louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03340376: Doxorubicin Alone Versus Atezolizumab Alone Versus Doxorubicin and Atezolizumab in Recurrent Cervical Cancer
Official title: Prospective Randomized Phase II Trial Comparing Doxorubicin Alone Versus Atezolizumab Alone Versus Doxorubicin and Atezolizumab in Recurrent Cervical Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Cervical Cancer
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2017-11-13
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open-label, multicenter, randomized phase II trial to evaluate the safety and efficacy of atezolizumab in patients with recurrent cervical cancer in second line therapy. A total of 48 patients will be randomized in 3 arms, each arm consisting of 16 patients:

Arm A: atezolizumab monotherapy q3w Arm B: atezolizumab combined with doxorubicin q3w Arm C: doxorubicin monotherapy q3w


Eligibility criteria: Inclusion Criteria:

* Squamous cell or adenocarcinoma of the cervix
* At least one prior chemotherapy regimen for recurrent or advanced disease with a platinum-taxane combination, but not more than two lines of chemotherapy or targeted therapy in recurrent/advanced setting
* Measurable disease
* ECOG≤2
* Adequate pretreatment hematologic, renal and hepatic function test
* Patients are allowed to have had bevacizumab during their prior treatment
* Evidence of non-childbearing status for women of childbearing potential

Exclusion Criteria:

* History of invasive malignancy other than cervical cancer unless there is no recurrence of these other primary tumors the last 3 years.
* Previous anthracycline-based chemotherapy
* Central nerve system metastases and leptomeningeal disease
* Active or history of autoimmune disease
* Prior allogenic bone marrow transplantation or prior solid organ transplantation
* History of idiopathic pulmonary fibrosis
* Known positive test for HIV, or active hepatitis B or hepatitis C
* Known active tuberculosis
* Severe infection within 4 weeks prior to initiation of study treatment
* Prior immunotherapy

Primary outcomes:
measure: Progression free survival
timeFrame: after 9 months
Secondary outcomes:
measure: Overall survival
timeFrame: after 24 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLeuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Ignace Vergote, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00180076: Budesonide for Maintenance Treatment of Collagenous Colitis
Official title: Efficacy and Safety of Budesonide in Maintenance Treatment of Collagenous Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Collagenous Colitis
Keywords: collagenous colitis
microscopic colitis
budesonide
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2005-09-16
Enrollment: 75
Sex: ALL
Minimum age (years): 18
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 whether orale budesonide is effective in maintaining clinical remission in patients with collagenous colitis.

Detailed description: The purpose of this study is to determine whether orale budesonide is effective in maintaining clinical remission in patients with collagenous colitis.

Eligibility criteria: Inclusion Criteria:

* collagenous colitis
* diarrhea
* written informed consent

Exclusion Criteria:

* infectious causes for diarrhea
* other inflammatory bowel diseases
* history of colonic surgery
* celiac disease
* malignancies
* severe concomitant diseases
* use of budesonide, steroids, mesalazine within the previous 2 weeks
* known intolerance to budesonide
* history of lack of response to budesonide
* pregnancy,lactation
* drug and/or alcohol abuse
* lack of compliance

Primary outcomes:
measure: Proportion of patients in clinical remission after 6 months
Secondary outcomes:
measure: time to relapse
measure: safety
measure: quality of life
measure: histological improvement
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Medical Department I, Technical University Hospital
Study officials:
affiliation: Medical Department I, Technical University Hospital, Dresden, Germany
name: Stephan Miehlke, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00555776: Effect of Gabapentin on Idiopathic Subjective Tinnitus
Official title: Phase 2 Effect of Gabapentin on Idiopathic Subjective Tinnitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Subjective Tinnitus
Keywords: tinnitus
gabapentin
Lead sponsor: Islamic Azad University of Mashhad
Sponsor class: OTHER
First posted: 2007-11-09
Enrollment: 70
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: The purpose of this study is to determine wether Gabapentin which is useful for treating neuropathic pains, is effective on idiopathic subjective tinnitus.

Detailed description: Tinnitus is the perception of sound in the absence of acoustic stimulation. It can be subjective or objective. .

Despite numerous researches,no effective treatment for people who suffer from tinnitus has yet been stablished.

As there are many evidences suggesting that loss of inhibition in the central nervous system may be responsible for many aspects of auditory dysfunction,including tinnitus; and as Gabapentin (Neurontin), a gama-aminobutyric acid (GABA) analogue, is an effective medication in conditions where inhibition in the CNS is impaired; we guess that Gabapentin might be useful for treating idiopathic subjective tinnitus.

Eligibility criteria: Inclusion Criteria:

* patients with subjective idiopathic tinnitus

Exclusion Criteria:

* tinnitus with known underlying cause
* pregnant women and patients younger than 18 or older than 75 years
* patients with impaired renal function

Primary outcomes:
measure: Reduction in the sensation of Tinnitus by the patient or complete resolution of tinnitus;by the patient's scoring it from one to ten, before and after prescribing Gabapentin.
timeFrame: two months
Secondary outcomes:
measure: Relieve of complications of tinnitus, such as sleep difficulties.
timeFrame: two months
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: ENT department of Mashhad Azad medical university
state: Khorasan razavi
Study officials:
affiliation: ENT department of Mashhad azad university of mashhad
name: Mahboobeh Adami Dehkordi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bakhshaee M, Ghasemi M, Azarpazhooh M, Khadivi E, Rezaei S, Shakeri M, Tale M. Gabapentin effectiveness on the sensation of subjective idiopathic tinnitus: a pilot study. Eur Arch Otorhinolaryngol. 2008 May;265(5):525-30. doi: 10.1007/s00405-007-0504-9. Epub 2007 Oct 25.
Clinical trial NCT05196776: Diagnostic Accuracy of Handheld vs Traditional Ultrasound
Official title: Diagnostic Accuracy of a Portable, Handheld Point-of-Care Ultrasound Device vs a Traditional Cart-Based Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Image, Body
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Patients receiving a point-of-care ultrasound will be randomized into a portable, handheld device or a traditional cart-based ultrasound machine to compare diagnostic capability.

Detailed description: Patients who require a point-of-care ultrasound examination of their kidneys, gallbladder, heart, lung, or aorta will be enrolled. Once enrolled, the patient will be randomized to receive the point-of-care ultrasound using a portable, handheld ultrasound or a traditional cart based model. The ultrasound examinations will be performed by emergency medicine post-graduate year 1-3 residents or an ultrasound fellow and reviewed by the supervising emergency medicine attending physicians credentialed in performing and interpreting point-of-care ultrasound.

Based on the clinical presentation, the provider will perform one of the following ultrasounds: cardiac to assess ejection fraction ( \<50%, 30-50%, \<30%), lung to assess for presence or absence of B-lines, gallbladder to assess for the presence or absence of gallstones, renal to assess for the presence or absence of hydronephrosis, or aorta to assess for the presence or absence of an aneurysm. The diagnostic accuracy of the portable, handheld and the cart-based model will be assessed using the following as the diagnostic standard: cardiology-interpreted echocardiogram, radiology-interpreted ultrasound or computed tomography, or quality review of the point-of-care ultrasound by 3 ultrasound fellowship trained physicians.

Eligibility criteria: Inclusion Criteria:

1. English and Spanish-speaking patients, who require a gallbladder, cardiac, renal, aorta, or lung ultrasound based on the discretion of the treating physician.

Exclusion Criteria:

1. All other non-English and non-Spanish speaking patients
2. Vulnerable groups
3. Patients unable to consent

Primary outcomes:
measure: Diagnostic Accuracy
timeFrame: 1 day
Secondary outcomes:
measure: Image Quality by Expert Review
timeFrame: 1 day
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Lewis Katz School of Medicine at Temple University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05529576: Multi-factor Model Constraction for Early Warning and Diagnosis of MDD
Official title: Multi-factor Model Constraction for Early Warning and Diagnosis of Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Major Depressive Disorder
Bipolar Disorder
Omega-3 Fatty Acids
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
Collaborators: name: Qingdao Mental Health Center
name: Harbin Medical University
First posted: 2022-09-07
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Current research on the pathogenesis of depression shows that imbalanced inflammatory factors are closely related to Major Depressive Disorder(MDD). As reported, physical exercise, Ω-3 fatty acids, and sulforaphane can be complementary therapies for moderate-to-severe depression. In addition, imaging studies have found changes in the structure and functional connectivity of the brain. Therefore, this study intends to collect clinical and biological information from patients with depression and healthy controls to establish a multi-factor model for early warning and diagnosis of major depressive disorder

Detailed description: The immune imbalance has been reported in patients with unipolar and bipolar depression. There is no unified conclusion in the field and severity of the immune imbalance, and the cause of cognitive impairment is unknown, which may be related to many factors. Omega-3 fatty acids are immune modulators that possess antidepressant effects.

This study includes three steps.

1. We will enroll bipolar and major depressive disorder patients who are in a depressive episode and enroll healthy controls. All subjects will be assessed at baseline
2. We will give omega-fatty acid treatment based on immune indicators
3. The follow-up will last for one year with five sessions.

Eligibility criteria: Inclusion Criteria:

* Outpatients in main-center and sub-centers
* Age between 18-65 years old
* Meet the DSM-IV diagnosis of depressive episode
* HAMD-17 score\>17 at baseline
* No antidepressant treatment within 6 weeks prior to enrollment
* Adequate cognition level to complete the tests necessary for the study
* Willing to sign the informed consent form

Exclusion Criteria:

* Have any contraindications to Ω-3 fatty acids
* Severe physical disease
* Diagnosed with schizophrenia, or other mental illness spectra
* Have received physical therapy

Primary outcomes:
measure: Depressive symptoms assessed by HAMD-17
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center IRB
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center(SMHC)
name: Jun Chen, M.D.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06755476: Psychological Counseling Program for Alzheimer's Patients' Caregivers
Official title: The Effect of Psychological Counseling Program (PsychoCP) for Alzheimer's Patients' Caregivers on Perceived Stress, Psychological Well-Being and Caregiver Burden
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Caregivers of Alzheimer&#39;s Disease or Memory Problem Patients
Perceived Stress
Well-Being (Psychological Flourishing)
Care Burden
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose: To investigate the effects of a psychological counseling program (PsychoCP) applied to caregivers of Alzheimer's patients on perceived stress, psychological well-being and care burden.

Design: The study will be conducted in a pre-test post-test control group, randomized controlled experimental research design.

Method: The study is planned to be carried out in Bağcılar Municipality Vefahâne Life Center, Antalya Alzheimer Patients and Patient Relatives Meeting Center and Osmaniye Family and Social Policies Directorate. The sample of the study will consist of 80 caregivers. They will be assigned to intervention (n=40) and control groups (n=40) by randomization.

Hypotheses Hypothesis1: The perceived stress level of caregivers who received PsychoDP is lower than those who did not receive PsychoCP.

Hypothesis2: The psychological well-being levels of caregivers who received PsychoDP are higher than those who did not receive PsychoCP.

Hypothesis3: The care burden of caregivers who received PsychoDP is lower than those who did not receive PsychoCP.


Eligibility criteria: Inclusion Criteria:

* Providing informal care to an individual with mild or moderate Alzheimer's disease
* Being a primary caregiver
* Providing care to the patient for at least six months
* Providing care to the patient for at least six hours per day
* Being literate
* Being able to speak and understand Turkish
* Being 18 years of age or older
* Being willing and able to participate in the study

Exclusion Criteria:

* Not being able to understand questions and express ideas
* Having a psychiatric disorder
* Not receiving any therapy services during the study

Primary outcomes:
measure: Perceived Stress Level
timeFrame: Two months
measure: Psychological Well-being Level
timeFrame: Two months
measure: The Burden of Caregiving
timeFrame: Two months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00700076: Pilot Study of ORG 25935 Modulation of Ketamine-induced Behavioral and Cognitive Effects in Healthy Male Subjects
Official title: Pilot Study of ORG 25935 Modulation of Ketamine-induced Behavioral and Cognitive Effects in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: ORG 25935
Ketamine
healthy subjects
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Organon
First posted: 2008-06-18
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Org 25935 is a new putative antipsychotic agent developed by N.V. Organon.The primary objective of this study is to investigate the effect of Org 25935 on ketamine-induced impairments in immediate recall.


Eligibility criteria: Inclusion Criteria:

* Male, 18 - 55 years

Exclusion Criteria:

* History of sensitivity/idiosyncrasy to the drugs used in the study or chemically related compounds or excipients which may be employed in the study or to any other unknown drug used in the past.

Primary outcomes:
measure: Attenuation of ketamine-induced cognitive deficits by Org 25935
timeFrame: +20 to +100 minutes
Secondary outcomes:
measure: Attenuation of ketamine-induced schizophrenia-like psychotic symptoms, perceptual alterations, subjective high and deficits in attention and working memory by Org 25935.
timeFrame: 0 to +100 minutes
measure: Investigation of interaction of polymorphisms of candidate genes e.g., BDNF, COMT with the effect of Org 25935 on ketamine induced psychotomimetic and amnestic deficits.
timeFrame: 0 to +100 minutes
Other outcomes:
Locations:
city: West Haven
country: United States
facility: Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University School of Medicine, Department of Psychiatry
name: Deepak C D'Souza, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01723176: Evaluation of Ultrasound of the Heart in Patients With Low Blood Pressure
Official title: Evaluating Critical Care Echocardiography in Patients With Cardiopulmonary Failure at the Time of Presentation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cardiopulmonary Failure
Keywords: goal-directed echocardiography
cardiopulmonary failure
critical care ultrasound
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2012-11-07
Enrollment: 0
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 who present to the medical intensive care unit with cardiopulmonary failure

Brief summary: Hypothesis: Goal-directed echocardiography by trained critical care physicians is equivalent to that of echocardiography technicians/cardiologists for the purpose of determining etiology (reason) of cardiopulmonary failure.


Eligibility criteria: Inclusion Criteria:

* Patients who present to the medical intensive care unit with cardiopulmonary failure

Exclusion Criteria:

* None

Primary outcomes:
measure: Assessment of left ventricular function
timeFrame: within four hours of ICU admission
Secondary outcomes:
measure: Presence of Pericardial Effusion and Severity
timeFrame: within 4 hrs of ICU admission
Other outcomes:
measure: Right ventricle dysfunction
timeFrame: within 4 hrs of ICU admission
Locations:
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
Study officials:
affiliation: NS-LIJ Health System
name: Justin Weiner, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03346876: Autonomic Dysfunction in Patients With Pectus Excavatum.
Official title: Autonomic Dysfunction in Patients With Pectus Excavatum.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pectus Excavatum
Autonomic Dysfunction
Surgery
Keywords: Pectus excavatum, heart rate variability
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 120
Sex: ALL
Minimum age (years): 13
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 13\~45 y/o pectus patients and healthy subjects

Brief summary: Investigators conducted a pilot study to to evaluate the autonomic function in participants with pectus excavatum before and after Nuss surgery.

Detailed description: Since pectus excavatum can cause cardiac arrhythmia, the cardiac autonomic function in participants with pectus excavatum might be impaired. However, to our knowledge, there is no any study to evaluate the cardiac autonomic function in participants with pectus excavatum.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of pectus excavatum
2. Agree to receive Nuss surgery to correct pectus excavatum

Exclusion criteria:

1. Major medical disease (asthma, heart failure, renal disease)
2. Known psychiatric disease
3. Known sleep-disordered breathing
4. Skeletal disease
5. Major surgery within 6 months

Primary outcomes:
measure: The impact of Nuss surgery on HRV in patients with pectus excavatum
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei
country: Taiwan
facility: Taipei Tzu-Chi Hospital, Buddhist Tzu-Chi Medical Foundation
Study officials:
affiliation: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
name: Mei-Chen Yang, MD
role: STUDY_CHAIR
References:
citation: Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
citation: Tobaldini E, Nobili L, Strada S, Casali KR, Braghiroli A, Montano N. Heart rate variability in normal and pathological sleep. Front Physiol. 2013 Oct 16;4:294. doi: 10.3389/fphys.2013.00294.
citation: Hsu YT, Cheng YL, Chang YW, Lan CC, Wu YK, Yang MC. Autonomic nervous system dysregulation in response to postural change in patients with pectus excavatum in Taiwan: a pilot study. J Cardiothorac Surg. 2022 May 3;17(1):89. doi: 10.1186/s13019-022-01835-5.