louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05989295: A Probiotic That Reduces Atopic Skin
Official title: The Efficacy, Safety and Acceptability of a Probiotic in Reducing the Scorad Index in Children With Atopic Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Skin
Children
Keywords: atopic skin;
eczema;
child population;
probiotic
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Methodex
First posted: 2023-08-14
Enrollment: 32
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To assess the efficacy and safety of the use of probiotics as food supplements in reducing the SCORAD index in children with atopic skin compared with placebo. This is a randomized, placebo-controlled, double-blind clinical trial with 2 parallel groups, which will include 32 patients who attend some of the research centers. Patients will be randomized into one of the 2 study groups (allocation ratio 1: 1): Experimental group (Lactobacillus rhamnosus LRa05) and placebo group (placebo). The reduction of the SCORAD index, the number of sprouts in 12 weeks, the days of use of topical corticosteroids and one valuations of the skin condition (hydration).


Eligibility criteria: Inclusion Criteria:

1. Patients with atopic dermatitis in the sprouts phase with a moderate SCORAD index (16-40).
2. Patients aged 2-14 years.

Exclusion Criteria:

* Patients intolerant to gluten, lactose or cow's milk protein.
* Patients who change the type of diet during the study to improve their atopic dermatitis.
* Patients with atopic dermatitis in remission phase (absence of sprouts and with SCORAD index = 0).
* Patients with an allergy or intolerance to any of the ingredients in the formulation of the product under study.
* Patients taking immunomodulators, topical or oral antibiotics, topical or oral antihistamines, oral corticosteroids or antineoplastics.
* Subjects whose condition does not make them eligible for the study, according to the investigator.

Primary outcomes:
measure: the outbreaks of atopic skin
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: CAP Alhambra of Hospitalet de Llobregat
city: Barcelona
country: Spain
facility: CAP La Mina Carrer Mar Sant Adrià de Besos
Study officials:
References:
Clinical trial NCT01668095: Biomarkers in Patients With Advanced Rhabdomyosarcoma
Official title: Developmental Pathway Drug-Targets in Advanced Rhabdomyosarcomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adult Rhabdomyosarcoma
Childhood Alveolar Rhabdomyosarcoma
Childhood Embryonal Rhabdomyosarcoma
Previously Treated Childhood Rhabdomyosarcoma
Recurrent Adult Soft Tissue Sarcoma
Recurrent Childhood Rhabdomyosarcoma
Stage III Adult Soft Tissue Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-08-17
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with rhabdomyosarcoma that has spread to other places in the body and usually cannot be cured or controlled with treatment.

Brief summary: This research trial studies tumor tissue to identify important proteins and biomarkers from patients with rhabdomyosarcoma that has spread to other places in the body and usually cannot be cured or controlled with treatment. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.

Detailed description: PRIMARY OBJECTIVES:

I. To investigate whether the expression of a subset of proteins (by immunohistochemistry), known to be Involved in the paired box (Pax)3, Pax7, and Patched-1 neuromuscular development pathways, are dysregulated in advanced and relapsed alveolar and embryonal rhabdomyosarcomas.

OUTLINE:

Immunohistochemistry is performed for each candidate target (Pax3, Pax7, and Patched-1) in each disease (alveolar, embryonal, and anaplastic rhabdomyosarcoma) for tissue microarray analysis.

Eligibility criteria: Inclusion Criteria:

* 8 tissue microarrays (TMA) slides of the following diseases available:

  * Alveolar rhabdomyosarcoma
  * Embryonal rhabdomyosarcoma
  * Anaplastic rhabdomyosarcoma

Primary outcomes:
measure: Prevalence of the candidate target (Pax3, Pax7, or Patched-1), and whether the candidate target is expressed in the tumor vs stroma
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Oncology Group
state: Pennsylvania
Study officials:
affiliation: Children's Oncology Group
name: Charles Keller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06328595: Muscular and Joint Symptoms in COVID-19 Patients: Insights From Syria
Official title: A Cross-Sectional Analysis of Muscular and Joint Symptoms in COVID-19 Patients: Insights From Syria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Musculoskeletal Pain
COVID-19
Keywords: Fatigue
Joint pain
Covid-19 vaccination
Malaise
Lead sponsor: Syrian Private University
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 1039
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: We collected participants by google form in syria

Brief summary: Observation study, shows the relation between musckeloskeletal symptoms with during and post Covid-19 infection, by asking participants questions about there age,job,which vaccination covid participants took, residual area, social status, number of time of covid-19 infection, number of joint affected and duration of joint pain and asking if there any malaise or fatigue


Eligibility criteria: Inclusion Criteria:

* Participants aged ≥ 18 years with a prior COVID-19 infection or suspicious COVID-19 infection and currently residing in Damascus.

Exclusion Criteria:

* Participants below 18 years, those unwilling to give consent, individuals with joint surgery history, pregnant women, or those who had taken immunosuppressive drugs before the study.

Primary outcomes:
measure: The Demographic characteristics were classified into four groups: Gender, Residual area, education level.
timeFrame: The study took 6 months to finish it with hard work, it was hard to reach our participants so we didn't only collect our data from google form we also colleted our data from Al-Mouassa University Hospital outpatients clinics and Damascus University
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Mohamad Zaid Ahmad Abdalla
Study officials:
References:
Clinical trial NCT01285895: Needs in Education for Pulmonary or Cardiopulmonary Transplanted Cystic Fibrosis Patients
Official title: Assessing of the Educational Needs of Patients Who Received a Lung Transplantation or a Simultaneous Heart-lung Transplantation for Mucoviscidosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: Lung and heart transplantations
Mucoviscidosis
Educational needs
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2011-01-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received a lung transplantation or a simultaeous heart-lung transplantation for mucoviscidosis

Brief summary: Main objective : This project aims to assess the educational needs of patients who received a lung transplantation or a simultaneous heart-lung transplantation for mucoviscidosis.

Specific objectives : Evaluate the specific needs dependent on seniority transplantation : 3 to 6 months, 6 months to 2 years, more than 2 years after transplantation

Secondary objectives :

* Assess the state of health
* Assess the knowledge
* Assess gestural know-how
* Assess the cognitive know-how
* Assess the behaviour adopted in reality by the patient
* Assess motivation psychosocial factors of :

  * self-efficacy and inefficiency
  * representation of obstacles, disadvantages of treatment
  * sense of control over their health
  * feeling of being supported by health professionals, by his close
  * representation of his responsibility to take care of his health, to follow his treatment, to be active about his treatment


Eligibility criteria: Inclusion Criteria:

* Patients who received a lung transplantation or a simultaneous heart-lung transplantation for mucoviscidosis

Exclusion Criteria:

* Patient with a psychiatric disorder
* Patient in intensive care
* Palliative patient
* Patient aged under 18 years old
* Patient refusal

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Valérie DAVID, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Européen Georges-Pompidou
name: Romain GUILLEMAIN, Profesor
role: STUDY_CHAIR
affiliation: Hospices Civils de Lyon
name: Jean-François MORNEX, Profesor
role: STUDY_CHAIR
affiliation: Hôpital Foch
name: Marc STERN, Profesor
role: STUDY_CHAIR
affiliation: CHU de Marseille
name: Martine REYNAUD-GAUBERT, Profesor
role: STUDY_CHAIR
affiliation: University Hospital, Toulouse
name: Marlène MURRIS-ESPIN, Doctor
role: STUDY_CHAIR
affiliation: CHU de Strasbourg
name: Romain KESSLER, Profesor
role: STUDY_CHAIR
References:
Clinical trial NCT01142895: Validation Study of G4 User Interface
Official title: Simulated Usability Trial of the T-Slim Ambulatory Insulin Infusion Pump
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Lead sponsor: Tandem Diabetes Care, Inc.
Sponsor class: INDUSTRY
First posted: 2010-06-11
Enrollment: 33
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Novice adult pumpers, experienced adult pumpers, and non-pumper adults

Brief summary: The purpose of this simulated useability study is to demonstrate the user interface and software design mitigate potential safety concerns.

Detailed description: These are the detailed descriptive planned outcomes of this useability study.

* To demonstrate that human-interface design mitigations lead to effective, efficient, and safe use.
* Validate that foreseeable misuse does not lead to a safety hazard or patient injury.
* Validate the effectiveness and comprehension of critical warnings and alerts, including vibratory, auditory, and textual cues.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of diabetes mellitus

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06485895: Clinical Evaluation of an IGRA Test for the Diagnosis of Active and Latent Tuberculosis
Official title: Clinical Evaluation of an IGRA Test for the Diagnosis of Active and Latent Tuberculosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: TUBERCULOSIS
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Methodology This is a single-center study carried out as part of routine patient care.

The aim of the study is to determine the performance of the 2nd generation TB-IGRA test in the diagnosis of tuberculosis.

Detailed description: It is planned to include 500 patients. An enrolment of 455 subjects will enable us to demonstrate sensitivity-specificity levels of 92% for a 95% confidence interval and a 0.05 degree of precision. To take account of non-analyzable samples or tests, the investigator will include 500 subjects

Eligibility criteria: Inclusion Criteria:

* Individual at least 18 years of age
* Patient presenting for treatment of tuberculosis disease
* Having undergone or benefiting from screening for tuberculosis using a medically prescribed reference IGRA test.
* Informed patient who has not expressed opposition to participating in the study.

French-speaking patient with unambiguous understanding of oral and written instructions.

Exclusion Criteria:

Persons in a period of exclusion from another study

* Pregnant, parturient or breast-feeding women;
* Person deprived of liberty by judicial or administrative decision

Primary outcomes:
measure: sensitivity of TB-IGRA 2nd generation test
timeFrame: 24 MONTHS
measure: specificity of TB-IGRA 2nd generation test
timeFrame: 24 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: ASSISTANCE PUBLIQUE HOPITAUX D EMARSEILLE
name: François CREMIEUX
role: STUDY_DIRECTOR
References:
Clinical trial NCT01159795: Studying Innate Immune Responses in Infants With Bronchiolitis
Official title: Investigating Type I and Type III Interferon Responses in Infants With Respiratory Syncytial Virus
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bronchiolitis
Keywords: Respiratory Syncytial Virus
Infant
Interferon
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2010-07-09
Enrollment: 250
Sex: ALL
Minimum age (years): 6
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants presenting with bronchiolitis presenting to St Mary's Hospital, London

Brief summary: This study aims to establish whether impaired innate immune responses are associated with severity of Respiratory syncytial virus (RSV) infection.

Detailed description: Respiratory syncytial virus (RSV) causes a spectrum of illness in healthy infants, ranging from asymptomatic infection to life threatening bronchiolitis with respiratory failure. The reasons for the differences in clinical presentation remain unknown. Interferons are natural antiviral factors and components of the innate immune response, which play a role in limiting viral replication.

We postulate that differences in clinical severity of RSV infection may be due to innate immune differences in the production of type I and III interferons (innate interferons). To test this hypothesis, we will recruit infants with mild, moderate and severe RSV bronchiolitis and compare production of innate interferons in blood and respiratory samples, using quantitative and functional analysis. We will determine whether interferon responses differ across a spectrum of clinical severity, and will relate them to viral load.

To establish whether defects in interferon production persist in those infants with severe infection, we will retest them following recovery and measure interferon responses after challenge with live RSV. Demonstrating a persisting defect may suggest a genetically determined defect requiring further investigation. Identification of the mechanisms of severe disease in patients without known risk-factors could lead to targeted therapy to prevent or treat severe disease.

Eligibility criteria: Inclusion Criteria:

* Bronchiolitis
* Infant

Exclusion Criteria:

* Age over 1 year
* Underlying chronic lung disease, prematurity, congenital heart disease

Primary outcomes:
measure: Nasal and blood interferon alpha, beta, lambda levels(protein level and gene expression)
timeFrame: At presentation (average = day 4 of symptoms)
Secondary outcomes:
measure: RSV viral load
timeFrame: At presentation (average = day 4 of symptoms)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Mary's Hospital
Study officials:
affiliation: Department of Paediatrics, Imperial College London
name: Michael Levin, FMed Sci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02748395: Lidocaine and Triamcinolone vs Saline Trigger Point Injection for Treatment of Chronic Abdominal Wall Pain
Official title: Lidocaine and Triamcinolone vs Saline Trigger Point Injection for Treatment of Chronic Abdominal Wall Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Chronic Abdominal Wall Pain
Abdominal Cutaneous Nerve Entrapment Syndrome
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the injection of triamcinolone and lidocaine is effective in relieving chronic abdominal wall pain.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of chronic abdominal wall pain
* Prior ultrasound or cross-sectional imaging of the abdomen to exclude other causes
* Baseline Brief Pain Inventory score ≥ 5

Exclusion Criteria:

* Multiple trigger points
* Abdominal wall hernia on exam
* Weight loss
* Rectal bleeding
* Recent change in bowel habits
* Decompensated cirrhosis or recurrent ascites
* Allergy or contraindication to study medications
* Known thrombocytopenia with platelet count \< 50,000
* Other diagnosis of chronic pain syndromes including fibromyalgia
* Unable to provide informed consent
* Pregnancy

Primary outcomes:
measure: Pain score
timeFrame: Baseline and 1 month
Secondary outcomes:
measure: Pain score
timeFrame: Baseline and 1 week
measure: Pain score
timeFrame: Baseline and 2 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01423695: Weekly Paclitaxel and Trastuzumab in Metastatic Breast Cancer
Official title: Weekly Application of Trastuzumab and Paclitaxel in the Treatment of HER2-overexpressing Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Lead sponsor: WiSP Wissenschaftlicher Service Pharma GmbH
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
name: Roche Pharma AG
First posted: 2011-08-26
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The 3 weekly combination of trastuzumab and paclitaxel has been approved for the treatment of advanced breast cancer based on a large pivotal study. However, mono and combination chemotherapy trials suggest that weekly paclitaxel has a better therapeutic index, especially in the palliative setting. The present trial examines the efficacy and safety of weekly paclitaxel over a limited duration combined with continued trastuzumab in HER2+ patients.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed metastatic breast cancer overexpressing HER2
* pretreatment with anthracycline in either the adjuvant or palliative setting.
* HER2 positivity was defined as 2+ or 3+ overexpression using the DAKO HercepTest, confirmed by fluorescence in-situ hybridization (FISH) if 2+.
* informed consent

Exclusion Criteria:

* more than 1 chemotherapy for advanced disease
* taxane or trastuzumab pretreatment
* brain metastases
* Eastern Cooperative Oncology Group (ECOG) performance status \>1
* pregnancy or lactation, childbearing potential without reliable contraception
* clinically significant cardiac disease,
* neutrophils \<1500/µl, platelets \<75,000/µl
* total bilirubin and creatinine \>1.5 × the upper limit of normal

Primary outcomes:
measure: Progression-free survival
timeFrame: Patient follow-up on average for 15 months and up to a maximum of 51 months
Secondary outcomes:
Other outcomes:
Locations:
city: Glauchau
country: Germany
facility: Dr. Matthias John
state: Sachsen
Study officials:
affiliation: Oncology Practice, Glauchau
name: Matthias John, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00836095: Comparison of ProSeal Laryngeal Mask Airway to Laryngeal Mask Airway Supreme
Official title: A Randomized Controlled Trial Comparing the ProSeal Laryngeal Mask Airway With the Laryngeal Mask Airway Supreme in Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adverse Effect of Unspecified General Anesthetics
Keywords: laryngeal mask, proseal
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2009-02-04
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Laryngeal mask airway is a widely used device in routine anesthesia for airway management during surgery. It consists of a tube with an inflatable cuff that is inserted into the mouth after induction of general anesthesia. The Proseal Laryngeal mask airway and the Laryngeal mask airway Supreme are two variants of the Laryngeal mask airway. The laryngeal mask airway Supreme is a newer version of the laryngeal mask airway.

The research is being done to compare two variants of the laryngeal mask airway: the Proseal laryngeal mask airway and the Laryngeal mask airway Supreme. This study will determine if the newer model, the Laryngeal mask airway Supreme, is easier to insert and is better positioned than the older model, the Proseal laryngeal mask airway. Both models are approved for use by the FDA, and are routinely used to assure the airway during general anesthesia.


Eligibility criteria: Inclusion Criteria:

* 18 - 75 years
* ASA I and II
* Mallampatti class: I and II
* Thyromental distance \> than 6.5 cm
* Interincisor distance \> than 3 cm
* BMI \< 35 Kg/m2
* Patients scheduled to undergo anesthesia with an LMA for minor extraperitoneal surgical procedures in supine position

Exclusion Criteria:

* Weight \< 50 kg
* BMI \> 35 Kg/m2
* Pregnant patients
* Known or expected difficult airway
* Patients with active, untreated and unresolved gastroesophageal reflux
* Esophageal pathology, pulmonary pathology
* Laparoscopic procedures
* ENT procedures, gastrointestinal procedures, intraperitoneal surgical procedure

Primary outcomes:
measure: Insertion Time
timeFrame: During intubation of the patient
Secondary outcomes:
measure: Insertion Success Rate
timeFrame: During intubation of the patient
Other outcomes:
Locations:
city: Hershey
country: United States
facility: PennState Hershey Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State
name: Sonia J Vaida, MD
role: PRINCIPAL_INVESTIGATOR
References: