louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04084899: The Effect of CPAP on Lung Hyperinflation in Patients With OSA
Official title: The Effect of Continuous Positive Airway Pressure Therapy on Lung Hyperinflation in Patients With Obstructive Sleep Apnoea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea
Continuous Positive Airway Pressure
Lung hyperinflation
Lead sponsor: University Hospital Olomouc
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with obstructive sleep apnoea syndrome indicated for CPAP therapy

Brief summary: Assessment of the lung hyperinflation by bodypletysmography in patients with obstructive sleep apnoea treated with continuous positive airway pressure therapy.

Detailed description: Rationale:

Obstructive sleep apnoea (OSA) is characterized by repetitive closure of upper airways leading to apnoea (complete airflow cessation) or hypopnoea (airflow limitation \> 50% + blood oxygen desaturation \> 3% or airflow limitation \> 30% blood oxygen desaturation \> 4%). The prevalence of lung hyperinflations in sleep apnoea patients and effect of continuous positive airway pressure (CPAP) therapy is not known.

Process:

Subjects included in the study will be obstructive sleep apnoea (OSA) patients diagnosed by respiratory polysomnography performed in the Sleep Laboratory, Department of Respiratory Medicine, University Hospital Olomouc.

Bodypletysmography will be performed in the time of OSA diagnosis and after 3 months of CPAP therapy.

Data will be statistically evaluated after completion of the target number of subjects.

Eligibility criteria: Inclusion Criteria:

* Obstructive sleep apnoea syndrome indicated for CPAP therapy (Apnoea- Hypopnoea index ˃ 15)

Exclusion Criteria:

* - Bilevel positive airway pressure therapy
* Total lung capacity \< 80% lower limit of normal values
* Obstructive ventilatory disorder
* Change in body weight ˃ 10%
* Change in smoking status

Primary outcomes:
measure: Change of Vital Capacity (VC) (ml)
timeFrame: 3 months
measure: Change of Forced Expiratory Volume in 1 second (FEV1) (ml)
timeFrame: 3 months
measure: Change of Total Lung Capacity (TLC) (ml)
timeFrame: 3 months
measure: Change of Residual Volume (RV) (ml)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
Study officials:
affiliation: Department of Respiratory Medicine, University Hospital Olomouc
name: Milan Sova, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02251899: A Disease Management Study Targeted to Reduce Health Care Utilization for Patients With Congestive Heart Failure
Official title: A Disease Management Study Targeted to Reduce Health Care Utilization for Patients With Congestive Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: The Focus is to Investigate Effects of a Disease Management Intervention for Patients With Congestive Heart Failure
Lead sponsor: Health Navigator
Sponsor class: OTHER
Collaborators: name: Region Stockholm
name: Ostergotland County Council, Sweden
name: Vastra Gotaland Region
name: Uppsala County Council, Sweden
First posted: 2014-09-29
Enrollment: 10000
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 aim of this study is to determine whether a nurse-managed telephone-based disease-management intervention can reduce healthcare utilization and improve self-assessed health status in patients with congestive heart failure.


Eligibility criteria: Inclusion Criteria:

* Patients with ≥1 unplanned inpatient occasion with primary diagnosis of heart failure ( I50) during the last 12 months
* Heart failure grade NYHA II- III
* Accurate heart failure diagnosis
* Living in one of four Swedish counties where the trial is ongoing

Exclusion Criteria:

* Deceased
* In a moribund state
* Significant cognitive loss and therefore cannot provide consent
* Psychosis diagnosis
* Severe hearing impairment
* Language difficulties
* Participants in another study

Primary outcomes:
measure: Number of hospitalizations
timeFrame: From randomization for up to 2 years
measure: Number of outpatient visits to medical doctor
timeFrame: From randomization for up to 2 years
Secondary outcomes:
measure: Mortality
timeFrame: From randomization for up to 2 years
measure: Length of hospital stays
timeFrame: From randomization for up to 2 years
measure: Total health care cost
timeFrame: From randomization for up to 2 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Stockholms Läns Landsting
Study officials:
affiliation: gustaf@pheph.se
name: Gustaf Edgren
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reinius P, Johansson M, Fjellner A, Werr J, Ohlen G, Edgren G. A telephone-based case-management intervention reduces healthcare utilization for frequent emergency department visitors. Eur J Emerg Med. 2013 Oct;20(5):327-34. doi: 10.1097/MEJ.0b013e328358bf5a.
Clinical trial NCT03879499: Postoperative CRP Levels and Vaginal Cuff Hematoma
Official title: The Value of Postoperative CRP Levels to Predict Postoperative Vaginal Cuff Hematoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Hematoma
Keywords: cuff hematoma
CRP levels
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 106
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women who underwent TLH operation with benign gynecological indications

Brief summary: After laparoscopic hysterectomy, authors aimed to determine cuff hematoma and a postoperative CRP value to help predict the other complications.

A total of 136 patients who underwent total laparoscopic hysterectomy (TLH) were evaluated. CRP, White blood cell (WBC) and hemoglobin values (Hb) were measured on the 1st, 2nd and 7th days before and after the operation. Complications, pre-postoperative vaginal length and female sexual function were evaluated. Fourteen patients who developed cuff hematoma during postoperative follow-up were analyzed with the receiver operating characteristics (ROC) curve. ROC curves with the largest area under the curve for each inflammatory marker were compared in order to define the marker with higher diagnostic accuracy.


Eligibility criteria: Inclusion Criteria:women who underwent TLH operation with benign gynecological indications

Exclusion Criteria:

* Decided to switch to laparotomy during operation
* postoperative complication due to relaparotomy
* infection (including urinary system and lung infections)
* Blood transfusion after TLH
* with rheumatic diseases
* length of hospital stay due to wound infection

Primary outcomes:
measure: Relationship between CRP Levels and cuff hematoma; crp levels
timeFrame: 1 week
measure: Relationship between CRP Levels and cuff hematoma; cuff hematoma measurement
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01484899: Smoking: a Risk Factor for Pulmonary Arterial Hypertension?
Official title: Smoking: a Risk Factor for Pulmonary Arterial Hypertension? A D-A-CH Pulmonary Hypertension Study (Germany- Austria - Switzerland)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Keywords: Pulmonary arterial Hypertension
Chronic thromboembolic pulmonary hypertension
smoking
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2011-12-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients seen at participating DACH -PH centers who have PH defined as mean pulmonary artery pressure \>25mmHg with a pulmonary capillary occlusion pressure ≤15mmHg will be asked to participate upon written informed consent

Brief summary: Environmental factors may play a role in the genesis of pulmonary hypertension, especially in endothelial dysfunction. One widespread environmental factor associated with systemic endothelial dysfunction is cigarette smoke. It may well be that cigarette smoking is not only a risk factor for systemic but also for pulmonary vascular diseases and herewith may interact with other risk factors such as a genetic background and associated conditions. The existing studies which deal with this subject are only small single center case control studies providing less data. Therefore a large European multicenter study is necessary.

The investigators hypothesis are:

* a history of tobacco smoke exposure is highly prevalent in patients with PAH compared to the unaffected general population.
* a history of tobacco smoke exposure is more prevalent in patients with PAH compared to CTEPH.


Eligibility criteria: Inclusion Criteria:

* pulmonary artery pressure \>25mmHg
* pulmonary capillary occlusion pressure ≤15mmHg

Exclusion Criteria:

* pulmonary artery pressure \<25mmHg
* pulmonary capillary occlusion pressure \>15mmHg

Primary outcomes:
measure: Difference in Prevalence of Smoking history in patients with PAH compared to unaffected general population
timeFrame: Assessment during outpatient consultation, an expected average of 1 day.
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: University Hospital of Graz
city: Innsbruck
country: Austria
facility: University Hospital of Innsbruck
city: Dresden
country: Germany
facility: University Hospital Dresden
city: Greifswald
country: Germany
facility: University of Greifswald
city: Heidelberg
country: Germany
facility: University Hospital of Heidelberg
city: Homburg
country: Germany
facility: University hospital of Homburg
city: Regensburg
country: Germany
facility: University Hospital of Regensburg
city: Würzburg
country: Germany
facility: University Hospital of Würzburg
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: Respiratory Clinic, Departement Heart, Vessel, Thorax, University Hospital Zurich
name: Silvia Ulrich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05113199: Virtual Dignity Therapy for Palliative Care Patients With Advanced Cancer
Official title: Feasibility and Acceptability of Virtual Dignity Therapy for Palliative Care Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Keywords: Dignity Therapy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if it is feasible and acceptable to recruit for and deliver the Virtual Dignity Therapy intervention to palliative care patients with advanced cancer.

Detailed description: This study is an investigator-initiated, single site Mayo Clinic Rochester prospective minimal risk pilot study to determine feasibility and acceptability of Virtual Dignity Therapy. The Dignity Therapy intervention is a brief, individualized psychotherapy that aims to relieve psycho-emotional and existential distress and improve the experiences of patients whose lives are impacted by serious illness. This therapy offers patients an opportunity to reflect on their life with a trained facilitator and share their thoughts and memories with family and other people in their life. This therapy consists of a total of 3 sessions, with each session 2-4 weeks apart, in which the investigator provides questions focused on life review. The sessions are recorded and transcribed. The interventionist will work with patients to edit the document and provide a final generativity document for patient to keep and give to loved ones.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* English fluency
* No diagnosed dementia
* Diagnosis of advanced cancer
* Expected prognosis \> 6 months
* Provide informed consent
* Ability to complete questionnaire(s) by themselves or with assistance

Exclusion Criteria:

* Other psychological co-morbidities such as untreated schizophrenia, bipolar disease
* Recent suicide attempt or psychiatric illness severe enough that hospitalization has been necessary in last 6 months
* Active delirium
* Participation in concurrent legacy offerings through the palliative care clinic

Inclusion Criteria for caregivers:

* Age ≥18 years
* English fluency
* Provide informed consent
* Supported patient through Dignity Therapy

Primary outcomes:
measure: Feasibility Number
timeFrame: 2 Years
measure: Acceptability
timeFrame: Week 8 (after 3rd intervention session)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Deirdre Pachman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04528199: [18F]FLOR (FC303) PET/CT Imaging in Patients With Prostate Cancer
Official title: A Phase 1 Study of [18F]FLOR (FC303) PET/CT Imaging in Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Metastatic Prostate Cancer
Keywords: [18F]FLOR
PET/CT
prostate cancer
J19145
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: FutureChem
First posted: 2020-08-27
Enrollment: 8
Sex: MALE
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 study is an open label, single-arm study designed to evaluate the safety and diagnostic performance of \[18F\]FLOR (FC303) PET/CT imaging to determine the presence or absence of metastatic prostate cancer. .

Detailed description: This research is being done to determine whether the radioactive compound called \[18F\]FLOR (FC303) is safe and well-tolerated in patients with metastatic prostate cancer.

Participants in this study will have tests, exams and procedures that are for study purposes. Participants will be in this study up to one month which will include up to three clinic visits.

Eligible patients diagnosed with metastatic prostate cancer will undergo a \[18F\]FLOR (FC303) PET-CT scan. This is the imaging procedure to assess where \[18F\]FLOR (FC303) has accumulated in the body.

Eligibility criteria: Inclusion Criteria:

* Males ≥18 years of age.
* Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.
* Histologically confirmed adenocarcinoma of the prostate.
* Radiologic evidence of local recurrence or new or progressive metastatic disease demonstrated on anatomical imaging (CT, or MRI), or whole-body bone scan within 4 weeks of Day 1.
* At least 2 weeks must have elapsed between last anti-cancer treatment administration and the imaging day. Imaging day will be scheduled before initiation of new systemic therapy for recurrent and/or progressive metastatic disease
* Screening clinical laboratory values within normal limits or judged not clinically significant by the investigator.

Exclusion Criteria:

* Subjects administered any radioisotope within five physical half-lives prior to study drug injection.
* Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.

Primary outcomes:
measure: Incidence of study drug emergent adverse events
timeFrame: Up to 10 days post-study drug dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Steven Rowe, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02151799: The Effects of Body Contouring: Abdominoplasty and Liposuction
Official title: Body Contouring - the Analysis of Non-invasive and Invasive Methods and Their Interventional Effects on Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Subcutaneous Abdominal Fat
Abdominal Skin Elasticity
Rectus Muscle Diastasis
Unpleasant Body Contour
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 143
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The data regarding the effects of aesthetic body contouring is insufficient. Poor results may related to preoperative psychological distress. Studies regarding eating disorder symptoms are lacking. Therefore studies using standardized and validated are needed. We decided to prospectively study quality of life, psychological distress, and eating disorder symptoms in body contouring (abdominoplasty or liposuction) patient populations. Used questionnaires are 15D quality of life, Raitasalo's modification of the Beck Inventory, and the Eating Disorder Inventory. We hypothesize that aesthetic body contouring plastic surgery has notable quality of life effects.


Eligibility criteria: Inclusion Criteria:

* patients requesting body contouring surgery

Exclusion Criteria:

* previous abdominal aesthetic surgery, simultaneous other aesthetic surgery at the same time

Primary outcomes:
measure: Quality of life
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Saariniemi KM, Salmi AM, Peltoniemi HH, Helle MH, Charpentier P, Kuokkanen HO. Abdominoplasty improves quality of life, psychological distress, and eating disorder symptoms: a prospective study. Plast Surg Int. 2014;2014:197232. doi: 10.1155/2014/197232. Epub 2014 Nov 24.
Clinical trial NCT01999699: A Study of the Immune Response to Heplisav in Healthy Older Adults
Official title: A Phase 1 Systems Biology Study to Investigate Immune Correlates of the Response to an Experimental Hepatitis B Vaccine (HEPLISAV) in Healthy Adults 50 to 70 Years of Age.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis B
Keywords: Heplisav
Lead sponsor: Dynavax Technologies Corporation
Sponsor class: INDUSTRY
Collaborators: name: Baylor Research Institute
First posted: 2013-12-03
Enrollment: 25
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will investigate the response of the immune system to a hepatitis B (HB) vaccine in healthy adults 50 to 70 years of age. This study is partially funded by the National Institute of Allergy and Infectious Diseases.

Detailed description: The purpose of this study is to examine how the immune system responds to vaccination with HEPLISAV.

Eligibility criteria: Inclusion Criteria:

* 50 to 70 years of age, inclusive
* In good health in the opinion of the principal investigator, based upon medical history and physical examination
* Serum negative for HBsAg, anti-HBs, antibody to hepatitis B core antigen (anti-HBc), hepatitis C virus (HCV), and human immunodeficiency virus (HIV)
* If female of childbearing potential, agree to consistently use a highly effective method of birth control from the screening visit through Week 12/Visit 10

Exclusion Criteria:

* Pregnant, breastfeeding, or planning a pregnancy
* Known history of an autoimmune disease
* Previously received any hepatitis B vaccine (approved or investigational)
* Body-mass index (BMI) \>30 kg/m2, diabetes mellitus (type 1 or 2), or other chronic medical condition that in the opinion of the principal investigator might interfere with the immune response to hepatitis B vaccination

Primary outcomes:
measure: Evaluate the changes in cellular responses and gene expression patterns in serial blood samples collected from healthy older adults after vaccination with HEPLISAV.
timeFrame: Day 1, 3, and 7 and on Day 28
measure: Determine which of these changes correlate with the development of protective levels of antibody (anti-HBs >/= 10 milli-international unit (mIU)/mL) to hepatitis B virus (HBV).
timeFrame: Day 1, 3, and 7 and on Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Johnson County Clinical Trials
state: Kansas
Study officials:
affiliation: Dynavax Technologies Corporation
name: Robert Janssen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02544399: Bone Microarchitecture in Women Practicing Golf
Official title: Is Golf a Sport Suited to the Female Skeleton After 60 Years? Pilot Study Evaluating the Microarchitecture 3D Carriers and Noncarriers Bones
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Microarchitecture
Keywords: Bone microarchitecture
Playing golf
Walkers
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-09-09
Enrollment: 67
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject practicing foot walk or golf or sedentary

Brief summary: After the age of 50, one in three women and one in eight men will experience at least one fragility fracture during the rest of their lives. It is currently recognized that physical activity has an osteogenic actions, especially when it includes the impact transmitted to the skeleton. In this context, the investigators propose a study to determine whether the regular practice of golf could be particularly beneficial for the skeleton, not only in the lower limbs, due to repeated impacts to the ground when it requires sustained walking, but also the upper limbs due to the impacts transmitted by the club at the time of striking the ball, as has been amply demonstrated with racquet sports.

Detailed description: Each patient will have 1 blood samples and 1 measure of bone by 3D micro-tomography (3D CT Scan).These examinations and sampling will take place on 1 day.

Eligibility criteria: Inclusion Criteria:

* Golfers: Regular playing golf for over 2 years at 8 to 12 hours per week recruited into golf clubs.
* Walkers: regular practice of walking for over 2 years at 8 to 12 hours per week recruited into the walking clubs.
* Sedentary: no intensive physical activity (\<2 hours / week), recruited in clubs seniors.

Exclusion Criteria:

* concomitant bone disease ,
* Hip prosthesis the dominant side
* Endocrinopathy
* hypercalcemia, vitamin D deficiency, hypo- or hyper calciuria
* Active smoking (more than 5 cigarettes / day), chronic alcoholism,
* Treatments received in the previous six months and resounding on bone metabolism such growth promoters, all osteoporosis, corticosteroids.

Primary outcomes:
measure: Bone volume / tissue volume
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Thierry THOMAS, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: