cyrilzakka/clinical-trials huggingface dataset:
Selara Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

To collect the efficacy and safety information of Eplerenone on patients with hypertension related to their appropriate use in daily practice.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female patients who are prescribed Selara tablet for Hypertension.

Exclusion Criteria:

* Subjects who have been prescribed Selara tablet.
Effect of Carvedilol Rapid Up-Titration in Patients With Heart Failure With Reduced Ejection Fraction

Guidelines-directed medical therapy has improved dramatically outcomes in heart failure with reduced ejection fraction (HFrEF) patients. Beta-blockers have the most beneficial effects on all caused mortality and rehospitalization on HFrEF, but unfortunately, since the discovery of beta-blocker therapy in HFrEF, there was no change in the way of titration, start low go slow, which resulted in difficulties in reaching optimal doses for some patients.

This study is a randomized controlled trial, single-center study in HFrEF patients, that held in Universitas Sebelas Maret Hospital, Central Java, Indonesia. The investigators divided 26 HFrEF patients consecutively into two groups, the first is the rapid up-titration group, which will get carvedilol up-titration every day, 3.125mg twice daily on the first day, 6.125mg twice daily on the second day, 12.5mg twice daily on the third day and 25mg twice daily on the fourth day consecutively. And the second group will have carvedilol titration according to established guidelines on Heart Failure, start 3.125mg twice daily, and up titrated every 2 weeks. Every patient will be checked for IL-6, TNF-α, NT-ProBNP, MDA, left ventricular Ejection Fraction, six minutes walking test, and Kansas City Cardiomyopathy Questionnaire on day 1, pre-discharge, and one month after hospitalization. The study was approved by the university ethics committee. The clinical parameters evaluated at admission were analyzed using variable comparative with Shapiro Wilk or one-way ANOVA, with three intervals analysis using repeated ANOVA (p\<0.05).

Eligibility Criteria:
Inclusion Criteria:

* Acute heart failure patient with reduced ejection fraction in Universitas Sebelas Maret Hospital with naive betablocker therapy
* Age \>18 years old
* Initial Heart Rate \> 50 bpm

Exclusion Criteria:

* Cardiogenic Shock
* Septicaemia
* High degree AV Block or on pace maker
* History of beta blocker intolerance
* Reactive Pulmonary disease
* Severe Peripheral artery disease
* Creatinine level \> 2.5 mg/dl
* Potassium serum \>5 mmol/L
Induction Treatment of Proliferative Lupus Nephritis With Leflunomide Combined With Prednisone

lupus nephritis accounts for the most morbidity and mortality in patients with SLE. Glucocorticoids combined with cyclophosphamide (CYC) are effective for the treatment of patients with proliferative lupus nephritis and have been the immunosuppressive regimen of choice for many years. However, some patients do not respond well to the regimen, and adverse effects of cyclophosphamide limit its use in certain patients. Leflunomide is a novel immunosuppressive agent currently used in the treatment of rheumatoid arthritis.There were a few pilot observational studies and reports suggesting leflunomide was also safe, well-tolerated and may be effective in SLE patients without important organ involvement. It has not been shown if leflunomide can be used in the treatment of patients with lupus nephritis. We therefore undertook a multi-center, controlled study to investigate the efficacy and safety profile of leflunomide compared with cyclophosphamide in the treatment of patients with biopsy proven proliferative lupus nephritis.


Eligibility Criteria:
Inclusion Criteria:

* All patients were diagnosed as SLE according to the updated criteria of American College of Rheumatology in 1997, had a systemic lupus erythematosus disease activity index (SLEDAI)equal or greater than 8; had evident renal diseases and biopsy-documented diffuse proliferative or focal proliferative lupus nephritis, with or without coincident membranous nephropathy, and pathological activity index (AI)equal or greater than 4

Exclusion Criteria:

* Patients who had received cyclophosphamide within the previous 3 months, cerebral lupus, severe infection, liver disease, pregnancy, and anticipated poor compliance with the protocol.
Establishment of a Predictive System for Perioperative Risk Assessment and Electronic Flowcharting Response Strategies in Thoracic Surgery

1. To establish a risk assessment scale for thoracic surgery for the Chinese population, and to classify patients; risk according to the relevant scale;
2. Combining the guidelines for the management of acute and critical illnesses in thoracic surgical care units and the characteristics of diagnosis and treatment operations, to make an AI-assisted diagnosis and treatment process software;
3. Evaluate whether the software can provide timely and correct diagnosis and treatment recommendations for critically ill patients, shorten the time for homogenized training of specialist intensivists, and reduce the hospitalization cost of patients under the review of resident training instructors of various specialties.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the Department of Thoracic Surgery of the Second Xiangya Hospital of Central South University for surgical treatment.

Exclusion Criteria:

* Patients admitted to the Department of Thoracic Surgery of the Second Xiangya Hospital of Central South University without surgical treatment.

Patients under the age of 18.
Dose Escalation Safety and Pharmacokinetic Study of AVE9633 as Single Agent in Relapsed/Refractory CD33-Positive Acute Myeloid Leukemia

The primary objective is to determine the maximum tolerated dose of AVE9633 and to characterize the dose limiting toxicity(ies). Secondary objectives are to determine the anti-leukemia activity, the global safety and the PK profile.


Eligibility Criteria:
Inclusion Criteria:

* Patients with CD33-positive acute myeloid leukemia, refractory or relapsed after standard treatment with no curative option available
* ECOG performance status 0 to 2

Exclusion Criteria:

* Therapy with gemtuzumab ozogamicin (Mylotarg) within 6 months prior to inclusion
* Allogenic transplantation within 6 months prior to inclusion
* Prior therapy (chemotherapy, targeted agents, radiotherapy) within 3 weeks except for hydroxyurea and for leukophoresis
* Previous treatment with AVE9633
* Poor kidney, liver and bone marrow functions
* Any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study
* Pregnant or breast-feeding women
* Patient with reproductive potential without effective birth control methods

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Effects of Genotypes on Interferon Signaling in Chronic Hepatitis C

The objective of this pilot project is to investigate the prognostic criteria for sensitivity of Chronic Hepatitis C (CHC) Genotype 1, patients to IFNa treatment. Signal transduction in peripheral blood mononuclear cell (PBMC) of control groups will be compared with that of CHC patients. For this study, 20 patients with Hepatitis C virus (HCV) infection who are to undergo standard antiviral therapy and 10 healthy donors (significant others of the HCV subject) will be enrolled. Signal transduction will be studied in peripheral blood of CHC subjects before the treatment, after 1 and 3 months of treatment, and 4-6 months following the completion of treatment.

In addition, the mechanism of non-responsiveness of HCV patients to IFNa will be studied. For this purpose, formation of complexes between STAT1 and its negative regulator, PIAS1 (immunoprecipitation, Western blot) will be examined. In comparing subjects on standard therapy vs the addition of betaine, (under separate studies) we will assess whether the formation of STAT1-PIAS1 complexes is due to impaired methylation on STAT1 on arginine residues which may be over come by the addition of betaine.

Eligibility Criteria:
Inclusion Criteria

* 19 years of age or older, of either gender
* History of chronic hepatitis C documented by HCVRNA or healthy family member/significant other
* Documented genotype 1 for hepatitis participants or no hepatitis infection for healthy control
* Subject prescribed antiviral therapy for hepatitis participants or none for healthy control
* Able to give informed consent

Exclusion Criteria

* Under 19 years of age
* Unable to give informed consent
Efficacy and Safety of AGN-199201 in Patients With Persistent Erythema Associated With Rosacea

This study will evaluate the safety and efficacy of AGN-199201 once daily compared to vehicle for the treatment of persistent moderate to severe facial erythema associated with rosacea.


Eligibility Criteria:
Inclusion Criteria:

-Moderate to severe persistent facial erythema associated with rosacea.

Exclusion Criteria:

* Greater than 3 inflammatory lesions on the face
* Current treatment with monoamine oxidase (MAO) inhibitors
* Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, scleroderma or Sjogren's syndrome.
Pursed Lip Breathing in Interstitial Lung Disease

This randomized, cross-over study aims at describing the effect of pursed lip breathing on exercise-induced dyspnea and exercise capacity in patients with interstitial lung disease.

The use of pursed lip breathing (PLB) to improve exercise tolerance in COPD patients has been widely documented. However, its efficacy in patients with interstitial lung disease (ILD) has yet to be confirmed. This study aims to determine if PLB improves perceived exertion and exercise capacity during a six-minute walk test (6MWT) in patients with ILD. To achieve this, a prospective randomized crossover trial will be performed, in which patients with ILD and restrictive ventilatory defect will be recruited via the ILD clinic of Hôpital Notre-Dame. The study will be performed in a single visit, on the day where patients attend a routine physician-prescribed follow-up 6MWT. Patients will be asked to perform a total of two 6MWT. Patients will be randomized to perform the first test with or without using PLB, and the order will be reversed for the second test, with patients serving as their own control. During tests, ventilatory variables will be continuously measured using a portable metabolic cart. The observed parameters will be: perceived exertion using the Modified-Borg Scale, respiratory rate, minute-ventilation, heart rate, peripheral oxygen saturation, and 6-minute walk distance (6MWD). It is expected that the use of PLB will be associated with a decrease of at least one unit on the Modified Borg Scale, which would be clinically significant. Moreover, it is expected that the decrease in dyspnea with PLB will be related to a decrease in respiratory rate minute ventilation during 6MWT. The clinical impact of this study could be significant as therapies allowing the improvement of dyspnea in patients with ILD are scarce.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of interstitial lung disease, based on the results of a multidisciplinary diagnosis discussion.
* Restrictive ventilatory defect (i.e. total lung capacity (TLC) \< 80% of predicted value) on pulmonary function testing.

Exclusion Criteria:

* Active cancer
* History of severe heart disease
* Neurological or orthopaedic problem that could interfere with exercise performance
* Physiological mixed syndromes (i.e. concomitant restrictive and obstructive defects)
* Exacerbation of disease or hospitalisation in the last 4 weeks prior to enrollment
* Long-term oxygen therapy
Trial of an Online Spanish Pivotal Response Treatment Training in Autism Spectrum Disorder

The goal of this clinical trial is to understand if an online course in Spanish can help Spanish-speaking parents use Pivotal Response Treatment (PRT) to support language and social skills in young children with Autism Spectrum Disorder (ASD). This study aims to reach families who may have trouble accessing autism services due to language, location, or cost barriers. The main questions it hopes to answer are:

* Can Spanish-speaking parents learn to effectively use PRT techniques to support their child's communication?
* Does this training improve children's language and social interactions?

Researchers will evaluate the effectiveness of the online course for parents who participate in regular virtual check-ins and submit videos showing their practice with PRT.

Participants in the study will:

* Complete online lessons over 12 weeks that teach PRT methods, specifically designed for Spanish-speaking parents
* Meet with a research team member every few weeks by phone or video to ask questions and receive feedback
* Provide video recordings of interactions with their child to track progress
* Complete brief surveys about their experience and child's communication abilities

By focusing on Spanish-speaking families, this study aims to increase access to effective autism support and reduce gaps in care. Researchers hope the findings will help develop better resources for families facing similar barriers and improve language and social outcomes for children with autism.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 2 to 5 years, 11 months at the time of consent
* Diagnosis of Autism Spectrum Disorder (ASD), confirmed through medical records and/or parent questionnaire
* Significant language delay, indicated by scores 2 standard deviations (SD) below the average for ages 2 and 3, or 3 SD below the average for ages 4 and 5 on the Vineland-3 Communication subscale or Expressive V-scale
* A Spanish-speaking parent or primary caregiver available to consistently participate in study activities and implement PRT in Spanish
* Stable on any psychotropic medications or biomedical interventions for at least 1 month before baseline, with no anticipated changes during the study
* Consistent treatment or intervention services (such as ABA, Floortime, or speech therapy) and stable school placement for at least 1 month before baseline, with no expected changes
* Limited to no more than 60 minutes of one-on-one speech therapy per week

Exclusion Criteria:

* Primary language of the child or parent is not Spanish
* Either the child or parent has a severe psychiatric disorder or an unstable medical condition
* Prior exposure to or adequate trial of Pivotal Response Treatment, resulting in the parent achieving fidelity in PRT implementation at baseline
* The child is currently receiving more than 15 hours of one-on-one Applied Behavior Analysis (ABA) therapy per week
Chewing and Oral Processing of Solid Food

Food texture modification is commonly used as an intervention for people with dysphagia (swallowing impairment). However, the field currently lacks a proper understanding of how this intervention works. The overall goal of this project was to collect measurements of food bolus transit through the oropharynx (i.e., mouth and throat) during chewing, oral processing and swallowing.

Aim: To explore chewing and oral processing behaviors across solid foods of different consistencies (minced and moist, soft \& bite-sized, regular).

Healthy adult participants will be asked to swallow foods representative of the "minced and moist", "soft and bite-sized" and "regular" consistency levels of the International Dysphagia Diet Standardisation Initiative.

We will measure the number of chews taken per bolus and the overall duration of chewing to understand differences across consistencies.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults under age 60

Exclusion Criteria:

* prior history of swallowing, motor speech, gastro-esophageal or neurological difficulties, chronic sinusitis or taste disturbance.
* history of surgery to the speech or swallowing apparatus (other than routine tonsillectomy or adenoidectomy)
* Type 1 Diabetes
* Current use of dentures
* cognitive communication difficulties that may hinder comprehension of the study documents or instructions
* known allergies to medical adhesive
* known allergies to ingredients of the food products used in the experiment .
In Home Hospital Care Program

To assess the hypothesis that In Home Hospital Care (IHHC) is as safe and effective, less burdensome to families, and less expensive for care of common acute pediatric problems now managed with hospitalization.

A randomized trial compared health care systems with and without IHHC. Eligible children presented to the Emergency Department of our medical center, had common acute problems, and were considered for hospital admission.

Physicians decided disposition from the emergency department. Note that subjects were not randomized directly to IHHC but to a system of care that either included IHHC or did not. To allow best use of scarce home nursing resources, we used a disproportionate selection favoring the system with IHHC.

Quality measures included adverse events, parent anxiety and satisfaction with care, family disruption, and perceived child health.

Eligibility Criteria:
Inclusion Criteria:

Randomized from acute care clients presenting in Emergency Department to IHHC

Exclusion Criteria:

Randomized from acute care clients presenting in Emergency Department to inpatient hospital care.
Effectiveness and Tolerability of Zavegepant for Acute Migraine Treatment Among Those Using CGRP Targeting Preventive Medications

Zavegepant (Zavzpret) is approved for the acute treatment of migraine with or without aura in the US. The purpose of this study is to investigate the effectiveness and tolerability of zavegepant for the acute treatment of migraine attacks amongst participants who are using calcitonin gene-related peptide (CGRP) migraine preventive treatments.

This is a phase IV, open-label, prospective, longitudinal clinical trial of intranasal zavegepant 10 mg, a CGRP receptor antagonist, for the acute treatment of migraine attacks amongst individuals who are concomitantly taking stable doses of CGRP targeting migraine preventive treatment (atogepant, eptinezumab, erenumab, fremanezumab, galcanezumab, rimegepant). The effectiveness and tolerability of zavegepant will be assessed in this specific participant population. Participants who are not already taking a CGRP-targeting migraine preventive treatment but who meet criteria for migraine prevention according to their clinician's discretion, will have the option to start rimegepant 75 mg every other day (qod) for two months. After two months, continued eligibility for participation in the clinical trial of zavegepant will be assessed. Those receiving rimegepant for migraine prevention through their participation in this study will have the option to receive rimegepant for up to 32 consecutive weeks.

Eligibility Criteria:
Inclusion Criteria

* Meets International Classification of Headache Disorders 3 (ICHD-3) diagnostic criteria for migraine with or without aura
* At least 18 years of age
* 2- 8 migraine attacks per month
* Participants should be on a calcitonin gene-related peptide (CGRP)-targeting preventive migraine medication on a stable dose for a) ≥2 months prior to zavegepant treatment if an oral gepant or a monoclonal antibody (mAb) injected monthly, or b) at least two treatments if a mAb injected each 3 months.

  * Atogepant
  * Eptinezumab
  * Erenumab
  * Fremanezumab
  * Galcanezumab
  * Rimegepant

Exclusion Criteria

* Primary headache disorders other than migraine (tension-type headache days are allowed)
* History of hypersensitivity reaction to zavegepant or to any of the components of zavegepant

Eligibility Notes

* Participants may have either episodic or chronic migraine.
* Prior use of zavegepant and other gepants is permitted.
* Participants can be using migraine preventive medications/treatments in addition to the CGRP-targeting preventive treatment, as long as those treatments have been stable for at least two months at the time of enrollment.

Additional Eligibility Criteria for Participants to Start on Rimegepant for Migraine Prevention

Inclusion Criteria:

• Must have 4 or more migraine days per month, on average, during the 2 months prior to the Screening Visit, according to participant self-report.

Exclusion Criteria

• History of hypersensitivity reaction to rimegepant or to any of the components of rimegepant.
Intubation of Obese Patients in the Operating Room with or Without Bag-Mask Ventilation

The aim of the study is to answer a daily question in the operating room: what is the safest technique for intubation of severe/morbid obese patients (BMI 35 or more). There is a great heterogeneity of practices on the subject, so the principle is to determine a common practice to facilitate the management of these patients.

Anesthesia consultation or pre-anesthesia visit:

* screening for inclusion and non-inclusion criteria
* patient information
* collection of consent
* inclusion

D0 (day of inclusion):

* before general anesthesia : collection of epidemiological data (history + clinical examinations) + randomization (Arm A/Not Vent : intubation without ventilation or Arm B/Vent : intubation with ventilation)
* general anesthesia : intubation according to randomization arm + collection primary endpoint + conduct of the intubation procedure + morbidity of the intubation procedure
* after general anesthesia : collection of secondary endpoints + conduct of the intubation procedure + morbidity of the intubation procedure + intraoperative respiratory morbidity
* post-interventional care room : collection of clinical parameters in the ICU : postoperative morbidity + study discharge (hospital discharge)

Eligibility Criteria:
Inclusion criteria:

* patient requiring general anesthesia with intubation for surgery or scheduled endoscopic procedures
* age \> 18 years
* with a BMI superior or equal to 35kg.m-²
* patient having signed an informed consent

Non-inclusion criteria:

* ambient air saturation \<90%
* urgent surgery \< 24 hours
* cardio-thoracic surgery
* mask ventilation not possible (e.g. ATCD, cervical irradiation, fixed mandible)
* formal contraindication to mask ventilation (e.g. occlusive syndrome, non fasting patient, symptomatic gastroesophageal reflux untreated or persistent under treatment)
* wish of the operator for high flow oxygen preoxygenation
* wish of an intubation without curare by the operator
* pregnant or breast-feeding women
* protected adults (guardianship, curatorship or safeguard of justice)
* participation in another randomized clinical research study concerning preoxygenation and relevant to the primary endpoint
* absence of affiliation to the French social security system