louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04732481: Evaluation of Corrected Carotid Flow Time Variations During Passive Leg Lift to Predict Response to Filling.
Official title: Evaluation of Corrected Carotid Flow Time Variations During Passive Leg Lift to Predict Response to Filling
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Organ Failure, Multiple
Lead sponsor: Centre Hospitalier de Cornouaille
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: During their ICU admission for organ failure or multiple organ failure, patients frequently receive volume expansion to increase cardiac output.

Brief summary: Patients hospitalized in intensive care often require intravenous administration of fluid in order to optimize the functioning of the heart and thus ensure perfusion of vital organs such as the kidneys, the brain or the digestive tract. However, it is necessary to find the right balance in fluid intake because it has been shown that excessive administration has a negative impact on patient survival, the length of their stay in intensive care or the duration of invasive mechanical ventilation.The passive leg lifting maneuver is regularly used to determine which patients should be infused with these large volumes (the patient's chest is placed in a horizontal position and the legs are elevated at 30 ° by tilting the bed for 2 minutes ). To be interpreted, this maneuver requires the presence of invasive devices (bloody arterial pressure catheter, PICCO monitor) or an operator experienced in cardiac ultrasound.Our study aims to evaluate an easy-to-use, non-invasive tool widely available in intensive care and emergency departments (carotid vascular doppler ultrasound) to assess the response to a passive leg lifting maneuver. . The measurements are taken before and after a passive leg lifting maneuver and then before and after a filling decided before inclusion by the doctor responsible for the patient.


Eligibility criteria: Inclusion Criteria:

* equipped with a PICCO2® continuous cardiac output monitoring device
* for which the practitioner in charge of the patient decides to administer a volume expansion

Exclusion Criteria:

* patients whose rhythm is non-sinus
* who have expressed their refusal to participate in the protocol
* contraindicated to passive leg lifting maneuvers (deep vein thrombosis, HTIC, BMI\> 40 or\> 14, spinal instability)
* pregnant women and patients clinically suspected of abdominal compartment syndrome

Primary outcomes:
measure: response to filling
timeFrame: 90sec
Secondary outcomes:
measure: cut-off value for positivity of the test
timeFrame: 90sec
Other outcomes:
Locations:
city: Quimper
country: France
facility: Ch Cornouaille
state: Finistere
Study officials:
References:
Clinical trial NCT04134481: Effect Of Clustered Nursing Interventions On Physiological Response In Critically Ill Patients
Official title: Physiological Responses Related to Clustered Nursing Interventions Among Mechanically Ventilated Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanically Ventilated Patients
Keywords: clustered nursing interventions
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2019-10-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 80 adult mechanically ventilated patients admitted to intensive care units of Alexandria Main University Hospital (unit I, unit III), General ICU of Damanhur Medical National Institute consists

Brief summary: To determine physiological responses related to clustered nursing interventions among critically ill patients.

Detailed description: Clustered nursing interventions are defined as group of interventions more than six for each patient in one nursing interaction.The study was conducted on 80 mechanically ventilated adult patients admitted to intensive care units of Alexandria Main University Hospital and Damanhour Medical National Institute. The most common procedures provided by nurses in direct care for those patients were vital signs measurements, central venous pressure measurement, suctioning, feeding, laboratory sampling, general care, repositioning, and administration of medications. Physiological parameters measured were end-tidal carbon dioxide using capnography, vital signs using bed side monitor, and oxygen saturation using pulse oximeter.

Eligibility criteria: Inclusion Criteria:

* adult patients of both sex, aged 18 years and over
* mechanically ventilated for ≥ 48 hours.

Exclusion Criteria:

* lung disorder (eg, COPD, asthma, lung cancer, pneumonia, ARDS)
* pregnancy.

Primary outcomes:
measure: change in end tidal CO2 in mmHg (EtCO2) change in oxygen saturation (SO2)
timeFrame: up to 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05094310: Genetic Predictors of Response to Acupuncture for Cancer-related Fatigue Among Breast Cancer Patients After Chemotherapy
Official title: Genetic Predictors of Response to Acupuncture for Cancer-related Fatigue Among Breast Cancer Patients After Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Single nucleotide polymorphisms
Breast Cancer
Cancer-related fatigue
Acupuncture
Lead sponsor: Affiliated Hospital of Qinghai University
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Genetic predictors of response to acupuncture for cancer-related fatigue among breast cancer patients after chemotherapy.

Detailed description: Cancer related fatigue(CRF) in patients with breast cancer has a great impact on their quality of life and treatment compliance. Many studies suggest that acupuncture has certain therapeutic effects on fatigue. In this clinical trial, we treated patients with acupuncture to alleviate their fatigue symptoms. Currently, studies have shown that cancer related fatigue in breast cancer patients is related to some biological factors. While acupuncture is used to treat fatigue, we will collect blood samples from patients for fatigue related single nucleotide polymorphisms（SNP）.

Based on CRF related biological factors, our study aims to screen SNPs that related to CRF related biological factors to guide electroacupuncture in the treatment of cancer-related fatigue and establish a prognostic model.

Eligibility criteria: Inclusion Criteria:

1. The patient was diagnosed with breast cancer.;
2. Breast cancer patients diagnosed with cancer related fatigue are included in our clinical study;
3. Voluntarily participate in the clinical trial and sign the informed consent form after informed consent (patients voluntarily accept the treatment and give informed consent);
4. Patients with previous local recurrence were eligible, but not patients with distant metastasis；
5. The basic indexes were consistent, and the blood routine and ECG were normal.

Exclusion Criteria:

1. The exclusion criteria were patients with needle phobia;
2. Low platelet count (\<50 000); co-morbidity with a bleeding disorder; co-morbidity with thyroid dysfunction; pregnancy; haemoglobin levels \<10 g/dl and haematocrit \<30; anaemia on active pharmacological treatment or receiving blood transfusion or steroids；
3. Life expectancy \<6 months；
4. lymphoedematous limbs.

Primary outcomes:
measure: Difference of BFI score change after treatment
timeFrame: 2 years
Secondary outcomes:
measure: Side effects related to electroacupuncture
timeFrame: 2 years
Other outcomes:
Locations:
city: Xining
country: China
facility: Qinghai University Affiliated Hospital
state: Qinghai
Study officials:
References:
Clinical trial NCT03253510: Measuring Biting Force of Poly-amide Complete Dentures
Official title: Comparison Between Biting Force of Heat Cured Poly Methylmethacrylate and Metal Reinforced Polyamide for Mandibular Complete Denture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complete Edentulism
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-08-18
Enrollment: 24
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to two more groups in parallel for the duration of the study
Primary purpose: TREATMENT

Brief summary: Randomized clinical trial to compare between biting force of mandibular complete denture constructed from two different materials; metal reinforced polyamide and conventional PMMA,The null hypothesis of the study that there will not be a difference between biting force of the complete denture constructed from metal reinforced polyamide and PMMA

Detailed description: Polyamide resins used in dentistry exhibit high flexibility, physical strength, heat and chemical resistance and the exceedingly rare allergy response. Although flexural strength, modulus of elasticity and rigidity of nylon (polyamide) denture base materials are relatively low, they demonstrate great impact strength, toughness, and resistance to fracture. It was suggested that by adding glass fibers to polyamides, their stiffness and other mechanical properties could be increased. The flexural properties of nylon denture base materials has promoted their usage only in conditions like unyielding undercuts, pronounced tuberosities, tori and bulging alveolar ridges. In 2013 Wadachi etal compared rigidity of polyamide and PMMA when used as a denture base material and concluded that; the modulus of elasticity of polyamide was very low in comparison to PMMA and was lower than ISO standard, and so they recommended that polyamide to be used as a denture base material it should be reinforced with metal frame

Eligibility criteria: Inclusion Criteria:

1. Male or female patient with age range from fifty five to sixty five completely edentulous and in good medical condition
2. Patients have skeletal Angle's class I maxillo-mandibular relationship and sufficient inter arch distance.
3. Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
4. Free from any tempro-mandibular disease.
5. Good oral hygiene

Exclusion Criteria:

1. Neuromuscular disorder and orofacial disease.
2. Tempromandibular joint and muscle pain
3. xerostomia or excessive salivation.
4. Limited mouth opening
5. Abnormal tongue behavior and/or size.
6. Intraoral soft and hard tissue pathosis

Primary outcomes:
measure: Biting force
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hadeer Hadi
Study officials:
References:
Clinical trial NCT03741010: Belviq Tablet® Post Marketing Surveillance Protocol
Official title: Belviq Tablet® Post Marketing Surveillance Protocol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Weight Loss
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2018-11-14
Enrollment: 3000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: residents of Korea, in real-world practice

Brief summary: Post-marketing surveillance of Lorcaserin

Detailed description: Lorcaserin(Belviq) is a selective 5-hydroxytryptamine receptor agonist, witch is used long term for weight loss in those who are obese. Lorcaserin was approved in 2015 the Republic of Korea for weigh loss in those who are obese. A post-marketing surveillance was conducted following the approval to obtain data on the safety and efficacy of lorcaserin for weigh loss in real-world practice.

Eligibility criteria: Inclusion Criteria:

Subjects who use the drug as an adjuvant therapy of diet therapy and kinesitherapy for weight control are selected.

1. Obese patients whose body mass index (BMI) is ≧30 kg/m2.
2. Overweight patients whose body mass index(BMI) is ≧27 kg/m2 and who have other risk factors(e.g. hypertension, dyslipidemia, type II diabetes mellitus)

Exclusion Criteria:

1. Patients with a hypersensitivity reaction to the drug or the ingredient of the drug
2. Female patients of childbearing potential and pregnant or lactating women
3. Patients taking another weight control drug
4. Patients with the medical history of drug abuse

Primary outcomes:
measure: Incidence of adverse event after this drug administration in general medical
timeFrame: 12 weeks
Secondary outcomes:
measure: The change from baseline to week 12 in the Body Mass Index(BMI)
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02591810: Treatment Options for Acute Distal Radioulnar Joint Instability
Official title: Comparison of Treatment Options for Acute Distal Radioulnar Joint Instability: A Prospective Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Wrist Injuries
Lead sponsor: Orlando Health, Inc.
Sponsor class: OTHER
First posted: 2015-10-30
Enrollment: 0
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: This prospective randomized control trial (PRCT) aims to compare the outcome of three treatments for acute distal radioulnar joint (DRUJ) injury with instability with or without concomitant distal radius fractures: serial splinting/casting with the hand and wrist in the most stable position for DRUJ reduction vs percutaneous DRUJ fixation with Kirschner wires vs open anatomic foveal repair of Triangular fibrocartilage complex (TFCC ) ligaments.

Detailed description: This is a prospective randomized control trial comparing three methods of treatment for acute DRUJ instability with or without concomitant distal radius fracture. Upon determination of residual DRUJ instability either preoperatively or intraoperatively after distal radius fracture fixation, patients will be randomized into one of the three treatment arms of the study: nonoperative treatment with immobilization, percutaneous DRUJ fixation with Kirschner wires, and open anatomic foveal repair of Triangular fibrocartilage complex TFCC ligaments with suture. Those patients undergoing Kirschner wire fixation will have their pins pulled in the clinic setting six weeks postoperatively. Outcomes will be assessed at follow up visits using the subjective and objective measures and clinical assistants will be blinded as to the treatment type. Physician-based assessment of functional outcome with be assessed using the Disability of the Arm, Shoulder and Hand (DASH) score and Mayo Wrist scores, as well as independent assessment of DRUJ instability, ROM, and grip strength. Patient-based assessment will include visual analog pain scores as well as satisfaction questionnaires.

Eligibility criteria: Inclusion Criteria:

1. Patients treated at Orlando Regional Medical Center,
2. 18 years or older,
3. Have an acute (less than 4 week old) injury with instability of the DRUJ.

Exclusion Criteria:

1. Younger than 18 years old,
2. Patients with an injury over 4 weeks old,
3. Previous history of ipsilateral upper extremity trauma,
4. Functional deficit,
5. Those who are unable to complete postoperative assessments. -

Primary outcomes:
measure: Evaluation and assessment of DASH scores.
timeFrame: Up to 5 years.
Secondary outcomes:
measure: Visual Analog Pain scale
timeFrame: Up to 5 years.
Other outcomes:
measure: Mayo wrist assessment scores
timeFrame: Up to 5 years
measure: Patient satisfaction
timeFrame: Up to 5 years
Locations:
Study officials:
affiliation: Orlando Health
name: Tara Roberts, BS
role: STUDY_CHAIR
References:
Clinical trial NCT04602910: Developing a Web-based Shared Decision-making Tool for Fertility Preservation
Official title: Developing a Web-based Shared Decision-making Tool for Fertility Preservation Among Reproductive-age Women With Breast Cancer: An Action Research Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm Female
Keywords: breast cancer
shared decision making
website
action research
fertility preservation
Lead sponsor: Mackay Medical College
Sponsor class: OTHER
Collaborators: name: Taipei Veterans General Hospital, Taiwan
First posted: 2020-10-26
Enrollment: 25
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of this study was to develop a web-based, shared decision-making (SDM) tool for helping patients with breast cancer make decisions on fertility preservation.

Detailed description: Background: The pregnancy rate after cancer treatment for female survivors is lower than that of the general population. Future infertility is a significant concern for patients with breast cancer and is associated with a poor quality of life. Reproductive- age patients with breast cancer have safe options when choosing the type of fertility preservation method to be applied. Better information and support resources aimed at women to support their decision making are needed.

Objective: The objective of this study was to develop a web-based, shared decision-making (SDM) tool for helping patients with breast cancer make decisions on fertility preservation.

Methods: We used the action research cycle of observing, reflecting, planning, and acting to develop a web-based SDM tool. The following four phrases were applied: (1) Observe and reflect: Collect and analyze the decision-making experiences of patients and health care providers; (2) Reflect and plan: Apply the initial results to create a paper design and modify the content; (3) Plan and act: Brainstorm about the web pages, and modify the content; (4) Act and observe: Evaluate the effectiveness, and refine the website SDM. Interviews, group meetings, and constant dialogue were conducted between the various participants at each step. The effectiveness was evaluated using the Preparation for Decision-Making (prepDM) scale.

Eligibility criteria: Inclusion Criteria:

* Health provider who ever cared the patients with breast cancer.
* Patients with breast cancer who are younger than 50 years old.

Exclusion Criteria:

* none

Primary outcomes:
measure: Preparation for Decision-Making
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Nursing
name: Sheng-Miauh Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tseng LM, Lien PJ, Huang CY, Tsai YF, Chao TC, Huang SM. Developing a Web-Based Shared Decision-Making Tool for Fertility Preservation Among Reproductive-Age Women With Breast Cancer: An Action Research Approach. J Med Internet Res. 2021 Mar 17;23(3):e24926. doi: 10.2196/24926.
Clinical trial NCT04535310: Wear Experience With Daily Contact Lenses Over a Long Day
Official title: Evaluation of Wear Experience With PRECISION1® Contact Lenses on Long Lens-wear Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens
Keywords: Daily Disposable Contact Lens
Spherical Contact Lens
Soft Contact Lens
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2020-09-01
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is evaluating the wear experience of a daily contact lens after 10, 12, 14, and 16 hours of lens wear.


Eligibility criteria: Inclusion Criteria:

* Must be a current spherical contact lens wearer with longs days of lens wear.
* Distance visual acuity of 20/25 or better with current contact lenses.
* Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI).
* Recent eye exam within the past year.
* Must have a working smart phone and be willing to download an app and/or receive and respond to texts.
* Ability to give informed consent.
* Willing to spend time for the study. Subjects will be required to attend three study visits, wear contact lenses on days between study visits, and must respond to push-notifications and/or texts on a smart phone for 5 days between visits 2 and 3.

Exclusion Criteria:

* No current ocular inflammation or infection as assessed by the study investigator.

Primary outcomes:
measure: Subjective Overall Comfort as Assessed Using the Visual Analog Scale (VAS)
timeFrame: Up to 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Optometry
state: Ohio
Study officials:
affiliation: The Ohio State University College of Optometry
name: Jennifer Fogt, OD, MS
role: PRINCIPAL_INVESTIGATOR
References: