louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05129059: Logotherapy Counseling Programme for Palliative Care Patients With Chronic Sorrow
Official title: The Effect of Logotherapy Counseling Programme on Dignity and Chronic Sorrow in Palliative Care Patients Experiencing Chronic Sorrow
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Palliative Care
Cancer
Keywords: logotherapy
nursing
meaning in life
chronic sorrow
dignity
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the effectiveness of logotherapy counseling program on chronic sorrow, meaning of life and dignity of palliative care patients.

Detailed description: Palliative care patients experience psychosocial and spiritual problems such as depressed mood, fear of metastasis, uncertainty, lack of pleasure, fear of suffering, and chronic sorrow. Logotherapy is a meaning-centered intervention helping the individual to discover the meaning of life and increasing the spiritual well-being and quality of life of the individual. In this study, the effect of logotherapy counseling program on dignity, chronic sorrow and meaning of life of palliative care patients will be evaluated.

In this study, the participants will be randomized in a single blind manner (participant) to either intervention (8 session-4 week logotherapy) or control (routine care) groups.

Eligibility criteria: Inclusion Criteria:

Hospitalized patients due to advanced cancer Patients informed of cancer diagnosis at least 1 month Patients reporting to have chronic sorrow Patients with palliative performance scale score at least 50% Patients having life expectancy more than 6 months Patients who volunteered to participate in the study and signed written informed consent

Exclusion Criteria:

Clinically diagnosed mental disorder Patients with palliative performance scale score \< 40%

Primary outcomes:
measure: meaning in life
timeFrame: baseline and 8 weeks
measure: dignity
timeFrame: baseline and 8 weeks
measure: chronic sorrow
timeFrame: baseline and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Hospital
Study officials:
affiliation: Baskent University
name: Yasemin Eskigülek
role: PRINCIPAL_INVESTIGATOR
affiliation: Baskent University
name: Sultan Kav
role: STUDY_DIRECTOR
References:
Clinical trial NCT02640859: Investigation of Metabolic Risk in Korean Adults
Official title: Investigation of Metabolic Risk in Korean Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2015-12-29
Enrollment: 1003
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Korean Adults

Brief summary: A cohort study with Korean adults to investigate biomarkers in prediction of cardiometabolic and other diseases

Detailed description: This is a prospective cohort study with Korean adults to investigate biomarkers in prediction of cardiometabolic and other diseases

Eligibility criteria: Inclusion Criteria:

* Healthy adults without chronic diseases
* Diabetic patients who are well controlled with oral antidiabetic agents
* Hypertensive patients who are well controlled with oral antihypertensive agents
* Dyslipidemic patients who are well controlled with oral lipid-lowering agents

Exclusion Criteria:

* Malignancy
* Chronic wasting disease
* Long-term steroid use

Primary outcomes:
measure: Incidence of cardiovascular disease
timeFrame: 5 years
Secondary outcomes:
measure: Incidence of diabetes mellitus
timeFrame: 5 years
measure: Incidence of fatty liver
timeFrame: 5 years
measure: Incidence of metabolic syndrome
timeFrame: 5 years
measure: Incidence of osteoporosis
timeFrame: 5 years
measure: Incidence of sarcopenia
timeFrame: 5 years
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
affiliation: SNUBH
name: Soo Lim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06357559: OCTA Changes in Choroidal Neovascularization in High Myopia
Official title: Optical Coherence Tomography Angiography Changes in Choroidal Neovascularization in High Myopia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Myopic Choroidal Neovascularisation
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with High Myopia ( Refractive Error \> -6D or Axial Length \> 26,5 mm ) with Fundoscopic Changes Consistent with CNVM.

Brief summary: To Analyze the Ability of Optical Coherence Tomography Angiography ( OCT-A ) to detect the presence of myopic Choroidal Neovascularization and to describe the structural features of Myopic CNV..

Detailed description: To Analyze the Ability of Optical Coherence Tomography Angiography ( OCT-A ) to detect the presence of myopic Choroidal Neovascularization and to describe the structural features of Myopic CNV.. regarding the size , shape , core , margin , Appearance , and activity of CNV..

Eligibility criteria: Inclusion Criteria:

* All Patients with High Myopia ( \> -6 D or Axial Length \> 26.5 mm ) with Fundoscopic Changes Consistent with CNVM , with Clear Media are Subjected to OCTA

Exclusion Criteria:

* Patients with Treated CNVs , or with other Causes of CNVs including :

Neovascular AMD , Idiopathic CNV , Traumatic , Inflammatory , Neoplastic , Degenerative ..

Primary outcomes:
measure: Describing the Choroidal Neovascularization in High Myopic Patients diagnosed by OCTA
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ohno-Matsui K, Ikuno Y, Lai TYY, Gemmy Cheung CM. Diagnosis and treatment guideline for myopic choroidal neovascularization due to pathologic myopia. Prog Retin Eye Res. 2018 Mar;63:92-106. doi: 10.1016/j.preteyeres.2017.10.005. Epub 2017 Oct 28.
Clinical trial NCT01039259: The Impact of Material on Microbiota in Association With Tongue and Lip Piercing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacteremia
Keywords: adolescent
body piercing/adverse effects
tongue piercing
tongue/microbiology
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
Collaborators: name: Austrian Society of Periodontology
First posted: 2009-12-24
Enrollment: 170
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 85 subjects with lip piercing 85 subjects with tongue piercing

Brief summary: Biofilms on oral piercings may serve as a bacterial reservoir and lead to systemic bacteraemia or local transmission of periopathogenic microbiota.

The investigators hypothesize that there are microbiological differences in bacterial samples collected from tongue /or lip piercings made of different materials. The investigators also hypothesize that the piercings carry the same characteristic bacteria as found in the piercing channels and that independently the biofilm on the tongue/adjacent teeth is similar to the other study locations.

85 subjects with tongue and 85 subjects with lip piercing will participate. Periodontal clinical parameters, traumata of hard tissues, and characteristics of the stud are evaluated. Sterile piercings of four different materials will be randomly allocated to the study subjects. After two weeks, microbiologic samples are collected and are processed by checkerboard DNA-DNA hybridization methods.


Eligibility criteria: Inclusion Criteria:

* lip/tongue piercing for at least six month in situ

Exclusion Criteria:

* pregnancy and lactating women
* medication with known effects on gingival tissues
* antibiotic medication in the last six months or need for antibiotic prophylaxis
* chlorhexidine use in the last six months
* non-plaque induced gingival disease
* prior diagnosis of periodontitis

Primary outcomes:
measure: microbiologic findings of piercing samples
timeFrame: 2 weeks
Secondary outcomes:
measure: microbiologic findings in piercing channels, microbiologic findings on the tongue/adjacent teeth
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Innsbruck Medical University
Study officials:
affiliation: Innsbruck Medical University
name: Ines Kapferer, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00592059: Systemic Consolidation Therapy After Chemoradiation Therapy Following Operation for High Risk Early Stage Cervical Cancer
Official title: A Phase II Study of Systemic Consolidation Therapy With Paclitaxel Plus Carboplatin Following Radical Hysterectomy and Adjuvant Chemoradiation for High Risk Early Stage Cervical Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Cancer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2008-01-11
Enrollment: 77
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Care clinic

Brief summary: The purpose of this study is to determine the therapeutic efficacy and complications of systemic consolidation therapy with paclitaxel plus carboplatin following radical hysterectomy and adjuvant chemoradiation for high risk early stage cervical cancer.

Detailed description: Systemic consolidation therapy with paclitaxel plus carboplatin (3 cycles per 3 weeks) following radical hysterectomy and adjuvant chemoradiation (3 cycles per 3 weeks) for high risk early stage cervical cancer will elevate the therapeutic efficacy by removing the microscopic metastatic lesions which could not be identified by naked eye and diagnostic imaging tests.

Eligibility criteria: Inclusion Criteria:

* patients who underwent radical hysterectomy for cervical cancer stage IB-IIA
* Patients who had at least one of the following risk factors in pathologic results; lymph node metastasis, positive residual resection margin, parametrial invasion
* above 20 years
* GOG performance status 0-2
* Informed consent
* Platelet\>100K, Hb\> 10.0 g/dl, ANC\>1500/mm3, Cr \<1.25\*upper normal limit, bilirubin\<1.5mg/dl, AST \& ALT\<\*3 upper normal limit
* Expected life \> 6 months

Exclusion Criteria:

* Peripheral neurotoxicity \> NCI grade 2
* Sever infection
* Previous history with chemotherapy or radiation therapy
* Pleural effusion, pericardial effusion, and ascites which could cause dyspnea \> NCI grade 2
* Paraaortic lymph node metastasis
* Allergy with platinum
* Previous history of atrial or ventricular arrhythmia or congestive heart failure
* Uncontrolled infection, diabetes mellitus, hypertension, ischemic heart disease, myocardiac infarct within 6 months
* Severe disease such as acute or chronic renal failure and acute cerebral infarct, cerebral hemorrhage, recurrent hepatitis, liver cirrhosis, unknown fever above 39 degrees centigrade

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jae Weon Kim, Professor
role: STUDY_DIRECTOR
affiliation: Seoul National University Hospital
name: Seung Su Han, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02432859: Electrical Stimulation and Expression of VEGF, VEGFR-2, HIF and NO in the Diabetic Foot Ulcer
Official title: The Effect of Electrical Stimulation on the Expression of VEGF, VEGFR-2, HIF and NO in the Diabetic Foot Ulcer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot
Lead sponsor: Tarbiat Modarres University
Sponsor class: OTHER
First posted: 2015-05-04
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether electrical stimulation is effective in the expression of VEGF, VEGFR-2, HIF-1α and NO and healing in diabetic foot ulcer.

Detailed description: 30 type 2 diabetic patients with ischemic foot ulceration were enrolled. Patients were randomly assigned to electrical stimulation (ES, n=15) or sham ES (placebo, n=15) groups. ES group received cathodal direct current for 1 h/day, 3 days/week, for 4 weeks (12 sessions). Wound fluid sample was collected for VEGF, VEGFR-2, HIF-1α and NO measurement in the first and last treatment sessions before and after intervention. Wound surface area (WSA) was measured at 1st, 6th, and 12th session.

Eligibility criteria: Inclusion Criteria:

* Ischemic diabetic foot ulcer
* Wagner classification DFU 2
* 0.5\<ABI\<0.9
* Mild to moderate diabetic neuropathy

Exclusion Criteria:

* Fracture in a lower limb
* A severe infection
* A malignancy
* Kidney failure
* Skin diseases
* Osteomyelitis
* Pregnancy

Primary outcomes:
measure: The wound fluid level of VEGF, VEGFR-2, HIF-1α and NO (pg/ml)
timeFrame: Change from Baseline in wound fluid level of VEGF, VEGFR-2, HIF-1α and NO at 4 weeks
Secondary outcomes:
measure: Wound surface area(cm2)
timeFrame: Change from Baseline in wound surface area at 2 and 4 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tarbiat Modares University
Study officials:
affiliation: Professor of Physical Therapy, Physical Therapy Department, Faculty of Medical Sciences, Tarbiat Modares Univercity
name: Giti Torkaman, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02144259: The Impact of Contraception on Postpartum Weight Loss
Official title: The Impact of Contraception on Postpartum Weight Loss: a Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2014-05-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a prospective mixed methods study to assess weight changes in women randomized to receive Implanon ® or Depo Provera® (DMPA) immediately postpartum compared to women who choose non-hormonal contraception or no contraception immediately postpartum. After enrollment, subjects return for a visit at 3, 6 and 12 months postpartum to be asked a series of questions, take a pregnancy test, and be weighed. Total length of participation for each subject is 1 year or until pregnancy.


Eligibility criteria: Inclusion Criteria:

* English speaking
* Aged 18-45 at enrollment (inclusive)
* Immediately postpartum of a live singleton infant, 37 weeks gestation, at HUP
* Desiring to delay another pregnancy for 6 months
* Willing and able to follow the study protocol

Exclusion Criteria:

* Breastfeeding during study participation
* Plans for relocation outside of Philadelphia in the next six months
* Plans for use of weight loss medication or diet pills in the next six months
* Women who wish to start Implanon ® or DMPA prior to discharge but who do not want to be randomized. 5. Issues or concerns in the judgment of the investigator that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study

Primary outcomes:
measure: Weight
timeFrame: 6 months from postpartum (baseline)
Secondary outcomes:
measure: Pregnancy Rate
timeFrame: 1 year
Other outcomes:
measure: Contraceptive Satisfaction
timeFrame: 1 year
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Courtney A Schreiber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02075359: Energy Expenditure and Physical Activity in Preschoolers
Official title: Novel Models to Predict Energy Expenditure and Physical Activity in Preschoolers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Total Energy Expenditure
Physical Activity Levels
Body Mass Index
Children
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Drexel University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-03-03
Enrollment: 119
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Child (3-5 years)

Brief summary: The purpose of this study is to calibrate the Actigraph, Respironics and CamNtech monitors, in a wide range of children using energy expenditure measured by respiration calorimetry. Energy expenditure will be predicted from the combination of heart rate and activity measured by accelerometry. Prediction equations for energy expenditure will be tested and validated against a stable isotope method called doubly labeled water for the measurement of free-living total energy expenditure.

Detailed description: In this study, the investigators will apply advanced technology (fast-response room calorimetry, doubly labeled water (DLW), accelerometers and miniaturized HR monitors) and sophisticated mathematical modeling techniques (cross-sectional time series, CSTS and multivariate adaptive regression splines, MARS) to develop and validate prediction models that capture the dynamic nature of physical activity (PA) and energy expenditure (EE) in preschool-aged children. CSTS and MARS models for the assessment of PA based on activity energy expenditure (AEE) and for the prediction of minute-by-minute EE will be developed in 100 preschool-aged children using 12-h room respiration calorimetry as the criterion method and validated in an independent sample (n=50) against 12-h room respiration calorimetry and the 7-d DLW method. In addition, the investigators will develop algorithms for the classification of PA levels and sleep/awake periods using statistical and machine learning methods and incorporate the results into our prediction models.

Eligibility criteria: Inclusion Criteria:

* Boys and girls between the ages of 3-5 years will be recruited from the local community. A total of 150 children will be studied. In Phase I, 100 children will be studied and in Phase II 50 children will be studied.

Exclusion Criteria:

* any medical illness or medication affecting growth or limiting participation in physical activities or sports.

Primary outcomes:
measure: Energy expenditure
timeFrame: up to 1 year
Secondary outcomes:
measure: physical activity
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: Children's Nutrition Research Center
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Nancy Butte, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01290159: The Development Of A Novel Biomarker For Early Identification Of The Individual's State Of Tolerance To Heat
Official title: Preliminary Study of Identifying the Tolerance to Heat by a Novel Biomarker of Oxidative Stress
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heat Stroke
Healthy
Keywords: tolerance to heat
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-02-04
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: young (18-28 years old) post heat stroke subjects, and matched healthy controls

Brief summary: Today, the level of tolerance to heat is based on physiological strain indices, with no correlates to any relevant biomarker. We hypothesize that oxidative stress (OS) and the formation of reactive oxygen and nitrogen species (ROS, RNS), which are part of the underling pathophysiology related to hyperthermia, can be used to identify tolerance/intolerance to heat. The aim of the present project is to develop a simple assay, based on specific designed sensitive biomarkers of OS that can be detected in a small blood sample, and to possibly correlate each individual's state of tolerance to heat to the level of OS. These biomarkers specially designed and synthesized to form a novel probe (not present as such in biological organs). The method will be based on the incubation of the suggested biomarkers with the patient's blood sample and the measurement of the level and type of oxidative alteration of the markers. For this goal, post heat stroke patients, with different levels of tolerance to heat and subjects during a process of acclimation to heat will be studied. Such a method will add to our ability to better determine the level of tolerance to heat and not rely only on the measurements of temperature and heart rate during an exercise-heat stress.


Eligibility criteria: Inclusion Criteria:

for study group: post heat stroke subjects. for control group: healthy subjects matched by age to study group

Exclusion Criteria:

for control group: any prior heat illness, Diabetes, heart failure, high blood pressure (SBP \>140mmHg), any febrile illness within the last two weeks prior to testing.

for study group: Diabetes, heart failure, high blood pressure (SBP \>140mmHg), any febrile illness within the last two weeks prior to testing

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Heller Institute of Medical Research, Sheba Medical Center
Study officials:
affiliation: Heller Institute of Medical Research, Sheba Medical Center, Tel Hashomer
name: Yoram Epstein, PhD
role: STUDY_DIRECTOR
affiliation: Heller Institute of Medical Research, Sheba Medical Center
name: Amit Druyan, MD
role: PRINCIPAL_INVESTIGATOR
References: