louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06098924: HD Patients' Depression and Happiness
Official title: The Impacts of Spiritual Health on Depression and Happiness Among Hemodialysis Patients: the Moderator Effects of Life-meaning and Post-trauma Growth
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hemodialysis
Keywords: spirituality
depression
happiness
post-trauma growth
life meaning
Lead sponsor: Chang Gung University of Science and Technology
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults with regularly hemodylysis

Brief summary: The aim of the study is to verify the mediating effect of life of meaning and post-traumatic growth in spirituality and psychological well-being (happiness, depression).

Detailed description: The research design is cross-sectional correlational study. Convenient sampling will be used to conduct to data collection. There are 300 patients with hemodialysis from a hemodialysis institution in the north Taiwan, and data collecting with self-administrated questionnaires. The instruments include demographic and disease-related information, Spiritual Health Scale short form, Chinese Happiness Inventory, Beck Depression Inventory-II, Life Attitude Profile, Posttraumatic Growth Inventory. The SPSS 22.0 statistical software will be used to analyze the data. Descriptive statistics, such as frequency, percentage, mean, and standard deviation (SD) will be used for participant characteristics and outcome measures. T-test, chi-square, ANOVA, post-hoc, ANCOVA, and Person's correlation will be conducted to test the relationships between the research variables.

Eligibility criteria: Inclusion Criteria:

* Patients who are over 20 years old
* voluntarily participate in the study and sign the respondent consent form
* have received routine hemodialysis treatment for more than three months
* have clear consciousness and can communicate in Mandarin and Taiwanese.

Exclusion Criteria:

* Patients whose medical records record a diagnosis of schizophrenia
* patients are taking antidepressant drugs

Primary outcomes:
measure: The status of spirituality among HD patients
timeFrame: 1 day
measure: The status of life-meaning among HD patients
timeFrame: 1 day
measure: The status of post-trauma growth among HD patients
timeFrame: 1 day
measure: The status of depression among HD patients
timeFrame: 7 minutes
measure: The status of happiness among HD patients
timeFrame: 1 day
measure: The mediating effect of life of meaning and post-traumatic growth
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung University of Science and Technology
state: N/A = Not Applicable
Study officials:
affiliation: Chang Gung University of Science and Technology
name: yachu hsiao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06728124: A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Obese/Overweight Subjects
Official title: A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Obese/Overweight Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Obesity/Overweight
Lead sponsor: Gan & Lee Pharmaceuticals.
Sponsor class: INDUSTRY
First posted: 2024-12-11
Enrollment: 630
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 is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study in adult obese/overweight subjects in China to evaluate the efficacy and safety of GZR18 Injection in the subjects.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years (as of the date of signing the Informed Consent Form (ICF)), male or female.
* Obese (BMI ≥ 28 kg/m2) or overweight (24 kg/m2 ≤ BMI \< 28 kg/m2) with at least one comorbidity.
* Able to understand the procedures and methods in this study; willing and able to maintain a stable diet and exercise lifestyle during the research period, and willing to sign the ICF voluntarily.
* Subjects of childbearing potential with no birth plan from the signing of ICF to 8 weeks after the last dose, willingness to take effective contraceptive measures, and no plan for sperm donation. Females of childbearing potential must not be lactating and must have negative results of pregnancy tests at screening and Visit 2 (before randomization).

Exclusion Criteria:

* Known or suspected hypersensitivity to glucagon like peptide-1 receptor agonist (GLP-1RA) drugs or excipients.
* History of drug abuse prior to screening.
* History of alcohol abuse within 6 months before screening.
* Weight change of \> 5.0% within 3 months before screening (self-report).
* Presence of limb deformity or mutilation affecting height measurement.

Primary outcomes:
measure: Percent change in weight from baseline (%)
timeFrame: From Week 0 to Week 48
Secondary outcomes:
measure: Proportion of subjects with ≥ 10%, 15%, 20%, and 25% decrease in weight from baseline
timeFrame: From Week 0 to Week 48
measure: Changes from baseline in weight
timeFrame: From Week 0 to Week 48
measure: Changes from baseline in body mass index (BMI)
timeFrame: From Week 0 to Week 48
measure: Changes from baseline in hip circumference
timeFrame: From Week 0 to Week 48
measure: Changes from baseline in waist circumference
timeFrame: From Week 0 to Week 48
measure: Changes from baseline in waist-hip ratio (waist circumference/hip circumference)
timeFrame: From Week 0 to Week 48
measure: Treatment emergent adverse events (TEAEs)
timeFrame: From Week 0 to Week 48
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00433524: Computed Tomography in Detecting Movement of the Esophagus in Patients Undergoing Radiation Therapy to the Chest
Official title: Evaluation of Esophageal Motion by Computed Tomography (CT) During the Course of Thoracic Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-02-12
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: RATIONALE: Comparing results of diagnostic procedures, such as computed tomography scan (CT scan), done before and after radiation therapy to help detect movement of the esophagus may help doctors plan the best treatment.

PURPOSE: This clinical trial is using CT scan to help detect movement of the esophagus in patients undergoing radiation therapy to the chest.

Detailed description: OBJECTIVES:

* Determine the inter- and intra-fraction movement of the esophagus using CT scans in patients undergoing thoracic radiotherapy.

OUTLINE: This is a pilot study.

Patients undergo CT scans at baseline and then once weekly during their scheduled radiotherapy sessions to determine esophageal placement while in the treatment position. CT scans are performed before and after the radiotherapy session. Pretreatment and post-treatment scans are compared.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Planning to undergo definitive thoracic radiotherapy

PATIENT CHARACTERISTICS:

Age

* Not specified

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* See Disease Characteristics
* No concurrent palliative thoracic radiotherapy

Surgery

* Not specified

Other

* Concurrent participation in other clinical trials allowed

Primary outcomes:
measure: Inter- and intra-fraction movement of the esophagus as measured by CT scans
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center - Philadelphia
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Andre A. Konski, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05567224: Connecting Low-Income Adults to Primary Care After Inpatient Discharge
Official title: Connecting Low-Income Adults to Primary Care After Inpatient Discharge
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Care Utilization
Health Care Seeking Behavior
Keywords: Health Care Costs
Hospitalizations
Emergency Department Use
Health Care Accessibility
Medicaid
Low-income populations
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 200
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: Patients age 18 or older who are currently enrolled in Tennesee's Medicaid program (TennCare) and who are presenting in VUMC's inpatient setting, and who report no active relationship with a primary care doctor.

Brief summary: Healthcare systems and insurers have tried to reduce costs by improving the care and coordination provided to patients with high healthcare spending. Often termed, "hotspotting", these interventions seek to lower costs by reducing care provided in fragmented, high-cost settings, including the emergency department and inpatient settings, by addressing the social determinants of health and improving patients' access to lower-cost, ambulatory settings. Vanderbilt University Medical Center (VUMC), in collaboration with Tennessee's Medicaid agency (TennCare), is piloting a program to reduce costs and improve the quality of care provided to high-risk TennCare enrollees by referring them from inpatient settings to VUMC primary care services. This study seeks to evaluate this pilot by comparing outcomes between Medicaid patients referred to VUMC primary care services and similar Medicaid patients not referred to VUMC primary care services using data from surveys and administrative sources, including electronic health records and health insurance claims.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Currently enrolled in Tennessee's Medicaid Program (TennCare)
* Presenting in VUMC's inpatient setting
* Reporting no active relationship with a primary care doctor
* Lives in Davidson County, Tennessee, or a surrounding county

Exclusion Criteria:

* Patients discharged to a setting other than the community (e.g. to a Skilled Nursing Facility)

Primary outcomes:
measure: Number of Inpatient Admissions
timeFrame: 30, 60, 90, 180, and 360 days
Secondary outcomes:
measure: Number of Emergency Department Visits
timeFrame: 30, 60, 90, 180, and 360 days
measure: Number of Primary Care Visits
timeFrame: 30, 60, 90, 180, and 360 days
measure: Average Health Care Spending
timeFrame: 30, 60, 90, 180, and 360 days
measure: Average Self-reported Health Status
timeFrame: 30, 60, 90, 180, and 360 days
measure: Average of Disease Specific Outcomes
timeFrame: 30, 60, 90, 180, and 360 days
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
Clinical trial NCT05268224: A Tear-based, Lab-developed Test for Breast Cancer for Women With Dense Breast Tissue
Official title: Investigation of a Tear-based, Lab-developed Biological Test for Breast Cancer, as a Supplemental Tool to Current Screening Recommendations for Women With Dense Breast Tissue.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer Screening
Lead sponsor: Namida Lab
Sponsor class: INDUSTRY
First posted: 2022-03-07
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who have been mammographically catagorized as having heterogenously dense or extremely dense breast tissue.

Brief summary: Investigation of a tear-based, lab-developed biological test for breast cancer, as a supplemental tool to current screening recommendations for women with dense breast tissue will explore if a tear-based biological test can be used as a support tool in the breast cancer screening protocol for women with dense breast tissue. The test was designed and validated by Namida Lab, Inc., a high complexity Clinical Laboratory Improvement Amendments (CLIA) certified lab.


Eligibility criteria: Inclusion Criteria:

Categorized as having heterogeneously dense or extremely dense tissue 18 years of age or older Able to understand the informed consent process Willing to comply with all study procedures

Exclusion Criteria:

Have an active eye infection Categorized as having fibro glandular densities or fatty breast tissue Currently diagnosed or are receiving treatment for breast cancer Under 18 years of age

Primary outcomes:
measure: Accuracy Measure
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Namida Lab
state: Arkansas
Study officials:
References:
Clinical trial NCT00376324: Study Evaluating the Pharmacokinetics of Tigecycline in Human Bone
Official title: An Open-Label, Multiple-Dose Study of the Pharmacokinetics of Tigecycline in Human Bone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: pharmacokinetics
human bone
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-09-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study to examine the concentration of the study drug, tigecycline, in human bone samples following the administration of multiple doses.


Eligibility criteria: Inclusion:

* Men and nonlactating and nonpregnant women greater than or equal to 18 years of age.
* Healthy as determined by the investigator on the basis of medical history, physical examination, vital signs, and 12-lead electrocardiogram (ECG).
* Have a high probability for compliance with and completion of the study.

Exclusion:

* Subjects with chronic osteomyelitis.
* Subjects who have known or suspected hypersensitivity to tigecycline or other tetracyclines.
* Involvement in other investigational studies of any type within 30 days before test article administration.

Primary outcomes:
measure: To determine both the bone and corresponding serum concentration of tigecycline at selected time points following adminstration.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Bhattacharya I, Gotfried MH, Ji AJ, Saunders JP, Gourley I, Diehl A, Korth-Bradley JM. Reassessment of tigecycline bone concentrations in volunteers undergoing elective orthopedic procedures. J Clin Pharmacol. 2014 Jan;54(1):70-4. doi: 10.1002/jcph.201. Epub 2013 Oct 24.
Clinical trial NCT01494324: Examinations of Tissue From Ablated Malignant Liver Metastases as Predictors of Outcome
Official title: Examinations of Tissue From Ablated Malignant Liver Metastases as Predictors of Outcome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Liver Cancer
Keywords: Liver
Thermal Ablation
Dynamic CT
09-122
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Rockefeller University
First posted: 2011-12-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to see if the investigators can do some tests on tissue from the area of the ablation. The investigators want to know if a test can help predict whether the ablation worked.

The treated tumor is normally evaluated with CT. The CT shows signs of treated tumor(s) in the area treated by ablation. However, cancer cells may begin to grow in or near the treated area. The CT scan cannot tell us if the cells are new cancer cells or if they are healthy liver cells that just look different because of the ablation. The test the investigators will study should be able to tell us the difference.


Eligibility criteria: Inclusion Criteria:

* Patients with diagnosed with secondary hepatic malignancy;
* Patients with confined liver disease or stable limited extrahepatic disease;
* Lesions of 5cm or less in maximum diameter;
* Patients who are not surgical candidates or refuse to undergo surgery and choose any percutaneous ablation as an alternative treatment option.
* INR\<1.5 \*for patients on Coumadin general clinical guidelines for IR ablation will be followed.
* Platelet count \> or = to 50,000

Exclusion Criteria:

* Patients \< 18
* Less than 5 mm distance of the tumor margin from a major vessel \>7mm in diameter)\*\*
* Less than 5 mm distance to a structure (GI or biliary tract), that cannot be protected from\*\*
* the ablation injury with technical modifications such as hydro or air dissection.
* INR \> 1.5 that cannot be corrected with fresh frozen Plasma\*
* Platelet count of \<50,000 that cannot be corrected with transfusion.
* Patient with more than 3 tumors treated with any percutaneous ablation
* Patients with more than 5 sites of extrahepatic disease (including nodes and pulmonary nodules)

  * for patients on Coumadin general clinical guidelines for IR ablation will be followed \*\*This will not be considered an exclusion criteria when IRE or Microwave is used.

    * This will not be considered exclusion when IRE is used

Primary outcomes:
measure: Tumor response
timeFrame: 3 years
Secondary outcomes:
measure: Duration of treatment response
timeFrame: 3 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Constantinos Sofocleous, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05868824: Dynamic Blood Inflammatory Profile in Atopic Dermatitis Patients (ADAMUNE)
Official title: Dynamic Blood Inflammatory Profile in Atopic Dermatitis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atopic Dermatitis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a prospective, single-center, class 2 study to better characterize the immune response in immune response in the blood of atopic dermatitis. Investigators are following in the referral center of Nice, 100 patients with atopic dermatitis. Investigators plan to include 30 patients. Blood samples will be collected to assess cytokine levels after non-specific immune stimulation. immune stimulation. Whole blood will be collected and stimulated with immune ligands (anti-CD3 T-cell stimulating ligands associated with Thymic Stromal LymphoPoietin (TSLP) or TLR agonist R848 7/8 agonist stimulating NK (natural killer) lymphocytes and promoting T cell response) on lyophilized freeze-dried spheres (LyoSphere, Qiagen) within 8 hours of blood collection.


Eligibility criteria: Inclusion Criteria:

* Patient aged ≥ 18 years.
* Patient with clinically diagnosed atopic dermatitis according to the criteria of Hanifin and Rajka.
* Moderate to severe defined by an Investigator's Global Assessment ³3 and eligible to systemic treatment.
* If the subject is a woman of childbearing potential, she has a negative urine pregnancy test.
* Subject is non-pregnant, non-lactating and is not planning for pregnancy during the study period.
* Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair his/her evaluation or which exposes the subject to an unacceptable risk by study participation.
* Subject is able to comprehend and willing to sign an Informed Consent and/or Assent Form.
* Affiliation to a social security scheme.
* Signed informed consent

Exclusion Criteria:

* Vulnerable person: pregnant or nursing woman, minor, adult under guardianship or deprived of liberty
* Patient with an infection
* Patient with other systemic inflammatory disease
* Patient with anti-inflammatory or immunosuppressive therapy
* Patient with a contraindication to JAK inhibitors
* Participants in other clinical therapeutic studies involving a drug that may interfere with the present evaluation

Primary outcomes:
measure: Compare the dynamic blood cytokines profile by stimulating blood with immune ligands
timeFrame: At baseline
measure: Compare the dynamic blood cytokines profile by stimulating blood with immune ligands
timeFrame: After 3 months
Secondary outcomes:
measure: Compare cytokine dosage according to the different phenotypes of patients with atopic dermatitis.
timeFrame: 6 months
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital
Study officials:
References:
Clinical trial NCT06123624: Desflurane and Sevoflurane on Remifentanil Requirement
Official title: Comparison of Desflurane and Sevoflurane on Remifentanil Requirement Using Analgesia Nociception Index-guided Anesthesia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Diseases
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 78
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to compare the desflurane and sevoflurane on remifentanil requirement using analgesia nociception index-guided anesthesia in patients undergoing spine surgery.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of herniated disc, injury of spinal cord, and neoplasm of spinal meninges

Exclusion Criteria:

* Hyperbilirubinemia
* Prior chronic pain
* Prior opioid abuse
* Cardiac arrythmia

Primary outcomes:
measure: remifentanil requirement
timeFrame: at time of the end of skin suture (up to 3 hours)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: