louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04561596: Virtually Augmented Self Hypnosis in Peripheral Vascular Interventions
Official title: Virtually Augmented Self Hypnosis: Randomized Controlled Trial in Peripheral Vascular Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Postoperative
Pain, Postoperative
Vascular Access Site Pain
Keywords: Anxiety
Pain
Virtual reality
Virtual reality autohypnosis
Hypnosis
Non-pharmacological approaches
Lead sponsor: University of Lausanne
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study is to compare patients anxiety and pain during percutaneous vascular interventions with and without virtual reality autohypnosis.

Detailed description: The participants in the control group will be treated under local anesthesia, following the usual care protocols.

The participants in the experimental group will be treated under the same conditions, except that they will experience virtual reality autohypnosis during the intervention.

Eligibility criteria: Inclusion Criteria:

* Informed consent as documented by signature
* \> 18 years
* Any indication for a percutaneous vascular interventional with a single vascular access (angiography, phlebography, arterial intervention, venous intervention) planned to be done under local anesthesia

Exclusion Criteria:

* No French language comprehension, deaf or visually impaired patient
* Inability to sign informed consent
* Need of sedative medication
* History of motion sickness
* History of psychiatric disease such as paranoia, schizophrenia, deep water phobia and dementia
* Patient does not tolerate the virtual reality mask during the pre operative visit at Day 1

Primary outcomes:
measure: Per procedural anxiety.
timeFrame: Day 1 (Immediately after the peripheral vascular intervention)
Secondary outcomes:
measure: Per procedural pain.
timeFrame: Day 1 (Immediately after the peripheral vascular intervention)
measure: Remembered per procedural anxiety.
timeFrame: 3 months
measure: Remembered per procedural pain.
timeFrame: 3 months
measure: Adverse events
timeFrame: Day 1
measure: Serious adverse events
timeFrame: Day 90
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV
state: Vaud
Study officials:
affiliation: Unil, CHUV
name: Salah Dine Qanadli, Prof. MD PhD
role: STUDY_DIRECTOR
References:
citation: Qanadli SD, Gudmundsson L, Gullo G, Ponti A, Saltiel S, Jouannic AM, Faouzi M, Rotzinger DC. Virtually Augmented Self-Hypnosis applied to endovascular interventions (VA-HYPO): Randomized Controlled Trial Protocol. PLoS One. 2022 Feb 23;17(2):e0263002. doi: 10.1371/journal.pone.0263002. eCollection 2022.
Clinical trial NCT01030796: Quitting Caffeine for Better Glucose Metabolism
Official title: Quitting Caffeine for Better Glucose Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2009-12-11
Enrollment: 25
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: This project is a pilot study of caffeine abstinence in coffee-drinkers who have type 2 diabetes. Evidence suggests that caffeine may impair the control of glucose levels, especially in those people who have type 2 diabetes. Eliminating caffeinated beverages from the diet might improve glucose control, but the difficulty of quitting is unknown. This pilot study will follow a small number of type 2 diabetic patients for three months after a brief intervention designed to help people quit caffeine. Data on success with maintaining abstinence and on changes in glucose control will be collected.


Eligibility criteria: Inclusion Criteria:

* 6-month history of type 2 diabetes
* impaired chronic glucose control (HbA1c \>= 7%)
* daily consumption of 250 mg caffeine or more in coffee, tea, and other caffeinated beverages

Exclusion Criteria:

* use of exogenous insulin
* use of non-diabetes medications that impact glucose metabolism
* medical of psychiatric history that prevents participation or increases risk
* current pregnancy
* current participation in other clinical trials
* deemed unable to comply with the study protocol for other reasons

Primary outcomes:
measure: Caffeine abstinence
timeFrame: baseline, 2 weeks, 1, 2, and 3 months
Secondary outcomes:
measure: HbA1c
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: James D Lane, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03888196: Evaluation of the Efficacy of Panax Ginseng on Lipid Metabolism in Men and the Relationship With Sports Practice.
Official title: Evaluation of the Efficacy of Panax Ginseng on Lipid Metabolism in Men and the Relationship With Sports Practice.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Sports Physical Therapy
Keywords: Panax
Lipid Metabolism
Sport Performance
Running
Ginseng
Lead sponsor: Universitat de Lleida
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Panax Ginseng (P ginseng), C.A. Meyer, Red, Chinese or Korean ginseng is a plant from eastern Asia and is one of the most widely used herbal products in the world. P ginseng has been been used for many years for different medical therapies. Previous studies have demonstrate that P. ginseng root extract supplementation may promote fat oxidation, increase hepatic glycogen levels and produce a glycogen-sparing and antifatigue effect during exercise in swimming rats. Notwithstanding, although there is some evidence of P. ginseng effects in humans, no evidence has been obtained respect to its supplementation in human sport performance. The aim of this study is to assess the effect of P ginseng extract supplementation on the lipid metabolism and sport performance in male endurance runners. For this purpose, the effect of supplementation for 2 weeks of 500 mg/day of P. ginseng will be evaluated in a sub-maximal physical stress test. Variables of lipid metabolism, energy consumption, fatigue, and endurance will be determined.


Eligibility criteria: Inclusion Criteria:

* Athletic men of aerobic type, who participate in a supervised training as a previous step to the accomplishment of competitions
* Which their age is older than 18 years
* Training superior or equal to 3 days per week and that these workouts are stable during the intervention.

Exclusion Criteria:

* Athletes with high blood pressure, with pharmacological treatment for hypercholesterolemia, diabetes, any psychiatric illness
* Athletes who practice sports without having the objective of increasing sports performance
* Athletes who use some type of ergogenic sport supplementation looking to optimize any aspect related to the sport.

Primary outcomes:
measure: Change from baseline plasmatic Total Lipids at 2 weeks
timeFrame: 2 weeks
measure: Change from baseline plasmatic Triglycerides at 2 weeks
timeFrame: 2 weeks
measure: Change from baseline Respiratory Exchange Rate at 2 weeks
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universitat de Lleida
name: Jose D Serrano, Dr
role: STUDY_CHAIR
affiliation: Universitat de Lleida
name: Alba Naudí, Dra
role: STUDY_DIRECTOR
affiliation: Universitat de Lleida
name: Cristian D Hernandez, PhD Student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05042596: Short Term Outcomes of Fracture Odontoid Management
Official title: Short Term Outcomes of Fracture Odontoid Management in Assuit University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spine Injury
Keywords: Odontoid fracture, upper cervical fracture, anterior odontoid screw, NDI.
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 24
Sex: ALL
Minimum age (years): 2
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patient with fracture Odontoid .

Brief summary: The aim of this study is to evaluate and assess the short-term outcomes of odontoid fracture cases admitted to trauma unit of Assiut university hospital.

Detailed description: patients with completed records, CTs, and Plain radiographs. Sufficient clinical records with documented NDI, The patient will be evaluated in 2 weeks, 6 weeks , and 3 , 6 months post operative .

Eligibility criteria: Inclusion Criteria:

* all patients with odontoid fractures admitted to Assiut University Hospital - Department of Orthopedics and Trauma between October 2021 and June 2023

Exclusion Criteria:

* patients who are not available for 6 months follow-up and those with insufficient documentation or records

Primary outcomes:
measure: Assess the short term outcomes of Odontoid fracture in skeletally mature patients
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut UNIVERSITY HOSPITAL
Study officials:
affiliation: Assiut University
name: Mohammad El-Sharkawi
role: STUDY_CHAIR
affiliation: Assiut University
name: Ahmed Abdelgawaad
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Mahmoud Ibrahim
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Ahmed Al-huthaifi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pal D, Sell P, Grevitt M. Type II odontoid fractures in the elderly: an evidence-based narrative review of management. Eur Spine J. 2011 Feb;20(2):195-204. doi: 10.1007/s00586-010-1507-6. Epub 2010 Sep 12.
citation: Wang J, Zheng W, Zhang Z, Li C, Zhou Y. [Percutaneous anterior odontoid and transarticular screw fixation for type II odontoid fractures in elderly patients]. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2013 Sep;27(9):1090-3. Chinese.
Clinical trial NCT01076296: A Post-Marketing Study for On Label Evaluation of the GE Vscan Ultrasound Imaging System
Official title: A Post-Marketing Study for On Label Evaluation of the GE Vscan Ultrasound Imaging System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Left Ventricular Dysfunction
Right Ventricular Dysfunction
Pulmonary Hypertension
Heart Valve Diseases
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Oregon Health and Science University
First posted: 2010-02-26
Enrollment: 1000
Sex: ALL
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: In-patient and outpatient population of OHSU Division of Cardiovascular Medicine

Brief summary: This study is to collect data and learn more about the Vscan Ultrasound Imaging System. It is an "observational" study with no additional procedures or intervention prescribed other than using the Vscan along with a routine medical physical exam.

Detailed description: The study requires 2 visits to OHSU.

At the first visit a cardiac physical exam will be done by a cardiologist.

At a second visit, a different cardiologist will perform an ultrasound scan (as part of your standard of care) using a Vscan Ultrasound System. The first and the second visit may be done on the same day depending upon your schedule and if it's convenient for you to stay. The total exam time for both the visits, including standard exam and the study device exam will be about 45 minutes.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* provided signed and dated informed consent and is willing to provide GE Healthcare with demographic data, cardiac medical history, information collected as part of the study
* New patients who have an echocardiogram less than 6 months and patients who will be undergoing an echocardiogram as part of their routine clinical care

Exclusion Criteria:

* Pregnant
* less than 18 years of age.
* unwilling to provide informed Consent

Primary outcomes:
measure: Percentage of Correct Diagnosis
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Sanjiv Kaul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00254696: Study Evaluating Antibiotic Utilization Measures and Control of Extended-Spectrum-Lactamases (ESBLs)
Official title: Association of Antibiotic Utilization Measures and Control of Extended-spectrum-lactamases (ESBLs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bacterial Infection
Keywords: bacterial infection
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-11-16
Enrollment: 710
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: * To determine the value of using piperacillin/tazobactam in reducing the cases of ESBL producing E. coli or K. pneumoniae colonization and infection.
* To determine the acquisition rate of ESBL producing E. coli or K. pneumoniae, both pre and post intervention in the selected medical centers.


Eligibility criteria: Inclusion Criteria:

* Patients admitted or transferred to the ICU/pulmonary/hematology units.
* Patients of either sex, 18 years of age or older

Exclusion Criteria:

* Pregnant and nursing women. Female of childbearing potential without using any birth control methods. Female of childbearing potential using oral contraceptives during study period. (Note: penicillin and beta-lactamase inhibitors may prevent oral contraceptives from working properly, increasing the chance of pregnancy).
* Patients who have the contraindications of using Tazocin (pipercillin/tazobactam)

Other exclusions apply.

Primary outcomes:
measure: Acquisition rate of ESBL producing E. coli or K. pneumoniae at the end of phase I (pre-intervention) and phase II (last 3 months)
Secondary outcomes:
measure: Infection rate of ESBL producing E. coli or K. Pneumoniae at the end of phase I (pre-intervention) and phase II (last 3 months)
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For China medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05300958: Deferoxamine Plus Chemotherapy for Metastatic Triple Negative Breast Cancer
Official title: Deferoxamine Plus Chemotherapy for Metastatic Triple Negative Breast Cancer: A Single-armed, Phase II Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Triple Negative Breast Cancer
Keywords: Deferoxamine plus chemotherapy
Objective Response Rate and safety
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate the efficacy and safety of chemotherapy plus deferoxamine in metastatic breast cancer whose evaluation is stable disease with a trend of progression.

Detailed description: This is a phase II, single center, prospective, single arm clinical trial. A lot of in vitro and in vivo study demonstrate that deferoxamine can increase anti-tumor effect. The objective of the study is to evaluate the efficacy and safety of chemotherapy plus deferoxamine in metastatic breast cancer whose evaluation is stable disease with a trend of progression after second-line. This study plans to recruit 30 subjects.

Eligibility criteria: Inclusion Criteria:

* Has measurable metastatic triple-negative breast cancer, with at least 1 measurable lesion per RECIST criteria.
* Fail second-line or above anti-tumor treatment
* Evaluation is stable disease with a trend of progression.
* Minimum life expectancy 16 weeks
* Histological confirmation of breast cancer on primary tumour at diagnosis/on biopsy of metastasis
* ECOG Performance Status (PS) 0-2 with no deterioration over previous 2 weeks
* Normal organ function.
* Has signed a Patient Informed Consent Form.

Exclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) score of ≥ 2
* Patients with severe liver and kidney insufficiency
* Deferoxamine Ingredients allergy
* With the exception of alopecia, any unresolved toxicities from previous therapy greater than CTCAE grade 1 before study treatment
* Inability or unwillingness to comply with study procedures, including inability to take regular oral medication
* Researchers consider it is not suitable for participation.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 6 months
Secondary outcomes:
measure: clinical benefit rate (CBR)
timeFrame: 6 months
measure: progression-free survival (PFS)
timeFrame: 6 months
measure: overal survival (OS)
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Zhong-yu Yuan, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03089658: Expanded Access to Avelumab for Treatment of Metastatic Merkel Cell Carcinoma (mMCC)
Official title: Temporary Authorization for Use (ATU) to Avelumab for Treatment of Adult Patients With Metastatic Merkel Cell Carcinoma (mMCC)
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Metastatic Merkel Cell Carcinoma
Keywords: Metastatic Merkel Cell Carcinoma
Expanded Access Program
Temporary Authorisation for Use
Avelumab
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2017-03-24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Expanded access to Avelumab solution for infusion will be made available for adult patients with mMCC whose disease has progressed after receiving at least one prior chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Measurable metastatic Merkel cell carcinoma according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1), has failed at least one line of adequately dosed chemotherapy in the metastatic setting and has subsequently progressed (where adequate dosing is defined as a minimum of 2 cycles)
* Not eligible for participation in any ongoing clinical trial for Merkel cell carcinoma including the Javelin Merkel 200 study (NCT02155647)
* Adequate hematological, hepatic and renal function as defined in the protocol

Exclusion Criteria:

* Brain metastases
* Prior organ transplantation, including allogeneic stem cell transplantation
* History of testing positive for human immunodeficiency virus (HIV) or known AIDS or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
* Concurrent, active, malignant disease (other than Merkel cell carcinoma) with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ as defined in protocol
* Previous or active autoimmune disease requiring systemic immunosuppressive therapy
* Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma
* Clinically significant (that is, active) cardiovascular disease: cerebral vascular accident / stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment) unstable angina, congestive heart failure (New York Heart Association Classification Class ≥ II), or serious cardiac arrhythmia requiring medication
* Persisting toxicity related to prior therapy of Grade \>1 NCI-CTCAE v 4.03 (alopecia and sensory neuropathy Grade ≤ 2 is acceptable)
* Being treated with chronic systemic corticosteroids or other chronic therapeutic immunosuppression
* Pregnant or lactating (for women of childbearing potential)
* Not using a highly effective contraception if the risk of conception exists

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Avelumab ATU Unit
Study officials:
References:
Clinical trial NCT03327558: Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects
Official title: Full-replicate Study of APRISO 375 mg Extended-release Capsules Versus the Approved APRISO 375 mg Extended-release Capsules in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ulcerative Colitis
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center, laboratory-blinded, randomized, two-treatment, two-sequence, four-period, full replicate, crossover bioequivalence study
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate and compare the bioavailability of mesalamine

Detailed description: The objective of this study is to evaluate and compare the bioavailability of mesalamine and therefore to assess the bioequivalence of 375 mg APRISOTM extended-release capsule manufactured at a new site versus the approved 375 mg APRISOTM extended-release capsule after a single oral dose administration under fasting conditions.

Eligibility criteria: Inclusion Criteria:

* Healthy male or female, at least 18 years of age
* Body mass index (BMI) between18.5 and below 32.0 kg/m2 (inclusive)
* Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, ECG and laboratory tests

Exclusion Criteria:

* Any contraindication to mesalamine according to the applicable labeling

Primary outcomes:
measure: Cmax (Maximum observed plasma concentration)
timeFrame: 3 hours after oral dose is taken
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Valeant Site 01
state: California
Study officials:
References: