louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03173079: Geriatric Assessment and Outcome in Patients Undergoing Transcatheter Aortic Valve Replacement
Official title: Geriatric Assessment and Outcome in Patients Undergoing Transcatheter Aortic Valve Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influence of Geriatric Functional State on the Outcome After TAVI
Possible Change in Geriatric Assessment After TAVI
Lead sponsor: Campus Bad Neustadt
Sponsor class: OTHER
Collaborators: name: Rhönklinikum AG
First posted: 2017-06-01
Enrollment: 220
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all-comers cohort

Brief summary: A geriatric assessment is becoming increasingly important in the treatment of patients with a percutaneous aortic valve replacement due to their comorbidities. The aim of this multimodal therapy concept is to examine the influence on the postoperative outcome. In addition to a comprehensive assessment of the individual frailty score, the subjective condition before and after TAVI is also evaluated using a standardized questionnaire ("Minnesota living with heart failure questionnaire").


Eligibility criteria: Inclusion Criteria:

* all patients with indication for TAVI according to the current guidelines

Exclusion Criteria:

* no indication for TAVI, indication for cardiac surgery, mentally disabled patients, patients with endocarditis or life expectancy of less than 2 years

Primary outcomes:
measure: Quality of Live score in the "Minnesota living with heart failure questionnaire"
timeFrame: 6 month
measure: frailty score
timeFrame: 6 month
measure: mortality after TAVI
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Neustadt an der Saale
country: Germany
facility: Cardiovascular Center Bad Neustadt
state: Bavaria
Study officials:
affiliation: Cardiovascular Center Bad Neustadt
name: Sebastian Barth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiovascular Center Bad Neustadt
name: Karsten Hamm, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01809379: Intraperitoneal Aerosol High-pressure Chemotherapy for Women With Recurrent Ovarian Cancer
Official title: Feasibility, Efficacy and Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Cisplatin and Doxorubicin in Women With Recurrent Ovarian Cancer: an Open-label, Single-arm Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Ovarian Cancer
Keywords: ovarian cancer, recurrent, chemotherapy, intraperitoneal
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2013-03-12
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial aims to assess efficacy and safety of an intraperitoneal, aerosol, high-pressure chemotherapy in women with recurrent ovarian cancer

Detailed description: This study aims to investigate the therapeutic efficacy of PIPAC using doxorubicin and cisplatin in women with recurrent ovarian cancer and disease progression with peritoneal carcinomatosis. The primary objective of this study is to determine the Clinical Benefit Rate (CBR) according to RECIST criteria after three cycles of PIPAC with cisplatin and doxorubicin.

Eligibility criteria: Inclusion Criteria:

* at least 2 lines of previous chemotherapy
* recurrent ovarian cancer
* patient is mobile
* informed consent

Exclusion Criteria:

* ileus
* necessity of parenteral nutrition

Primary outcomes:
measure: Clinical Benefit Rate
timeFrame: 6 months
Secondary outcomes:
measure: safety
timeFrame: 6 months
Other outcomes:
measure: tumor apoptosis assessment, videolaparoscopy assessment of response, CA 125 assessment of response
timeFrame: 6 months
Locations:
city: Bochum
country: Germany
facility: Ruhr University Bochum
state: NRW
Study officials:
affiliation: Runr University Bochum
name: Clemens Tempfer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tempfer CB, Winnekendonk G, Solass W, Horvat R, Giger-Pabst U, Zieren J, Rezniczek GA, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy in women with recurrent ovarian cancer: A phase 2 study. Gynecol Oncol. 2015 May;137(2):223-8. doi: 10.1016/j.ygyno.2015.02.009. Epub 2015 Feb 18.
Clinical trial NCT04530279: Clinical Assessment of Burns in Norway
Official title: Accordance of Clinical Assessment of Burn Depth and %TBSA Between Referring Hospitals and the National Norwegian Burn Centre
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Burns
Keywords: clinical assessment
TBSA
national burn centre
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The cohort was defined as patients transferred to the burn unit at Haukeland university hospital during 2014.The incidence of burns in Norway is 15.5 /100 000/ year (pop.

5.2 mill), and 70-100 patients a year is treated at the national burn centre. The

Australian and New Zealand Burn Association (ANZBA) referral criteria are used:

* Burns \> 10% Total Body Surface Area (TBSA)
* Burns \> 5% TBSA in children
* Full Thickness burns \> 5% TBSA
* Burns of Special Areas - Face, Hands, Feet, Genitalia, Perineum, Major Joints and circumferential limb or chest burns
* Burns with inhalation injury
* Electrical burns
* Chemical burns
* Burns with pre-existing illness
* Burns associated with major trauma
* Burns at the extremes of age - young children and the elderly
* Burn injury in pregnant women
* Non-accidental burns

Brief summary: Clinical assessment of burn depth and area can be challenging even for experienced surgeons. Still, the assessment is fundamental for the treatment, as it determines the fluid treatment and indication for escharotomy and need for referral to a burn centre.There are few studies comparing the initial evaluation of burn depth and surface with that of a specialist burn centre. The aim of this study was to make such a comparison for a cohort of patients admitted to a specialist burn centre during one year.The cohort was defined as patients transferred to the burn unit at Haukeland university hospital during 2014.


Eligibility criteria: Inclusion Criteria:

* Patients transferred to the burn unit at Haukeland university hospital during 2014

Exclusion Criteria:

* Readmissions
* Patients transported to Haukeland directly from the site of the accident

Primary outcomes:
measure: Burn depth
timeFrame: 1 year
measure: The percentage of total body surface area (TBSA) burnt
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
state: Vestland
Study officials:
affiliation: Haukeland University Hospital
name: Ragnvald L Brekke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05808179: Shifting Sleep Timing in Teens
Official title: Passive Phototherapy to Improve Sleep in Teens
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Insufficiency
Sleep
Adolescent Behavior
Lead sponsor: VA Palo Alto Health Care System
Sponsor class: FED
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-04-11
Enrollment: 160
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to determine whether a combination of a novel lighting intervention and a behavioral intervention are able to increase total sleep time in adolescents. The main questions this trial aims to answer are whether this combination therapy is able to meaningfully increase total sleep time in adolescents, and do so over a sustained period of time, and whether such a changes is associated with concomitant changes in mood and cognitive performance.


Eligibility criteria: Inclusion Criteria:

1. Aged 14-18 and a full-time student in grades 9-12
2. Male or female
3. Willing and with a schedule permitting them to go to bed at an earlier time
4. Planning on sleeping at home in their bedroom for at least 75% of the study

Exclusion Criteria:

1. Currently taking any medications (including over-the-counter medications, e.g., melatonin) specifically for the treatment of sleep disorders
2. Sleep only in the prone (face-down) position

Primary outcomes:
measure: Total sleep time
timeFrame: 20 weeks
Secondary outcomes:
measure: Melatonin timing
timeFrame: 8 weeks
measure: Mood
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References:
Clinical trial NCT01969279: Radiographic Influences of Bisphosphonate Treatment on Femur
Official title: Radiographic Influences of Long-term Bisphosphonate Treatment on Femur
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Femur Fracture
Keywords: Osteoporosis
Bisphosphonate
Atypical femoral fracture
Side effect
Lead sponsor: Tomidahama Hospital
Sponsor class: OTHER
First posted: 2013-10-25
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Oateoporosis patients using bisphosphonate more than four years.

Brief summary: Although there is strong evidence that bisphosphonates prevent certain types of osteoporotic fractures, there are concerns that these medications may be associated with rare atypical femoral fractures (AFF). But the relationship between long-term bisphosphonate treatment and AFF is unclear. In this study, the investigators would like to analyze the long term effects on femur by bisphosphonate treatment.The participants are treated in the investigators hospital more than four years.

Detailed description: Bisphosphonates have been widely used in the treatment of osteoporosis. Recently, long-term use of bisphosphonates increases the risk for AFFs in older women, according to the results of a population-based, nested case-control study. Unique radiographic pattern of AFF is reported, such as simple transverse or short oblique fracture with breaking of medial cortex and cortical thickness. But radiographic evaluation were performed for fracture patients in previous reports and the femoral condition of long-term bisphosphonate treatment patients before fracture is not known.

The main objective of this study is to reveal the effects of long-term bisphosphonate treatment on femur.

Eligibility criteria: Inclusion Criteria:

* Patients using bisphosphonate more than four years

Exclusion Criteria:

* patients who could not use bisphosphonate

Primary outcomes:
measure: Influence of long-term bisphosphonate treatment on femur.
timeFrame: Up to 24 month
Secondary outcomes:
measure: Longitudinal effects of bisphosphonate treatments on femur
timeFrame: Up to108 months
Other outcomes:
Locations:
city: Yokkaichi
country: Japan
facility: Tomidahama Hospital
state: Mie
Study officials:
References:
Clinical trial NCT06985979: Exploring the Needs of HIU Patients Within the Emergency Department
Official title: Exploring the Needs of High-intensity User Patients Within the Emergency Department: Informing the Development of a Psychosocial Service
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: High Intensity Users
Frequent Attenders
Lead sponsor: East Lancashire Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The participants of this study will include patients who have been identified by the ED Cerna database to have attended the Emergency Department at Blackburn Royal Teaching Hospital over 5 times in the last 12 months.

All MDT staff within the Emergency Department at Blackburn Royal Teaching Hospital will be invited to participate (e.g. ED consultants, doctors, junior doctors, nurses as well as reception and portering staff).

Brief summary: The aim of this qualitative interview study is to explore the unmet needs of patients who frequently attend the emergency department and the challenges of the staff who support them.

The study will interview 10 patients who frequently attend the emergency department and 10 staff members working within the emergency department.


Eligibility criteria: Inclusion Criteria:

Patients who have attended the Emergency Department at Blackburn Royal Teaching Hospital over 5 times in the last 12 months All MDT staff within the Emergency Department at Blackburn Royal Teaching Hospital

Exclusion Criteria: Patients under 18 Patients who have not attended the Emergency Department 5 times or more Staff who do not work in the Emergency Department.

Primary outcomes:
measure: Qualitative Interview Data
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Blackburn
country: United Kingdom
facility: Blackburn Royal Teaching Hospital
Study officials:
References:
Clinical trial NCT03206879: Fecal ESBL Resurgence During Antibiotic Treatment
Official title: Fecal ESBL Resurgence During Antibiotic Treatment
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Antibiotic Drug Resistance
Keywords: ESBL
Enterobacteriaceae
multidrug-resistance
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: Sorlandet Hospital HF
name: Helse Stavanger HF
name: Sykehuset Telemark
name: Oslo University Hospital
name: Sykehuset Ostfold
First posted: 2017-07-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult, hospitalized patients previously infected by ESBL-E.

Brief summary: Norwegian hospitals are struggling to control spread of extended-spectrum beta-lactamase producing Enterobacteriaceae (ESBL-E) in health care settings. Strict screening and isolation criteria are enforced in hospital, and patients previously infected by ESBL-E are regarded as possible ESBL-E carriers indefinitely. This observational multi-centre cross-sectional study aims to estimate the duration of fecal ESBL-E carriage and to assess the risk of ESBL-E resurgence during hospital stay for patients previously infected by ESBL-E. Through better knowledge of these risk factors, infection control procedures may be better tailored to rhe individual patient.


Eligibility criteria: Inclusion Criteria:

Patients with previous infection or colonization with ESBL-E admitted to one of the participating wards. -

Exclusion Criteria:

* Not able to give informed consent.

Primary outcomes:
measure: fecal carriage of ESBL-E
timeFrame: Baseline
Secondary outcomes:
measure: fecal ESBL-E carriage developed during admission
timeFrame: Baseline (admission)
Other outcomes:
Locations:
Study officials:
affiliation: Akershus univversitetssykehus HF
name: Silje B Jørgensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05848479: Effect of Clamshell Exercise on Lumbopelvic Stability and Low Back Pain in Post Partum Women
Official title: Effect of Clamshell Exercise on Lumbopelvic Stability and Low Back Pain in Post Partum Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbosacral Instability
Low Back Pain Post Partum
Keywords: clamshell exercise
lumbopelvic instability
low back pain
post partum
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 44
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted on 44 females with postpartum LBP \& pelvic instability, selected from Dar of women hospital in port said to investigate effect of clamshell exercise on lumbo-pelvic stability and low back pain in postpartum women.


Eligibility criteria: Inclusion Criteria:

1. Post-partum females complaining of LBP and lumber instability
2. Their age will be ranged from 25-35 years.
3. Their BMI will be ranged from 25-30 kg/m2

Exclusion Criteria:

1. Spinal deformity.
2. Lower limb deformity.
3. Osteosarcoma
4. Mental disorders. 5-25\>BMI\>30

6-Performing any physical exercise at the time of the study. 7-Bad general Health

Primary outcomes:
measure: Change in the degree of lumbopelvic instability
timeFrame: change in the lumbopelvic instability degree will be measured at baseline and after 6 weeks of the interventions
measure: lumbopelvic range of motion
timeFrame: change in the lumbopelvic instability degree will be measured at baseline and after 6 weeks of the interventions
Secondary outcomes:
measure: severity of pain intensity
timeFrame: change in the lumbopelvic instability will be measured at baseline and after 6 weeks of the interventions
measure: the degree of function disability
timeFrame: change in the lumbopelvic instability will be measured at baseline and after 6 weeks of the interventions
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01886079: The Effects of Dexmedetomidine on Postoperative Renal Function in Valvular Heart Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Kidney Injury
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-06-25
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of study is to compare the incidence of acute kidney injury in patients receiving perioperative dexmedetomidine or placebo undergoing valvular heart surgery.


Eligibility criteria: Inclusion Criteria:

* adult patients over the age of 20 scheduled for valvular heart surgery

Exclusion Criteria:

* Left ventricular-ejection fraction \< 30%
* Preexisting congestive heart failure
* Severe coronary artery disease
* Hemodynamically unstable arrhythmia
* Cardiogenic shock during perioperative period
* Ventricular assist device
* Severe renal dysfunction (eGFR \< 15ml/min per 1.73m2)

Primary outcomes:
measure: Comparison of postoperative renal function in patients with or without dexmedetomidine undergoing valvular heart surgery:
timeFrame: 24 hours after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT04405479: Resting Postural Tremor in Multiple Sclerosis
Official title: Spectral Analyses of Resting Postural Tremor Measured by Accelerometer and Gyroscope as a Predictive Tool of Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Keywords: Tremor
Accelerometer
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People with MS and healthy volunteers

Brief summary: Early diagnosis is a key factor for effective treatment of multiple sclerosis. Accelerometer and gyroscope measurement of tremor could screen potential motor control dysfunction and predict a risk for development of multiple sclerosis.

Detailed description: The aim of this study is to test whether specially developed accelerometer and gyroscope can differentiate pattern of resting postural tremor in healthy and people with multiple sclerosis.

Spectral analysis and the correlation of the average signal spectra will be computed. Moreover, categorization based on the tremor component according to the maximum likelihood estimation will be done.

Eligibility criteria: Inclusion Criteria:

Group 1:

* Definite diagnosis of MS
* prevailed motor deficit of upper extremities, but without visible tremor
* stable clinical status in the preceding 3 months
* Expanded Disability Status Scale score (EDSS) ≥ 2 ≤ 7.5, and
* no corticosteroid therapy in the preceding month

Group 2:

* Healthy volunteers in the age of 20-70 years will be employed
* There will be defined as persons without any neurological disease diagnose at the time of the measurement.

Exclusion Criteria (both groups):

Patients with factors disturbing mobility (e.g. stroke, pregnancy, fractures) were excluded from the study.

Primary outcomes:
measure: Tremor
timeFrame: baseline
Secondary outcomes:
measure: Hand grip strength
timeFrame: baseline
measure: Hand and arm function
timeFrame: baseline
measure: Psychomotor processing speed
timeFrame: baseline
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Department of neurology
city: Prague
country: Czechia
facility: Deparment of revmatology and rehabilitation
city: Praha
country: Czechia
facility: Kamila Řasová
Study officials:
affiliation: Third Faculty of Mecicine, Charles Univerzity
name: Kamila Řasová, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: