louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03485794: Collection of Blood in Studying Metabolites in Patients With Prostate Cancer
Official title: Metabolic Profiling of Peripheral Blood Mononuclear Cells (PBMCs) by LC-MS in Prostate Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Carcinoma
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-04-02
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men with prostate cancer who are patients at the University of Southern California (USC) Westside Cancer Center

Brief summary: This pilot research trial utilizes the collection of blood in studying metabolites in patients with prostate cancer. Metabolites are the small molecule products of cellular metabolism that are produced naturally in all living cells. Collecting blood in order to study metabolites may help doctors monitor and treat prostate cancer more effectively.

Detailed description: PRIMARY OBJECTIVES:

I. Develop blood sample collection and preparation procedures for reliable, meaningful metabolomic profiling of peripheral blood mononuclear cells (PBMCs) by liquid chromatography/quadruple-time of flight/mass spectrometry (LC/Q-TOF/MS) that can be implemented in a clinical setting.

II. Optimize data analysis methods and software usage to create a metabolic profile for patients at the time of blood collection.

III. Compare metabolite profiles of isolated PBMCs versus (vs.) other blood fractions (plasma, red blood cells \[RBCs\], and whole blood).

IV. Identify elements of the PBMC metabolite profile that may correlate to patient disease state.

OUTLINE:

Patients undergo collection of blood for metabolic profiling via LC/Q-TOF/MS.

Eligibility criteria: Inclusion Criteria:

* All subjects will have histologically confirmed prostate cancer
* Provide written consent/authorization to participate in this study
* Have no signs or symptoms of active infection
* Exhibit a willingness to comply with the experimental procedures as outlined in this protocol

Primary outcomes:
measure: Blood sample collection
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Jonathan Katz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04944394: Psychological and Ethical Support for Hospital Professionals During the COVID-19 Pandemic: Suitability and Post-crisis Implications for the Experience of All Professionals
Official title: Psychological and Ethical Support for Hospital Professionals During the COVID-19 Pandemic: Suitability and Post-crisis Implications for the Experience of All Professionals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychological Stress
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 4522
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all professionals working in hospitals

Brief summary: SARS-COV-2 has created an unprecedented health crisis, resulting in unprecedented mobilization of all hospital professionals. The massive influx of patients overwhelmed the human, therapeutic and material resources available, and teams were confronted with an unusually heavy workload in a highly stressful emergency context. These professionals were thus exposed to a risk of over-investment in a context of acute and repetitive stress over an indefinite period of time, combining a heavy workload, emotional challenges and specific ethical issues. These factors simultaneously affected the professional sphere but also the personal and family spheres (lockdown, risk of contamination). In this context, the mental health of hospital staff is considered to be more important than ever, as emphasized on numerous occasions by the Director General of Health and the French Minister for Health and Solidarity. Mental health involves the way in which individuals respond specifically to work-related suffering by developing individual and collective defensive strategies. Thus, the question of the mental health of hospital professionals cannot be considered without taking into account the strategies implmented to combat stress, and the factors that contribute or not to the construction and stabilization of the work environment (collaboration, support).


Eligibility criteria: Inclusion Criteria:

All professionals working in hospitals Professionals involved in the organization of psychological and ethical support may also be interviewed to provide the information necessary to describe and evaluate the support provided and how it changed over time.

Exclusion Criteria:

None

Primary outcomes:
measure: Score assessed by Global Health Questionnaire GHQ-12
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT01264094: A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period
Official title: A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Chronic Hepatitis B
Lead sponsor: Bukwang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2010-12-21
Enrollment: 200
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 purpose of this study is to evaluate the efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period.


Eligibility criteria: Inclusion Criteria:

1. Patient is 18 years and older.
2. Patient is documented to be HBsAg positive for \> 6 months and HBV DNA positive.
3. Patient is HBeAg positive or negative.
4. Patient has ALT levels ≥ 80 IU/L
5. Patient who is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
2. Patients previously treated with interferon within the previous 3 months.
3. Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
4. Patient is coinfected with HCV, HDV or HIV.
5. Patient is pregnant or breast-feeding.
6. Patient has a clinically relevant history of abuse of alcohol or drugs.
7. Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic(except HCC)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy.
8. Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]

Primary outcomes:
measure: Proportion of patients with HBV DNA below the assay limit of detection
Secondary outcomes:
measure: The change of HBV DNA from the baseline.
measure: Proportion of patients with HBeAg loss and/or seroconversion.
measure: Biochemical improvement (e.g. ALT normalization).
measure: Proportion of sAg loss
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
References:
Clinical trial NCT00976794: Efficacy of Combined Treatment for Young Bipolar I Disorder
Official title: Efficacy and Tolerability of the Combination of LIthium and CArbamazepine Compared to Lithium and VALproic Acid in the Treatment of Young Bipolar Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar I Disorder
Keywords: BD I
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2009-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of the combination of lithium and carbamazepine compared with lithium and valproate treating young bipolar patients.

Detailed description: After the diagnostic assessments, the patients are allocated for one of the following groups of treatment:

Group I: lithium + valproic acid

Group II: lithium + carbamazepine

Patients will be followed up for 8 weeks in phase I (acute treatment), 6 months in phase II (continuation treatment) and 12 months in phase III (maintenance treatment). Scales raters will be blind to the treatment.

During phase II and III will continue only patients that achieve response, measured according to initial symptoms score in phase I.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Bipolar Disorder, type I, in current episode (manic/hypomanic, mixed or depression)
* The patient or his (her) legal representative should understand the nature of the study and sign the Informed Consent.

Exclusion Criteria:

* Schizophrenia or schizoaffective disorder
* Mental retardation
* Unstable clinical diseases

Primary outcomes:
measure: The main outcome will be the number of patients that achieve and remain in remission to each treatment at the end of each phase of the study.
timeFrame: August 2012
Secondary outcomes:
measure: Secondary outcome will include the proportion of patients that had response but not remission to each treatment at the end of each phase of the study
timeFrame: August 2012
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Institute of Psychiatry - University of São Paulo
Study officials:
References:
citation: Fountoulakis KN, Vieta E, Sanchez-Moreno J, Kaprinis SG, Goikolea JM, Kaprinis GS. Treatment guidelines for bipolar disorder: a critical review. J Affect Disord. 2005 May;86(1):1-10. doi: 10.1016/j.jad.2005.01.004.
citation: Missio G, Moreno DH, Demetrio FN, Soeiro-de-Souza MG, Dos Santos Fernandes F, Barros VB, Moreno RA. A randomized controlled trial comparing lithium plus valproic acid versus lithium plus carbamazepine in young patients with type 1 bipolar disorder: the LICAVAL study. Trials. 2019 Oct 26;20(1):608. doi: 10.1186/s13063-019-3655-2.
citation: Campos RN, Costa LF, Bio DS, Soeiro de Souza MG, Garcia CR, Demetrio FN, Moreno DH, Moreno RA. LICAVAL: combination therapy in acute and maintenance treatment of bipolar disorder. Trials. 2010 Jun 23;11:72. doi: 10.1186/1745-6215-11-72.
Clinical trial NCT04010994: Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation
Official title: Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation: a Home Stimulation Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Glaucoma
Electrical Stimulation
Home Treatment
Lead sponsor: University of Magdeburg
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 50
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 aim of the present study is to investigate the possibilities of visual field enhancement with electrical stimulation (ES) as a home stimulation method, in a total of 50 patients with optical neuropathy, who have already been treated with ES in the past.

Furthermore, factors responsible for response variability and treatment effectiveness are also explored: (i) the role of mental stress (or stress resilience), (ii) the status of biomarkers, such as the systemic stress hormone levels and blood supply to the eye and brain (specifically vascular dysregulation) and (iii) the influence of personality, anxiety, depression and lifestyle. The study serves to further validate this ES procedure for the treatment of visual impairment. Specifically, better efficacy, better compliance, lowest response variability are expected after long-term home use.


Eligibility criteria: Inclusion Criteria:

* Patients with glaucoma, disease duration at least 6 months
* stable visual field defect across baseline measurement (subjects with spontaneous fluctuations and recovery of vision excluded)
* presence of residual vision and detectable gradual transition between the intact and the absolutely blind part of the visual field according to evaluation of the clinician
* best corrected visual acuity at least 0.4 (20/50 Snellen) or better

Exclusion Criteria:

* autoimmune diseases in the acute stage
* neurological and mental diseases
* diabetic retinopathy
* addictions
* hypertension (maximum 160/100 mmHg)
* retinitis pigmentosa-
* pathological nystagmus
* non-distant tumors or recurrent tumors
* photosensitivity
* pregnancy
* electric or electronic implants (e.g. heart pacemaker)
* metal implants in the eyes or head (with the exception of dental prosthesis or shunts)

Primary outcomes:
measure: Visual field size
timeFrame: 3 months
Secondary outcomes:
measure: EEG connectivities in the visual system
timeFrame: 3 months
measure: Level of vascular regulation/dysregulation in the eye
timeFrame: 3 months
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: Institute of Medical Psychology
Study officials:
References:
citation: Gall C, Schmidt S, Schittkowski MP, Antal A, Ambrus GG, Paulus W, Dannhauer M, Michalik R, Mante A, Bola M, Lux A, Kropf S, Brandt SA, Sabel BA. Alternating Current Stimulation for Vision Restoration after Optic Nerve Damage: A Randomized Clinical Trial. PLoS One. 2016 Jun 29;11(6):e0156134. doi: 10.1371/journal.pone.0156134. eCollection 2016.
Clinical trial NCT00920894: Effect of Plant Stanol Esters on Blood Lipids
Official title: The Effect of Plant Stanol Esters on Serum Total and Lipoproteins Lipids, Non-cholesterol Sterols and Apolipoproteins in Subjects With Elevated Blood Lipid Concentration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elevated Blood Lipids
Lead sponsor: Clinical Life Sciences Ltd.
Sponsor class: OTHER
First posted: 2009-06-15
Enrollment: 112
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to measure the effect of plant stanol esters on serum total and lipoproteins lipids, non-cholesterol sterols and apolipoproteins in subjects with elevated fasting blood lipid concentrations

Detailed description: The link between high serum low-density lipoprotein (LDL) cholesterol and cardiovascular disease has long been recognized. Dietary plant stanol esters have been shown to effectively reduce serum levels of total and LDL cholesterol. Plant stanols decrease the absorption of both biliary and dietary cholesterol from the small intestine and thereby reduce serum LDL cholesterol levels.

This study aims to verify the effect of plant stanol esters on blood lipids. Subjects with elevated fasting blood lipid concentrations will be randomized to study groups. The groups consume yoghurt type minidrink containing plant stanol ester (2 g plant stanols per day) or similar minidrink without plant stanol esters. After 10 weeks study period serum total and lipoproteins lipids, non-cholesterol sterols and apolipoproteins will by analyzed.

Eligibility criteria: Inclusion Criteria:

* Elevated blood lipids
* Body Mass Index \< 35 kg/m2
* Stable body weight

Exclusion Criteria:

* Receiving medications or supplements other than stable statin therapy known to affect lipid metabolism
* Severe obesity
* Hyperglycemia
* Severe diseases (inc. diabetes, unstable CVD, malignant disease, inflammatory disease, gastrointestinal disease)
* Hepatic, kidney or thyroid disease or disorder
* Pregnancy or breast feeding
* Severe intolerance or allergy to any ingredient of test product

Primary outcomes:
measure: plasma lipids
timeFrame: 10 weeks
Secondary outcomes:
measure: plasma lipoprotein lipids non-cholesterol sterols
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Vuokatti
country: Finland
facility: Clinical Life Sciences Ltd
Study officials:
References:
Clinical trial NCT06643494: Elimination of Prostate Cancer Treatment Side Effects Using a Nutraceutical
Official title: Alleviating Androgen Deprivation Therapy (ADT) + External Beam Radiation (EBR) Treatment Side Effects in Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Lead sponsor: Optimal Health Research
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 100
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The study consists of a single group of subjects included in the study design, in which all subjects receive a single intervention, N-111, and the outcomes are assessed over time.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Does nutraceutical N-111 lower the number of side effects occurring during ADT + External Beam Radiation (EBR) prostate cancer treatment?

Detailed description: Researchers will compare nutraceutical N-111 to a placebo (a look-alike substance that contains no active ingredients) and control group to see if N-111 works to alleviate side effects of prostate cancer treatment.

Participants will:

Take N-111 or a placebo by mouth every day for the duration of the ADT + EBR therapy. Fill out the self-evaluation reporting form weekly during EBR therapy and every three months during ADT therapy to assess their symptoms or lack of symptoms.

The patients will see a physician once a week during the EBR therapy and once every three months for the duration of the ADT therapy.

Eligibility criteria: Inclusion Criteria:

* Male undergoing treatment for prostate cancer with ADT + EBR.

Exclusion Criteria:

* Everyone else

Primary outcomes:
measure: Self-reporting
timeFrame: Weekly for the duration of EBR (6 weeks). Monthly for the duration of ADT (2 years).
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Optimal Health Research
state: Utah
Study officials:
affiliation: Optimal Health Research
name: Alan Jeppsen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04116294: Using a Computer-assisted Prescription to Decrease Inappropriate Use of Plain Abdominal Radiography in Emergency Department
Official title: Using a Computer-assisted Prescription to Decrease Inappropriate Use of Plain Abdominal Radiography in Emergency Department
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plain Abdominal Radiography
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2019-10-04
Enrollment: 400
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Before after. During the before period, standard of care. During the after period, computer-assisted prescription for plain abdominal radiography (reminding the indication for this procedure).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to assess whether a computer-assisted prescription allows a reduction of the overall number of inappropriate PAR in emergency departments.


Eligibility criteria: Inclusion Criteria:

* Patients aged 16 or more with a PAR.

Exclusion Criteria:

* Refusal to participate

Primary outcomes:
measure: Incidence of plain abdominal radiopraphy (PAR) with an inappropriate indication
timeFrame: Same ED consultation (or max 24 hours)
Secondary outcomes:
measure: Incidence of additional radiological examination (CT, US, IRM) after the PAR
timeFrame: Same ED consultation (or max 24 hours)
Other outcomes:
Locations:
city: Geneve
country: Switzerland
facility: Hôpitaux Universitaires de Geneve
city: Meyrin
country: Switzerland
facility: Hôpital de La Tour
Study officials:
References:
Clinical trial NCT03809494: HemaTrate™ in the Treatment of Critical Limb Ischemia
Official title: Clinical Study of the Use of an Autologous Blood Filtration Device in the Treatment of Critical Limb Ischemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Critical Limb Ischemia
Ischemia
Keywords: lower extremity
Peripheral Arterial Disease
Ischemia
Peripheral Blood Stem Cell Transplantation
Leukocytes, Mononuclear
Transplantation, Autologous
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2019-01-18
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the performance of the HemaTrate™ Blood Filtration system in the treatment of critical limb ischemia. The primary endpoint measure is comparing the percentage of patients between the treatment arm and control arm who have freedom from major amputation, arterial intervention below the knee, and death through 12 months.


Eligibility criteria: Inclusion Criteria:

1. Critical Limb Ischemia in the study leg with ischemic rest pain and/or ulcer/minor tissue loss (Rutherford 4 or 5)
2. Previously failed an endovascular or surgical treatment of the study lower leg and is not being considered for additional intervention within the next 3 months OR is unsuitable for revascularization

Exclusion Criteria:

1. Simultaneously participating in another investigational study (e.g., drug or device)
2. Pregnant or breastfeeding, or planning to become pregnant within the next 12 months
3. Major surgery (open cardiac, vascular, or abdominal procedure) within the past 90 days
4. Endovascular intervention within the past 30 days
5. Current dialysis, or expected to need dialysis within the next 12 months
6. Previous above the ankle amputation in the study leg

Primary outcomes:
measure: Freedom from vascular or endovascular arterial intervention below the knee of the study leg
timeFrame: 12 months
measure: Freedom from major amputation of the study leg
timeFrame: 12 months
measure: Death
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary, Manchester Vascular Centre
state: Great Britian
city: Leeds
country: United Kingdom
facility: The Leeds Teaching Hospital NHS Trust
state: West Yorkshire
city: London
country: United Kingdom
facility: St Thomas' Hospital
Study officials:
affiliation: St Thomas' Hospital
name: Bijan Modarai, PhD, FRCS
role: STUDY_CHAIR
affiliation: University Hospital Ostrava
name: Václav Procházka, MD, PhD, MSc
role: STUDY_CHAIR
affiliation: Centro Cardiologico Monzino IRCCS
name: Giulio Pompilio, MD, PhD
role: STUDY_CHAIR
References: