louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02103621: Assisting Obsessive Compulsive Disorder (OCD) Patients With Discontinuing Long-term Serotonin Reuptake Inhibitors (SRIs)
Official title: Discontinuation of Long-term SRIs in Obsessive Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive Compulsive Disorder
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-04-04
Enrollment: 14
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: TREATMENT

Brief summary: This study will address questions of fundamental clinical significance including: (1) whether OCD patients maintained on long term SRIs can be discontinued without symptom exacerbation, (2) whether trans-diagnostic cognitive-behavioral treatment will reduce worsening following discontinuation compared to Taper and Monitoring, and (3) whether predictors of successful SRI discontinuation can be identified.


Eligibility criteria: Inclusion Criteria:

1. 18 or older
2. Presence of mild to moderate OCD symptoms
3. Patient's treating clinician agrees that SRI discontinuation is clinically appropriate
4. Adequate trial of SRI (≥10 weeks) in the current treatment episode
5. Maintenance on SRI dose that has not increased due to significant clinical worsening in the two years prior to enrollment
6. English speaking

Exclusion Criteria:

1. Clinically significant suicidality or a suicide attempt within the past year
2. Presence of any clinical features warranting a higher level of care (partial or inpatient hospitalization)
3. Current or recent (past 6 months) alcohol or drug dependence or abuse
4. Current or past psychotic disorder or bipolar disorder
5. Moderate to severe depression, as indicated by a Hamilton Rating Scale for Depression (HRSD) (17-item) ≥ 14 or recent major depressive episode (past 6 months)
6. History of severe OCD (YBOCS ≥ 28)
7. Prior adverse experience with SRI discontinuation
8. Primary compulsive hoarding
9. Cognitive impairment that would interfere with study participation
10. Concomitant psychosocial treatment w/ proven efficacy in the treatment of OCD
11. Previous adequate trial of exposure-based treatment (e.g., history of 12 or more sessions) in past 5 years
12. Use of non-SRI psychotropic medications for OCD in the 3 months prior to enrollment.

Primary outcomes:
measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
timeFrame: 14 weeks post baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Christina L Boisseau, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00518921: Capadenoson in Angina Pectoris
Official title: Phase IIa Efficacy and Safety Trial of Capadenoson in Patients With Chronic Stable Angina
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Chronic Stable Angina
Keywords: adenosin agonist
chronic stable angina
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-08-21
Enrollment: 0
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center and multi-national,randomized, double blind, placebo-controlled, 28-day treatment study with BAY 68-4986 taken orally or a matching placebo.


Eligibility criteria: Inclusion Criteria:

* The primary diagnosis is chronic stable angina of mild-moderate intensity as defined by the Canadian Cardiovascular Society Functional Class II-III, in the presence of definitive coronary artery disease.
* Male or female subjects aged 35 to 75 years (if female, only if postmenopausal or permanently sterilized)
* Stable angina of mild-moderate intensity (Canadian class II-III) with anti-anginal medication not changed for the last 5 weeks

Exclusion Criteria:

* Inability to withdraw current anti-anginal therapy
* Inability to withdraw any concomitant therapy that would interfere with interpretation of study results

Primary outcomes:
measure: Total exercise time
timeFrame: 28 days for ETT and 42 days for safety
Secondary outcomes:
measure: Time to angina onset
timeFrame: 28 days
Other outcomes:
Locations:
city: Brno
country: Czech Republic
city: Hodonin
country: Czech Republic
city: Kromeriz
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Plzen
country: Czech Republic
city: Praha 13
country: Czech Republic
city: Praha 6
country: Czech Republic
city: Balatonfured
country: Hungary
city: Kecskemet
country: Hungary
city: Miskolc
country: Hungary
city: Pecs
country: Hungary
city: Zalaegerszeg
country: Hungary
city: Hadera
country: Israel
city: Rehovot
country: Israel
city: Safed
country: Israel
city: Mestre
country: Italy
state: Venezia
city: Genova
country: Italy
city: Pavia
country: Italy
city: Trieste
country: Italy
city: Bialystok
country: Poland
city: Gdansk
country: Poland
city: Gdynia
country: Poland
city: Katowice
country: Poland
city: Krakow
country: Poland
city: Legnica
country: Poland
city: Lodz
country: Poland
city: Starogard Gdanski
country: Poland
city: Szczecin
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Wroclaw
country: Poland
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Nitra
country: Slovakia
city: Nove Zamky
country: Slovakia
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01643421: Effect of a Program of Deep Inspiration Combined to Expiratory Positive Airway Pressure in Asthmatic
Official title: Effects of a Program of Deep Inspiration Combined to Expiratory Positive Airway in Quality of Life and Heart Rate Variability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Improvement of Functional Capacity.
Improvement of Quality of Life.
Improvement of Cardiovascular Autonomic Control.
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2012-07-18
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of a deep inspiration combined to expiratory positive airway pressure protocol on respiratory function, quality of life, exercise tolerance and heart rate variability in adults with severe asthma.

Detailed description: Asthma is associated with high morbidity and significant mortality. This disease has functional impact on activities of daily living (ADLs) and according to some studies in the United States and Europe, the percentage of asthmatics who have significant restrictions in their ADLs is quite significant. Asthma is characterized as a major public health problem, not only in Brazil but worldwide. Currently there are few studies reporting the effects of a domiciliary program of deep inspiration associated with positive expiratory pressure in the airways of asthmatics. This study aims to analyze the benefits of this program on lung function, quality of life and response to exercise.

Eligibility criteria: Inclusion Criteria:

* Age between 20 and 80
* Severe asthma

Exclusion Criteria:

* Disagreement with consent form
* Other respiratory disease
* Acute severe asthma
* Pregnancy or breastfeeding
* Current smoking
* Lack of capable of conducting the study visits

Primary outcomes:
measure: The effect of deep inspiration and positive expiratory airway pressure in quality of life in adults with severe asthma
timeFrame: Change in quality of life at 5 week
Secondary outcomes:
measure: The effect of deep inspiration and positive expiratory airway pressure in respiratory function in adults with severe asthma.
timeFrame: Change in respiratory function at 5 week
measure: The effect of deep inspiration and positive expiratory airway pressure in heart rate variability in adults with severe asthma.
timeFrame: Change in heart rate variability at 5 week
measure: The effect of deep inspiration and positive expiratory airway pressure in exercise tolerance in adults with severe asthma.
timeFrame: Change in exercise tolerance at 5 week
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Pedro Dal Lago
state: RS
Study officials:
References:
Clinical trial NCT01136421: Magnesium Sulfate Versus Ipratropuim Bromide in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COPD Exacerbation
Keywords: COPD exacerbation
Magnesium sulfate
Ipratropium bromide
Emergency departement
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2010-06-03
Enrollment: 124
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment with short acting β2 agonists for exacerbations of COPD results in clinical improvement. It has not been established whether combining short acting β2 agonists to other bronchodilators is more effective than β2 agonists alone. The aim of this study is to evaluate the efficacy and safety of combination of SABA and MgSO4 in comparison to SABA and ipratropium bromide (IB) in patients attending the emergency department for AECOPD.

Detailed description: Patients presenting to the emergency department with exacerbation of COPD are randomized to receive nebulised ipratropuim bromide or combined nebulised and an intravenous bolus of magnesium sulfate during 1 hour.

Eligibility criteria: Inclusion Criteria:

* 40 years old or over
* have known or suspected COPD based on pulmonary function test, arterial blood gas, clinical history, physical examination, and chest radiograph
* worsening of dyspnea within 2 weeks,
* partial pressure of arterial carbon dioxide (PaCO2) \>45 mmHg
* respiratory rate \>24/min
* arterial pH \<7.35
* partial pressure of arterial oxygen (PaO2) \<50 mmHg under room air

Exclusion Criteria:

* hypersensitivity to anticholinergics and to magnesium sulfate
* patients that received anticholinergics within 6 hours before ED admission
* systolic arterial pressure \<90 mmHg or need to vasoactive drugs

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: University Hospital of Monastir
state: Monstir
city: Mahdia
country: Tunisia
facility: Soudani Marghli
Study officials:
affiliation: University of Monastir
name: semir nouira, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06846021: Integral Single-cell Landscape of Immunological Hallmarks for Ankylosing Spondylitis
Official title: Single-cell Immunomics Research on the Onset and Different Outcomes in Patients with Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankylosing Spondylitis
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Three HLA-B27-positive health donors (HDs) with matching age were enrolled via genetic screening, and fourteen AS patients were recruited at Fujian provincial hospital from May to July 2021. All AS patients satisfied the modified New York (NY) criteria, and the categorization of three disease groups (EA, LD and RM) was according to clinical hallmarks and imaging evidences. The five patients in the EA group were in the early stage of disease, showing obvious symptoms, and had not yet received standard treatments, including various NSAIDs and DMARDs. The five patients in the LD group were all disabled, and confirmed by radiographic evidence of structural damage in hip joints and spinal deformity. The four patients in the RM group received standardized treatment under the guidance of specialist doctors, and maintained clinical remission and normal laboratory indicators for over six months. Patients in both EA and RM groups were confirmed to have no structural damage or deformities by radiographic evidences.


Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of ankylosing spondylitis Clinical hallmarks and imaging evidences

Exclusion Criteria:

Pregnant patients Other diseases, tumors and injuries

Primary outcomes:
measure: Assessment of the immunological characteristics regarding the onset and outcomes of ankylosing-spondylitis patients relying on single-cell transcriptomics analysis for four groups of subjects (including health donors and patients in early active stage, l
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Orthopedic Outpatient Room
Study officials:
References:
Clinical trial NCT03125421: Prevention of Pressure Sores in the Prone Position in ARDS Patients
Official title: A Nursing Strategy to Prevent Pressure Sores in the Prone Position in ARDS Patients. A Multicenter Controlled Prospective Stepped Wedge Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Sores
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: A nursing strategy to prevent pressure sores in the prone position in Acute Respiratory Distress Syndrome (ARDS) patients. A multicenter controlled prospective stepped wedge trial.


Eligibility criteria: Inclusion Criteria:

* 18 years or more in age
* staying in Intensive Care Unit (ICU)
* Intubated
* mechanically ventilated
* severe ARDS defined as arterial Pressure in Oxygen (PaO2)/ Oxygen Inspired Fraction (FIO2) \< 150 mmHg with positive end-expiratory pressure (PEEP) ≥ 5 cmH2O and FIO2 ≥ 0.60
* prone positioning indicated by the clinician in charge
* weight \< 140 kgs
* agreement to participate obtained from the confidence person of the patient
* affiliated to social protection insurance

Exclusion Criteria:

* contra-indication to the prone positioning
* prone positioning before inclusion
* person under legal protection
* pregnancy
* weight \> 140 kg
* tracheotomy
* extracorporeal membrane oxygenation (ECMO)
* Refusal to participate

Primary outcomes:
measure: number of patients with a new pressure sore of any stage in any predetermined location
timeFrame: day 7 after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hopital Croix Rousse
Study officials:
affiliation: Hospices Civils de Lyon
name: Lucile Gay
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06426121: Clinical Validation of BACTEC™ Plus Aerobic/F Culture Vials Compared With Equivalent Product
Official title: Clinical Validation of BACTEC™ Plus Aerobic/F Culture Vials Compared With Equivalent Product
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2024-05-23
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with suspected blood infection who are at risk of sepsis

Brief summary: This study is a multi-center, randomized clinical validation. Subjects should be fully informed of this protocol and related risks, and can only be enrolled into this study after signing the informed consent form. Blood collection of the subjects at the same puncture point at a single site will be injected into the test vial and the control vial respectively, and the vials will be transferred to the BACTEC system for culture and the results will be observed. After the BACTEC system incubation completion, the vials will be subcultured. Strains grown on plates will be identified using appropriate methods and, if possible, at the species level.


Eligibility criteria: Inclusion Criteria:

* Subject is willing to provide written informed consent to sponsor.
* Blood specimens
* Patients with suspected blood infection that have one or more of the following characteristics :

  a) Body temperature \> 38°C or body temperature \<36°C; b) chills; c) increased peripheral blood leukocyte count (count \> 10.0×109/L, especially if there is a "left shift") or decrease (count \< 3.0×109/L); d) Respiratory rate \> 20 beats/min or arterial partial pressure of carbon dioxide (PaCO2) \<32mmHg; e) Heart rate\> 90 beats/min; f) mucocutaneous hemorrhage; g) coma; h) Multi-organ dysfunction; i) decreased blood pressure; j) Elevated inflammatory response parameters such as C-reactive protein or hypersensitive C-reactive protein, procalcitonin (PCT), 1,3-β-D-glucan (G test), etc.

Exclusion Criteria:

* Subjects have been enrolled in this study and samples have been collected
* Patients with severe and very severe anemia (last hemoglobin \<60g/L within seven days)
* Females with known pregnancy

Primary outcomes:
measure: consistency rate
timeFrame: 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02283021: Expression and Sequence of Calcium Channels in Non-small Cell Lung Carcinoma (NSCLC)
Official title: Expression and Sequence of Calcium Channels in Non-small Cell Lung Carcinoma (NSCLC)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: NSCLC
Keywords: expression of L-type calcium subunits
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2014-11-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with NSCLC and patients not diagnosed with NSCLC

Brief summary: Calcium is an extremely important ion used in our body for many processes. One of its tasks is to control gene expression. Cells intake calcium from their surroundings though special calcium channels located on the surface membranes of the cells.

The great many studies on such calcium channels were performed on excitable cells such as muscle, heart or neuronal cells, where the calcium ions are controlled by voltage. Surprisingly, not much is known about the identity of calcium subunits in non-excitable cells like epithelial cells (which compose most of the connective tissue in the body), liver cells, lung cells, immune system cells, etc.

Recently, the investigators have shown that calcium channels from muscles are, in fact, expressed in T cells of the immune system, where they are used for proliferation. The investigators postulated that probably other cell types, especially cancerous cell types, might be using these subunits similarly.

The aim of this study is to determine the identity and sequence of calcium subunits expressed in non-small cell Lung Carcinoma (NSCLC), which accounts for 80% of the worldwide lung cancer deaths.

Detailed description: Initial examination of NSCLC cell lines determined that they express the mRNA of voltage gated calcium subunits, found normally in neurons. Furthermore sequence analysis of these subunits has shown that modifications have occurred.

The aim of the study in NSCLC patients is to sequence and clone the calcium channel subunits expressed in their tumor. Expression and Sequence will be compared between the normal and cancerous lung tissue for each patient.

Eligibility criteria: Inclusion Criteria:

* NSCLC patients
* Patients without NSCLC
* Men or woman between 18-80 years of age

Exclusion Criteria:

* Pregnant woman

Primary outcomes:
measure: mRNA expression and sequence of calcium channel subunits in NSCLC
timeFrame: up to 1 month per patient
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah Medical Organization
name: Hadas Lamberg, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03380221: Effects of Fresh Watermelon Consumption on Satiety and Cardiometabolic Health
Official title: Effects of Fresh Watermelon Consumption on Satiety and Cardiometabolic Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Satiety
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The goal of the proposed study is to determine the effects of fresh watermelon fruit consumption on satiety, metabolic parameters and weight management.


Eligibility criteria: Inclusion Criteria:

* 18-55 years old
* BMI 25-40

Exclusion Criteria:

* Smoker
* Pregnant woman
* Required dietary supplement use
* Required medication of metabolic disorders
* Allergy to watermelon or gluten

Primary outcomes:
measure: Change of Satiety
timeFrame: 0, 20, 40, 60, 90 and 120 minutes post snack consumption
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Exercise and Nutritional Sciences, SDSU
state: California
Study officials:
References:
citation: Lum T, Connolly M, Marx A, Beidler J, Hooshmand S, Kern M, Liu C, Hong MY. Effects of Fresh Watermelon Consumption on the Acute Satiety Response and Cardiometabolic Risk Factors in Overweight and Obese Adults. Nutrients. 2019 Mar 12;11(3):595. doi: 10.3390/nu11030595.