louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01149265: Online Support Groups for Depression and Anxiety
Official title: Randomised Controlled Trial of an Existing Online Support Group for Depression and Anxiety
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Depression
Anxiety
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2010-06-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of online support groups for anxiety and depression.

Detailed description: In recent years the number of online support groups for conditions like depression and anxiety has grown rapidly. Millions of people are thought to be using them around the world. This research aims to help find out whether the use of online support groups is beneficial and to learn more about what happens in these groups.

This research will compare online support groups with expressive writing. Expressive writing involves people writing about their thoughts and feelings, often upsetting ones, for a short period of time. In online support groups giving and receiving support from others can be helpful while expressive writing about emotional issues can be cathartic.

1,000 participants will be recruited online from the UK, USA and Canada and randomly assigned to either an existing online support group or to an expressive writing condition.

Eligibility criteria: Inclusion Criteria:

* Self-defined depression \& anxiety
* Resident in the UK, US or Canada
* Access to the internet

Exclusion Criteria:

-

Primary outcomes:
measure: The Center for Epidemiological Studies Depression Scale
timeFrame: Zero, three and six months
Secondary outcomes:
measure: Satisfaction with Life Scale
timeFrame: Zero, three and six months
measure: The Medical Outcomes Study Social Support Survey
timeFrame: Zero, three and six months
measure: Generalised Anxiety Disorder Assessment
timeFrame: Zero, three and six months
measure: The Illness perception questionnaire
timeFrame: Zero, three and six months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London
Study officials:
affiliation: University College, London
name: Chris Barker
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dean J, Potts HW, Barker C. Direction to an Internet Support Group Compared With Online Expressive Writing for People With Depression And Anxiety: A Randomized Trial. JMIR Ment Health. 2016 May 17;3(2):e12. doi: 10.2196/mental.5133.
Clinical trial NCT06418165: Vienna Hypothermic Oxygenated Machine Perfusion Study
Official title: Vienna Hypothermic Oxygenated Machine Perfusion for Liver Transplantation Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: End Stage Liver Disease
Hepatocellular Carcinoma
Keywords: Liver Transplantation
Hypothermic Oxygenated Machine Perfusion
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 500
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 listed for and undergoing liver transplantation using a liver graft which was subjected to hypothermic oxygenated machine perfusion

Brief summary: In this observational cohort study data on all patients undergoing liver transplantation after hypothermic oxygenated machine perfusion at Medical University of Vienna will be prospectively recorded. Investigation of short- and long-term outcome in this cohort will be conducted.


Eligibility criteria: Inclusion Criteria:

* patients undergoing liver transplantation with the use of hypothermic oxygenated machine perfusion
* age ≥ 18 years

Exclusion Criteria:

* pregnancy
* partial grafts
* the anatomical integrity of the liver is not preserved in a way that makes the perfusion of the liver possible

Primary outcomes:
measure: Incidence of ischemic-type biliary lesions
timeFrame: Within one year after liver transplantation
Secondary outcomes:
measure: Rate of early allograft dysfunction
timeFrame: Evaluated within the first 7 postoperative days
measure: Rate of primary non-function
timeFrame: Evaluated in the immediate postoperative period, specifically within the first postoperative week
measure: Incidence of re-transplantation
timeFrame: Evaluated in the immediate postoperative period, specifically within the first postoperative week
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna, Division of Transplantation
name: Gabriela A Berlakovich, Prof, MD
role: STUDY_CHAIR
affiliation: Medical University of Vienna, Division of Transplantation
name: Georg Györi, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05876065: Capecitabine and Cyclophosphamide (XC) as Maintenance Therapy for Advanced Breast Cancer
Official title: Efficacy and Safety of Capecitabine and Cyclophosphamide (XC) Versus Physician's Choice as Maintenance Therapy for Advanced Breast Cancer: a Randomized, Controlled, Open-label Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Advanced Breast Cancer
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy and safety of capecitabine and cyclophosphamide (XC) versus physician's choice as maintenance therapy for patients with advanced breast cancer who achieved disease control after salvage treatment.


Eligibility criteria: Inclusion Criteria:

* Female, age≥18 years old
* ECOG≤2
* Pathologically confirmed primary breast cancer, with pathologically or radiologically confirmed recurrent or metastatic lesions
* HR+/HER2+ or HR-/HER2+ or HR-/HER2-
* At least one measurable lesion or bone-only disease (osteolytic or mixed) according to RECIST v1.1
* Disease control (complete response + partial response + stable disease) after salvage treatment
* Expected survival ≥6 months
* Adequate organ function

Exclusion Criteria:

* during pregnancy and lactation
* Patients with central nervous system metastasis

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: From the date of starting maintenance therapy to the date of first documentation of disease progression or death from any cause (up to approximately 1 year)
Secondary outcomes:
measure: Adverse events
timeFrame: From the date of starting maintenance therapy to the end of the treatment (up to approximately 1 year)]
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiaotong University
Study officials:
affiliation: Renji Hospital,School of Medicine, Shanghai Jiaotong University
name: Wenjin Yin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02113865: Score System for Prediction Risk and Early Diagnosis of HCC in HIV/HCV Patients
Official title: Obtención de un Panel de puntuación ("Score System") Para la predicción de Riesgo Individualizado y la detección Precoz de Carcinoma Hepatocelular (HCC) en Sujetos Coinfectados VIH/VHC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acquired Immunodeficiency Syndrome Virus
Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted
Hepatocellular Carcinoma
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
Collaborators: name: Fundación Mutua Madrileña
First posted: 2014-04-15
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV/HCV coinfected patients from Infectious Diseases Department

Brief summary: The aim of this study is to establish a clinical score panel based on clinical, molecular and genetic parameters that allow us to stratify and obtain an early detection of patients with an increased risk of developing hepatocellular carcinoma (HCC).

Detailed description: Transversal study design like a "proof of concept".

Primary objective:

The main objective is try to stablish a descriptive panel (first phase of a score system) based in the conjunction or sum of several clinical and laboratory parameters (molecular and genetic factors). The aim is to detect in a fast, early and successful way those patients that presents a high risk to develop an hepatocellular carcinoma (HCC) in the future in a specific population: HIV and HCV coinfected patients. The establishment of this panel will allow clinicians set up a correct treatment decreasing the probability of liver cirrhosis and HCC.

Eligibility criteria: Inclusion Criteria:

* Human immunodeficiency virus chronic infection
* Hepatitis C virus chronic infection
* No other liver viral coinfections

Exclusion Criteria:

* Alcohol consume
* Immunosuppressor or immunoactive treatment

Primary outcomes:
measure: Sera inflammatory markers
timeFrame: 1 day (Routine visit to normal following in Infectious Disease Department)
Secondary outcomes:
measure: Sera apoptotic markers
timeFrame: 1 day (Routine visit in disease following at Infectious Disease Department)
Other outcomes:
measure: Evaluation of genetic polymorphisms distribution between study groups of relevant genes probably implicated in the disease
timeFrame: 1 day (Routine visit in normal following at Infectious Disease Department)
Locations:
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
Study officials:
affiliation: Fundación para la Investigación Biomédica del Hospital Ramón y Cajal
name: Beatriz S Sastre, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00448565: Prediction of Extubation Success by the Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation
Respiratory Failure
Extubation
Keywords: extubation
prediction
Lead sponsor: Ospedale Regionale Bellinzona e Valli
Sponsor class: OTHER
First posted: 2007-03-19
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in interdisciplinary ICU

Brief summary: The evidence-based approach to wean and consecutively extubate patients is based solely on objective criteria/tests. The introduction of subjective criteria could further improve the actual method.


Eligibility criteria: Inclusion Criteria:

* all intubated patients ready for a spontaneous breathing trial

Exclusion Criteria:

* not awake
* not collaborative

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Ospedale Regionale Bellinzona e Valli
state: Ticino
city: Geneva
country: Switzerland
facility: University hospital, Service des Soins intensifs
Study officials:
affiliation: Ospedale Regionale Bellinzona e Valli
name: Andreas Perren, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05587166: Ultrasound-Guided Oblique Short-Axis Adductor Canal Block.
Official title: Ultrasound-Guided Oblique Short-Axis Adductor Canal Block: Can the Oblique Approach Facilitate Perineural Catheter Insertion: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adductor Canal Block
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The ideal pain management for knee surgery should provide excellent analgesia while minimizing opioid consumption and allowing early mobilization and rehabilitation.

The use of the continuous technique in ACB allows the delivery of a larger quantity of local anaesthetic into the adductor canal than in the single-shot technique.

The usual approach for ultrasound-guided ACB catheter insertion is through short-axis in-plane approach in which the ultrasound transducer is applied horizontally over the femoral artery and saphenous nerve. In this approach, the catheter is inserted through a 90-degree angulation with the nerve which might make the catheter insertion difficult.

In the new oblique position, the catheter will be inserted in a less than 90-degree angulation. This study speculates that decreasing the angle of catheter insertion will make catheter insertion easier and faster.


Eligibility criteria: Inclusion Criteria:

* adult patients more than 18 years
* ASA I-III
* scheduled for unilateral knee surgery under spinal anesthesia with an adductor canal perineural catheter planned for postoperative pain control

Exclusion Criteria:

* Patient who had an allergy to any drug used in the study
* Patients with neuropathy of any etiology in the affected extremity, hepatic or renal failure.
* pregnant females
* Patients who are unable to communicate with the investigators and hospital staff

Primary outcomes:
measure: catheter placement time (minutes)
timeFrame: starting from time of syringe removal from placement needle to time of complete threading of the catheter at 20-cm mark measured in minutes and over 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01085266: An Extension of the HORIZON Protocol Evaluating the Safety of Dimebon (Latrepirdine) in Subjects With Huntington Disease
Official title: HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects With Huntington Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Huntington Disease
Lead sponsor: Medivation, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2010-03-11
Enrollment: 362
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open-label extension study of the HORIZON protocol evaluating the safety of dimebon (latrepirdine)in subjects with Huntington disease.


Eligibility criteria: Inclusion Criteria:

* Successful completion of 26 weeks of blinded treatment in the HORIZON study

Exclusion Criteria:

* Any other medical illness or unstable medical condition that may interfere with their ability to comply with study procedures and abide by study restrictions, or may interfere with the ability to interpret safety information.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04197466: Comparison of Different Treatments for Overactive Bladder Syndrome
Official title: Comparison of Different Treatments for Overactive Bladder Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Overactive Bladder Syndrome
Overactive Detrusor
Keywords: Pelvic Floor Muscle Exercise
Kinesio taping
Electric Stimulation
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effects of pelvic floor muscle exercises, electrical stimulation and taping in patients with overactive bladder


Eligibility criteria: Inclusion Criteria:

* Women
* Being Volunteered to participate
* Diagnosed as overactive bladder

Exclusion Criteria:

* Pregnant women
* Patients with a comorbid neurological disorder
* A mental problem that may prevent cooperation and evaluation
* Acute infection
* Sensory loss
* Malignancy

Primary outcomes:
measure: Bladder Diary
timeFrame: Before the treatment, at end of 6 weeks
Secondary outcomes:
measure: King Health Questionnaire
timeFrame: Before the treatment and end of 6 weeks
measure: Pelvic Floor Muscle Strength
timeFrame: Before the treatment and end of 6 weeks
measure: Overactive bladder symptoms
timeFrame: Before the treatment, at end of 6 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt Üniversitesi
Study officials:
References:
Clinical trial NCT02906566: Retinol on Human Skin Aging in East Asian Descent
Official title: Discovery of Effects of Retinol on Human Skin Aging in Individuals of East Asian Descent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intrinsic Aging of Skin
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: There has been increasing evidence for different rates of natural aging in humans and one of the best organs to study human aging is skin. Studies have demonstrated anti-aging effects of topical agents (such as creams, gels, lotions, or ointments) and one of them, retinol or vitamin A, was shown to decrease fine wrinkling in skin of older individuals. Additionally, studies of retinol in humans have largely occurred in white populations and so this study aims to focus on skin aging in individuals of East Asian descent as they represent a majority of the world population. This study aims to better characterize the molecular basis of rejuvenation effects and to potentially discover new topical agents with similar and/or more effective preservation of skin youthfulness.


Eligibility criteria: Inclusion Criteria:

* able to provide written informed consent
* older group: age between 50 and 75 years
* young group: age 18 to 25 years
* all four grandparents of Han Chinese, Japanese, Korean descent
* body mass index within normal or overweight range
* no history of weight loss of \>20 lbs within past 5 years

Exclusion Criteria:

* skin condition in the areas of skin biopsy that would obscure results of analysis
* topical creams or treatment to arms 2 weeks prior to study baseline visit
* individuals with known hypersensitivity to retinoid class of agents (older group only)
* prior anti-aging treatments to arms including retinol, microdermabrasion within 2 weeks of baseline visit
* prior laser therapy or surgical procedure to arms
* prior radiation or other trauma (extensive burns or abrasions) to arm skin
* hormone-based therapy within 4 weeks of enrollment

Primary outcomes:
measure: Number of Genes Upregulated or Downregulated as Assessed by RNA Sequencing (Older Group, Retinol Versus Placebo)
timeFrame: Week 12
measure: Number of Genes Upregulated or Downregulated as Assessed by RNA Sequencing (Younger Group Versus Older Group as Baseline)
timeFrame: Week 1
Secondary outcomes:
measure: Transepidermal Water Loss
timeFrame: Baseline; Week 12
measure: Severity of Arm Skin Wrinkling
timeFrame: Baseline; Week 12
measure: Elasticity on Arm Skin
timeFrame: Baseline; week 12
measure: Count of Participants With Skin and Subcutaneous Adverse Events as a Measure of Type and Severity of Adverse Events
timeFrame: Baseline through week 12
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Dermatology
state: California
Study officials:
References:
Clinical trial NCT04785066: Efficacy of Pulmozyme® on Arterial Recanalization in Post-thrombectomy Patients Managed for Ischemic Stroke (NETs-target)
Official title: Evaluation of the Efficacy of Dornase Alfa (Pulmozyme®) on Arterial Recanalization in Post-thrombectomy Angiography in Patients with Ischemic Stroke by Thrombolysis and Eligible for Thrombectomy (NETs-target)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Ischemic Stroke
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2021-03-05
Enrollment: 44
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: The functional prognosis of patients with ischaemic stroke treated by thrombolysis and thrombectomy is associated with complete reperfusion of the occluded artery defined by an mTICI 2C or 3 score at the end of thrombectomy. However, this complete reperfusion is only obtained in 60% of patients. Most often, incomplete reperfusion is due to the persistence of distal occlusions, which are inaccessible to mechanical thrombectomy. Drug treatment, combined with thrombectomy to increase the rate of complete reperfusion, would be a major advance in the management of these patients.

This is a non-randomized, monocentric, open-label, phase II trial to evaluate efficacy of dornase alfa intravenous administration in patients treated with intravenous thrombolysis and eligible for thrombectomy for ischemic stroke of the anterior circulation.


Eligibility criteria: Inclusion Criteria:

* Ischemic stroke by proximal intracranial occlusion (internal carotid artery, middle cerebral artery in its M1 or M2 segment) isolated from the anterior circulation eligible for cerebral thrombectomy.
* Transferred to the NRI block for a cerebral thrombectomy.
* Treated by thrombolysis intravenous (Aleplase or Tenecteplase) as recommanded by European stroke organisation
* With DWI-ASPECT score\>5 to MRI

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Known allergy to Dornase alfa or one of its excipients.

Primary outcomes:
measure: Evaluate the efficacy of intravenous administration of dornase alfa (Pulmozyme®) on arterial recanalization in post-thrombectomy patients managed for ischemic stroke
timeFrame: 3 months after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation Adolphe de Rothschild
Study officials:
References:
Clinical trial NCT00875966: Comparative Bioavailability Study of Azithromycin 200mg/5mL Suspension Following a 600mg Dose Under Fed Conditions
Official title: Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Eon and Pfizer Inc. (ZITHROMAX) 200mg/5mL Azithromycin Suspension Following a 600mg Dose in Healthy Adult Volunteers Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infections
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-04-06
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the bioequivalence of Azithromycin 200mg/5mL oral suspension.


Eligibility criteria: Inclusion Criteria:

* No clinically significant findings on physical exam, medial history or laboratory tests on screening

Exclusion Criteria:

* Positive test for HIV or hepatitis B and C
* Treatment for Drug or alcohol abuse
* Any other important criteria in the protocol

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 37 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: