cyrilzakka/clinical-trials huggingface dataset:
BeGrow Study to Treat Pulmonary Artery (PA) Stenosis in Newborns and Infants

Objective of the study is to assess safety and performance of the BeGrow Stent System for newborns and infants in pulmonary artery stenosis.

The Bentley InnoMed "BeGrow Stent System for Newborns and Infants" is a stent delivery system indicated for intraluminal placement in the pulmonary arteries of newborns and infants for the treatment of Pulmonary Artery Stenosis.

Eligibility Criteria:
Inclusion Criteria:

* Single lesion(s) which can be treated with a 6 mm BeGrow stent (only one stent per lesion allowed).
* Pulmonary artery stenosis - patient must at least have one of the following diseases:

  * Haemodynamically relevant proximal or distal branch pulmonary artery stenosis with a reduction of the vessel diameter when the vessel/patient is large enough to accommodate a stent,
  * Haemodynamically relevant stenosis of the main pulmonary artery segment that results in elevation of the Right Ventricle (RV) pressure, provided that the stent definitely will not compromise a functioning pulmonary valve and will not impinge on the pulmonary artery bifurcation,
  * Any degree of stenosis in patients with single ventricle circulation
  * Critically ill postoperative cardiac patients when it has been determined that branch pulmonary artery stenosis is resulting in a definite haemodynamic compromise in a patient/vessel of any size, particularly if balloon dilatation is unsuccessful
* Signed written informed consent (by parents/legal guardians)
* Lesion can be accessed with a guide wire or balloon catheter
* Age ≤ 24 months and weight ≥ 2 kg
* Adequate stent length available

Exclusion Criteria:

* The following lesions are excluded from treatment with BeGrow stent:

  * Shunt stenosis
  * Valvular and subvalvular pulmonary stenosis
* Patients with known hypersensitivity to the stent material (L605 cobalt-chromium).
* Patients with clinical or biological signs of infection.
* Patients with active endocarditis.
* Patients with known allergy to acetylsalicylic acid, other antiplatelet agents or heparin.
* Presence of other previously implanted stents in the same lesion or in close proximity to stent (direct stent-stent contact).
* Patients with known coagulation disorder.
* Patients where direct stent-stent contact or overlapping cannot be avoided.
* Patients where contact to the vessel wall over the entire stent length cannot be ensured after dilatation (especially in short and thick lesions).
* Patients where the BeGrow stent could protrude freely into adjacent vessels after expansion/dilatation, including the pulmonary arterial bifurcation.
* Implantation of the BeGrow stent in the pulmonary arterial bifurcation.
A Study to Evaluate ITCA 650 Compared to Sitagliptin as add-on Therapy for the Treatment of Type 2 Diabetes

Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin monotherapy in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* HbA1c between 7.5% - 10.5%
* on metformin monotherapy
* BMI between 25 \& 45 kg/m2

Exclusion Criteria:

* taking thiazolidinedione, sulfonylurea, DPP-4, exenatide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
* history of pancreatitis
Study of TRAVATAN in Subjects With Iris Pigmentation Changes

The purpose of this study was to monitor iris pigmentation changes over a 5-year period in patients with open-angle glaucoma or ocular hypertension. To be eligible for the study, these individuals must have experienced an iris pigmentation change while previously dosing with TRAVATAN.


Eligibility Criteria:
Inclusion:

* Diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension;
* Has experienced an iris pigmentation change while dosing with TRAVATAN;
* Currently dosing with TRAVATAN;
* Other protocol-defined inclusion criteria may apply.

Exclusion:

* Any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or ocular hypertension;
* Not currently using TRAVATAN;
* Females of childbearing potential if pregnant, breast-feeding, or not using highly effective birth control measures;
* History of any severe ocular pathology (including severe dry eye);
* Other protocol-defined exclusion criteria may apply.
Transdermal Estrogen in Women with Anorexia Nervosa

Randomized, placebo-controlled study investigating the use of physiologic, transdermal estrogen for low bone mass in adult women with anorexia nervosa.

Anorexia nervosa is a prevalent psychiatric with a lifetime prevalence of up to 2.2%. Among the many medical co-morbidities associated with anorexia nervosa, the most common is significant bone loss, which can persist despite weight recovery. Nearly 90% of women with anorexia nervosa have osteopenia and this low bone mass is associated with an increased fracture risk. Nearly 30% of women with anorexia nervosa report a history of a fracture and a prospective study demonstrated a 7-fold increased risk of fracture in women with anorexia nervosa compared to age-matched controls. Because anorexia nervosa is a chronic disease that can persist despite psychiatric and nutritional counseling, the bone loss and increased fracture risk can persist and lead to lifelong morbidity. Therefore, finding a treatment for bone loss associated with anorexia nervosa is of critical importance.

This 18-month randomized, placebo-controlled study will investigate in women (ages 20 to 45 years old) with anorexia nervosa whether treatment with transdermal estrogen replacement will increase bone mineral density (BMD).

Eligibility Criteria:
Inclusion Criteria:

1. Female
2. 19-45 years of age
3. DSM-5 psychiatric criteria for anorexia nervosa
4. \<85% of ideal body weight as defined by the 1983 Metropolitan Life Insurance Height and Weight Tables
5. Amenorrhea
6. T-score of \< -1.0 at spine or hip

Exclusion Criteria:

1. Diseases known to affect bone metabolism, including untreated thyroid dysfunction, vitamin D deficiency, Cushing's syndrome, diabetes mellitus or renal insufficiency (eGFR \< 60)
2. Personal history of venous or arterial clot
3. History of stroke or myocardial infarction
4. History of hypercoagulable disorder
5. Personal history or history of a first-degree relative with breast cancer
6. History of hereditary angioedema
7. Any medication known to affect bone metabolism, including systemic glucocorticoids within three months of the baseline visit, depot medroxyprogesterone within 6 months of the baseline visit, oral bisphosphonates within one year of the baseline visit or IV bisphosphonates within three years of the baseline visit
8. Bone fracture within the prior 12 months
9. Serum potassium \< 3.0 meq/L, serum ALT \> 3 times the upper limit of normal or Hemoglobin \< 10 g/dL
10. Fasting serum triglyceride level \> 150 mg/dL
11. Pregnant or breastfeeding (or desiring pregnancy within the next 18 months)
12. Active substance abuse
13. Elevated PTH level
14. 25-OH vitamin D level \< 20 ng/mL
15. Low phosphorus level
REspiratory diSEAse cohoRt Studies of CHinese Medicine for Pneumonia (RESEARCH-Pneumonia)

The purpose of this study is to evaluate the clinical efficacy and safety of dialectical treatment in the patients with pneumonia after discharge in a prospective cohort study: one is the Traditional Chinese Medicine (TCM) cohort, which has been evaluated and has certain effects; The other is a non traditional Chinese medicine queue.

The incidence, hospitalization rate, and mortality associated with pneumonia are significant, contributing to a substantial disease burden. Post-discharge follow-up and intervention strategies for pneumonia patients are often insufficient, leaving patients vulnerable to readmission or mortality due to recurrent pneumonia and related complications. In clinical practice, there is a predominant focus on the amelioration of clinical symptoms during hospitalization, with limited attention to ongoing outpatient interventions aimed at reducing readmission rates. Consequently, there is a pressing need for cohort studies on pneumonia.

This study is a multicenter, prospective cohort study involving adult patients discharged after pneumonia treatment. Approximately 5,000 patients will be enrolled, with follow-up assessments conducted every three months over the course of one year. After one year, patients will be stratified into two cohorts based on the duration of Traditional Chinese medicine (TCM) treatment received (e.g., continuous treatment for two months or intermittent treatment for three months per year). One cohort will consist of patients receiving TCM, while the other will include those who did not receive TCM. The primary endpoint is the rate of hospital readmission, while secondary outcomes include treatment satisfaction, physician-reported outcomes, patient-reported outcomes, quality of life, nutritional status, incidence of acute upper respiratory tract infections, and survival. This study aims to evaluate the clinical efficacy and safety of TCM in the management of adult pneumonia patients following discharge.

Eligibility Criteria:
Selection Criteria:

* Hospitalized patients with a confirmed diagnosis of pneumonia (HAP, CAP).
* Age ≥18 years.
* Signed informed consent form.

Exclusion Criteria:

* Patients with confusion, consciousness disorders, dementia, and various mental illnesses;
* Patients with altered mental status, dementia, consciousness disorders, or various psychiatric conditions;
* Those who are completely unable to care for themselves or are bedridden long-term; and those currently participating in other clinical drug trials.
* Known to be allergic to treatment drugs.
Registration Study for Rare Type of Pulmonary Hypertension

The knowledge on the rare type of pulmonary hypertension which can not be explained by left heart disease, respiratory disease or congenital heart disease is very limited. Investigators aim to setup a national registration study for the rare type of pulmonary hypertension, to understand the natural history, survival, progression, genetic and environmental contributions to disease.

The main research contents of this registration study includes:

1. Build a baseline database of the rare type of pulmonary hypertension. Collect general information, on-set symptoms and time, laboratory examination, imaging results, right heart catheterization and treatment information.
2. Follow up recruited patients at regular intervals（6m\~1y). Collect information on change in patients condition, laboratory test and treatment.
3. Conduct genetic testing for gene mutation related or hereditary pulmonary hypertension. Link the clinical database to genetic database.
4. Establish bio-bank for serum/plasma, urine, stool, tissues or cells.
5. Establish prognostic study based on the clinical follow-up and genetic database.
6. Draw diagnostic and treatment algorithm for the rare type of pulmonary hypertension.

Controls subjects: blood sample and medical data collected once.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Patients diagnosed as idiopathic pulmonary artery hypertension, hereditary pulmonary artery hypertension, hereditary hemorrhagic telangiectasia associated pulmonary artery hypertension, pulmonary veno-occlusive disease, pulmonary capillary hemangiomatosis associated pulmonary artery hypertension, cavernous transformation of portal vein associated pulmonary artery hypertension, special type of congenital heart disease associated pulmonary artery hypertension, chronic thromboembolism pulmonary hypertension.
* All patients should have undergone right heart catheterization, diagnosed according to the guideline.

Exclusion Criteria:

The participant may not enter the study if ANY of the following apply:

* Patients unwilling or unable to provide written consent for participation in the study.
* Not suffering from the rare type of pulmonary artery hypertension;

Inclusion criteria-Controls

* Participant is willing and able to give informed consent for participation in the study.
* Self-reported to be healthy
Hypertension and Cardiovascular Risk Associated With Obstructive Sleep Apnea in Adult in Guadeloupe (French West Indies)

The MAPA is the reference method to estimate the PA during the SAHOS. The MAPA can be recommended over 48 hours: indeed, the PA falls at the beginning of every apnea then increases gradually up to a pressif peak arising at the time of the ventilatoire resumption. These variations arise under the influence of 4 stimulus: the désaturation in O2, the rise of the PaCO2, the increase of the respiratory effort and the microawakening of the end of apnea who are at the origin of a sympathetic stimulation.

Consequently a better diagnostic approach of the HTA (confirmation of a resistant HTA, an identification of the masked HTA and the patients " not dipper " by the MAPA), the identification of the SAHOS, and a better coverage) of the associated cardiovascular risk factors are essential and establish a stake in public health.

To investigator's knowledge, no datum or study on the association HTA-SAHOS and its consequences was until then realized in the French overseas departments.

In Guadeloupe, data on the relationships between arterial hypertension and obstructive sleep apnea are unavailable. The aim of this study was: to assess the frequency of hypertension and non-dipper pattern evaluated by 48-hour ambulatory blood pressure monitoring in an adult population identified obstructive sleep apnea/non-obstructive sleep apnea during overnight polygraphy ; to determine the cardio-metabolic factors associated with obstructive sleep apnea.

Eligibility Criteria:
Inclusion Criteria:

* Patient suspected of SAHOS;
* Patient or third-party responsible for receiving information on the study and who signed informed consent ;
* Patient age over 18 years; Patient living in Guadeloupe.

Exclusion Criteria:

* Patient non-affiliated to the social security scheme ;
* Patient with obstructive bronchopneumopathy, neuro-muscular pathology,
* central and mixed SAS, cardiac arrhythmia,
* systemic and chronic inflammatory syndrome ; -
* Pregnant and lactating patient ;
* patient in emergency.
Digital 3D Breast Tomosynthesis Versus 2D in Clinical Evaluation of High Risk Women

Patients with a higher breast cancer risk (higher than 17% according to the IBIS calculation) will receive a 2D digital mammography together with a 3D tomosynthesis (so called combo tomo) of both breasts in two views in order to investigate the additional value of tomosynthesis in the diagnosis of breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* women
* more than 17% risk for breast cancer (IBIS calculation)
* \> 40y old

Exclusion Criteria:

* \< 40y old
A Study of Carbon-14-Labelled [14C] LY3556050 in Healthy Male Participants

The main purpose of this study is to evaluate how much of the study drug (LY3556050), administered as a single dose that has the radioactive substance 14C incorporated into it, passes from blood into urine, feces and expired air in healthy male participants. The study will also measure how much of the study drug gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study will last up to approximately 58 days including the screening period.


Eligibility Criteria:
Inclusion Criteria:

* Male participants who are overtly healthy as determined by medical evaluation
* Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²), inclusive
* Males who agree to use highly effective or effective methods of contraception

Exclusion Criteria:

* Have known allergies to LY3556050, related compounds, or any components of the formulation of LY3556050, or history of significant atopy
* Have clinically significant abnormal BP and/or pulse rate as determined by the investigator
* Have had exposure to significant diagnostic, therapeutic, or employment-related radiation within 12 months prior to dosing
Ghrelin Repeated Dose Study

Frailty is a geriatric syndrome leading to physical deterioration including muscle wasting (sarcopenia) and unintentional weight loss. There are currently no approved therapies for frailty. Ghrelin is a hormone produced by the stomach that stimulates appetite centers in the brain. The investigators already know that a single dose of Ghrelin improves food intake immediately after the dose in frail older people. In this study, the investigators are trying to find out if repeated daily doses of ghrelin will help frail older people improve food intake for multiple days in a row.

The study design is an open label, repeated dose administration study in which we will examine the safety and efficacy of repeated subcutaneous ghrelin administration in frail individuals. There will be a screening visit plus three additional study visits at the CTRC on Days 1, 2, and 7. Participants will receive an injection of ghrelin subcutaneously once daily on Days 1 and 7 and will self-administer the subcutaneous injection before breakfast on Days 2-6 at home. A food record will be kept from Day -3 to Day 6. We will assess the efficacy of repeated ghrelin doses to sustainably increase caloric intake from pre-treatment baseline without hyperglycemia or raising of cortisol levels.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with three, four or five frailty criteria using the Fried frailty criteria

Exclusion Criteria:

1. Diabetes mellitus or fasting glucose ≥ 126 mg/dL
2. Hospitalization for stroke, myocardial infarction, coronary artery bypass graft surgery, vascular surgery in the past six months.
3. New York Heart Association Class III or IV congestive heart failure
4. Therapy for cancer in the past 12 months, except non-melanoma skin cancer
5. BMI ≥ 30 kg/m2
6. Current use of corticosteroids other than topical, ophthalmic, and inhaled preparations
7. Therapy with megestrol acetate or dronabinol within the last 6 weeks
8. Thyroid stimulating hormone measured as \< 0.4 mU/L or greater than 10mU/L
9. Abnormal liver function tests (LFTs \> 2x upper limit of normal)
10. Hemoglobin \< 11g/dL
11. Insulin-like growth factor-I (IGF-I) above the age-specific reference range
12. History of surgery within the last 30 days
13. Unstable medical or psychological conditions or unstable home or food environment
14. Cognitive deficit as defined by a Folstein Mini Mental State Exam score \< 24/30
15. Depression (defined as a score of \> 11 on the Geriatric Depression Questionnaire)
Designing Optimal Prevention and Management of Postoperative Nausea and Emesis for Patients Undergoing Laparoscopic Sleeve Gastrectomy

Bariatric surgery remains the most effective therapy for obesity. Postoperative nausea and vomiting (PONV) are commonly reported following bariatric surgery. The proposed study focuses on the most common bariatric procedure performed, laparoscopic sleeve gastrectomy (LSG), and aims to assess the effect of a post-operative nausea and vomiting-specific intervention. The investigators hypothesize that the intervention group will experience a reduction of nausea-related prolonged hospital stay and significantly improve patient-reported quality of recovery from surgery and quality of life.

To test this hypothesis, participants undergoing sleeve gastrectomy will be randomized to two groups: control vs Nausea specific-intervention group. All subjects will be assessed with a nausea specific questionnaire at 1, 4, 12, 24 hours and 3 weeks after surgery. Patient satisfaction with recovery will be assessed using specialized questionnaires at baseline, 24 hrs. and 3 weeks following surgery. Serial assessments of nausea, vomiting, quality of life and quality of recovery, will allow the investigators to identify an effect on incidence and severity of Post-operative Nausea and Vomiting. Importantly, the investigators will evaluate for an impact in patient-reported measures of quality of life.

The total sample size is 83. This study will provide valuable insight on the epidemiology of post-operative nausea and vomiting after hospital discharge following Sleeve gastrectomy, which is currently poorly characterized. By allowing the investigators to assess the overall incidence of nausea and vomiting at different time points, this study will afford the opportunity to identify a time period of high incidence and further adjust our prevention efforts accordingly in future studies.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years and older) undergoing LSG

Exclusion Criteria:

* Allergy to medications delineated in the protocol (muscle blockade, anesthetics, reversal agents)
* Inability to provide informed consent
* History of chronic nausea and emesis requiring medication
* Poorly controlled diabetes (HgA1c\>9 mg/dl),
* History of previous bariatric or gastro-esophageal surgery
FoCo: Evaluating a Training to Increase Attention and Awareness of Healthcare Professionals

Introduction: A significant increase in the risk of injury and illness at work has been associated with fatigue, stress, haste, distraction, emergency situations, excessive noise, complex procedures and anger among other factors.

Most of these factors are related to the lack of attention to work in progress, which can be improved by training attention and awareness during daily activities, as it would encourage a resumption of focus on the task at hand and the possible risks associated with it. . The primary objective of this project is to evaluate the effects of training to increase attention and awareness for daily activities - FoCo - outlined for healthcare professionals in their work schedule. Method: Health professionals from 18 to 60 years of age, of both sexes, will participate in the study, working in 3 units, one in the care of patients in a Emergency Care Unit (UPA), in an Elderly Residential and in a Center. Intensive Care (ICU). In the UPA will be included 25 professionals in group A and 25 in group B; In the Residential of Elderly, 40 professionals will be included in group A and 40 professionals in group B; In the ICU will be included 30 professionals in group A and 30 in group B. They will be randomized in both groups. Group A will receive training in the FoCo program and group B will be a waiting group. After a period of one month, group B will receive training in FoCo and group A will be instructed to continue on their own to apply FoCo in their daily lives (Fig.1). Participants will be evaluated before, after one month and after two months. Expected Outcomes: After training, an increase in mindful, attention and awareness scale, self-compassion scale, positive affect, speed of digit and symbol test is expected. It is also expected to reduce negative affects, perceived stress and an increased perception of possible incidents.


Eligibility Criteria:
Inclusion Criteria:

* be available to participate in the training and to perform the evaluations before and after it.

Exclusion Criteria:

- being away or on vacation during the research project, being in psychiatric treatment.