louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00037505: Major Depression and Inflammatory Risk Markers for Coronary Heart Disease
Official title: Major Depression and Inflammatory Risk Markers for Coronary Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: American Heart Association
First posted: 2002-05-20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The overall purpose of this research is to examine whether depression influences immune system function. Studies indicate that individuals who are depressed experience coronary heart disease at a higher rate than expected. This study's goal is to begin identifying mechanisms that might be responsible for this process. This research also examines whether behavioral processes (e.g. smoking) or hormonal processes (e.g. adrenaline release) are responsible for immune system differences between depressed and nondepressed people

Detailed description: To qualify for participation, subjects are to be between the ages of 18-55, medically healthy and free of all medication three months prior to enrollment. Half of them will be clinically depressed; the remaining one half will be healthy controls without a history of psychiatric illness. All subjects who qualify for the study will attend two laboratory sessions. During the first visit, participants will undergo a structured psychological interview, complete questionnaires about their mood, personality, and behavior, and have blood drawn to assess their immune system function. During the second visit, participants will complete additional questionnaires about their mood, personality, and behavior. The subjects will also participate in a mock job interview to look at their body's response to stress. Before and after the interview, the subjects will have blood drawn and be asked to collect saliva samples to assess their immune system function. In addition to the two laboratory visits, participants will be asked to collect additional information while going about their normal activities. In order to accomplish this, they will be given a small hand held portable computer. Four times each day for four days, the computer will signal them to collect a saliva sample. This will be used later to measure hormone levels. This study will explore changes in the immune system and metabolic system that might predispose depressed individuals to develop heart disease

Eligibility criteria: For eligibility, potential subjects will be 18-55 years of age, free of all medication during the past three months, and have no history of chronic illness involving the cardiovascular, endocrine, immune systems

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
References:
Clinical trial NCT01402505: Transvaginal NOTES Sleeve Gastrectomy
Official title: Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Trans-Vaginal Sleeve Gastrectomy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Obesity
Keywords: obesity
sleeve gastrectomy
transvaginal NOTES
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2011-07-26
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between the ages of 18-75 who present in the UC San Diego Surgical Specialties clinic and have been cleared by the Bariatric and Metabolic Institute (BMI) team for bariatric surgery will be evaluated for participation in this trial. If the inclusion and exclusion criteria are met, the patients will be offered participation in the trial.

Brief summary: This is a prospective chart review/data collection study of natural orifice translumenal endoscopic surgery (NOTES) for sleeve gastrectomy, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a transvaginal NOTES sleeve gastrectomy. Data will be collected and reviewed through 12 months post-op.


Eligibility criteria: Inclusion:

1. Diagnosis of morbid obesity BMI \> 40
2. Female, age 18-75
3. Mentally competent to give informed consent
4. Scheduled to undergo a transvaginal NOTES sleeve gastrectomy

Exclusion:

1. Pregnant women
2. BMI \< 40

Primary outcomes:
measure: To assess outcomes related to the transvaginal NOTES approach to laparoscopic sleeve gastrectomy (through data collection).
timeFrame: 1 year
Secondary outcomes:
measure: To assess pain associated with the transvaginal NOTES approach to laparoscopic sleeve gastrectomy (through data collection).
timeFrame: 1 year
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: UCSD
name: Santiago Horgan, M.D., FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00560105: Randomized Controlled Eight-Week Study of the Safety and Efficacy of the Lung Flute
Official title: A Proof of Principal Randomized Controlled Eight-Week Study of the Safety and Efficacy of the Lung Flute in Adults With Chronic Obstructive Pulmonary Disease. A FDA 510(k) Equivalency Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: COPD
Lead sponsor: Medical Acoustics LLC
Sponsor class: INDUSTRY
First posted: 2007-11-19
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an eight-week, randomized, controlled, two arm parallel study. The study consists of, a screening visit, two weeks of intervention-free run-in randomization, clinic visits week 0, 1, 2, 4, 6, and 8 weeks during the intervention period to collect 24 hour sputum and to confirm techniques of device use and entries into daily diaries. Twenty-four (24) hour sputum samples will be collected and weighed at each clinic visit. In addition to clinic visits, subjects will be expected to make daily diary entries of COPD symptoms. Clinical evaluation will include adverse event surveillance, and St. Georges Respiratory questionnaire.

Detailed description: No further details

Eligibility criteria: Inclusion Criteria:

* Age of over 40 with COPD

Exclusion Criteria:

* Children,
* New mothers; and
* Women intending to become pregnant

Primary outcomes:
measure: Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight
timeFrame: 8 weeks
Secondary outcomes:
measure: FEV1 - Baseline and Device Comparisons
timeFrame: 8 weeks
measure: Quality of Life Questionnaire/Daily Diary
timeFrame: 8 weeks
measure: Change in CCQ Score
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: VA Western NY Healthcare System
state: New York
Study officials:
affiliation: VA Western NY Healthcare System
name: Sanjay Sethi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01403805: Effects of the Oral Care With Vaccines for Pneumonia in Elderly; Going Home Together Both Physician and Dentist
Official title: The Interventional Study in the Effects of Oral Care With Vaccines at Nursing Home; the Role of the Partnership With Physician, Dentist and Other Co-medical Stuff
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia
Keywords: Oral care
Vaccine
Pneumonia
Elderly
Prevention
Primary care
Lead sponsor: Yubari Kibounomori
Sponsor class: OTHER
Collaborators: name: Health Research Foundation
First posted: 2011-07-27
Enrollment: 199
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Prospective study comparing the effects of interventions (combined oral care and pneumococcal plus influenza vaccinations) in preventing pneumonia and increasing the survival rate from pneumonia.

Detailed description: The elderly population can be expected to increase not only in developed countries, but also in developing countries. Pneumonia is one of the most common causes of death in the elderly.

The investigators conducted a prospective study comparing the effects of interventions (combined oral care and pneumococcal plus influenza vaccinations) in preventing pneumonia and increasing the survival rate from pneumonia in consecutive elderly patients at a nursing home in Yubari during one year from 2009, with the results in a non-intervention group.

Eligibility criteria: Inclusion Criteria:

* The residents or an agent who understand the purpose of this study and give informed consent.

Exclusion Criteria:

* The residents contraindicated to vaccine

Primary outcomes:
measure: Number of Participants With Pneumonia
timeFrame: 1 year
Secondary outcomes:
measure: Death From Pneumonia
timeFrame: 1 year
Other outcomes:
measure: Leaving Nursing Home
timeFrame: These participants were followed for the duration of nursing home stay, an average of 22 weeks.
measure: Reject Oral Care
timeFrame: This participant rejected oral care before treatment, Day 1
measure: Reject Vaccine
timeFrame: These participants rejected vaccine before treatment, Day 1
measure: Died Before Oral Care Starting
timeFrame: This participant was died before treatment, Day 1
Locations:
city: Yubari
country: Japan
facility: Yubari Kibounomori
state: Hokkaido
Study officials:
affiliation: Yubari Health Care Research Center
name: Hirofumi Hashimoto, M.D.,Ph.D.
role: STUDY_DIRECTOR
affiliation: Yubari Kibounomori
name: Masahiro Hatta, D.D.S.
role: STUDY_CHAIR
affiliation: Mukawa town National Health Insurance Hobetsu clinic
name: Takahiro Ichiki, M.D.
role: STUDY_DIRECTOR
affiliation: Yubari Health Care Research Center
name: Katsushi Nagamori, M.D.
role: STUDY_DIRECTOR
affiliation: Yubari Health Care Research Cente
name: Hiroyuki Morita, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yubari Health Care Research Center
name: Masako Hatta, D.D.S.
role: STUDY_DIRECTOR
affiliation: Yubari Kibounomori
name: Tomohiko Murakami, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02538705: Safety and Efficacy Study of Neovasculgen (Pl-VEGF165) Gene Therapy in Patients With Diabetic Foot
Official title: Safety and Efficacy Study of Pl-vegf165 to Treat Diabetic Foot Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcers Related to Diabetic Foot Syndrome
Keywords: Diabetic foot syndrome
Ulcers
Lead sponsor: Human Stem Cell Institute, Russia
Sponsor class: OTHER
Collaborators: name: Ryazan State Medical University
name: Vidnoe District Hospital
First posted: 2015-09-02
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether pl-vegf165 (Neovasculgen) is effective in the treatment of ulcers related to diabetic foot syndrome

Detailed description: This is a open clinical trial assessing the therapeutic efficacy of pl-vegf165 (Neovasculgen) in treating ulcers related to diabetic foot syndrome. Each patient will undergo several intramuscular injections with a treatment dose of pl-vegf165 (Neovasculgen) in calf of affected extrimity.

Study participants at the first study visit will complete study questionnaires, their foots will be assessed clinically for ulceration. After this initial assessment, the patients will undergo intramuscular injections of pl-vegf165 (Neovasculgen) in a calf altered with ulcers due to diabetic foot syndrome.

At three month post-injection, the patient will complete study questionnaires, their foots will be assessed clinically for ulceration, and their foots will undergo non-invasive transcutaneous oximetry measurement. At six months post-injection, the patient will again complete study questionnaires, their foots will be assessed clinically for ulceration and will undergo non-invasive transcutaneous oximetry measurement.

Eligibility criteria: Inclusion Criteria:

* obtained voluntary informed consent for participation in the clinical study
* presence of diabetic foot syndrome
* presence at least one active ulcer at baseline

Exclusion Criteria:

* Any disease that can, in the opinion of the treating physician, affect the outcome of the study
* Patients with addictive disorders or substance abuse
* Pregnancy or nursing
* All other exclusion criteria listed in the summary of product characteristics (SmPC)

Primary outcomes:
measure: Area of diabetic foot ulcers
timeFrame: 180 days
Secondary outcomes:
measure: Transcutaneous oxygen pressure
timeFrame: 180 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Human Stem Cell Institute
Study officials:
References:
Clinical trial NCT01190605: Evaluating Factors That Impact Loss to Follow-up Among Postpartum HIV-infected Women in Mississippi
Official title: Evaluating Factors That Impact Loss to Follow-up Among Postpartum HIV-infected Women in Mississippi
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: HIV
postpartum
postpartum entry into HIV care
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: Brown University
First posted: 2010-08-27
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women in Mississippi with HIV infection who have been pregnant and received perinatal HIV care at University of Mississippi Medical Center are eligible to participate in a questionnaire study on the factors that affect entry into HIV care after delivery

Brief summary: Women with HIV infection in Mississippi who are pregnant or who have had their baby in the past year can agree to fill out a questionnaire about what helps or hurts return to care for HIV infection after having a baby. The combined results should show the most common things that keep women from getting care for HIV infection after having a baby. This will help design another study in order to help more women get into care for HIV infection after having a baby.

Detailed description: Following recruitment and completion of informed consent, a participant will be given a questionnaire to look at factors that help or hinder access to HIV care after delivery. After finishing the initial questionnaire the participant will get a Wal-Mart gift card for $15. The participant may then be asked to complete a longer interview for which she would receive an additional gift card for $25. The combined results will be used to design an interventional study to improve entry into HIV care after delivery.

Eligibility criteria: Inclusion Criteria:

* age 18 years or older
* women with HIV infection who are pregnant or up to 2 months postpartum
* English speaking
* able to give informed consent

Primary outcomes:
measure: linked to long-term HIV care
timeFrame: within six months of delivery
Secondary outcomes:
measure: assessment for depression
timeFrame: cross-sectional at time of study visit
measure: assessment of intimate partner violence
timeFrame: cross-sectional at time of study visit
measure: assessment of stigma
timeFrame: cross-sectional at time of study visit
measure: attended a postpartum visit
timeFrame: within six months of delivery
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Binford T Nash, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06820905: Hyperinflammation and Hyperferritinemia in Critically Ill Patients
Official title: Hyperinflammation and Hyperferritinemia in Critically Ill Patients: a Retrospective Observational Single-center Analysis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Critical Illness
Sepsis
Hyperferritinemia
Hyperinflammatory Syndrome
Keywords: criticall illness
sepsis
ferritin
hyperinflammatory syndrome
sepsis phenotype
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 1962
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: critically ill patients; mix-cases medical ICU population

Brief summary: Analysing trajectory of critically ill patients with signs of hyperinflammation


Eligibility criteria: Inclusion Criteria:

* critically ill patients
* admission between 01.01.2020 and 31.12.2024 (5yrs)

Exclusion Criteria:

* none

Primary outcomes:
measure: hyperferritinemia
timeFrame: 2025
Secondary outcomes:
measure: etiology and association of hyperferritinemia
timeFrame: 2025
measure: mortality a morbidity
timeFrame: 2025
measure: treatment strategy
timeFrame: 2025
measure: stratification
timeFrame: 2025
Other outcomes:
Locations:
city: Pilsen
country: Czech Republic
facility: Faculty of Medicine and Teaching Hospital, Charles University
Study officials:
affiliation: Faculty of Medicine and Teaching Hospital, Charles University, Pilsen, Czech Republic
name: Thomas Karvunidis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03885505: An Analysis of the Quality of Life and Sexual Quality of Life of Cervical Cancer Radiotherapy Patients
Official title: An Analysis of the Quality of Life and Sexual Quality of Life of Cervical Cancer Radiotherapy Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Cancer
Radiotherapy Side Effect
Quality of Life
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cervical cancer patients treated by radiotherapy

Brief summary: Cervical cancer radiotherapy patients have a decline in quality of life and sexual quality of life

Detailed description: Objective: To investigate the quality of life and sexual quality of life and its influencing factors in cervical cancer undergoing radiotherapy patients.

Methods:The cervical cancer cancer scale (FACT-Cx4.0) and the female sexual function index (FSFI) in the cancer treatment function evaluation system were used. The quality of life and sexual quality of life of cervical cancer patients undergoing radiotherapy in PUMC Hospital were analyzed and scored to analyze the effects of age, education level, clinical stage and treatment methods on the quality of life and sexual quality of life of cervical cancer radiotherapy patients

Eligibility criteria: Inclusion Criteria:

* adult female
* diagnosed with cervical cancer' and acquire therapy as part of treatment
* undertaken or have finished radiotherapy in Peking Union Medical College Hospital
* agreed with informed consent

Exclusion Criteria:

* with cognitive dysfunction or cannot fulfilled the questionaire
* refuse or quit the research
* submit questionnaire with missing information

Primary outcomes:
measure: using fact-cx4.0 to evaluate the qol of cervical cancer patients undergoing radiotherapy
timeFrame: through study completion, an average of half a year
Secondary outcomes:
measure: using fsfi to evaluate the qol of cervical cancer patients undergoing radiotherapy
timeFrame: through study completion, an average of half a year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03466905: Does Assessment of Ambulance Medical Service Leads to Reduced Number of Transports to the Emergency Room?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emergency Medical Service
Assessment
Registered Nurse
Lead sponsor: Dalarna County Council, Sweden
Sponsor class: OTHER
Collaborators: name: County Council of Halland, Sweden
First posted: 2018-03-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: There is a need to reduce the number of ambulance transports to the Emergency Room to the patients who are not in need of urgent medical care. There are currently no studies and the aim of the study is to investigate if the ambulance transports to the Emergency Room can be reduced by a dialogue between a Registered Nurse in ambulance and a Medical Doctor in the Primary Care (called "Ambulant assessment"). In this connection there is also a need to follow up patients that not have been transported to the Emergency Room, secondary ambulance transport, relapse within 48 hours, type of examination and treatment and mortality.


Eligibility criteria: Inclusion Criteria:

* patients \>18 years
* ambulance missions in the Community of Borlänge/Falun (case) and Community of Leksand (control)
* weekday and weekend, 08:00 to 22:00
* initially evaluated not to need urgent Medical care according RETTS

Exclusion Criteria:

* initially evaluated need urgent Medical care according RETTS
* the patient unable to give consent to the study
* patient with existing care plan
* ambulance mission without patient

Primary outcomes:
measure: Number of visits to the Emergency Room
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Falun
country: Sweden
facility: County Council of Dalarna
state: Dalarna
Study officials:
References: