cyrilzakka/clinical-trials huggingface dataset:
Copeptin After an Oral Stimulation With Macimorelin in Healthy Volunteers

This study investigates stimulation of the posterior pituitary gland by oral Macimorelin (a ghrelin receptor Agonist) to be a novel diagnostic test in the polyuria-polydipsia syndrome.

Copeptin measurements upon intravenous arginine stimulation discriminate patients with diabetes insipidus versus patients with primary polydipsia with a high diagnostic accuracy. An oral test would be easier to perform, causes less risks and discomfort for the patients and would require less resources in clinical practice. This study investigates stimulation of the posterior pituitary gland by oral Macimorelin (a ghrelin receptor Agonist) to be a novel diagnostic test in the polyuria-polydipsia syndrome.

Eligibility Criteria:
Inclusion Criteria:

* No medication except hormonal contraception

Exclusion Criteria:

* Body Mass Index (BMI) \> 40kg/m2 or BMI \< 18.5 kg/m2
* participation in a trial with investigational drugs within 30 days
* vigorous physical exercise within 24 hours before the study participation
* Alcohol intake within 24 hours before study participation
* pregnancy and breastfeeding
* Evidence of disordered drinking habits and diuresis defined as polyuria \>50ml/kg body weight/24h and polydipsia \>3l /24h
* a prolonged QT interval (QTc \>500 ms) or concomitant treatment with drugs that prolong the QT/QTc.
* Intention to become pregnant during the course of the study
* Known allergy towards Macimorelin
Long Term Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension

The purpose of this study is to evaluate the long-term safety and tolerability of the combination of aliskiren and amlodipine given to patients with essential hypertension. This study is being conducted to support registration of the fixed combination of aliskiren/amlodipine in the treatment for hypertension in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Patients that complete CSPA100A1301 study
* Patients whose blood pressure at Visit 7 of CSPA100A1301 study must be well controlled

Exclusion Criteria:

* Patients who experienced any serious adverse events considered drug related in CSPA100A1301 study
* Presence of major protocol violation in CSPA100A1301 study

Other protocol-defined inclusion/exclusion criteria may apply
Neuroinflammation and Age-associated Brain Pathology: Two Potential Mechanisms of Cognitive Impairment in Ovarian Cancer

This clinical study will use the small molecule translocator protein (TSPO) ligand, 18F-labeled DPA- 714, to visualize and quantify neuroinflammation in treatment naivete women with stage 1-4 newly diagnosed ovarian cancer (without brain metastases) prior to starting neoadjuvant chemotherapy treatment (baseline) and within a month of completing first 6 cycles of cytotoxic chemotherapy treatment (follow-up). In addition, we will use the well-characterized small molecule PET(Positron Emission Tomography) tracer, 11C-labeled Pittsburgh compound B (PiB) to visualize and quantify the regional brain distribution of pathological amyloid deposition at baseline only. The brain amyloid PET and MRI data acquired through this study will be correlated with cognitive test data, clinical data, genetic testing, and biospecimens collected in this study.


Eligibility Criteria:
Inclusion Criteria:

1. 50 years of age or older
2. Female gender
3. Newly diagnosed treatment naïve women with stage III/IV epithelial ovarian cancer (without known brain metastases).
4. High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971.
5. English is primary language
6. Planned neoadjuvant chemotherapy with platinum and taxane drugs

Exclusion Criteria:

1. Contraindication to MRI
2. Pregnancy
3. Lactation
4. Individuals who are unable to participate in the imaging portion due to severity of their medical condition
5. Chronic infectious disease (e.g. HIV, HCV)
6. Chronic inflammatory disease (e.g., fibromyalgia, MS, etc) or autoimmune disease
7. Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation
8. Blood or blood clotting disorder
9. Cancer that has metastasized to the brain
10. Positive urine hCG test day of procedure or a serum hCG test within 48 hours prior to the administration of \[18F\]DPA-714 and \[11C\]PiB.
11. Currently enrolled in a clinical trial utilizing experimental therapies.
12. Low affinity binder for TSPO ligands based on genotyping for SNP rs6971.
13. Prior brain tumor or other neurological condition known to affect cognition
14. A diagnosis of dementia unrelated to cancer or an adjusted MMSE score \< 24
Modeling of Intracerebral Vascularization After Extracorporeal Membrane Oxygenation in Children

Extra corporeal membrane oxygenation (ECMO) is a transient supplementation technique that alleviates hemodynamic and ventilatory failure. Its implementation requires carotid arterial and jugular venous cannulation in newborns or children weighing less than 20 kg. The impact of ECMO on arterial circulation was studied by Doppler ultrasound and shows a redistribution of flows within the circle of Willis.

This study aims to model cerebral flow in children who have been cared from jugulocarotid ECMO and compare cerebral hemodynamics according to the technique of reconstruction of the common carotid artery after decanulation (reconstruction or ligation).

Extra corporeal membrane oxygenation (ECMO) is a transient supplementation technique that alleviates hemodynamic and ventilatory failure. Its implementation requires carotid arterial and jugular venous cannulation in newborns or children weighing less than 20 kg. The impact of ECMO on arterial circulation was studied by Doppler ultrasound and shows a redistribution of flows within the circle of Willis.

When ECMO is stopped, carotid decanulation is done either by ligation or by reconstruction, depending on the practices of the surgical team and the peroperative findings. The reconstruction allows a restoration of blood flow to the internal carotid artery and the middle cerebral artery with a disappearance of compensation by the circle of Willis.

Vascular flow modeling is a computational method derived from imaging for the hemodynamic study of fluids, including pressures and flow rates at different points in a vessel. Data from the literature on the modeling of cerebral vascularization in newborns are scarce.

This study aims to model cerebral flow in children who have been cared from jugulocarotid ECMO and compare cerebral hemodynamics according to the technique of reconstruction of the common carotid artery after decanulation (reconstruction or ligation).

Eligibility Criteria:
Inclusion Criteria:

For everyone :

1. Information and non-opposition of holders of parental authority
2. Newborn, infant and child \<20kg
3. Hospitalization in pediatric and neonatal intensive care unit (PICU) of Trousseau Hospital
4. Performing a Magnetic Resonance Angiography (MRA) as part of the treatment

   For patients treated with ECMO: study population
5. Hemodynamic or respiratory failure
6. Requiring the use of extracorporeal circulation with jugulo-carotid cannulation
7. Weaned alive off Extra corporeal membrane oxygenation (ECMO)

   For patients with hypoxic-ischemic encephalopathy: control population
8. hypoxic-ischemic encephalopathy diagnosed at birth

Exclusion Criteria:

1. Contraindication to MRA
2. Opposition of holders of parental authority
Microarray Analysis of Sinus Samples From Patients With and Without Chronic Rhinosinusitis.

The purpose of this study is to compare the bacteria, fungi, and viruses that are present in the sinuses of patients with chronic rhinosinusitis to patients without sinus disease using a new technology, called a microarray, that will allow more accurate identification of microorganisms than current laboratory methods.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* History of chronic rhinosinusitis (CRS)
* Impaired CRS-specific quality of life
* Evidence of sinus disease on a CT scan

Exclusion Criteria:

* Control patients with any evidence of CRS by history, survey, or imaging criteria
Active Play Intervention for Preschoolers

The goal of this randomized clinical trial is to examine the effects of a planned movement in preschool-aged children. The main question is to determine

\* What are the effects of a planned movement program on physical activity, body composition, fundamental motor skills, and time on task in preschool children aged 3-5 years?

Researchers will compare a planned movement program to a control group, where current instruction is implemented.

A majority of preschool children do not participate in the recommended levels of physical activity and are deficient in fundamental motor skills. These deficits may also impact body composition. Preschool teachers serve as the gateway to providing physical activity opportunities at preschool but many fail to do so. As play is developmentally appropriate for preschools and part of many curriculums adding active elements to play may be a feasible solution for teachers to implement physical activity opportunities. This project will evaluate the effect of a planned movement program that incorporates elements of active play on preschoolers' body composition, physical activity, time on task, and fundamental motor skills at week 0, week 12, and week 24. Physical Activity will be assessed throughout the school year with a wrist-worn wearable accelerometer. Body composition will be assessed with a foot-to-foot bioelectrical impedance scale. Fundamental motor skills will be assessed by the Peabody Developmental Motor Scales 2nd Edition and Time on-task will be measured by observing children in their classroom. The outcomes of this study will be used to implement sustainable physical activity programming for preschoolers.

Eligibility Criteria:
Inclusion Criteria:

* 3 to 5 years of age
* attending one of the preschools 5 days a week.

Exclusion Criteria:

* less than 3 years of age
* greater than 5 years of age at the beginning of the study
* attends the preschool 2 days or 3 days a week
Effects of Lumbopelvic Stabilization-based Physiotherapy and Rehabilitation Training in Duchenne Muscular Dystrophy

This study aims to examine the effectiveness of supervised lumbopelvic stabilization in relation to factors associated with lower urinary tract symptoms in children diagnosed with Duchenne Muscular Dystrophy (DMD) who have lower urinary tract dysfunction. Children aged between 8 and 12 years, at stages 1-4 according to the Vignos scale, and who have a score of 8.5 or higher on the Dysfunctional Voiding Symptom Score (DVSS), will be included in the study. Demographic information will be collected through a general assessment form, while lower urinary tract symptoms will be assessed using the DVSS, a researcher-developed evaluation form, and a three-day bladder diary. Bowel symptoms will be evaluated using the Rome IV criteria and a seven-day bowel diary. Physical performance will be assessed via the Timed Up and Go Test and Gower's Test, muscle strength using the microFET2 hand dynamometer, lumbar lordosis angle with a Bubble inclinometer, participation in daily living activities via the Barthel Index, and perceived well-being of both the child and the parent will be assessed using the Faces Rating Scale. Participants will be randomly assigned to two groups (Treatment and Active Control) using a block randomization method. In the Active Control group, children will receive only urotherapy education. In the Treatment group, children will receive supervised, online, lumbopelvic exercise-based physiotherapy and rehabilitation sessions, in addition to urotherapy, conducted by a physiotherapist. The sessions will last eight weeks, with a total of 24 sessions. At the end of the eight-week period, both groups will be re-evaluated using the same assessment methods. Intra-group and inter-group comparisons will be completed using appropriate analytical methods.


Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with DMD by a specialist physician,
* Having received a score of 8.5 or higher on the Voiding Disorders Symptom Score (VMSS),
* Being between the ages of 8-12,
* Continuing ambulation (Vignos Scale Stage 1-4),
* Volunteering to participate in the study by parents and reading and signing the informed consent form.

Exclusion Criteria:

* Having another neuromuscular disease diagnosed other than DMD and/or accompanying DMD,
* Having family and/or child having cooperation problems in completing the evaluations for any reason,
* Lack of internet infrastructure or technical infrastructure that may cause difficulty in continuing distance education/follow-up,
* Having difficulty in understanding and speaking the Turkish language.
Taste Evaluation of Different Liquid Formulations With Eliglustat

Primary Objective:

The purpose of this study is to assess the palatability of eliglustat prototype liquid formulations in healthy subjects.

The total duration of the study for each subject will be approximately 5 weeks (screening period from Day -28 to Day -2, treatment period of 3 days, and follow-up call on Day 5).

Eligibility Criteria:
Inclusion criteria :

* Healthy male and female subjects, 18 to 55 years of age, inclusive.
* Normal smell and taste ability to discriminate odor and flavor differences.

Exclusion criteria:

* Poor metabolizer phenotype status for CYP2D6 (predicted based on genotype).
* Subject who has smoked within 3 months of inclusion.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART2)

This study is a multicenter, non-interventional, retrospective, medical chart review of participants with metastatic renal cell cancer(mRCC) treated with avelumab plus axitinib as a first-line therapy in Japan between 20 December 2019 and 17 October 2022. All decisions regarding clinical management and treatment of the participating patients were made by the investigator as part of standard care in real-world clinical setting and were not contingent upon the patient's participation in the study. Data will be collected if available per study site.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnoses of mRCC based on the General Rule for Clinical and Pathological Studies on RCC (Fifth Edition) before receiving avelumab plus axitinib as first-line therapy. Patients with mRCC who have unresectable disease, either unresectable locally advanced or metastatic disease.
2. Age over 18 years at the time of the first administration of avelumab plus axitinib as firstline therapy for mRCC (baseline).
3. Index date from 20 December 2019 to 17 October 2022.

Exclusion Criteria:

1. Patients participating in a prospective interventional clinical trial assessing an investigational product during the observation period.
2. Patients (or a patient's legally representative) refusing to provide patient data during the consent process.
Concomitant Intranasal Antihistamine and Corticosteroid in Stepwise Treatment Strategy for Allergic Rhinitis

Patients with perennial allergic rhinitis whose symptoms are not controlled (visual analogue scale \[VAS\] ≥5) by 2-week treatment with intranasal corticosteroid will receive concomitant intranasal antihistamine and corticosteroid for 2 weeks. After 2-week treatment, changes in clinical parameters including VAS, total nasal symptom score (TNSS), total ocular symptom score (TOSS), rhinoconjunctivitis quality-of-life questionnaires (RQLQ) will be evaluated.

Patients with perennial allergic rhinitis whose symptoms are not controlled (visual analogue scale \[VAS\] ≥5) by 2-week treatment with intranasal corticosteroid will receive concomitant intranasal antihistamine and corticosteroid. In addition to VAS, total nasal symptom score (TNSS), total ocular symptom score (TOSS), rhinoconjunctivitis quality-of-life questionnaires (RQLQ) will be measured before treatment (baseline) and 2 week after treatment. The differences between parameters before treatment and those after 2-week treatment will be statistically analyzed using paired student t test, and p\<0.05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Perinnial allergic rhinitis diagnosed by a doctor
* Positive for one or more of inhalant perinneal allergen in skin prick test or serum specific IgE measurement
* Age: 19 years or older
* Allergic rhinitis symptoms not controlled (VAS ≥5) by 2-week treatment with intranasal corticosteroid

Exclusion Criteria:

* Compliance for one or more drugs in last 2 weeks: \<80%
* Use of oral corticosteroid, oral or intranasal decongestant in last 2 weeks
* Initiation of allergen-specific immunotherapy in last 12 months
* Seasonal allergic rhinitis
* Chronic rhinosinusitis other than allergic rhinitis
* Nasal polyposis
* Comorbid diseases including infectious, respiratory, cardiologic, renal, gastrointestinal, endocrinologic, oncologic, hemotologic and immunologic disorders which investigators judge to affect on the study significantly.
* Patients' rejection
* Pregenancy or lactation
Automated Control of Mechanical Ventilation During General Anaesthesia

Prospective, bicentric observational study to assess a novel system for automated control of mechanical ventilation (Smart Vent Control, SVC) during general anesthesia.

The "Automated control of mechanical ventilation during general anesthesia study (AVAS study) is an international investigator-initiated bicentric observational study investigating the application of Smart Vent Control (SVC) during general anesthesia. The main objective of this study is to describe the application of SVC and to assess its safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Planned elective surgery of the upper limb, lower limb or peripheral vascular surgery in general anesthesia
* Patient is classified as American Society of Anesthesiologists physical status (ASA) I, II or III
* Age ≥ 18 years
* Written consent of the patient for study participation

Exclusion Criteria:

* Mild, moderate or severe acute respiratory distress syndrome (ARDS)\[10\]
* Known chronic obstructive pulmonary disease Gold stage III or higher
* Two or more of the following organ failures

  * Mild, moderate or severe ARDS
  * Hemodynamic instability: systolic blood pressure \< 90 mm Hg, mean arterial pressure \< 70 mm Hg or administration of any vasoactive drugs.
  * Acute renal failure: oliguria (urine output \< 0.5 ml/kg/h for at least 2 hours despite of adequate management or creatinine increase \> 0.5 mg/dl
  * Cerebral failure: loose of consciousness or encephalopathy
* Patient is pregnant.
Postpartum HPV Vaccination

Human papillomavirus (HPV)-related cancers are on the rise in the United States. Furthermore, greater than 90% of cervical cancer cases are attributable to HPV, and cervical cancer disproportionately affects women of color in both incidence and mortality. Due to low HPV vaccine uptake in the US, innovative approaches to vaccinating vulnerable populations are necessary in order to maximize the cancer prevention potential of this vaccine. The puerperium is a time period when women are engaged in the healthcare system and have almost universal access to affordable health care. Two prior studies have shown that postpartum HPV vaccination is acceptable to patients, and high rates of vaccination were achieved in these primarily Hispanic populations. However, data show that the immune response in young women is less robust than in adolescents, and no studies have examined immunogenicity in postpartum women specifically. We propose an HPV vaccination pilot study in women who receive postpartum care at University of Alabama at Birmingham (UAB) hospital. We will examine the acceptability, uptake and immunogenicity of the vaccine in the postpartum setting.


Eligibility Criteria:
Inclusion Criteria:

* postpartum day 0-4 after vaginal or Cesarean delivery at UAB hospital

Exclusion criteria

* Fetal demise or miscarriage, autoimmune disorder, HIV, Hepatitis B/C, chronic steroid use, preeclampsia, non-English speaking
Study to Evaluate Overall Survival in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Letrozole

This is a retrospective, multicenter, observational study in Japan. The primary objective is to evaluate overall survival (OS) in Japanese patients with HR+/HER2- advanced breast cancer who have been treated with palbociclib plus letrozole. This observational study was planned as follow-up study of Japanese phase 2 study of palbociclib (NCT01684215, phase 2 portion of A5481010 study).


Eligibility Criteria:
Inclusion Criteria:

1. Participated, treated with palbociclib plus letrozole in J-Ph2, and was under follow-up for survival at the study completion of J-Ph2.
2. For patients who are still alive and have routine visits to the study site, evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. For patients who are still alive and had been transferred to another hospital, evidence that the patient has been informed of all pertinent aspects of the study and oral or written informed consent is obtained. For patients who had already passed away, the conduct of this study will be disclosed, and the patients' legally acceptable representatives will be guaranteed an opportunity to refuse data collection for the patients in accordance with the Ethical Guidelines for Medical and Health Research Involving Human Subjects

Exclusion Criteria:

1. There are no exclusion criteria for this study.