louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06743997: A Study to Compare Eutropin Formulations in Healthy Volunteers for Bioavailability, Safety, and Tolerability
Official title: A Randomized, Open Label, Single Subcutaneous Dose, 2x2 Crossover Study to Investigate the Relative Bioavailability, Safety and Tolerability Among Different Eutropin Formulations in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2024-12-20
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: A randomized, Open Label, Single Subcutaneous Dose, 2x2 Crossover Study to Investigate the Relative Bioavailability, Safety and Tolerability among Different Eutropin Formulations in Healthy Volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy adults aged 19 to 40years at screening.
* Voluntarily decide to participate and provide written informed consent.
* Able to receive the investigational product (IP) and pre-treatment drugs.
* Wiliing and able to comply with study requirements, including follow-up visits and blood/urine sampling.

Exclusion Criteria:

* History of conditions contraindicating somatropin or pre-treatment drugs.
* Clinically significant medical history.
* Participation in another clinical trial and receipt of an investigational product within 80 days prior to the first IP administration.

Primary outcomes:
measure: AUClast of somatropin
timeFrame: 0 to 24 hours post-dose
Secondary outcomes:
measure: AUCinf of somatropin
timeFrame: 0 to 24 hours post-dose
measure: Cmax of somatropin
timeFrame: 0 to 24 hours post-dose
measure: Tmax of soatropin
timeFrame: 0 to 24 hours post-dose
measure: T1/2β of somatropin
timeFrame: 0 to 24 hours post-dose
measure: Change in IGF-1 levels
timeFrame: 0 to 24 hours post-dose
measure: Change in IGFBP-3 levels
timeFrame: 0 to 24 hours post-dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT06313697: A Study to Evaluate the Safety, Immunogenicity, and Pharmacokinetics of GR2102 in Healthy Adult
Official title: A Randomized, Double-blind, Placebo-controlled, Single-dose Administration of GR2102 Injection in Healthy Adult Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Pharmacologic of GR2102
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Respiratory Syncytial Virus Infections
Keywords: respiratory syncytial virus
RSV
respiratory infection
Lead sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-03-15
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the goal this clinical trail is to evaluate the safety、Pharmacokinetic and immunogenicity of GR2102 injection。 Subjects will be enrolled in different groups in sequential order, and within each group will be randomly assigned to receive either GR2102 injection or placebo administration, with each Subjects will be enrolled in only one of these groups。

Detailed description: This is a randomized, double-blind, placebo-controlled, single-dose administration study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamic profile of GR2102 Injection in healthy adult Chinese subjects.

After signing the informed consent form, subjects who meet the criteria for enrollment will be entered into different groups according to the randomization number.Subjects will be enrolled in only one of these groups.

Only after the 8 subjects in the current group have completed at least 7 days of safety and tolerability observations and have been determined to be safe and tolerable, will another group of subjects be allowed to proceed to the next group .

After completion of dosing, follow-up will be at least 150 days.

Eligibility criteria: Inclusion Criteria:

1. Healthy adult subjects
2. Signed informed consent

Exclusion Criteria:

1. Signs and symptoms of upper respiratory tract infection prior to randomization
2. Prior use of RSV vaccine or RSV antibody-based medications
3. history of malignant tumor

Primary outcomes:
measure: Adverse events
timeFrame: 150 days post dose
Secondary outcomes:
measure: Maximum Observed Serum Concentration
timeFrame: 150 days post dose
measure: Terminal Elimination Half Life
timeFrame: 150 days post dose
measure: anti-respiratory syncytial virus neutralizing antibodies titer levels
timeFrame: 150 days post dose
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
state: Shandong
Study officials:
affiliation: Shandong First Medical University
name: wei zhao, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05793697: Assessment Of Different Scores In Predicting Outcome In AECOPD Patients In Emergency Department
Official title: Assessment Of Different Scores In Predicting Outcome In Acute Exacerbation Of Chronic Obstructive Pulmonary Disease Patients In Emergency Department
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patient presented to ED with acute exacerbation of COPD no gender discrimination from 18 years to unlimit age

Brief summary: evaluate the value of different scores in predicting hospital mortality and Need for MV In patients presented to ED with AECOPD.

Detailed description: Chronic obstructive pulmonary disease (COPD) is one of the top three causes of death worldwide, and 90% of deaths occur in low- and middle-income countries.

Acute exacerbation of chronic obstructive pulmonary disease(AECOPD) is defined as an acute change in patient's dyspnea, cough, or sputum beyond normal variability that is sufficient to warrant a change in therapy. AECOPD has a negative effect on the quality of life, admission and readmission rates, and disease progression.

For these reasons, appropriate management of acute exacerbations is recommended by national and international organizations.

Identifying high-risk dying patients on hospital admission helps in triaging them to the required level of care.

The use of early warning scores in follow-up is recommended for the early detection of critically ill patients and the prediction of clinical deterioration. CURB65, BAP65, qSOFA , DECAF and NEWS, which mainly involve mental status, respiratory rate, oxygen saturations, pulse, blood pressure, age, BUN level, etc., can be used to predict AECOPD-associated mortality in ED given the simple structure and data availability.

Eligibility criteria: Inclusion Criteria:

* All patient presented to ED with acute exacerbation of COPD.

Exclusion Criteria:

* Patient presented with acute insult affecting other system.
* Patient transferred to other centers.
* Inadequate data.

Primary outcomes:
measure: Evaluate the value of different scores in predicting hospital mortality
timeFrame: one year
Secondary outcomes:
measure: Value of these scores in predicting need for MV.
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Assiut Uneversity
name: reham mo abdelmonem, MD
role: STUDY_DIRECTOR
References:
citation: Redfern OC, Smith GB, Prytherch DR, Meredith P, Inada-Kim M, Schmidt PE. A Comparison of the Quick Sequential (Sepsis-Related) Organ Failure Assessment Score and the National Early Warning Score in Non-ICU Patients With/Without Infection. Crit Care Med. 2018 Dec;46(12):1923-1933. doi: 10.1097/CCM.0000000000003359.
Clinical trial NCT01845597: Survivorship and Outcomes of Robot Assisted Medial Partial Knee Replacement
Official title: Survivorship and Outcomes of Robotically Assisted Medial UKA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unicompartmental Knee Arthroplasty
Lead sponsor: Northwest Surgical Specialists, Vancouver
Sponsor class: OTHER
Collaborators: name: Stryker Instruments
First posted: 2013-05-03
Enrollment: 145
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent a MAKOplasty procedure by the investigating surgeon and received a medial MCK onlay implant.

Brief summary: The purpose of this study is to determine the survivorship rate of robotic assisted medial partial knee replacement at a two, five, and ten years.

Detailed description: The purpose of this study is to determine the survivorship rate of robotically guided MultiCompartmental Knee system (MCK) medial onlay Unicompartmental Knee Arthroplasty (UKA) implants at a two, five, and ten year follow up.

Eligibility criteria: Inclusion Criteria:

* over 21 years of age
* underwent primary robotically guided UKA and received a medial MCK onlay implant by the investigating surgeon
* at least 24 months post-operative

Exclusion Criteria:

* Patients will be excluded from participation in the study if they are cognitively unable to answer study questions

Primary outcomes:
measure: 10 Year Survivorship of Components
timeFrame: 10 years after surgery
Secondary outcomes:
measure: 5 Year Survivorship of Components
timeFrame: 5 years after surgery
measure: 2 Year Survivorship of Components
timeFrame: 2 years after surgery
Other outcomes:
Locations:
city: Vancouver
country: United States
facility: Rebound Orthopedics and Neurosurgery
state: Washington
Study officials:
affiliation: Rebound Orthopedics and Neurosurgery
name: Todd Borus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01315197: Massage for Low Back Pain in Nursing Staff
Official title: Application of Massage for Low Back Pain in Nursing Staff
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low back Pain
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-03-15
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objectives: Semi experimental Clinical Trial aimed at verifying the effectiveness of massage for lower back pain occupational as well as to assess the influence of technique in performing work activities and life in the team nursing.

Detailed description: Method: 18 officials received 7-8 massage sessions, twice per week, with the same protocol points. Data were collected on baseline, after one and two months and they responded 2 questionnaires (Functional Assessment of Oswestry and Risk Assessment in Movement and Transfer Scale) and the Numeric Pain Scale.

Eligibility criteria: Inclusion Criteria:

1. Voluntary participation in the study of employees with availability of time for submission to the sessions
2. Not be pregnant
3. Hold shift of at least 6 hours daily
4. Do not go on vacation or leave care during the study period
5. Reporting back pain self-reported or confirmed by medical diagnosis
6. Not having passed off due to back pain in past 6 months
7. Do not submit spondylolisthesis, disc herniation and sciatic pain self-reported or confirmed by medical diagnosis
8. Do not use anti-inflammatory drugs
9. Individuals that showed greater than 0 (zero) in the Numerical Pain Scale (10) Score higher than 15 on the Functional Assessment Questionnaire Oswestry

Exclusion Criteria:

* Employees who left the study or that lost more than one session

Primary outcomes:
measure: Application of Massage for Low Back Pain in Nursing Staff
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Talita P Borges
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borges TP, Greve JM, Monteiro AP, da Silva RE, Giovani AM, da Silva MJ. Massage application for occupational low back pain in nursing staff. Rev Lat Am Enfermagem. 2012 May-Jun;20(3):511-9. doi: 10.1590/s0104-11692012000300012. English, Portuguese, Spanish.
Clinical trial NCT00713297: Implementation of a Novel Computerized Physician Order Entry System
Official title: Implementation of a Novel Computerized Physician Order Entry System to Reduce Medication Errors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Computerized Physician Order Entry
Keywords: medication errors
computerized physician order entry
pharmaceutical care
chemotherapeutic agents
reengineering
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University
First posted: 2008-07-11
Enrollment: 80
Sex: ALL
Minimum age (years): 24
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NTUH pharmacists

Brief summary: The objective of this prospective study is to build a real-time interactive platform where doctors and pharmacists may communicate and solve patients' drug-related problems (DRP) immediately and document accordingly. This study will also design a computerized physician order entry (CPOE) system utilizing default protocol for chemotherapy order entry.

Detailed description: To err is human. Most errors are caused by problems in the system. Punishing health personnel cannot prevent the same mistakes. The only solution is a good medication system. CPOE system can prevent prescribing errors. The CPOE system is always the major step in some studies concerning reducing prescribing errors, dispensing errors or administering errors. In this user-friendly and convenient era, improvement in the CPOE system is an immediate need.

Eligibility criteria: Inclusion Criteria:

* NTUH pharmacists

Exclusion Criteria:

* NTUH pharmacists who have never recorded drug related problems

Primary outcomes:
measure: the timeliness and efficiency of pharmacist's response in DRPs, the average prescription error rate and the satisfaction questionnaire before and after implementation of the new CPOE system.
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Pharmacy, N.T.U.H.
name: Fe-Lin L. Wu, MSCP,Ph D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03860597: Memantine Effects on Sensorimotor Gating and Neurocognition in Schizophrenia
Official title: Memantine Effects on Sensorimotor Gating and Neurocognition in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizo Affective Disorder
Schizoaffective Disorder
Healthy
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This application seeks to determine if neurophysiological metrics of memantine (MEM)-enhanced early auditory information processing (EAIP) in schizophrenia (SZ) mediate gains in auditory processing fidelity (APF) and auditory learning.


Eligibility criteria: Inclusion Criteria:

* diagnosis of schizophrenia OR schizoaffective-depressed OR healthy subjects
* ages 18-50 for all subjects
* double barrier contraception for all subjects
* not pregnant for all subjects

Exclusion Criteria:

* DSM-IV Axis I or II Diagnosis for for healthy subjects
* MEM or amantadine for patients
* current substance abuse for all subjects
* current recreational drug use for all subjects
* history of other significant medical illness (e.g. cancer, diabetes, heart disease, HIV, seizures) for all subjects
* open head injury or closed head injury with loss of consciousness \> 1 min for all subjects
* hearing or visual impairment for all subjects
* pregnancy for all subjects
* dementia for all subjects
* mental retardation for all subjects

Primary outcomes:
measure: Prepulse Inhibition (PPI)
timeFrame: 7 and 14 days post baseline
measure: Mismatch Negativity (MMN); Unit of Measure of MMN is Microvolts.
timeFrame: 7 and 14 days post baseline
measure: Gamma Auditory Steady-state Response (ASSR). The Primary Unit of Measure of Auditory Steady State Response (ASSR) is Gamma Evoked Power (γEP), Expressed as "Microvolts-squared".
timeFrame: 7 and 14 days post baseline
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Clinical Teaching Facility (CTF-B102) at UCSD Medical Center
state: California
Study officials:
References:
citation: Molina JL, Voytek B, Thomas ML, Joshi YB, Bhakta SG, Talledo JA, Swerdlow NR, Light GA. Memantine Effects on Electroencephalographic Measures of Putative Excitatory/Inhibitory Balance in Schizophrenia. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Jun;5(6):562-568. doi: 10.1016/j.bpsc.2020.02.004. Epub 2020 Feb 22.
Clinical trial NCT03402997: Tissue Resistivity in Breast Cancer Patients
Official title: Minimally Invasive Procedure for the Discrimination of Tissue Resistivity in Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
Collaborators: name: Politecnico di Milano
name: Clinical Trial Unit Ente Ospedaliero Cantonale
First posted: 2018-01-18
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The target population of this study are female patients with first radiological diagnosis of breast cancer needing for surgery and subsequent histological examination to confirm the diagnosis.

Brief summary: The resistivity measurements will be done by introducing a needle-probe into fresh healthy, peritumoral, and tumoral ex vivo tissues.

Detailed description: Patients affected by breast cancer will have their tissue analysed immediately following their surgical excision for the treatment of breast cancer. Two probes will be used: a linear probe of 4 needle-electrodes positioned in a row that is able to perform Electrical Impedance Spectroscopy (EIS) measurements and a circular probe of 8 needle-electrodes arranged into a circular pattern that is able to generate cross sectional images (Electrical Impedance Tomography maps). Firstly, the linear probe will be inserted in the tumor parenchyma at a penetration depth of about 2 mm and the tissue impedance measurement will be performed along a broad spectrum of frequencies for few minutes. Approximately 10 seconds for each measurement will be needed. Subsequently, if the size of the tissue will allow it, the circular probe will be inserted in the tumor parenchyma at the same penetration depth and 10 cross sectional maps will be generated (approximately 30 seconds in total). Both information obtained using the linear and the circular probes will be integrated for a full characterization of the tissue under examination.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* First radiological diagnosis of breast adenocarcinoma needing a histological confirmation
* Written Informed Consent

Exclusion Criteria:

* Tumor mass diameter \< 1 cm
* Surgical specimen (harbouring tumoral + peritumoral tissue) diameter \< 2 cm

Primary outcomes:
measure: Breat tissue characterization
timeFrame: 30 minutes from surgery
Secondary outcomes:
measure: Evaluation of the precision of each EIS measurement
timeFrame: 30 minutes from surgery
measure: Correlation between electrical and biological results
timeFrame: 30 minutes from surgery
Other outcomes:
Locations:
city: Mendrisio
country: Switzerland
facility: Ospedale Regionale di Mendrisio
Study officials:
References:
Clinical trial NCT06342297: Dermatoscopy Guided Resection for Skin Cancer
Official title: Dermatoscopy Guided Resection Margins in Basal Cell Carcinoma and Cutaneos Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Basal Cell Carcinoma
Cutaneous Squamous Cell Carcinoma
Surgical Margin
Keywords: Dermatoscopy
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 400
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: In this randomizid controlled trial the aim is to use dermatoscopy in deciding the resection margin for patients with suspected or verified basal cell carcinoma or cutaneous squamous cell carcinoma. The outcome is radical/non radical resection of the lateral margins in the pathology report.

Detailed description: In basal cell carcinoma and especially cutaneous squamous cell carcinoma the prognosis is very good if the tumour is radically removed in the primary resection. In this study we propose that the use of dermatoscopy in deciding the surgical margins can increase the proportion of radically removed tumours. In this randomized clinical trial the use of dermatoscopy in deciding the surgical margins in patients with suspected or verified basal cell carcinoma or cutaneous squamous cell carcinoma is assessed. The outcome measure is radical/non radical resection of the lateral margins. In the control group dematoscopy is not used in deciding the surgical margin. 400 patients with suspected or verified BCC or cSCC will be included, 200 in each group.

Eligibility criteria: Inclusion Criteria:

* Patients with primary suspected or verified basal cell carcinoma or cutaneous cell carcinoma

Exclusion Criteria:

* Recurrent tumours
* Previous radiotherapy of the tumour area
* If the patient cannot understand the study i nformation

Primary outcomes:
measure: Pathology resection side margin (radical/not radical)
timeFrame: Pathology report usually within two weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
References: