louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05900167: Feeding Intolerance Risk Prediction Model in Patients With Enteral Nutrition Through Nasogastric Tube
Official title: Feeding Intolerance Risk Prediction Model in Patients With Enteral Nutrition Through Nasogastric Tube
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Enteral Nutrition
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 442
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The sample size calculation method of this study was based on the results of previous literature studies to obtain enteral nutritional feeding intolerance According to the sample size estimation method of N= \[(risk variable) ×(5 \~ 10)\]

,the incidence of feeding intolerance was 41.3%,so at least 269 samples are needed for further examination.Considering a 10% loss of follow-up rate, the estimated sample size is 299 cases, the data collected in this part of the study as the model Develop the data set.Using the ratio of modeling group: test group = 7:3, and considering 10% loss of follow-up rate, the minimum sample of test group was 143 cases. Therefore, a total of at least 442 samples are needed in this study.

Brief summary: To explore the risk factors of enteral feeding intolerance in critically ill patients, build a risk prediction model and verify it, in order to provide reference for early identification and screening of high-risk groups

Detailed description: Based on the previous literature study, the risk factors of enteral feeding intolerance in critically ill patients were obtained, and the general demographic, disease and treatment information of patients were collected. Four machine learning algorithms, namely traditional logistic regression, random forest, support vector machine and naive Bayes, were used to construct risk prediction models, and the optimal model was selected and verified by comparing the model performance

Eligibility criteria: Inclusion Criteria:

* The nutritional status of the patient is assessed by the doctor and the need for enteral nutrition is determined;Patients with first nasogastric tube insertion and successful enteral feeding;There was no gastrointestinal discomfort before enteral nutrition;Patients (or family members) authorized to participate in this study and signed informed consent

Exclusion Criteria:

* Previous gastrointestinal disease or gastrointestinal surgery;enteral nutrition through gastrostomy tube or jejunostomy tube;discontinuation or suspension of enteral nutrition for special reasons other than feeding intolerance;Patients with serious lack of clinical data

Primary outcomes:
measure: Feeding intolerance
timeFrame: Follow-up was considered complete when the patient reached 7 days of enteral nutrition, the patient was transferred from the ICU, or the patient experienced nutritional interruption for other reasons
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04255667: Eyelid Crush for Marginal Eyelid Surgery
Official title: Outcome of Eyelid Crush for Intraoperative Hemostasis of Eyelid Margin Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Eyelid Diseases
Keywords: eyelid margin
hemostasis
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 60 patient with marginal eyelid diseases surgeries will undergo surgeries

Brief summary: Surgery involves eyelid margin asscocited with intraoperative bleeding. Proper intra-operative homeostasis is essential for good intraoperative procedure and postoperative results.

Detailed description: baseline and postoperative full ophthalmic examination was done.Procedure include all surgeries involving eyelid margin

Eligibility criteria: Inclusion Criteria:

* All surgeries involving eyelid margin

Exclusion Criteria:

* bleeding tendency

Primary outcomes:
measure: amount of intraoperative bleeding
timeFrame: intraoperative
Secondary outcomes:
measure: time of operation
timeFrame: intraoperative
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: INMC
Study officials:
affiliation: Benha university faculty of medicine
name: TAREK R ELHAMAKY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06260267: A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults With Mild to Moderate Ulcerative Colitis
Official title: A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults With Mild to Moderate Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Ulcerative Colitis
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-02-15
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: To explore the safety of FE 999322 (microbiota suspension) and FE 999324 (microbiota capsule) versus placebo in subjects with active mild to moderate ulcerative colitis (UC).


Eligibility criteria: Inclusion Criteria:

* Subject aged ≥18 at screening
* Established diagnosis of ulcerative colitis by standard clinical, endoscopic and histological criteria, for more than 3 months at screening

Exclusion Criteria:

* Active disease or history of Crohn's disease
* Active disease or history of irritable bowel syndrome (IBS) or any other chronic intestinal disease apart from UC
* Active gastrointestinal infection.

Primary outcomes:
measure: Treatment-emergent adverse events from baseline to week 52
timeFrame: From baseline to week 52
Secondary outcomes:
Other outcomes:
Locations:
city: North Little Rock
country: United States
facility: Ferring Investigational Site
state: Arkansas
city: Hamden
country: United States
facility: Ferring Investigational Site
state: Connecticut
city: Inverness
country: United States
facility: Ferring Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Ferring Investigational Site
state: Florida
city: Orange City
country: United States
facility: Ferring Investigational Site
state: Florida
city: Glenview
country: United States
facility: Ferring Investigational Site
state: Illinois
city: Gurnee
country: United States
facility: Ferring Investigational Site
state: Illinois
city: Shreveport
country: United States
facility: Ferring Investigational Site
state: Louisiana
city: Boston
country: United States
facility: Ferring Investigational Site
state: Massachusetts
city: Oklahoma City
country: United States
facility: Ferring Investigational Site
state: Oklahoma
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References:
Clinical trial NCT04427267: Assessment of Thermal Condition of Health Workers Who Use Personal Protective Equipment From Biological Hazards During Their Work With COVID-19 Patients
Official title: Assessment of Thermal Condition of Health Workers Who Use Personal Protective Equipment for Biological Factors During Their Work With COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thermal Condition of Health Workers Who Use Personal Protective Equipment From Biological Hazards During Their Work With COVID-19 Patients
Keywords: Thermophysiology
Personal protective equipment from biological hazards
Medical workers
COVID-19
Lead sponsor: Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health workers

Brief summary: This research will provide data on thermal condition of medical workers who use personal protective equipment from biological hazards. Aquired data will be used to define acceptable period of use for these protective costumes.

This research will recruit 6 volunteers. During 6 hours each subject will perform their work using protective costume. Heart rate, skin and air temperature under costume and hygrometric data will be registered. Also there will be questionnaires for volunteers for subjective assessment of thermal and moisture sensations.


Eligibility criteria: Inclusion Criteria:

* healthy individuals (based on medical screening)

Exclusion Criteria:

* endocrinological diseases and disorders
* health deviations at the time of the study

Primary outcomes:
measure: Skin thermometry
timeFrame: 6 hours
measure: Hygrometry under costume
timeFrame: 6 hours
measure: Heart rate
timeFrame: 6 hours
measure: Air thermometry
timeFrame: 6 hours
measure: Air hygrometry
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Scientific Institution Izmerov Research Institute of Occupational Health
Study officials:
References:
Clinical trial NCT05008367: Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty
Official title: Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: Naestved Hospital
Sponsor class: OTHER
Collaborators: name: Copenhagen Trial Unit, Center for Clinical Intervention Research
First posted: 2021-08-17
Enrollment: 485
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: Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial This explorative post-hoc analysis is a substudy of the DEX-2-TKA-trial (NCT03506789) investigating diffefferent subgroups of the patients included in the main trial.

Detailed description: Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial This explorative post-hoc analysis is a substudy of the DEX-2-TKA-trial (NCT03506789) investigating diffefferent subgroups of the patients included in the main trial.

Eligibility criteria: Inclusion Criteria:

* Participation in the DEX-2-TKA-trial

Primary outcomes:
measure: Cumulative usage of morphine 0-48 hours postoperatively
timeFrame: Time Frame: 0-48 hours postoperatively
Secondary outcomes:
Other outcomes:
measure: Subgroup analysis on heterogeneity in intervention effect of age
timeFrame: Time Frame: 0-48 hours postoperatively
measure: Subgroup analysis on heterogeneity in intervention effect of sex
timeFrame: Time Frame: 0-48 hours postoperatively
measure: Subgroup analysis on heterogeneity in intervention effect of ASA group
timeFrame: Time Frame: 0-48 hours postoperatively
measure: Subgroup analysis on heterogeneity in intervention effect of preoperative pain at rest
timeFrame: Time Frame: 0-48 hours postoperatively
measure: Subgroup analysis on heterogeneity in intervention effect of preoperative pain when active
timeFrame: Time Frame: 0-48 hours postoperatively
measure: Subgroup analysis on heterogeneity in intervention effect of type of anesthesia
timeFrame: Time Frame: 0-48 hours postoperatively
measure: Subgroup analysis on heterogeneity in intervention effect of prior daily use (last month) of analgesic medication
timeFrame: Time Frame: 0-48 hours postoperatively
Locations:
city: Brøndbyvester
country: Denmark
facility: Gildhøj Privathospital
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Køge
country: Denmark
facility: Sjællands Universitetshospital, Køge
city: Næstved
country: Denmark
facility: Næstsved Sygehus
city: Odense
country: Denmark
facility: Odense Universitetshospital
Study officials:
References:
Clinical trial NCT00886067: Positron Emission Tomography (PET) Study
Official title: An Open-label Positron Emission Tomography (PET) Study Using 2 [18F] F A85380 to Determine α4β2 Neuronal Nicotinic Receptor (NNR) Occupancy of AZD1446 After Oral Administration to Male and Non-fertile Female (Non-nicotine Users) Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: AZD1446
PET examination
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-04-22
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose is to study the occupancy at the α4β2 neuronal nicotinic receptor's (NNRs) and to determine the relation between plasma concentration of AZD1446 and the occupancy at α4β2 NNRs.


Eligibility criteria: Inclusion Criteria:

* Physically healthy volunteers
* Body weight between 50 to 100 kg and body mass index (BMI) between 19 and 30 kg/m2

Exclusion Criteria:

* History of any clinically significant disease or disorder
* History of severe allergy/hypersensitivity reactions
* Participation in a PET examination as part of a scientific study during the past twelve months

Primary outcomes:
measure: Determine whether and to what extent AZD1446 can displace radioligand 2-[18F]-F-A85380 from binding to α4β2 neuronal nicotinic receptors (NNRs) and to describe the relationship between plasma concentrations of AZD1446 and its occupancy at α4β2 NNRs.
timeFrame: One PET assessment on baseline day and one PET assessment at the drug treatment day
measure: Plasma concentration (Cmax, tmax, AUC)
timeFrame: During time period of the PET assessment
Secondary outcomes:
measure: Safety and tolerability (AEs, vital signs, lab)
timeFrame: During the whole study
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca Södertälje
name: Björn Paulsson, MD, PhD
role: STUDY_DIRECTOR
affiliation: AstraZeneca CPU Huddinge
name: Ingemar, Bylesjö, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04741867: The Effect of Education Based on Roy Adaptation Model for Infertile Individuals on Adaptation and Coping With Stress
Official title: Hasan Kalyoncu University Health Sciences Institute
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Education
Lead sponsor: Gaziantep Islam Science and Technology University
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Psychosocial counseling applied together with infertility treatment programs makes infertile women more resistant to stress, increases the effectiveness of infertility treatments and encourages infertile patients to continue treatment by improving their mental health.

It appears that learning adaptation strategies in infertile couples is concurrent with health promotion. In addition to medical treatments, it is aimed to add training to be given in accordance with the Roy Adaptation model, to adapt to the process and infertility, and to control stress in infertile individuals in the management of the process.

The study was planned to examine the effect of education based on the roy adaptation model for infertile individuals on adaptation and coping with stress.


Eligibility criteria: Inclusion Criteria:

* 18-45age difference

Primary infertility

Exclusion Criteria:

- Secondery infertility

Primary outcomes:
measure: Training effectiveness
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu Üniversitesi
Study officials:
affiliation: Hasan Kalyoncu University
name: Ayşe Duygu Özbaş
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05489367: Does COVİD-19 m-RNA Vaccine Affect Fertility and Over Reserve ?
Official title: Does COVİD-19 m-RNA Vaccine Affect Fertility and Over Reserve ?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Virus Infection
Ovarian Function Insufficiency
Fertility Disorders
Vaccine Adverse Reaction
Keywords: ovarian reserve
covid-19
vaccine
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2022-08-05
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 74 ovulatory women who were not vaccinated with Biontech.

Brief summary: Women's ovarian reserve and fertility were compared before and after 2 doses of vaccination

Detailed description: our study ıs desıgned as an observatıonal clınıcal study. the purpose ıs to compare the over reserve tests of the patıents before and after vaccıne, to determıne ıf the over reserve and fertılıty of women are affected by the vaccıne.women who applied to the vaccination outpatient clinic for the first dose of vaccine were included in the study.those who have never been vaccinated and have not had covid 19 infection were included in the study.antı ullerıan hormone level ıs the laboratory parameters that best showıng the ovary reserve today. ovarian reserve tests including amh were checked and their fertility was questioned and their information was recorded.

the same tests were repeated after the volunteers received 2 doses of vaccine. ın the power analysis, it was calculated that 104 volunteers should be included in the study.the study will be terminated when 104 volunteers are reached.

Eligibility criteria: Inclusion Criteria:

* between 18-45 years old
* have ever had a covid vaccine
* not be infected with covid 19

Exclusion Criteria:

* pregnancy
* diagnosis of any kind of cancer
* oral contraceptive usage
* endometrioma
* PCOS
* menopause
* menstrual irregularity
* premature ovarian insufficiency

Primary outcomes:
measure: Ovarian reserve tests and fertility status of 74 women before and after vaccination
timeFrame: 6 months after receiving the 2nd dose of vaccine
Secondary outcomes:
measure: AMH difference between vaccinated and unvaccinated groups
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Training and Research Hospital
state: Gaziosmanpaşa
Study officials:
References:
Clinical trial NCT06724367: TRANSSPINAL DIRECT CURRENT STIMULATION ON FUNCTIONAL MOBILITY IN POST-STROKE PATIENTS
Official title: TRANSSPINAL DIRECT CURRENT STIMULATION ON FUNCTIONAL MOBILITY IN POST-STROKE PATIENTS
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 20
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 this clinical trial is to investigate the effects of transspinal direct current stimulation on the functional mobility of post-stroke patients.

The main question it aims to answer is:

Is transspinal direct current stimulation able to improve functional mobility in post-stroke patients?

The researchers will compare transspinal direct current stimulation associated with gait training with sham transspinal direct current stimulation associated with gait training. To verify the effects of stimulation on the functional mobility of post-stroke patients.

Participants:

* They will be assessed before starting the care, after the care has been completed, 15 and 30 days after the care has been completed.
* They will take part in 10 sessions of transspinal direct current stimulation associated with gait training.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ischemic or hemorrhagic stroke, provided by a neurologist.
* Age group greater than or equal to 18 years, of both sexes.
* Any stage of the disease.
* Presence of lower limb sensorimotor disorder related to the stroke
* Absence of cognitive impairment verified through the Mini Mental State Examination (score ≥ 18 for illiterate individuals and ≥ 24 for educated individuals) modified for the Brazilian population.

Exclusion Criteria:

* With other neurological injuries
* With vestibular, visual, cardiovascular or osteomyoarticular disorders of the lower limb that may affect the performance of the proposed tests
* Who have a pacemaker or metallic implants in their spine

Primary outcomes:
measure: Timed up and go test
timeFrame: From the start of treatment until 30 days after the end of treatment.
Secondary outcomes:
measure: Functional Ambulation Classification
timeFrame: From the start of treatment until 30 days after the end of treatment.
measure: Fugl-Meyer Assessment Scale
timeFrame: From the start of treatment until 30 days after the end of treatment.
measure: Mini-Balance Evaluation Systems Test (MiniBESTest)
timeFrame: From the start of treatment until 30 days after the end of treatment.
measure: Modified Ashworth scale
timeFrame: From the start of treatment until 30 days after the end of treatment.
measure: Patient Global Impression of Change Scale
timeFrame: Only in the evaluation immediately after treatment.
Other outcomes:
Locations:
Study officials:
References: