louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00385099: Effects Of GW876008 On The Bowel In Patients With Irritable Bowel Syndrome
Official title: A Phase IIa Pharmacodynamic Study of Antagonism of Irritable Bowel Syndrome (IBS) Symptoms by GW876008, a Corticotrophin Releasing Factor 1 Receptor Antagonist (CRF1-RA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Colon
Keywords: IBS
stress
CRF1
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-10-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if GW876008 in Irritable Bowel Syndrome patients will reverse stress-induced hypersensitivity, by looking at thresholds for perception and pain.


Eligibility criteria: Inclusion criteria:

* Must have irritable bowel syndrome.

Exclusion criteria:

* Subjects who have been taking any medication for the treatment of irritable bowel syndrome within 6 months prior to the start of the study.

Primary outcomes:
measure: Percent change from Baseline in Laser Doppler regional Rectal Mucosal Blood Flow (RMBF) measured in response to physiological stress (cold water pressor test)
timeFrame: Baseline (pre-dose) and Study Days 1, 2 and 3
measure: Percent Change from Baseline in Laser Doppler regional RMBF measured in response to psychological stress (dichotomous listening test)
timeFrame: Baseline (pre-dose) and Study Days 1, 2 and 3
Secondary outcomes:
measure: Number of participants with adverse events (AE) and serious adverse events (SAE)
timeFrame: Up to Week 14
measure: Number of participants with abnormal clinical chemistry data of clinical concern
timeFrame: Up to Week 14
measure: Number of participants with abnormal hematology data of clinical concern
timeFrame: Up to Week 14
measure: Participant perceived stress as assessed by a Visual Analogue Scale
timeFrame: Study Days 1, 2 and 3
measure: Systemic autonomic nervous system response as assessed by systolic blood pressure (SBP) and diastolic blood pressure (SBP)
timeFrame: Up to Week 14
measure: Systemic autonomic nervous system response as assessed by heart rate (HR).
timeFrame: Up to Week 14
measure: Percent change from Baseline in participant reported threshold for pain as a measure to assess Visceral (rectal) electro sensitivity
timeFrame: Baseline (pre-dose) and Study Days 1, 2 and 3
measure: Percent change from Baseline in participant reported threshold for perception of an electrical stimulus as a measure to assess Visceral (rectal) electro sensitivity
timeFrame: Study Days 1, 2 and 3
measure: Change from Baseline in RMBF at 90 minutes post-dose
timeFrame: Baseline (pre-dose) and Study Days 1, 2 and 3
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01686399: A Sustainable Diet for Hadassah Employees Workers
Official title: A Sustainable Diet for Hadassah Employees
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Physical Activity
Keywords: Sustainable diet
Health promotion
Obesity
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-09-18
Enrollment: 450
Sex: ALL
Minimum age (years): 21
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this protocol is to use a multidisciplinary approach to convey nutrition and activity messages to randomly selected Hadassah Medical Center employees. The intervention will be for one academic year and include frontal talks, email and internet focus group interactions, public demonstrations and a focused intervention within the hospital kitchen.

The outcomes are specific parameters of dietary modifications, degree of physical activity and health related perspectives. Outcomes will be recorded at baseline and by the end of the intervention ( one year).

Detailed description: The participants will be selected randomly from the campus employees. They will be exposed to multiple levels of health promotion at the work place as well as via multiple media tools. Analysis will be performed at baseline by using multiple nutrition and health perception questionnaires. A second group from the employees will be selected for assessment of the same outcomes at the end of the year.

Eligibility criteria: Inclusion Criteria:

Hadassah medical center employees Age 21-67

-

Exclusion Criteria:

- Refusal to participate

Primary outcomes:
measure: Change in amount of fruit/vegetable consumption per day
timeFrame: one year
Secondary outcomes:
measure: Amount of physical activity per week
timeFrame: one year
Other outcomes:
measure: Amount of soft drinks consumed per day
timeFrame: one year
Locations:
city: Jerusalem Region
country: Israel
facility: Hadassah Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Ram Weiss, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05977699: Reversibility of Methacholine Induced Bronchoconstriction
Official title: Salbutamol Reversal of Methacholine Induced Bronchoconstriction: Vibrating Mesh Nebulizer Versus Pressurized Metered Dose Inhaler
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Asthma
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study will compare salbutamol reversibility of methacholine induced bronchoconstriction between a pressurized metered dose inhaler with a spacer versus nebulizer administration using a vibrating mesh nebulizer.


Eligibility criteria: Inclusion Criteria:

* age (years) at least 18, male or female
* no confounding health issue (i.e. no health conditions, other than asthma, that would put the participant at risk or affect data integrity)
* baseline FEV1 ≥ 65% predicted (per Quanjer GLI 2012)
* methacholine PD20 ≤ 800mcg

Exclusion Criteria:

* respiratory infection within 4 weeks of Visit 1
* exposure to triggers of respiratory symptoms within 4 weeks of Visit 1
* currently pregnant or breastfeeding
* current smoker (cigarettes, vaping)

Primary outcomes:
measure: Lung function recovery
timeFrame: up to 60 minutes post salbutamol administration
Secondary outcomes:
measure: Time to lung function recovery
timeFrame: 0-60 minutes
measure: Heart rate
timeFrame: 0-60 minutes
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Asthma Research Lab University of Saskatchewan Room 346 Ellis Hall
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Don Cockcroft, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04220099: Electroencephalogram (EEG) and Electroconvulsive Therapy(ECT) Response in Schizophrenia
Official title: Pretreatment Electroencephalogram (EEG) May Predict Electroconvulsive Therapy(ECT) Effect in Schizophrenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: schizophrenia patients

Brief summary: This study is designed to find quantitative Electroencephalogram(qEEG) biomarkers to predict Electroconvulsive Therapy(ECT) Response in Schizophrenia

Detailed description: The purpose of this proposal is to explore quantitative Electroencephalogram(qEEG) biomarkers that would predict Electroconvulsive Therapy(ECT) Response in Schizophrenia (SZD). The investigators will recruit 30 SZD patients who are preparing for ECT treatment and assesse psychotic symptoms using Positive and Negative symptom scale(PANSS) before and after 8-sessions clinical course of ECT treatment. These patients needed ECT treatment are assessed by clinicians according to American Psychiatric Association(APA) guidelines. Meanwhile resting EEG will be recorded for 10 minutes before the first episode of ECT treatment. Decrease of PANSS scores will be calculated after the last session of ECT treatment to distinguish responder/non-responder.

Eligibility criteria: Inclusion Criteria:

* DSM-5 criteria for SZD
* patients needed ECT treatment assessed by clinicians using American psychological Association(APA) guidelines.
* symptoms must be of at least moderate severity (PANSS score \>71)
* age between 18 to 60 years old
* medications will be stable for at least four weeks prior to ECT, and there will be no dose changes unless medically necessary

Exclusion Criteria:

* any additional current psychiatric comorbidity
* pregnancy or prepare to have a baby
* current use of any Antiepileptic drugs
* history of taking any kinds of Physicotherapeutics within 6 months
* severe psychotic symptoms that make patients could not accomplish the clinical interview

Primary outcomes:
measure: Change in Positive and negative syndrome scale（PANSS）score
timeFrame: up to 4 weeks
measure: EEG functional connectivity difference between response and nonresponse group
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Zhen Wang, Ph.D M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03680599: Connection to Health for Smokers
Official title: Connection to Health for Smokers -- A Comprehensive Program to Reduce Tobacco-Related Health Disparities in CHCs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of the study is to develop and test Connection to Health for Smokers (CTHS), a comprehensive program to support smokers to quit and improve smokers' general health. The program will be designed for implementation by health educators in community health centers.

Detailed description: The investigators will use a participatory approach to develop and test the feasibility and acceptability of CTHS in community health center sites in Contra Costa County. Development of the program will be informed by active engagement with a patient advisory group composed of current smokers and clinical team members who serve current smokers in community health centers. Feasibility and acceptability will be assessed by implementing the CTHS program for patients in 3 clinical sites, using the RE-AIM evaluation framework. Primary outcomes will include the number and proportion of enrolled smokers who create at least one health-related action plan with a health educator, and stated intention of clinical teams to continue using CTHS after the research. The investigators will enroll 90 smokers in CTHS and 90 additional smokers in Enhanced Standard of Care (ESC) which will be the active comparison group. Participants will be randomly assigned. Smoking status will be reassessed after 3 months. Primary outcomes will include number of 24-hour quit attempts, and 7-day smoking abstinence, as well as changes in self-efficacy and readiness to quit smoking among participants who do not quit. Results of this pilot program will inform further development of the CTHS program for testing in larger scale clinical trials.

Eligibility criteria: Inclusion Criteria:

- Must have smoked cigarettes in the last 7 days

Exclusion Criteria:

- Speaking languages other than English or Spanish

Primary outcomes:
measure: Program Reach, Effectiveness, Adoption, Implementation, and Maintenance
timeFrame: 3 months
Secondary outcomes:
measure: 7-day smoking abstinence
timeFrame: 3 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Michael Potter, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06729099: Validity of Brain Metastasis Risk Predictive Model in Hormone Positive Breast Cancer Patients
Official title: Validity of Brain Metastasis Risk Predictive Model in Hormone Positive Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer, Estrogen Receptor-Positive
Keywords: breast cancer
Hormonal receptor positive
brain metastasis risk
Prediction model
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical records of women with HR+ breast cancer in clinical oncology department in Assiut University Hospital, Assiut, Egypt.

Brief summary: This study aims to validate a prediction model of brain metastasis risk for females with HR+ breast cancer by using variables collected at diagnosis.

Detailed description: 1. Data collection:

   Age at BC diagnosis, tumor size, axillary adenopathy, clinical stage, HER2 status, Ki67 proliferation index and the modified Scarff-Bloom-Richardson grade of differentiation.
2. Analysis Plan:

   Continuous variables as means and standard deviation (SD) if they follow a normal distribution; if not, as medians and IQR (interquartile range). Numbers and percentages display categorical variables.
3. Model validation:

The association between covariates and the diagnosis of brain metastases by performing logistic regression analyses; odds ratio (OR), 95 % confidence intervals (CI), and p-value will be estimated. Variables with a p-value \< 0.05 in the univariate logistic regression analysis will be further assessed in a multivariate logistic regression analysis.

For the clinical use of the model, we will use a score to each variable as that designed by Cacho-Díaz B. et. al. then, we will categorize patients into three risk groups according to the sum of the scores. We will employe a Cox regression analysis to assess each group's risk of developing brain metastases. Adjusted hazard ratios (aHRs), 95 % CIs, and p values will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of HR-positive primary invasive breast cancer.

Exclusion Criteria:

1. Patients if they were diagnosed with brain metastases at the time of initial breast cancer diagnosis or within the subsequent three months.
2. Bilateral breast cancer.
3. Synchronic cancer (i.e., lung cancer, melanoma).
4. Paitents presenting neurologic symptoms without follow-up or lacking a contrast-enhanced magnetic resonance image (cMRI).
5. Incomplete clinicopathological information at the time of diagnosis.

Primary outcomes:
measure: Validity of prediction model of brain metastases risk for females with HR+ breast cancer
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02030899: The Comparison Between the Stand-alone Cage and the Autologous Iliac Bone Graft/Anterior Plating in the Single-level Surgical Treatment of the Cervical Spine
Official title: The Comparison Between the Stand-alone Cage and the Autologous Iliac Bone Graft/Anterior Plating in the Single-level Surgical Treatment of the Cervical Spine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Vertebrae
Single
Degenerative Disease
Keywords: Cervical vertebrae
single
degenerative disease
Fusion
Sagittal angle
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: ACDF with plate and autologous bone
Primary purpose: TREATMENT

Brief summary: The use of plate in addition to autologous bone is better then stand alone cage fusion regarding fusion rate and segmental lordosis.

Detailed description: cage: MC+® cage plate: atlantis® plate

Eligibility criteria: Inclusion Criteria:

* Single level degenerative cervical spine disease
* aged 30 - 70
* no improvement of symptom for 8 weeks of non-surgical treatment.
* degeneration in other levels without stenosis, accepted

Exclusion Criteria:

* osteoporosis
* disease with poor bone quality
* Cancer
* Previous cervical spine surgery
* Multiple levels disease
* Ossification of posterior longitudinal ligament
* Kyphosis at the index level
* Developmental stenosis (diameter of C7 spinal canal \< 10mm)

Primary outcomes:
measure: Fusion rate
timeFrame: 2 years
Secondary outcomes:
measure: Segmental angle
timeFrame: 2 years
measure: cervical lordosis
timeFrame: 2 years
measure: pain change
timeFrame: 2 years
measure: functional status change.
timeFrame: 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT00364299: Prevention of Ventilator-Associated Pneumonia by Automatic Control of the Tracheal Tube Cuff Pressure
Official title: Prevention of Ventilator-Associated Pneumonia by Automatic Control of the Tracheal Tube Cuff Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator-Associated Pneumonia
Mechanical Ventilation
Keywords: Ventilator-associated pneumonia
Mechanical ventilation
Tracheal tube cuff pressure
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Fondo de Investigacion Sanitaria
name: Sociedad Española de Neumología y Cirugía Torácica
First posted: 2006-08-15
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: The aspiration of contaminated secretions pooled above the endotracheal tube cuff secondary to inadvertent falls of cuff pressure is the main pathogenic mechanism of ventilator-associated pneumonia (VAP). Aim of the study: To assess the efficacy of an automatic device for the continuous regulation of tracheal tube cuff pressure in decreasing the incidence of VAP.

Detailed description: Design: Prospective, randomized, controlled trial, with 2 groups: study (automated control of cuff pressure) and control (standard control of cuff pressure). Setting: Respiratory Intensive Care Unit (RICU). Subjects: Patients \>18 yr, intubated and ventilated. Interventions and measurements: Study group (cuff pressure will be kept constant at 25 cmH2O with the automatic device) and control group (cuff pressure control every 8 h. at the same level using a manual pressure controller, according with standard routine); recording of clinical variables at admission and during RICU stay, and end-point variables (incidence of VAP, etiologic microorganisms, RICU and hospital stay, RICU and 60-d mortality. Expected results: Lower incidence of VAP in study group, compared with control group.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years,
* Orotracheal intubation for less than 24 hours
* Expectancy to remain on mechanical ventilation for more than 48 hours

Exclusion Criteria:

* Pneumonia
* Witnessed macroscopic aspiration

Primary outcomes:
measure: Incidence of ventilator-associated pneumonia
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Servei de Pneumologia, Hospital Clinic
Study officials:
affiliation: Hospital Clinic, Barcelona,Spain.
name: Miquel Ferrer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06680999: Title Endovascular Treatment of Superior Cave Syndromes Reaching the Trifurcation: a Single-Center Case Series
Official title: Title Endovascular Treatment of Superior Cave Syndromes Reaching the Trifurcation: a Single-Center Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Superior Cave Syndrome
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated by endovascular surgery (stenting) at Hospices Civils de Lyon between March 2019 and July 2023 for superior cave syndrome with lesions reaching the trifucation (elective involvement of the superior vena cava)

Brief summary: Superior vena cava syndrome (SCS) is caused by obstruction of blood flow in the superior vena cava, which allows venous return from the upper half of the body to the heart.

The causes are most often oncological, but can also be benign (coagulopathy, Behçet) or iatrogenic (catheterisation, PAC).

The surgical management of superior vena cava syndromes (SCS) involves the use of innovative endovascular techniques, which have become the therapy of first choice for symptomatic patients, whether the occlusion occurs in a benign or malignant context. For occlusive lesions involving the trifurcation, there are several surgical approaches and strategies, but very little data on their efficacy. In particular, Y-stenting has been described in several case reports as a means of treating the SCS and keeping the two jugulo-subclavian veins (VJSC) patent. This innovative technique has been used for several years by the vascular surgery team at Hôpital Louis Pradel.

The aim of our study is to assess the feasibility and medium-term efficacy of innovative endovascular treatments for SCS involving the trifurcation.


Eligibility criteria: Inclusion Criteria:

* All patients treated by endovascular surgery (stenting) at Hospices Civils de Lyon between March 2019 and July 2023 for superior cave syndrome

Exclusion Criteria:

* Minor patients
* Patients unable to give consent
* Patients unable to understand French
* Patients with lesions not reaching the trifurcation (elective involvement of the superior vena cava)

Primary outcomes:
measure: Technical success, immediate clinical success
timeFrame: The primary endpoint will be evaluated by : - Technical success defined by patency postoperatively and at 1 month follow-up confirmed by phleboscanner. Assessment of patency after revascularisation will be based on CT scan data (if possible) or on the r
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Vascular and Endovascular Surgery Department, Hôpital Louis Pradel, Hospices Civils de Lyon
Study officials:
References: