louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01075776: The Effects of C-type Natriuretic Peptide on Human Forearm Blood Vessels
Official title: The Effects of C-type Natriuretic Peptide on Endothelial Function Following Ischaemia-Reperfusion in the Human Forearm
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ischaemia-reperfusion (IR) Injury
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: University College, London
First posted: 2010-02-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To determine the effects of whether increasing CNP concentrations slightly above normal will improve the functioning of blood vessels after the interruption in the flow of blood. In this study we are looking at the function of the blood vessels of the forearm, as a substitute for those in the heart


Eligibility criteria: Inclusion Criteria:

* Healthy human volunteers on no systemic medication, excepting the oral contraceptive pill

Exclusion Criteria:

* History of medical illness
* Unwillingness to sign consent form
* Use of non-OCP medications
* Hypertension on examination of the blood pressure

Primary outcomes:
measure: Change in area under curve dose-response to acetylcholine after IR injury
timeFrame: 2h
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Queen Mary University London
Study officials:
affiliation: Queen Mary University London
name: Ahluwalia Amrita, BSc PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00229476: Study of Medication and Placebo Response in Major Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depressive Disorder, Major
Keywords: Depression
EEG
QEEG
cordance
Zoloft
sertraline
placebo
electroencephalogram
brain
antidepressants
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
name: Pfizer
name: Massachusetts General Hospital
First posted: 2005-09-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary purpose of the research study is to use recordings of brain electrical activity (through electroencephalogram, or EEG) and symptom measurements to determine whether patients are likely to show a response to medication or placebo treatment during a treatment trial for depression.


Eligibility criteria: Inclusion Criteria:

* Clinical Diagnosis of Unipolar Major Depression

Exclusion Criteria:

* Substance Abuse, Psychotic Disorder, History of Severe Head Trauma

Primary outcomes:
measure: depressive symptoms
Secondary outcomes:
measure: brain electrical activity (EEG)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Neuropsychiatric Institute & Hospital
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Andrew F. Leuchter, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leuchter AF, Cook IA, Witte EA, Morgan M, Abrams M. Changes in brain function of depressed subjects during treatment with placebo. Am J Psychiatry. 2002 Jan;159(1):122-9. doi: 10.1176/appi.ajp.159.1.122.
citation: Cook IA, Leuchter AF, Morgan M, Witte E, Stubbeman WF, Abrams M, Rosenberg S, Uijtdehaage SH. Early changes in prefrontal activity characterize clinical responders to antidepressants. Neuropsychopharmacology. 2002 Jul;27(1):120-31. doi: 10.1016/S0893-133X(02)00294-4.
citation: Leuchter AF, Morgan M, Cook IA, Dunkin J, Abrams M, Witte E. Pretreatment neurophysiological and clinical characteristics of placebo responders in treatment trials for major depression. Psychopharmacology (Berl). 2004 Dec;177(1-2):15-22. doi: 10.1007/s00213-004-1919-2. Epub 2004 Jul 14.
Clinical trial NCT03502876: Tolerance and Resistance to Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL
Official title: Tolerance and Resistance to Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL): Analysis of Real-life Data: "Snapshot" at 3 Years From the End of Ibrutinib ATU. A National Study of the FILO-LLC Group
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: B Cell Chronic Lymphocytic Leukemia
Lead sponsor: French Innovative Leukemia Organisation
Sponsor class: OTHER
First posted: 2018-04-19
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with CLL and treated by ibrutinib in the ATU

Brief summary: Assessment of the mutational profile of the residual clone and the distribution of lymphocyte subpopulations at 3 years of treatment with ibrutinib

This project has an epidemiological part: to establish the percentage of patients, in a real-life situation, still undergoing treatment 3 years after its initiation, as well as a biological part: to determine the evolution of the clone and the prevalence of BTK mutations and PLCg2 in the absence of clinical or biological criteria for scalability.

Detailed description: Observationnal and biological study

Eligibility criteria: Inclusion Criteria:

* patients included in the ATU (epidemiology)
* under treatment at 3 years of ibrutinib
* more than 18 years old

Exclusion Criteria:

* no ibrutinib treatment

Primary outcomes:
measure: Ibrutinib resistance
timeFrame: under treatment at 3 years of ibrutinib
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: FILO French Innovative Leukemia Organization
city: Tours
country: France
facility: Project manager
Study officials:
affiliation: French Innovative Leukemia Organization
name: Florence CYMBALISTA, MD PD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00781976: Antiviral Activity of AZD7295 in HCV Carriers
Official title: A Randomised, DB, PC Study to Determine the PK, Safety and Tolerability Profile and Antiviral Activity of Multiple Oral Doses of AZD7295 in Otherwise Healthy Male and Female Hepatitis C Carriers With Compensated Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Lead sponsor: Arrow Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-10-29
Enrollment: 31
Sex: ALL
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: PK, safety study of AZD7295 in HCV carriers


Eligibility criteria: Inclusion Criteria:

* HCV carrier

Exclusion Criteria:

* concurrent medications

Primary outcomes:
measure: Plasma AZD7295 concentrations and pharmacokinetics
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Prof Ed Gane
Study officials:
affiliation: Auckland Clinical Services
name: Ed Gane
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04455776: Safety Evaluation of Propofol Sedation for Magnetic Resonance Imaging in Pediatric Patients
Official title: Incidence of Adverse Events During Propofol Sedation for Magnetic Resonance Imaging in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiparametric Magnetic Resonance Imaging
Propofol Adverse Reaction
Sedation Complication
Anesthesia; Adverse Effect
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 99
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients under 16 years undergoing magnetic resonance imaging under propofol sedation.

Brief summary: Propofol is often used for sedation in children undergoing magnetic resonance imaging. The investigators will perform a chart review of 4 month of activity (about 100 cases) and review the incidence and severity of adverse events of this sedation technique.

Detailed description: Magnetic resonance imaging in children, especially under 6 years of age, is often performed under sedation. Propofol is a common drug used in this settings. In our institution, sedation is most often done by a propofol bolus of 2-5 mg/kg in order to reach a deep level of sedation as defined by Coté et al. If judged necessary by the attending anaesthesiologist, a additional propofol bolus of 0.5-1 mg/kg may be given. For longer lasting exams, the attending anaesthesiologist can chose to use a continuous infusion of propofol. The investigators will review the charts of 4 month of magnetic resonance imaging, which will give us a cohort of about 100 patients. Baseline characteristics, detailed sedation technique used will be recorded. Adverse events defined as:

* Oxygen desaturation measured by transcutaneous oximetry SpO2≤94%
* hypercapnia measure by end-tidal CO2 \>45 mm Hg
* movement of the patient

Assuming a non-normal distribution (tested by a Kolmogorov-Smirnov test), variables will be reported as median and interquartile range. Statistical tests will be done by non-parametric tests, Mann Whitney U. Non continuous variables will be analyzed by a Chi-square test.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients scheduled for MRI under sedation by an anaesthesiologist
* Age \< 16 years

Exclusion Criteria:

* Age \> 16 years
* Sedation performed by a non-anesthesiologist

Primary outcomes:
measure: Hypoxemia
timeFrame: 90 minutes
measure: Hypercapnia
timeFrame: 90 minutes
measure: Movements
timeFrame: 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hôpital Universitaire des Enfants Reine Fabiola
Study officials:
affiliation: CHU Brugmann
name: Denis Schmartz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00063427: Study Evaluating MAC-321 in Colorectal Cancer
Official title: A Phase 2, Open-Label Study of MAC-321 Administered Intravenously as a Single Agent for the Treatment of Advanced Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Neoplasms
Colonic Neoplasms
Rectal Neoplasms
Keywords: Colorectal Cancer
Colorectal Carcinoma
Colorectal Tumors
Neoplasms, Colorectal
Colorectal Neoplasms
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2003-06-27
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Assess the clinical activity of MAC-321 administered IV as a second-line or third-line antineoplastic agent to subjects with advanced colorectal cancer. Clinical activity will be assessed by determining the percentage of subjects exhibiting an objective response (complete plus partial responses). Tumor response will be assessed following modified Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.


Eligibility criteria: Inclusion Criteria:

* Histologic and/or cytologic diagnosis of metastatic or relapsed colorectal cancer at any time during disease but not candidates for surgical resection.
* Prior treatment with at least 1 conventional approved therapeutic regimen.
* Subjects who have failed prior cytotoxic chemotherapy regimens containing irinotecan (CPT-11), 5 fluorouracil (5-FU), and/or oxaliplatin for advanced (relapsed) metastatic colon cancer are eligible

Exclusion Criteria:

* Other chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks before signing the ICF (6 weeks if the previous chemotherapy included nitrosoureas or mitomycin)
* Prior radiotherapy to \>25% of bone marrow
* Prior exposure to MAC-321

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03251976: CPR Decision Aid For Patients With Advanced Gynecologic Malignancies
Official title: The Effect of a CPR Decision Aid on CPR Knowledge and Code-Status Preferences in Patients With Advanced Gynecologic Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advance Care Planning
Keywords: ovarian cancer
cardiopulmonary resuscitation
end of life care
endometrial cancer
cervical cancer
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research is to assess the effect of a cardiopulmonary resuscitation (CPR) decision aid video on CPR knowledge and end-of-life preferences in women with advanced gynecologic malignancy. We will assess the baseline CPR knowledge in our research population, gauge the improvement after viewing a decision aid video, and evaluate its effects on patient preferences regarding CPR.


Eligibility criteria: Inclusion Criteria:

* patients with stage III or greater cervical, ovarian, or uterine malignancies
* receiving chemotherapy at UAB gynecologic oncology infusion center

Exclusion Criteria:

* early stage gynecologic cancer
* receiving chemotherapy at a different location
* Non-English speaking
* deafness
* blindness

Primary outcomes:
measure: CPR knowledge
timeFrame: one month after intervention
Secondary outcomes:
measure: CPR preference
timeFrame: baseline
measure: CPR preference
timeFrame: one month after intervention
measure: CPR knowledge
timeFrame: baseline
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Kerri Bevis, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00157976: Double-Masked Study of Photrex (Rostaporfin) Photodynamic Therapy in the Treatment of Age-Related Macular Degeneration
Official title: A Phase III Randomized, Multicenter, Multinational, Double-Masked, Placebo-Controlled Study of Photrex (Rostaporfin) Photodynamic Therapy in the Treatment of Classic and Occult Subfoveal Choroidal Neovascularization Associated With AMD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Macular Degeneration
Keywords: Macular Degeneration
AMD
Visual Acuity
Lead sponsor: Miravant Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 660
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to confirm the efficacy and safety of rostaporfin (PHOTREX) photodynamic therapy (PDT) in the treatment of classic and occult subfoveal choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD).


Eligibility criteria: Inclusion Criteria:

Patients with age greater than or equal to 50 years with at least one subfoveal CNV membrane secondary to AMD that can be demonstrated by fluorescein angiography.

Primary outcomes:
measure: Visual Acuity
Secondary outcomes:
measure: Angiographic changes
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Multiple Investigators
city: Brno-Bohunice, Olomouc, Praha
country: Czech Republic
facility: Multiple Investigators
city: Warsaw, Bydgoszcz, Lubin
country: Poland
facility: Multiple Investigators
city: Bucharest
country: Romania
facility: Multiple Investigators
Study officials:
affiliation: Miravant Pharmaceuticals
name: Wendy J. Snyder, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05588076: Endometrial Lesions Predictions
Official title: Predictive Factors of Endometrial Lesions in Patients With Abnormal Uterine Bleeding
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrial Neoplasms
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 900
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This cross-sectional study was approved by the Institutional Ethics Committee and conducted in the Beijing Friendship Hospital, Capital Medical University in China

Brief summary: To explore the risk factors of endometrial lesions in patients with abnormal uterine bleeding and establish prediction models which can discriminate between different endometrial etiologies of abnormal uterine bleeding(AUB).


Eligibility criteria: Inclusion Criteria:

* 1) non-pregnancy related abnormal uttering bleeding（AUB） in women of 18-60 years old; 2)women who had indications for hysteroscopy and endometrial histology in the study period

Exclusion Criteria:

* 1) postmenopausal women, 2) AUB due to other causes such as hormones or medications, coagulation disorders, and vascular malformation of the uterus; 3) final diagnosis outside the scope of this study.

Primary outcomes:
measure: pathology of endometrial lesions
timeFrame: 1 year
Secondary outcomes:
measure: Ultrasonographic Examination
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
Study officials:
affiliation: Beijing Friendship Hospital
name: Wenjing Zhang, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05857176: Assessment of Safety and Satisfaction Toward COVID-19 Vaccines.
Official title: Assessment of Safety and Satisfaction Toward COVID-19 Vaccines: A Cross-sectional Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Vaccine Adverse Reaction
Lead sponsor: Damanhour University
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2023-05-12
Enrollment: 508
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects participating in the study are residents in Egypt who complete the online questionnaire.

Brief summary: This is a cross-sectional, web-based online survey done with the use of a Google Form-questionnaire to gather information from the general public regarding their knowledge, satisfaction, and tolerability about the COVID-19 vaccine.

Detailed description: * A cross-sectional study was conducted. The subjects participating in the study are residents in Egypt.
* An online questionnaire, designed on Google Forms, was written in Arabic language and delivered to participants via social media (primarily Facebook, WhatsApp and Linkedin).
* The questionnaire comprised two categories of inquiries. The first is demographic data of the subject. The second is questions about COVID-19 vaccine-related data, such as whether had taken the vaccine or not, the type of vaccine administered, side effects encountered from the vaccine , if got enough information regarding the vaccine and where obtain the vaccine information from and if reluctant to taking the vaccine and the reasons for hesitancy. All participants were permitted to terminate the survey at any time of the study.

Eligibility criteria: Inclusion Criteria:

* all adults (age ≥ 18 years) complete the questionnaire were considered eligible to participate in the survey.

Exclusion Criteria:

* Incomplete questionnaires were excluded from the final analysis.

Primary outcomes:
measure: headache incidence
timeFrame: 3 month
measure: fever incidence
timeFrame: 3 month
measure: fatigue incidence
timeFrame: 3 month
measure: pain at site of injection incidence
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Rehab Hussein Werida
state: Elbehairah
Study officials:
affiliation: Damanhour University
name: Rehab H Werida, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Malik A, Malik J, Ishaq U. Acceptance of COVID-19 vaccine in Pakistan among health care workers. PLoS One. 2021 Sep 15;16(9):e0257237. doi: 10.1371/journal.pone.0257237. eCollection 2021.
citation: Lazarus JV, Ratzan SC, Palayew A, Gostin LO, Larson HJ, Rabin K, Kimball S, El-Mohandes A. A global survey of potential acceptance of a COVID-19 vaccine. Nat Med. 2021 Feb;27(2):225-228. doi: 10.1038/s41591-020-1124-9. Epub 2020 Oct 20.
Clinical trial NCT01568827: Inflammation, Polyphenols, and Genetics
Official title: Inflammation, Polyphenols, and Genetics: A Pilot Study in Overweight and Obese Adult Males to Determine Whether Black-Raspberry Consumption Affects Markers of Inflammation in Study Participants Fed a High-Fat, High-Calorie Challenge Meal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Overweight
Obese
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Medical College of Wisconsin
First posted: 2012-04-02
Enrollment: 10
Sex: MALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Pilot study to determine whether daily consumption of blackraspberry powder (high in polyphenols) can reduce markers of inflammation and to determine whether genetics influence baseline levels of inflammatory markers as well as individual's response to polyphenols. A total of 10 males participated in this cross-over study.

Detailed description: A high-fat, high-calorie challenge meal is administered to induce an inflammatory response in overweight and obese adult males. Serum levels of CRP, TNF-alpha, and IL-6 are measured prior to the challenge meal and at various times (1,2,4,8, and 12 hours) after the challenge meal. The challenge meal is given once without intervention and once after 5 daily doses of concentrated black-raspberry powder mixed in water.

Eligibility criteria: Inclusion Criteria:

* adult males over 55 years of age
* overweight or obese

Exclusion Criteria:

* history of adverse reaction to berries or berry products
* history of adverse reaction to high-fat, high-calorie challenge meal
* significant liver or renal insufficiency
* significant cognitive impairment

Primary outcomes:
measure: Serum IL-6
timeFrame: acute (0-12 hours) after inflammation-causing challenge meal
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State Univesity
state: Ohio
Study officials:
affiliation: Ohio State University
name: Joseph P Kitzmiller, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sardo CL, Kitzmiller JP, Apseloff G, Harris RB, Roe DJ, Stoner GD, Jacobs ET. An Open-Label Randomized Crossover Trial of Lyophilized Black Raspberries on Postprandial Inflammation in Older Overweight Males: A Pilot Study. Am J Ther. 2016 Jan-Feb;23(1):e86-91. doi: 10.1097/MJT.0b013e3182a40bf8.