louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01920282: Nebivolol, Lifestyle Modification and Arterial Stiffness
Official title: Effect of Nebivolol and Lifestyle Modification on Large Artery Stiffness in Middle-Aged and Older Hypertensive Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2013-08-09
Enrollment: 45
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Numerous anti-hypertensive drugs have been reported to be efficacious in reducing central arterial stiffness and these effects may contribute to improved outcomes in hypertensive patients. However, the results of several studies suggest that beta-blockers may actually increase arterial stiffness. In contrast, there is limited evidence to suggest that nebivolol, a third generation beta-blocker that augments release of vascular nitric oxide, reduces central arterial stiffness in hypertensive individuals. Unfortunately, only a few studies have addressed this issue and all of these studies relied on indirect, blood pressure dependent measures of arterial stiffness. In addition, none of these studies focused on middle-aged and older, obese hypertensives, a population with accelerated arterial stiffening and at risk for cardiovascular diseases. Thus, the potential utility of nebivolol as a therapy to reduce large artery stiffness, particularly among the latter population, remains unclear.


Eligibility criteria: Inclusion Criteria:

* Stage 1 hypertension
* 40-75 years
* Weight stable (+/-2 kg)
* Sedentary to recreationally active
* Willing to be randomized to one of three arms
* Verbal and written consent
* Approval by medical director

Exclusion Criteria:

* Blood pressure outside stated range
* Diabetes or taking diabetes medications
* Total cholesterol \>6.2 mmol/L; triglycerides \>4.5 mmol/L
* Past or current ischemic heart disease, stroke, respiratory disease, endocrine or metabolic disease, neurological disease, or hematological-oncological disease
* Medications (including but not limited to antihypertensives, statins or other with anti-inflammatory actions) or antioxidant vitamins or supplements
* Known allergy or hypersensitivity to nebivolol or any of its components
* Inability to perform regular physical activity or participate in other components of lifestyle modification
* Pregnant or planning to become pregnant

Primary outcomes:
measure: Beta-stiffness Index
timeFrame: 12 weeks
Secondary outcomes:
measure: Insulin Sensitivity (HOMA-IR)
timeFrame: 12 weeks
Other outcomes:
measure: Oxidized LDL Concentration
timeFrame: 12 weeks
Locations:
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Kevin P Davy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05180682: Effectiveness of Supervised Training Program on Mobility and Balance Confidence in Individual With Lower Limb Amputation
Official title: Effectiveness of Supervised Training Program on Mobility and Balance Confidence in Individual With Lower Limb Amputation: A Quasi-Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Keywords: Lower limb Amputation
Balance
Mobility
Lead sponsor: NCS University System
Sponsor class: OTHER
Collaborators: name: Khyber Medical University Peshawar
First posted: 2022-01-06
Enrollment: 46
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were non randomly allocated to two groups and and were analyzed in the end of the study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: It was quasi experimental study where the researchers assess the effectiveness of supervised training program on mobility and balance confidence in individual with lower limb amputation.


Eligibility criteria: Inclusion Criteria:

1. Age range 15-55 years.
2. Both genders: (male and females).
3. Trans-tibial amputation
4. Patients involved in prosthetic rehabilitation (strengthening, balance training, stretching exercises and gait training).

Exclusion Criteria:

1. Patient with cognitive problem.
2. Infection
3. Neuromas
4. Limb swelling

Primary outcomes:
measure: Balance confidence
timeFrame: One month
measure: Mobility
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Pakistan Institute of Prosthetic and Orthotic Sciences, Peshawar
state: Khyber Pakhtunkhwa
Study officials:
affiliation: Khyber Medical University Peshawar
name: Hazrat Bilal, MSPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04379882: Feasibility Study Evaluating the Silva Module During the Anaesthesiology Consultation Before an Elective Surgery
Official title: Feasibility Study Evaluating the Silva Module During the Anaesthesiology Consultation Before an Elective Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Preoperative Anxiety
Lead sponsor: Oncomfort
Sponsor class: INDUSTRY
Collaborators: name: Erasme University Hospital
First posted: 2020-05-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this feasibility study, feasibility, acceptability and an initial clinical efficacy of the new module of Hypnosis and Virtual Reality (or Digital Sedation), Silva, will be evaluated. This feasibility study meets objectives of Oncomfort's design validation and design verification steps. Silva will be tested on a sample of 10 patients in the environment where the product is intended to be used, a hospital environment. If results do not fit with user needs, design will be adapted according to results and a new phase of design validation will be implemented. The Silva module is a Digital Sedation module designed for management of pain and anxiety in perioperative patients.

Detailed description: Subjects will be recruited during the anaesthesiology consultation preparing to an elective surgery.

First, subject will be asked to self-assess anxiety and comfort. In order to evaluate anxiety, subject will use a 0-10 rating Visual Analogue Scale (VAS) where 0 = no anxiety at all, and 10= the worst imaginable anxiety. The same scale will be used to measure the level of comfort where 0 means no comfort at all and 10 very comfortable.

Subject should be positioned laying on a reclining chair during the session. This session will last for 30 minutes. After the experiment, participants will be asked to rate anxiety, level of comfort, level of immersion and dissociation.

Several questions will be asked to the patient to evaluate his/ her experience, the Silva module, and the sensations experienced.

The study will be ended by an evaluation of adverse event (AE) and the evaluation of the caregivers.

Eligibility criteria: Inclusion Criteria:

• Subject more than 18 years old

Exclusion Criteria:

* Deaf subject
* Blind
* Non-proficiency in French (Module language)
* Psychiatric disorder
* Head or face wounds
* Neurological disease
* Chronic pain and/or chronic analgesics consumption
* Medication affecting the autonomic nervous system
* Dizziness

Primary outcomes:
measure: Evaluate the acceptability and the patient's qualitative reported experience of Silva
timeFrame: Day 1 of the intervention
Secondary outcomes:
measure: Evaluate Anxiety
timeFrame: Day 1 of the intervention
measure: Evaluate Comfort
timeFrame: Day 1 of the intervention
measure: Evaluation of agreeability of the Digital Sedation session
timeFrame: Day 1 of the intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05895682: A Clinical Trial to Verify the Accuracy of Seers Technology's Pulse Oximeter (mobiCARE +Pulse, MP100W) in Healthy Volunteers
Official title: A Clinical Trial to Verify the Accuracy of Seers Technology's Pulse Oximeter (mobiCARE +Pulse, MP100W) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxygen Saturation
Keywords: Oxygen Saturation
Lead sponsor: Seers Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-08
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: It is important to evaluate the accuracy of the pulse oximeter, which is commonly used in clinical practice. The US FDA only allows the use of devices that meet the ISO 80601-2-61:2017 standard in the United States. According to the ISO 80601-2-61:2017 standard, the accuracy of the oxygen saturation (SpO2) of the pulse oximeter should have an error range of less than 4.0% compared to the actual arterial blood oxygen saturation (SaO2) in the range of 70-100%. To prove compliance with this requirement, it is necessary to conduct a clinical trial that induces hypoxemia in healthy adults and compares and evaluates the arterial blood oxygen saturation values of the pulse oximeter's SpO2 and the arterial blood oxygen saturation values of the carbon monoxide-oxygen meter (CO-oximeter).


Eligibility criteria: Inclusion Criteria:

* healthy adults between 20 and 50 years
* volunteers who have plasma proportion of carboxyhemoglobin 3%
* volunteers who have plasma proportion of methemoglobin 2%
* volunteers who have total plasma hemoglobin concentration over 10 g/dL

Exclusion Criteria:

* History of respiratory diseases
* History of cardiovascular disease
* Smokers (including ex-smokers)
* Pregnant
* History of fainting
* History of diabetes
* Obesity (BMI\> 30 kg/m2)
* Allen's test results, those who do not recover the color of their fingers and palms within 10 seconds
* History of allergic reaction to lidocaine, a local anesthetic

Primary outcomes:
measure: Accuracy of SpO2
timeFrame: 2 day
Secondary outcomes:
Other outcomes:
Locations:
city: Pyeongtaek-si
country: Korea, Republic of
facility: Seers Technology Co., Ltd.
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT04344782: Trial Evaluating Efficacy and Safety of Bevacizumab (Avastin®/Zeribev®) in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort
Official title: Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-19- BEVA Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: COVID19 Pneumonia
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 130
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: Bevacizumab, ZERIBEV® (Pfizer)/AVASTIN® (Roche) 25 mg/ml ®, is a recombinant humanised monoclonal IgG1 antibody It seems interesting to use bevacizumab in severe patients infected with SARS-CoV-2 requiring hospitalization in conventional unit or in ICU.

This protocol CORIMUNO19-BEVA will evaluate the efficacy and safety of AVASTIN®/ ZERIBEV® (bevacizumab) COVID-19 patients hospitalized in conventional units.

This phase 2 randomized clinical trial aimed at evaluating the efficacy and safety of AVASTIN®/ ZERIBEV® (bevacizumab) alone versus standard of care (SoC) in patients hospitalized in conventional units.


Eligibility criteria: Inclusion Criteria:

* Patients Requiring more than 3L/min of oxygen
* WHO progression scale = 5 to 8

Exclusion Criteria:

* Patients in 9 WHO progression class
* Patients with exclusion criteria to the CORIMUNO-19 cohort.
* Hypersensitivity to Bevacizumab or to any of their excipients.
* Pregnancy
* Active Cancer with undergoing treatment
* Oxygen patient requiring long-term oxygen before hospitalization
* Patient already included in a therapeutic trial; however, inclusion should be discussed case by case with the trial coordinator.
* Contraindication to bevacizumab, risk of bleeding especially hemoptysis, active venous or arterial thromboembolic disease and recent surgery.
* Hypersensitivity to the active substance or one of the excipients

Primary outcomes:
measure: Proportion of surviving patients without need for intubation for respiratory support
timeFrame: day 14
Secondary outcomes:
measure: Saturation of Oxygen in the blood (SaO2)
timeFrame: day 14
measure: Arterial oxygen partial pressure (paO2)
timeFrame: day 14
measure: Ratio of arterial oxygen partial pressure to fractional inspired oxygen (paO2/FiO2)
timeFrame: day 14
measure: CT-scan score
timeFrame: day 14
measure: dyspnea
timeFrame: day 28
measure: overall survival
timeFrame: day 14 and 28
measure: admissionn to the intensive care unit (ICU)
timeFrame: day 14 and day 28
measure: incidence of mechanical ventilation
timeFrame: day 14 and day 28
measure: hospital length of stay
timeFrame: day 28
measure: incidence of adverse event
timeFrame: day 28
measure: VEGF plasma concentration
timeFrame: day 28
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01612182: The Incidence of Extended-spectrum β-lactamase (ESBL) Klebsiella Pneumonia in Patient on Renal Replacement Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End-stage Renal Disease
Keywords: end-stage renal disease
renal replacement therapy
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2012-06-05
Enrollment: 1289
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients had admitted in single center

Brief summary: The prevalence of ESBL Klebsiella pneumonia was higher in patient with renal replacement therapy.


Eligibility criteria: Inclusion Criteria:

* The age of patient was between 18 yrs and 79 yrs.
* The patient who showed Klebsiella pneumonia in 1st culture result of any site during hospitalization

Exclusion Criteria:

* The level of serum albumin was below 2.0 or over 5.0
* The level of AST or ALT was 2 times of normal level or the level of bilirubin was over 2.0 mg/dL during 1month.
* The level of Body mass index was below 15 or over 30
* Pregnancy

Primary outcomes:
measure: The prevalence of ESBL Klebsiella pneumonia in renal replacement therapy
timeFrame: During hospitalization
Secondary outcomes:
measure: The prevalence of ESBL Klebsiella pneumonia in patient with pneumonia and renal replacement therapy
timeFrame: during hospitalization
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Inje University Seoul Paik hospital Instituional Board Review
state: Je dong 2ga, Jung gu
Study officials:
References:
Clinical trial NCT05867082: Effects of Neural Mobilization on Respiratory Parameters in Chronic Neck Pain
Official title: Effects of Neural Mobilization on Respiratory Parameters, Pain, Range of Motion, and Neck Awareness in Patients With Chronic Neck Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Respiratory
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 26
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: Neural mobilization (NM) is commonly used to treat nerve disorders, and it is useful for disorders associated with neck and arm pain. This study aimed to determine the effects of NM on respiratory function in patients with chronic neck pain.

Methods: Overall, 26 patients with neck pain were randomly assigned to two groups: NM or control. In these participants, respiratory function and active cervical range of motion were assessed before and after intervention. Furthermore, the participants were provided a visual analog scale (VAS) and Fremantle Neck Awareness Questionnaire (FreNAQ). Each participant underwent 15 treatment sessions (5 days per week for 3 weeks). Further, in the NM group, in addition to conventional treatment, 10 sessions of neural mobilization were performed.


Eligibility criteria: Inclusion Criteria:

* Individuals aged 25-65 years,
* those with neck pain for \>3 months
* those with complaints of pain, tension
* numbness on neurodynamic nerve tests

Exclusion Criteria:

* individuals with spinal stenosis,
* neurological diagnosis, malignancy,
* upper extremity vascular problems,
* osteoporosis,
* pregnancy,
* history of newly repaired peripheral nerves,
* inflammatory processes,
* cervical spine and upper extremity surgeries,
* conditions affecting lung capacity (such as asthma, bronchitis, and diabetes mellitus)

Primary outcomes:
measure: Pulmonary function test
timeFrame: Change from baseline respiratory function at 3 weeks
measure: Range of Motion (ROM) of the Joint
timeFrame: Change from baseline ROM at 3 weeks
measure: Pain Intensity
timeFrame: Change from baseline pain intensity at 3 weeks
Secondary outcomes:
measure: Fremantle Neck Awareness Questionnaire (FreNAQ in Turkish (FreNAQ-T)
timeFrame: Change from baseline FreNAQ-T at 3 weeks
Other outcomes:
Locations:
city: Gebze
country: Turkey
facility: Medical Park Gebze Hosptal
state: Kocaeli
Study officials:
affiliation: Medical Park Gebze Hospital
name: Elif Tunç, Msc
role: STUDY_DIRECTOR
References:
Clinical trial NCT01336582: Pharmacokinetic Study of SYP-0704A and Taxotere to Treat Patient With Advanced Solid Cancer
Official title: Phase I Trial to Compare Pharmacokinetics and Safety of SYP-0704A With Taxotere in Subjects With Advanced Solid Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Keywords: suitable candidate
single agent docetaxel therapy
Advanced Solid Tumor
Lead sponsor: Samyang Biopharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2011-04-18
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Primary Objective: Evaluation of the pharmacokinetic equivalence of two Docetaxel formulations in terms of AUC and Cmax.

Detailed description: Comparison of pharmacokinetic parameters (T1/2β, CL, Vdss) Safety as measured by adverse events

Eligibility criteria: Inclusion Criteria:

* Subjects who aged 18 years or older.
* Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial.
* Subjects who have histologically or cytologically confirmed advanced solid tumor.
* Subjects who are a suitable candidate for single agent docetaxel therapy for their advanced solid tumors that have failed to standard therapy.
* Subjects who have fully recovered from reversible toxic effects of prior therapy. The prior chemotherapy, immunotherapy, hormone therapy, surgery, and/or radiotherapy should be completed at least 21 days before the first administration of investigational product.

Exclusion Criteria:

* Subjects who have had a major surgery other than tumor ablation within 2 weeks prior to the screening/baseline visit.
* Subjects who have a history of metastasis or currently have a metastasis to the central nervous system (CNS).
* Subjects who have a preexisting sensory or motor neuropathy of grade ≥ 2 based on NCI CTCAE V3.0.

Primary outcomes:
measure: Pharmacokinetics of SYP-0704A and Taxotere in terms of AUC
timeFrame: 3 months
Secondary outcomes:
measure: Pharmacokinetics of the T1/2 of SYP-0704A and Taxotere
timeFrame: 3 months
measure: Pharmacokinetics of the CL of SYP-0704A and Taxotere
timeFrame: 3 months
measure: Pharmacokinetics of the Vdss of SYP-0704A and Taxotere
timeFrame: 3 months
measure: Number of paticipants with Adverse Events
timeFrame: 3months
Other outcomes:
Locations:
city: Pusan
country: Korea, Republic of
facility: Inje Pusan paik University hospital
state: Jin-Gu
Study officials:
affiliation: Inje Pusan Paik university hospital
name: Shin je gook, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05906082: Vape-Free Text-Messaging: Pilot Study
Official title: Text-messaging E-cigarette Cessation Intervention for Young Adults in Rural Areas: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: E-cigarette Use
Lead sponsor: University of Wisconsin, Milwaukee
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a small pilot randomized controlled trial to evaluate the feasibility, acceptability, and preliminary efficacy of the e-cigarette cessation text-messaging intervention with young adults in rural areas.


Eligibility criteria: Inclusion Criteria:

* English speaking
* 18-24 years
* everyday e-cigarette use in the past month
* ownership of a mobile phone or smartphone with texting and internet access abilities
* knowledge of how to use text messages
* plan on quitting e-cigarette use within one month
* home address in a rural county of Wisconsin, Minnesota, North Dakota, and South Dakota

Exclusion Criteria:

* Individuals who reported use of other tobacco products (e.g., cigarettes, smokeless tobacco) than e-cigarettes in the past month

Primary outcomes:
measure: Number of participants recruited and randomized
timeFrame: Throughout 12 months
measure: Self-reported proportion of text messages read
timeFrame: At 1 month
measure: Retention rates (proportion of participants remained until 1 month post-intervention from enrollment)
timeFrame: At 1 month
measure: Level of acceptability of the intervention
timeFrame: At 1 month
measure: Proportion of salivary cotinine samples returned
timeFrame: At 1 month
measure: Self-reported 7-days point prevalence abstinence from ENDS and other tobacco
timeFrame: At 1 month
measure: Concentration of cotinine in saliva
timeFrame: At 1 month
measure: Nicotine dependence (Penn State Electronic Cigarette Dependence Index)
timeFrame: At 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: University of Wisconsin-Milwaukee
state: Wisconsin
Study officials:
References: