing data collection.

Prospective medical data will be collected at 6 months to 1 year after enrollment and then at least once per year for patients up to 5 years and 5 years for their relatives.

Participants will complete a self-questionnaire during their regular follow-up consultations or by accessing a secure interface.


Eligibility Criteria:
Inclusion Criteria:

Confirmed diagnosis of IIP established based on clinical, radiological, or functional criteria.

Confirmed diagnosis of non-IPF progressive fibrotic interstitial lung disease (PF-ILD) with fibrosis ≥ 10% on CT scan, disease worsening not related to pulmonary embolism, decompensated heart failure, or lower respiratory tract infection, and disease progression despite "appropriate management" evaluated over a period of up to 24 months:

* A relative decline in Forced Vital Capacity (FVC) of at least 10% from predicted value, with or without clinical deterioration, or
* A combination of at least 2 of the following criteria: a relative decline in FVC between 5% and 10% from predicted value, worsening respiratory symptoms, increased extent of pulmonary fibrosis on thoracic CT scan.

Confirmed diagnosis of Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD) (American College of Rheumatology criteria), with a total score ≥ 9 and disease extent involving ≥ 10% of the lungs (defined by reticular abnormalities, honeycombing, and ground-glass opacities) on high-resolution CT (HRCT) scan.

For relatives: First degree relatives of patients carrying a mutation in TERT, TERC, RTEL1, TINF2, DKC1, PARN genes, and other telomere related genes that may be described in the future and included.
Plasma Homocysteine Distribution in the United States

To describe the distribution of homocysteine and prevalence of hyperhomocysteinemia with emphasis on race, sex and age. To determine the extent to which hyperhomocysteinemia is associated with status of folate and vitamin B12. Finally, to describe the relationships between prevalence of hyperhomocysteinemia and prevalence of cardiovascular disease and assess the importance of this risk factor as a cause of vascular disease among US adults. The study was renewed for one year to investigate normal homocysteine concentrations among children and to identify nutritional and non-nutritional determinants of total homocysteine concentrations in children.

BACKGROUND:

Hyperhomocysteinemia, a condition of elevated plasma homocysteine concentrations resulting from impaired sulfur amino acid metabolism, may be a powerful risk factor for occlusive vascular disease. However, little is known about the distribution of hyperhomocysteinemia in the general population. Furthermore, inadequate nutritional status might be a strong determinant of hyperhomocysteinemia, but its importance at a population level (as measured by the prevalence of hyperhomocysteinemia associated with inadequate nutrition) has received little study. Finally, levels of homocysteine associated with elevated risk of vascular disease have not been clearly established.

DESIGN NARRATIVE:

Using previously collected plasma samples, studies were conducted on the distribution of homocysteine and prevalence of hyperhomocysteinemia with emphasis on race, sex and age. Investigations were undertaken on the extent of the relationship of hyperhomocysteinemia to folate and vitamin B12. Finally, the relationships were described between prevalence of hyperhomocysteinemia and prevalence of cardiovascular disease and the importance of this risk factor as a cause of vascular disease among US adults was assessed..

Eligibility Criteria:
No eligibility criteria
An Asian Study to Assess the Properties and Profile of Ticagrelor in Patients With Stable Coronary Artery Disease

The purpose of the study is to determine the drug characteristics of Ticagrelor, and to determine if 4 weeks treatment will reduce the blood clotting.


Eligibility Criteria:
Inclusion Criteria:

* Any Percutaneous Coronary Intervention, more than 3 months prior to randomization
* Previous documented acute coronary syndrome (ACS), more than 3 months prior to randomisation
* Treatment with ASA

Exclusion Criteria:

* ACS, transient ischemic attack (TIA), or Stroke within the 3 months prior to randomisation
* Known concurrent disease of stroke or TIA with atrial fibrillation
* Persons who are being treated with blood clotting agents that cannot be stopped
Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects

This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids. The length of participation will be up to 7 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Is a man or woman aged 18 years or older.
* Has a body weight \>= 38 kg.
* Has cancer (active or in remission), and has cancer-related pain (ie, pain due to cancer or treatment of cancer).
* Has a life expectancy of \>= 6 months.
* Has a performance status of 0, 1, or 2 based on the Eastern Cooperative Oncology Group (ECOG) scale.
* Is taking opioids for cancer-related pain, and not just as-needed doses.
* Has a diagnosis of OIC as determined by the investigator.
* Is willing to follow the protocol instructions on laxative use during the study.

Exclusion Criteria:

* Has a history of chronic constipation before starting opioids.
* Has renal disease receiving dialysis.
* Has an ostomy for stools.
* Is a pregnant or breastfeeding woman.
A Pharmacokinetic (PK) and Pharmacodynamic (PD) Dose-ranging Phase II Study of Ticagrelor in Paediatric Patients With Sickle Cell Disease

The purpose of this Phase II dose-ranging study is to investigate pharmacokinetic (PK) and pharmacodynamic (PD) properties of various doses of ticagrelor followed by 4 weeks of twice-daily treatment in paediatric patients with sickle cell disease

This is a multicenter, open-label, dose-ranging study of ticagrelor followed by a double blind, placebo-controlled extension phase in paediatric patients with sickle cell disease (SCD).

Part A: Patients will be randomised 1:1 to receive one of two dosing schedules consisting of two single weight-adjusted doses of ticagrelor. Pharmacokinetic (PK) parameters and pharmacodynamic (PD) measurements will be determined following each dose. Platelet aggregation will be measured using the VerifyNow™ P2Y12 assay.

Following these 2 single doses, all patients will receive open-label one-week treatment with ticagrelor twice daily to determine tolerability prior to randomisation into Part B.

Part B: In this part patients will be randomised (2:1 ratio) to ticagrelor twice daily or placebo for a 4-week treatment phase.

During the study, patients will be followed for the occurrence of vaso-occlusive crisis (VOC) and for other disease manifestations such as daily pain, analgesic use and complications of SCD.

Eligibility Criteria:
Inclusion criteria

* Children aged ≥2 to \<18 years of age
* Diagnosed with homozygous sickle cell (HbSS) or sickle beta-zero-thalassaemia (HbS/β0)

Exclusion criteria

* At risk for haemorrhagic or bradycardic events
* Significant hepatic impairment
* Renal failure requiring dialysis
* Concomitant oral or intravenous therapy with strong CYP3A4 (cytochrome) inhibitors, CYP3A4 substrates with narrow therapeutic indices, or strong CYP3A4 inducers.
* Surgical procedure planned to occur during the study.
* Patients who are currently pregnant or breastfeeding or planning to become pregnant during the study.
* Patients who have known hypersensitivity or contraindication to ticagrelor.
Bioinformation Therapy for Intestinal Cancer

The aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable intestinal cancer.

By enrolling patients with unresectable intestinal cancer adapted to enrolled criteria, this study will document for the first time the synergistic effect of cancer ablation and life information rehabilitation therapy. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies
* Body tumor 1-6, with at least one tumor length \> 2 cm
* KPS ≥ 70, lifespan ：3 - 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction