louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05663060: Evaluation Study of the Intestinal Microbiota and Quality of Life in Patients Suffering From IBS Treated With Bifidice
Official title: Evaluation Study of the Intestinal Microbiota and Quality of Life in Patients Suffering From Irritable Bowel Syndrome Treated With Bifidice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Irritable bowel syndrome is the most common functional gastrointestinal disease and is characterized by high prevalence and chronic course.The pathology has a strong impact on the quality of life of affected patients and on health and social costs, these related to reduced productivity.The scarce efficacy and heavy side effects of traditional therapies lead these patients to often resort to alternative or complementary therapies. From the evaluation of the evidence of various probiotic preparations and food supplements, the investigators have used a commercial preparation characterized by the presence of bifidobacteria which have demonstrated some efficacy in thinking of improving the quality of life of these patients to evaluate quality of life, ability productivity and trend of some indices of disease severity in a small number of patients. These preliminary data could represent a starting point for more in-depth evaluations, also with placebo-controlled studies.


Eligibility criteria: Inclusion Criteria:

* Patients aged ≥18 years
* Diagnosis of IBS according to Rome IV criteria
* Mild to moderate disease, as measured by FBDSI
* Absence of signs and symptoms that may suggest organic damage and, if indicated, negative instrumental investigations (colonoscopy and/or imaging)
* Prescription of Bifidice, according to normal clinical practice
* Informed consent expressed in written form

Exclusion Criteria:

* Patients undergoing surgical resection of the stomach, gallbladder, small or large intestine
* History of inflammatory bowel disease
* Severe SII, measured by FBDSI
* Active peptic ulcer
* History of ischemic colitis
* Active infectious enteritis
* Diagnosed with hypo- or hyperthyroidism
* Need for pharmacological treatments for IBS, antibiotics, antidepressants and laxatives
* Therapy in progress with drug or supplements included in the list of those not allowed (Paragraph N: to be established)
* Any disease that may affect gastrointestinal function and could interfere with appropriate assessment of abdominal pain or discomfort

Primary outcomes:
measure: Modification of teh intestinal microbiota
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Humanitas Research Hospital
Study officials:
References:
Clinical trial NCT00002260: An Open-Label, Crossover Study to Assess the Effect of Food on the Oral Bioavailability and Pharmacokinetic Profile of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects
Official title: An Open-Label, Crossover Study to Assess the Effect of Food on the Oral Bioavailability and Pharmacokinetic Profile of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Biological Availability
alovudine
Food
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To characterize the pharmacokinetics of orally administered FLT (in a liquid formulation) after single doses in both the fed and fasting states; to assess the effect of food on the oral bioavailability of FLT


Eligibility criteria: Inclusion Criteria

Patients must have:

* Positive ELISA test confirmed by Western blot analysis.
* Asymptomatic.
* Willing to sign an informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Oral candida infection documented by morphology or by a response to antifungal therapy within two months prior to study entry.
* Oral hairy leukoplakia at any time prior to entry.
* Temperature \> 37.8 C.
* Any malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ.
* Significant chronic underlying medical illness which would prevent continuous participation in this clinical trial.
* Unwilling to sign an informed consent.
* Zidovudine induced hematological toxicity.

Prior Medication:

Excluded:

* Therapy with antiretroviral drugs or immunomodulators within seven days before entry.
* Therapy with any investigational drug during the preceding 30 days.

Patients may not have:

* Oral candida infection documented by morphology or by a response to antifungal therapy within two months prior to study entry.
* Oral hairy leukoplakia at any time prior to entry.
* Temperature \> 37.8 C.
* Any malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ.
* Significant chronic underlying medical illness which would prevent continuous participation in this clinical trial.
* Unwilling to sign an informed consent.
* Zidovudine induced hematological toxicity.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hosp
state: Maryland
Study officials:
References:
Clinical trial NCT01591694: National Child Traumatic Stress Network (NCTSN) Quality Improvement Initiative Database
Official title: National Child Traumatic Stress Network (NCTSN) Quality Improvement Initiative Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Traumatic Stress Disorder
Anxiety
Depression
Conduct Disorder
ADHD
Keywords: child trauma
maltreatment
physical abuse
sexual abuse
emotional abuse
abandonment
domestic violence
community violence
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
First posted: 2012-05-04
Enrollment: 4193
Sex: ALL
Minimum age (years): 2
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children enrolled in treatment at the Family Center and their caregivers

Brief summary: Trauma-informed treatment will improve emotional regulation and behavior.

Detailed description: The proposed study is to request permission to continue federally mandated data collection to examine the clinical outcomes of children at the Family Center at Kennedy Krieger Institute who are enrolled in evidence-based and promising trauma-informed treatments as part of the National Child Traumatic Stress Network funded by the Substance Abuse and Mental Health Services Administration. The purpose of the National Child Traumatic Stress Initiative(NCTSNI) Evaluation is to determine the extent to which the NCTSI, through the National Child Traumatic Stress Network (NCTSN), has raised the standard of care and improved access to services for traumatized children. In addition, the evaluation assesses the extent to which the NCTSI has served as a national resource capable of improving children's access to high-quality, trauma-informed mental health services. This data, previously collected and managed by the Category I NCTSN Center at Duke will now be managed by ICF Macro in a data system entitled NICON.

Eligibility criteria: Inclusion Criteria:

* Children enrolled in treatment at the Family Center and caregivers

Exclusion Criteria:

* Psychosis,
* Inability to comply with directions

Primary outcomes:
measure: Behavior
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Family Center at Kennedy Krieger Institute
state: Maryland
Study officials:
affiliation: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: Harolyn Belcher, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06746194: The Value of 68Ga-FAPI PET/CT in the Efficacy Evaluation of Advanced Unresectable Hepatocellular Carcinoma Patients Undergoing Systemic Antitumor Therapy
Official title: The Value of 68Ga-FAPI PET/CT in the Efficacy Evaluation of Advanced Unresectable Hepatocellular Carcinoma Patients Undergoing Systemic Antitumor Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma (HCC)
Keywords: hepatocellular carcinoma
68Ga-FAPI
PET/CT
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients and outpatients at Ruijin Hospital who meet the inclusion criteria.

Brief summary: This study aims to investigate the value of 68Ga-FAPI PET/CT in the efficacy evaluation of advanced unresectable hepatocellular carcinoma patients undergoing systemic antitumor therapy.

Detailed description: The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo a 68Ga-FAPI PET/CT before treatment and after 3-month treatment. The imaging response measurements will be compared with the histopathological results as gold standard.

Eligibility criteria: Inclusion Criteria:

1. Pathological and clinical diagnosis of advanced unresectable hepatocellular carcinoma patients.
2. Signed and dated informed consent form.
3. Commitment to comply with research procedures and co-operation in the implementation of the full research process.
4. Aged 18-75 years old.

Exclusion Criteria:

1. Patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
2. Intestinal perforation, complete intestinal obstruction
3. Pregnant women and women who may be pregnant, women who are breastfeeding.
4. Non-compliant person

Primary outcomes:
measure: The responses to systemic antitumor therapy of advanced unresectable hepatocellular carcinoma
timeFrame: Within 1 week of enrollment and up to 3 months
measure: Standardized uptake value(SUV)
timeFrame: Within 1 week of enrollment and after up to 3 months
Secondary outcomes:
measure: Progress free survival
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT04696094: The Role of m6A RNA Modification in Moyamoya Disease
Official title: The Role of m6A RNA Modification in Moyamoya Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Moyamoya Disease
Keywords: m6A
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 160
Sex: ALL
Minimum age (years): 4
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Moyamoya disease patients

Brief summary: The purpose of this study is to detect the change of m6A RNA modification from peripheral blood of patients with moyamoya disease, and to assess the relationship between clinical characteristics.

Detailed description: Moyamoya disease (MMD) is a rare cerebrovascular disorder characterized by occlusion of bilateral internal carotid and intracerebral arteries with the compensatory growth of fragile small vessels. The etiology of disease is still unclear. The pathology is associated with blood vessels, characterizing the molecular changes of blood in patients with MMD may yield insights into the disease. N6-methyladenosine (m6A) is identified to be the most common and abundant RNA molecular modification in eukaryotes, and involves in a variety of metabolic processes of RNA, such as RNA transcription, shearing, nuclear transport, and translation ability. The propose of this study is to investigate the change of m6A RNA modification in patients blood with moyamoya disease and its influence on clinical indicators, aiming to provide potential pathogenesis of moyamoya disease.

Eligibility criteria: Health volunteers' inclusion criteria:

Age between 4-60; Male or female;

Exclusion criteria:

Exclude the volunteers with history of cerebrovascular disease.

Primary outcomes:
measure: m6A RNA modification in peripheral blood
timeFrame: 2021.1.1-2021.12.31
Secondary outcomes:
measure: Suzuki grade
timeFrame: 30days
measure: Modified Rankin Scale score
timeFrame: 6months
measure: New clinical vascular events
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT03462394: Increasing Patient Engagement in the Annual Well Visits Program
Official title: Increasing Patient Engagement in the Annual Well Visits Program at NYU Langone Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Annual Visit, Well Visit
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-03-12
Enrollment: 5475
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Members attributed to NYU Langone Health under a shared savings arrangement who are due for preventive services and/or screenings and are eligible to be receiving a reminder call.

Brief summary: NYU Langone Health calls patients to remind them to schedule their annual well-health appointments (including annual well visit, mammograms, etc.). The proposed study will test different iterations of the call script with the goal of increasing call completion rate and the number of scheduled appointments within an appropriate timeframe.


Eligibility criteria: Inclusion Criteria:

* Members attributed to NYU Langone Health under a shared savings arrangement who are due for preventive services and/or screenings and are eligible to be receiving a reminder call.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Number of scheduled annual visits
timeFrame: 6 months
Secondary outcomes:
measure: Call completion rate
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Leora Horwitz, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06705894: An Observational Study on Respiratory Complications After Gastrointestinal Endoscopy Assisted With Anesthesia
Official title: An Observational Study on Respiratory Complications After Gastrointestinal Endoscopy Assisted With Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia, Aspiration
Keywords: Gastrointestinal endoscopy
Respiratory complications
Sedation
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 6739
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population undergoing gastrointestinal endoscopy examination at Qingdao University Affiliated Hospital from December 2024 to February 2025.

Brief summary: The purpose of this study is to investigate the incidence of respiratory complications after gastroenteroscopy, and establish a Logistic regression model to analyze the related risk factors of respiratory complications.

Detailed description: Gastrointestinal endoscopy is currently the most widely used and reliable technique for diagnosing digestive tract diseases.With the increasing need for pain relief and the improvement of anesthesiology technology, more and more patients prefer to undergo gastroenteroscopy under sedation or anesthesia.The painless technique of gastroenteroscopy is an anesthetic method , and like other anesthesia techniques, it brings risks as well as comfort.However, current studies mainly focus on respiratory and circulation-related adverse events during the examination , while little attention is paid to delayed respiratory complications after examination.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old;
2. Qualified gastrointestinal tract preparation in strict accordance with the preparation requirements related to gastroenteroscopy;

Exclusion Criteria:

1. Patients with respiratory system symptoms or history before surgery;
2. Patients in need of a tracheal intubation;
3. Refuse follow-up;

Primary outcomes:
measure: Postoperative cough
timeFrame: 24 hours after surgery
measure: Postoperative fever
timeFrame: 24 hours after surgery
measure: Short of breath
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Adverse events during surgery
timeFrame: During surgery
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shangdong
Study officials:
References:
Clinical trial NCT02917694: A Feasibility Study to Assess Pre Admission Status and Six Month Outcomes After Major Trauma
Official title: A Feasibility Study to Assess Pre Admission Status and Six Month Outcomes of Major Trauma Patients Admitted to an Intensive Care Unit, Using the WHO DAS 2.0.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Trauma
Lead sponsor: Oxford University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to ICU after multiple trauma

Brief summary: This study aims to assess the feasibility of obtaining details about a patients previous level of function from the patient of friend/relative, after they have been admitted an intensive care unit (ICU). It will also assess the feasibility of re-assessing level of function at 6 months after the patient has been discharged from ICU.

Detailed description: Currently there is no standardised way of obtaining details about a patients pre-admission level of function. the process of gaining this history is often done by several different people with no standard questions asked.

There is also a need to be able to measure what happens to patients after they leave ICU, and compare their abilities to preadmission status.

This feasibility study will aim to investigate:

* the time taken to train the physiotherapy team in the use of the outcome measure
* the ability to obtain pre admission functional status from patients/friend/relative on admission to ICU
* the ability to follow patients up at 6 months post discharge with re-assessment of the outcome measure

Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study
* Participants relative or friend (consultee) is willing and able to give informed consent for participation in the study (where the patient is unable to give informed consent)
* Male or Female, aged 18 years or above
* Injury Severity Score greater than 9
* Admitted as an emergency to AICU
* Experienced at least 24 hours level three care during their admission

Exclusion Criteria:

* Non UK resident (due to potential loss to follow up)
* Unwilling to consent
* No GP details available
* Patients with a palliative diagnosis or established on a palliative treatment pathway

Primary outcomes:
measure: WHODAS 2.0 completion rate
timeFrame: 2 days
Secondary outcomes:
measure: Time to questionnaire completion rate
timeFrame: 2 days
measure: WHODAS 2.0 completion rate
timeFrame: 6 months post ICU discharge
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: Oxfod University Hospitals NHS Foundation Trust
name: Rebekah Haylett, BSc (Hons)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04735094: The Use and Effectiveness of Balloon for Endobronchial Ultrasonography
Official title: Randomized Control Trial of the Use and Effectiveness of Balloon for Endobronchial Ultrasonography.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer Staging
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Although balloons appear to improve ultrasound image quality, it's use can be technically difficult for segmental airways because of anatomical limitations to convex probe imaging. Furthermore, it is uncertain whether this leads to a better diagnostic yield. To our knowledge, there are currently no studies showing that the use of balloon improves diagnostic yield with EBUS. We hypothesize that the use of balloon may increase the diagnostic yield by improving ultrasound image quality and reduce the duration of the procedure.The aim of this study is to analyse whether the use of balloon during linear EBUS 1) improves diagnostic yield, 2) reduces the duration of the procedure, and 3) improves ultrasound image quality with increased operator satisfaction in terms of ease of procedure.


Eligibility criteria: Inclusion criteria:

* Adults aged ≥18 years
* Patient referred for EBUS guided TBNA of mediastinal LNs
* The para-tracheal lymph node (LN) station 4R is planned to be biopsied.

Exclusion criteria

-Patient referred for EBUS and 4R is NOT planned to be biopsed

Primary outcomes:
measure: Diagnostic yield
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CHUM
state: Quebec
Study officials:
References: