louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00386659: Immune Reconstitution in naïve HIV Patients With CD4 <100 Cells/mL When Treated With Lopinavir or Efavirenz.
Official title: A Randomized, Pilot Study on the Antiviral Activity and Immunological Effects of Lopinavir/Ritonavir vs. Efavirenz in Treatment-naïve HIV-Infected Patients With CD4 Cell Counts Below 100 Cells/mm3
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: HIV Infection
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2006-10-11
Enrollment: 60
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: Pilot, randomized, parallel, open-label, controlled, clinical study evaluating virological response in plasma and extra-plasmatic compartments, together with the degree and kinetics of immune reconstitution in treatment-naïve patients with CD4 count below 100 cells/mL, when treated with tenofovir and abacavir together with lopinavir or efavirenz.


Eligibility criteria: Inclusion Criteria:

* HIV-infection
* Antiretroviral-naive
* CD4 cell count below 100 cells/mm3

Exclusion Criteria:

* Pregnancy
* Current opportunistic infection requiring parenteral therapy
* Current malignancies requiring parenteral chemotherapy
* Any contraindication to the study drugs

Primary outcomes:
measure: Proportion of patients with viral load below 20 copies/ml in plasma and lymphoid tissue at 12 months.
Secondary outcomes:
measure: Degree and kinetics of recovery of the immune system.
measure: New CDC C events
measure: Mortality
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: CSU Bellvitge
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital de Sant Pau
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Josep M Gatell, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04408859: Quality of Life in Advanced Gastric Cancer Patients Receiving Neoadjuvant Chemotherapy
Official title: Quality of Life in Patient With Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Gastric Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: QOL; Quality of Life;Gastric Cancer; Gastrectomy;Neoadjuvant Chemotherapy
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 290
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: Patients who have had curative resection at Beijing Cancer Hospital for advanced gastric cancer and finish the questionnaire.

Brief summary: The purpose of this study is to explore the influence of neoadjuvant chemotherapy in the long term quality of life with advanced gastric cancer patients.

Detailed description: Preoperative adjuvant chemotherapy combined with postoperative adjuvant therapy mode was included in the 2018 version of the National Comprehensive Cancer Network (NCCN) guideline as an optional treatment (category 2B) for prospective resectable advanced gastric cancer cases (≥cT2, any N).At home and abroad, the research on neoadjuvant chemotherapy for advanced gastric cancer mainly focuses on the safety and long-term survival, and there are few studies on the quality of life. This study, according to EORTC QLQ-C30 and QLQ-STO22 assessment scale, explores the long term effect of neoadjuvant chemotherapy on the quality of life in patients with advanced gastric cancer.

Eligibility criteria: Inclusion Criteria:

* Patients age older than 18 years (including 18 years old);
* Diagnosis of adenocarcinoma of the stomach
* The clinic stage is ≥T2 and any N stage
* Patient had curative surgical resection, including proximal, distal, or total gastrectomy

Exclusion Criteria:

* Psychiatric or psychological abnormality precluding informed consent or ability to complete questionnaires
* Non-psychiatric disorder causing a lack of capacity to give consent or an inability to complete questionnaires (ie dementia, stroke)
* Early gastric cancer.

Primary outcomes:
measure: Quality of life index
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03199859: Early Diagnosis and Treatment Standardization of Delirium
Official title: Early Diagnosis and Treatment Standardization of Delirium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Keywords: gastric cancer
postoperative
subsyndromal delirium
quality of life
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-06-27
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the gastric cancer department of general surgery at Seoul National University Hospital due for surgical resection were included.

Brief summary: 1. Observe the characteristics of delirium patients, searching for early diagnostic methods or finding risk factors
2. Design a guideline for delirium, diagnosis or treatment

Detailed description: The study is consisted of two parts; First, observational study of gastric cancer patients admitted to hospital, diagnosing the presence of delirium or subsyndromal delirium and collecting patient data, including assessment, self-report surveys, and electronic medical records.

Second, Designing a guideline for treating delirium patients in Korea using the study data and reviewing other studies, guidelines.

Eligibility criteria: Inclusion Criteria:

* Curable malignant gastric cancer

Exclusion Criteria:

* Gastrointestinal stromal tumor
* Uncurable cancer

Primary outcomes:
measure: Delirium Rating Scale-98
timeFrame: Till 1 year after surgery
Secondary outcomes:
measure: Functional assessment of cancer therapy - gastric cancer
timeFrame: Till 1 year after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT05567159: A Study of Donanemab (LY3002813) in Healthy Participants
Official title: A Phase 1, Open-Label Study to Characterize the Pharmacokinetics of Donanemab Following Intravenous Doses in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-10-05
Enrollment: 42
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: BASIC_SCIENCE

Brief summary: The main purpose of this study is to assess how fast donanemab (LY3002813) gets into the blood stream and how long it takes the body to remove it when administered as single dose in healthy participants. The study will also evaluate the safety and tolerability of donanemab. The study will last up to approximately 22 weeks.


Eligibility criteria: Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation
* Have a body mass index (BMI) of 19.0 and 32.0, kilograms per meter squared (kg/m²), inclusive.
* Females of childbearing potential will be excluded from the study.

Exclusion Criteria:

* Have allergies to either humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone
* Have a history within the past 5 years of a primary or recurrent malignant disease
* Have used over-the-counter or prescription medications, including herbal medication, within 7 days prior to dosing
* Are pregnant or intend to become pregnant or to breastfeed during the study
* Smoke more than 10 cigarettes per day or are unable to abide by investigative site smoking restrictions
* Have a history of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, carotid, carotid artery occlusion, stroke or epilepsy or family history of dementia or Down's syndrome

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Four Weeks (AUC[0-4 Weeks]) of Donanemab (i.e) Period 2, Period 4, Period 6.
timeFrame: Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on days 1, 15, 29, 43, 57, 71
measure: PK: Maximum Observed Concentration During a Dosing Interval at Steady State (Cmax, ss) of Donanemab
timeFrame: Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on day 71
measure: PK: Area Under the Concentration Versus Time Curve During a Dosing Interval at Steady State (AUCτ,ss) of Donanemab
timeFrame: Predose, end of infusion, 24, 48, 72, 96, 168, 336 hours post-dose on day 71
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: ICON Early Phase Services Lenexa Center
state: Utah
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04564859: The Efficiency of HHHFNC Between Unheated Oxygen Therapy in Difficult Weaning Patients After Extubation in RCC
Official title: The Efficiency of Heated Humidifier High-Flow Nasal Cannula Between Unheated Oxygen Therapy in Difficult Weaning Patients After Extubation in Respiratory Care Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critically Illness
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Fu Jen Catholic University
First posted: 2020-09-25
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the efficacy of Heated Humidified High-Flow Nasal Cannula compared with noninvasive positive-pressure ventilation in the prevention of extubation failure in patients with prolonged mechanical ventilation.

Detailed description: There have been many clinical trials comparing the role of Heated Humidified High-Flow Nasal Cannula or Noninvasive positive pressure ventilation in the prevention of extubation failure.

These review all have similar results summarized here:

Compared with Noninvasive positive pressure ventilation, Heated Humidified High-Flow Nasal Cannula provides better patient comfort, fewer oxygen desaturation episodes, lower likelihood of interface displacement, and, lower reintubation rate than Noninvasive positive pressure ventilation.

However, most of these clinical trials focused on participants experiencing acute respiratory failure.

Investigators of this study want to find something difference between oh these two groups.

Eligibility criteria: Inclusion Criteria:

* Age: Over 20 years of age
* the requirement of at least six hours of mechanical ventilation per day for at least 14 consecutive days

Exclusion Criteria:

* Pregnancy
* Status post tracheostomy
* Neuromuscular diseases
* Signed "do not resuscitate" order
* Unplanned extubation

Primary outcomes:
measure: Re-intubation rate
timeFrame: within 72 hours of extubation
Secondary outcomes:
measure: Mortality rate
timeFrame: up to 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Chen-Chun Lin, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03125759: The Association of Omentin and Ischemic Stroke
Official title: The Association of Omentin and Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Brain Ischemia
Adipokines
Mutation
Keywords: Ischemic Stroke
Omentin
Lead sponsor: Xi'an No.3 Hospital
Sponsor class: OTHER_GOV
First posted: 2017-04-24
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the study population is from primary care clinic, physical examination center, and social volunteers.

Brief summary: This observational study aims to research whether there is a relationship between omentin and ischemic stroke on the aspects of incidence, severity, and recovery etc.

Detailed description: To study the possible relationship between omentin and ischemic stroke, we intend to recruit the newly found acute ischemic stroke patients and patients without any stroke history and analysis the difference of plasma omentin level and the ITLN, which is the gene symbol of omentin.

Eligibility criteria: Inclusion Criteria:

* For ischemic stroke group,acute clinically defined ischemic stroke
* For control group, without any history of stroke

Exclusion Criteria:

For ischemic stroke group

* Hemorrhagic Stroke
* Previous Ischemic Stroke For control group
* The expected life expense less than 3 years

Primary outcomes:
measure: the odds ratio of omentin plasma concentration between cases and controls
timeFrame: up to 3 years
measure: the frequency difference of single nucleotide polymorphism(SNP) of omentin in the enrolled subjects
timeFrame: up to 3 years
Secondary outcomes:
measure: the NIHSS assessed for functional outcome of stroke
timeFrame: up to 3 years
measure: the modified Rankin Scale assessed for functional disability
timeFrame: up to 3 years
measure: the Barthel index assessed for functional independence in activities
timeFrame: up to 3 years
measure: the number of all cause death
timeFrame: up to 3 years
measure: the number of re-stroke in case group
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xi'an No.3 Hospital
state: Shanxi
Study officials:
affiliation: Xi'an No.3 Hospital
name: Tian Ye, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02704559: Study to Explore Drug-drug Interactions Between DWC20155 and DWC20156 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2016-03-10
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, open-label, oral dose, crossover study to explore drug-drug interactions between DWC20155 and DWC20156 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Accepts healthy volunteers.

Exclusion Criteria:

* Who has allergy to investigational product

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 0~24hr
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: 0~24h
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Busan Paik Hospital
Study officials:
References:
Clinical trial NCT04008459: Walking and Balance Related to Sagittal Spinal Posture Alignment
Official title: WiSPA: Walking and Balance Related to Sagittal Spinal Posture and Alignment
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hyperkyphosis
Walking, Difficulty
Balance; Distorted
Spinal Disease
Osteoporosis
Spine Degeneration
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 41
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with a degenerative spinal condition who have been referred to outpatient physiotherapy treatment.

Brief summary: This study aims to improve understanding of the relationship between spinal alignment and walking and balance in people who have degenerative spinal conditions.

Detailed description: This prospective cohort study will include people who are attending physiotherapy to address a degenerative spinal condition and measure them longitudinally. The investigators will measure spinal alignment, walking capacity and pattern, dynamic balance, and back muscle strength along with self-reported measures that reflect the person's functional self-efficacy, quality of life, and general health. Physical and self-reported outcome measures will be assessed at baseline before the physiotherapy-led exercise class commences, after completion at 6 weeks, and 6 months post baseline.

Eligibility criteria: Inclusion Criteria:

* Participant is diagnosed with a degenerative spinal condition.
* Participant is willing and able to give informed consent for participation in the study.
* Men and women aged 18 years or older.
* Participant is able to understand and participate safely in a physiotherapy measurement assessment.
* Participant is enrolled in physiotherapy.

Exclusion Criteria:

* Participant is unable to stand independently.
* Participant has a neurological condition which alters motor function and/or postural control.

Primary outcomes:
measure: Change in sagittal spinal alignment
timeFrame: 6 weeks post-baseline
Secondary outcomes:
measure: Sagittal spinal alignment
timeFrame: 6 months
measure: 2 minute walk test
timeFrame: 6 weeks and 6 months
measure: Gait analysis
timeFrame: 6 weeks and 6 months
measure: Tragus to wall distance
timeFrame: 6 weeks and 6 months
measure: Four Square Step Test
timeFrame: 6 weeks and 6 months
measure: Timed loaded standing test
timeFrame: 6 weeks and 6 months
measure: 36-item Short Form Health Survey (SF-36)
timeFrame: 6 weeks and 6 months
measure: Visual analogue pain scale
timeFrame: 6 weeks and 6 months
measure: Activities-specific Balance Confidence Scale
timeFrame: 6 weeks and 6 months
measure: Modified gait efficacy scale
timeFrame: 6 weeks and 6 months
measure: Sagittal spinal alignment
timeFrame: Within 2 weeks of baseline
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Nuffield Orthopaedic Centre
state: Oxon
Study officials:
affiliation: University of Oxford
name: Erin Hannink, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00940459: Subjective and Conjunctival Response to Edge Design of Different Silicone Hydrogels
Official title: Subjective and Conjunctival Response to Edge Design of Different Silicone Hydrogels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lenses
Keywords: contact lenses
conjunctival staining
contact lens wear
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-07-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study was to evaluate the effect of different contact lens edge designs on the circumlimbal conjunctiva.


Eligibility criteria: Inclusion Criteria:

* Minimum age of 18 years old
* Adapted contact lens wearer
* Sign informed consent
* Normal eyes with the exception of the need for visual correction
* Astigmatism less than or equal to -0.75 diopter
* Spherical prescription range between -10.00 and +6.00 diopters
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Any known sensitivity to the test articles used in the study
* Monocular vision
* Lid or conjunctival infections or abnormalities
* Conjunctival staining greater than Grade 1
* Corneal staining greater than Grade 2
* Corneal edema or opacifications
* Aphakia
* Any previous corneal surgery
* Iritis
* Recent significant changes in visual acuity
* Ocular disease that contraindicates contact lens wear
* Tarsal abnormalities greater than Grade 2
* Any ophthalmic medication
* Any systemic medication or condition that might affect the subject's participation in the study
* Chronic upper respiratory infections or colds
* Pregnancy or planning to become pregnant
* Lactation
* Seasonal allergies
* Known infections or immunosuppressive disease
* Participation in other studies
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Circumlimbal Conjunctival Staining (CCS)
timeFrame: After 10 days of wear
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Optometric Technology Group Ltd
Study officials:
References:
citation: Maissa C, Guillon M, Garofalo RJ. Contact lens-induced circumlimbal staining in silicone hydrogel contact lenses worn on a daily wear basis. Eye Contact Lens. 2012 Jan;38(1):16-26. doi: 10.1097/ICL.0b013e31823bad46.
Clinical trial NCT06007859: Patients Who Underwent Thyroid Ultrasonography at Our Institution Were Selected for Shear Wave Elastography of Thyroid Nodules, and the Maximum and Mean Values of the Modulus of Elasticity of the Nodules in Transverse and Longitudinal Sections Were Analyzed.
Official title: Influence of Section Orientation of Ultrasound Shear Wave Elastography on the Measurement of Thyroid Nodules Stiffness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Nodules
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 67
Sex: ALL
Minimum age (years): 22
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with thyroid nodules attending the First Affiliated Hospital of Shandong First Medical University were selected.

Brief summary: The objective of this observational study was to evaluate the effect of transverse and longitudinal sections on the measurement of thyroid nodule stiffness by shear wave elastography. The main questions it aims to answer are: (i) to compare the diagnostic efficacy of different section orientations of shear wave elastography for the diagnosis of benign and malignant thyroid nodules; (ii) to analyze the correlation between the two orientations of transverse and longitudinal sections of shear wave elastography; and (iii) to compare the reliability and consistency of the two orientations of transverse and longitudinal sections of shear wave elastography for the diagnosis of thyroid nodules. Participants will undergo routine ultrasound examination of the thyroid gland and shear wave elastography, and the measured modulus of elasticity of the nodules in both transverse and longitudinal sections will be recorded.


Eligibility criteria: Inclusion Criteria:

All patients underwent preoperative shear-wave elastography ultrasonography; thyroid nodules ranged from 3 to 20 mm in size; all nodules underwent puncture biopsy or surgery to obtain pathologic results.

Exclusion Criteria:

Unavailability of pathology results for various reasons; poor quality of ultrasound images; missing data.

Primary outcomes:
measure: elastic modulus values
timeFrame: The elastic modulus values of different sections were recorded immediately after the patients underwent routine ultrasound and shear wave elastography and the recorded results were saved.
Secondary outcomes:
Other outcomes:
Locations:
city: Shandong
country: China
facility: QianfoshanH
Study officials:
References: