louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02196597: Value of Anorectal Manometry Before Ileo- or Sigmoidostomy Closure After Rectal Resection
Official title: Prospective Multi-center Evaluation of the Value of Anorectal Manometry Before Closure of Protective Ileostomy or Sigmoidostomy After Rectal Resection in Patients With Rectal Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fecal Incontinence
Quality of Life
Keywords: anorectal manometry
Lead sponsor: German Society for Neurogastroenterology and Motility
Sponsor class: OTHER
First posted: 2014-07-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients operated for rectal carcinoma in three German centers

Brief summary: Background: High prevalence of fecal incontinence after rectal resection in patients with rectal carcinoma.

Hypothesis: Anorectal manometry done before ileostomy or sigmoidostomy closure can predict fecal incontinence.

Methods: Anorectal manometry before, 1 month and 6 month after closure. Anorectal endosonography before and 1 month after closure. Prediction of postoperative incontinence by the surgeon (digital sphincter examination). Visual analog scales for continence, subjective success of operation, and global well being; Wexner and Vaizey incontinence score; Parks incontinence classification; Rockwood fecal incontinence quality of life score; each before, 1 and 6 month after closure.


Eligibility criteria: Inclusion Criteria:

* all patients planned for ileo- or sigmoidostomy closure after rectal resection for rectal carcinoma

Exclusion Criteria:

* preoperative incontinence for solid stool
* dementia
* pregnancy
* latex allergy

Primary outcomes:
measure: predictive value of preoperative anorectal manometry for postoperative fecal incontinence
timeFrame: 6 month postoperative
Secondary outcomes:
measure: fecal incontinence in patients with/without neoadjuvant radiochemotherapy
timeFrame: six month postoperative
measure: predictive value of the surgeon's preoperative evaluation
timeFrame: six month postoperative
Other outcomes:
measure: prediction of postoperative fecal incontinence by the score of Stadelmaier and Matzel (Score =18.230 - 0.94x anastomotic level - 0.18 x resting pressure + 3.72 x radiochemotherapy (done 1, not done 0)
timeFrame: six month postoperative
Locations:
city: Landshut
country: Germany
facility: Hosptial Landshut-Achdorf
city: Memmingen
country: Germany
facility: Hospital Memmingen
city: Vilsbiburg
country: Germany
facility: Hospital Vilsbiburg
Study officials:
affiliation: German Society for Neurogastroenterology and Motility
name: Christian Pehl, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stadelmaier U, Bittorf B, Meyer M, Hohenberger W, Matzel KE. [Can continence function after rectal resection be prognostically estimated?]. Chirurg. 2000 Aug;71(8):932-8. doi: 10.1007/s001040051158. German.
Clinical trial NCT01062997: Volar Locked Plating Versus Bridging External Fixation
Official title: Volar Locked Plating Versus Bridging External Fixation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Distal Radius Fracture
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Haukeland University Hospital
First posted: 2010-02-05
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients between the age of 18 and 70 diagnosed with a C2- or C3-type fracture

Brief summary: A randomized, prospective comparison of volar locked plating versus Hoffman II bridging external fixation supplemented by K-wire fixation in patients with comminuted distal radius fractures, AO/OTA type C2 \& C3.

Hypothesis:

There is no significant difference in using volar plates compared to Hoffman II bridging external fixation supplemented by K-wire fixation in patients with comminuted distal radius fractures, AO/OTA type C2 \& C3 as evaluated by a Quick-DASH score at 24 months follow-up.

Detailed description: We have designed a randomized, prospective study for comparison of volar locked plating versus Hoffman II bridging external fixation supplemented by K-wire fixation in patients with comminuted distal radius fractures, AO/OTA type C2 \& C3. On the basis of power analysis a total of 140 patients are to be included in this project. The follow-up period is 2 years and evaluation is based on x-ray analysis, grip strength, range of movement, pain and various tools to measure quality of life and satisfaction with the treatment (EQ-5d, SF-36, Quick-DASH).

Eligibility criteria: Inclusion Criteria:

* All patients admitted to Ahus and Lillestrom legevakt with a distal radius fracture are to be classified according to the system of the Orthopaedic Trauma Association (AO/OTA).
* All patients between the age of 18 and 70 diagnosed with a C2- or C3-type fracture, or a dislocated C1-fracture, are eligible for inclusion.

Exclusion Criteria:

* Gustillo-Anderson type III open fractures
* Previous distal radius/ulna-fracture and/or disabling hand injury of the same extremity
* Dementia
* Congenital anomaly
* Bilateral radius fracture
* Pathological fracture other than osteoporotic fracture
* Congenital bone disease (for example osteogenesis imperfecta)
* Age below 18 and above 70
* Disabling nury to other parts og the movement apparatus at the same time as the current injury

Primary outcomes:
measure: Quick-DASH
timeFrame: 2 year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Sykehusveien 25, Nordbyhagen
country: Norway
facility: Akershus University Hospital
state: Lorenskog
Study officials:
References:
Clinical trial NCT02070497: Effectiveness of Nursing Case Management for Lung Cancer Patients
Official title: The Effectiveness of Nursing Case Management for Lung Cancer Patients in a Taiwan Medical Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-02-25
Enrollment: 415
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study is to investigate the effectiveness of nursing case management for lung cancer patients in a Taiwan medical center.

Detailed description: Purpose: The study is to investigate the effectiveness of nursing case management for lung cancer patients in a Taiwan medical center. The outcome variables include of percentages of patients accepted treatment in our medical center, average lengths of stay, unplanned re-admission rate, average admission times of emergency department per year, percentages of patients rejecting treatment, completing rate of treatment, withdrawing rate of treatment, improving rate of patients' treatment compliance, patients' satisfaction with healthcare, and staffs' satisfaction with case management.

Methods: The study will employ a quasi-experimental research design. The patients with new-diagnosed lung cancer and accepting case management will be assigned to the experimental group； The patients with new-diagnosed lung cancer in the period of one year ago and without accepting case management will be assigned to the control group；The third group is the patients with non-new-diagnosed lung cancer and with accepting case management. The staffs are the doctors within the lung cancer medical team.

The lung cancer case management database, patients' satisfaction questionnaire, and staffs' satisfaction questionnaire will be used to measure the effectiveness. Statistical software SPSS for Windows version 17.0 will be used to analyze the data.

Expected results: The research outcome will to confirm the impact of case management on the lung cancer patients and could be the reference data for future cancer case management model.

Eligibility criteria: Inclusion Criteria:

* patients with lung cancer

Exclusion Criteria:

* younger than 20 years old

Primary outcomes:
measure: chart review
timeFrame: One year
Secondary outcomes:
measure: patients' satisfaction questionnaire
timeFrame: 1 day
measure: staffs' satisfaction questionnaire
timeFrame: 1 day
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital Research Ethics Committee
Study officials:
affiliation: Department of Nursing, National Taiwan University Hospital
name: Ming-Ying Hong, RN, Master
role: STUDY_CHAIR
References:
Clinical trial NCT03408197: Two Warming Methods in Knee Arthroplasty
Official title: Comparison of Two Warming Methods in Knee Arthroplasty. A Prospective, Randomized Non-inferiority Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia, Accidental
Keywords: inadvertent, intraoperative hypothermia, prewarming
core temperature monitoring
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study two warming methods will be compared in knee arthroplasty surgery. Barrier EasyWarm will be used in the study group and BairHugger upper body warming blanket in the control group. Both groups will be prewarmed 30 minutes before spinal anaesthesia. In the operating room warming will be continued with the same warming method. Primary end point is core temperature after arriving to post anaesthesia care unit. Hypothesis is that Barrier EasyWarm is not inferior to BairHugger in preventing inadvertent intraoperative hypothermia.

Few methods exist to measure the core temperature non-invasively. Zero-heat-flux technique is used in this study. During the study we will test the accuracy of the 3M BairHugger Temperature Monitoring System by placing two sensors onto the patients (n = 30) fore head. After that the accuracy of the Dräger Tcore is examined by comparing it with the 3M BairHugger Temperature Monitoring System. So the patients (n=30) have both these different core temperature monitoring systems on their foreheads. This observational monitoring study is performed from the patient number 80 until the end.


Eligibility criteria: Inclusion Criteria:

* BMI 25-40
* ASA class I-III
* elective primary unilateral kneearthroplasty
* spinal anaesthesia

Exclusion Criteria:

* ASA class \> III
* unstable coronary artery disease
* revision surgery, bilateral arthroplasty
* general anaesthesia
* decreased mental status

Primary outcomes:
measure: Core temperature after arriving to the post-anaesthesia care unit
timeFrame: one hour
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Maija-Liisa Kalliomäki
role: STUDY_DIRECTOR
References:
citation: Lauronen SL, Kalliomaki ML, Kalliovalkama J, Aho A, Huhtala H, Yli-Hankala AM, Makinen MT. Comparison of zero heat flux and double sensor thermometers during spinal anaesthesia: a prospective observational study. J Clin Monit Comput. 2022 Oct;36(5):1547-1555. doi: 10.1007/s10877-021-00799-6. Epub 2022 Jan 3.
Clinical trial NCT04406597: Safety, Effectiveness and Operability of Using the New Tissue Containment System During Laparoscopic Ovarian Cystectomy
Official title: Safety, Effectiveness and Operability of Using the New Tissue Containment System With Hard Pipes Which Can Assemble With Detachable Trocars Seamlessly for Tissue Removal During Laparoscopic Ovarian Cystectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ovary Neoplasm
Surgery
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed to evaluate the safety, effectiveness and operability of performing in-bag cystectomy and morcellation with the new tissue containment system during laparoscopic ovarian cystectomy. Premenopausal women, aged 18-45 undergoing laparoscopic cystectomy.


Eligibility criteria: Inclusion Criteria:

* Premenopausal woman patient age 18-45 years
* Women with regular period
* Women with ovarian neoplasm (size: 3-10cm)
* Laparoscopic surgery required
* Body mass index 18.5-27.9kg/m2
* Subject able to comprehend and give informed consent for participation in this study
* Signed informed consent form

Exclusion Criteria:

* Patient is not considered suitable for a laparoscopic ovarian cystectomy procedure
* The ovaries and pelvic cavity are severely adhered, and the tumor ruptures when free
* Women with Polycystic ovary syndrome
* Baseline AMH less than 0.5ng / mL
* Known to have participated in any other clinical trials or hormone therapy within 3 months
* Women during pregnancy and lactation
* Women in acute stage infection of reproductive system or other parts
* Women combined with severe central nervous system, cardiovascular system, liver and kidney, digestive tract, respiratory system, endocrine metabolism (thyroid disease, Cushing syndrome, hyperprolactinemia) and skeletal muscle system and mental disorders contraindicating laparoscopic surgery
* Women with known or suspected poor compliance who cannot complete the trial
* Those who can not sign the informed consent

Primary outcomes:
measure: The exposure rate
timeFrame: End of study - approximately two years
Secondary outcomes:
measure: The ovarian reserve function
timeFrame: Three months after the surgery
measure: Mean procedure time
timeFrame: Within one week after the surgery
measure: Estimated blood loss during operation
timeFrame: Within one week after the surgery
measure: Rate of Intra- or post-operative complications
timeFrame: Three months after the surgery
measure: The patients' life quality postoperative: questionaire
timeFrame: Three months after the surgery
measure: The Surgery Task Load Index
timeFrame: Within one week after the surgery
measure: The rate of failure during in-bag cystectomy procedure
timeFrame: End of study - approximately two years
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04793997: Microbiome Therapy in Covid-19 Primary Care Support
Official title: Covid-19 Primary Care Support With Microbiome Therapy.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: SARS-CoV Infection
Corona Virus Infection
Keywords: lactobacilli
Probiotics
Throat spray
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind, randomized, placebo controlled
Primary purpose: TREATMENT

Brief summary: This double-blind, randomized, placebo-controlled study aims to investigate whether a throat spray containing probiotic bacteria (i.e. microbiome spray) can reduce the symptoms and complaints of the SARS-CoV-2 virus in patients with mild to moderate symptoms. In addition, the aim is to investigate whether the microbiome spray can prevent transmission of the SARS-CoV-2 virus to household members.


Eligibility criteria: Inclusion Criteria:

* Patients in primary care with a positive SARS-CoV-2 test based on PCR
* Instructed during screening and agreed not to use other probiotic nutritional supplements outside of the study during the study period
* Sign the consent form

Exclusion Criteria:

* Antibiotic use at baseline and during the study
* Vaccinated against SARS-CoV-2 at start of the study (both for index patients and household members that participate)
* Pregnant women
* History of use of probiotic supplements in the past two weeks
* Current diagnosis of cancer or immunosuppressive therapy within the past 6 months
* Acute and chronic infectious and inflammatory upper airway diseases (eg acute / chronic rhinosinusitis)
* Clinically significant bleeding disorder
* Any other medical condition that, in the principal investigator's opinion, warrants exclusion from the trial

Primary outcomes:
measure: Change in severity of COVID-19 infection symptoms after using microbiome spray
timeFrame: 3 weeks
Secondary outcomes:
measure: Change in duration of COVID-19 infection symptoms after using microbiome spray
timeFrame: 3 weeks
measure: Change in absolute numbers of SARS-CoV-2 after using microbiome spray
timeFrame: 3 weeks
measure: Change in absolute numbers of specific bacterial pathogens after using microbiome spray
timeFrame: 3 weeks
measure: Change in microbiome of nose/throat region after using microbiome spray.
timeFrame: 3 weeks
measure: Prevalence of antibodies against SARS-CoV-2 in the index patients' household members
timeFrame: 3 weeks
measure: Prevalence of COVID-19 in the index patients' household members
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Veronique Verhoeven
Study officials:
References:
Clinical trial NCT03777397: Awareness About Breast Cancer Screening
Official title: Study of Awareness of Hospices Civils de Lyon Workers About Breast Cancer Screening
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 2264
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women employees of Hospices Civils de Lyon

Brief summary: Breast cancer is the most common cancer in French women, with 52000 new cases each year.

Shift work and night work is recognized by International Agency for Research on Cancer as a potential risk factor. Epidemiological studies find, for most of them, an increased risk of breast cancer compared with general population. Physiological hypothesis rely on the melatonin role in defense against tumorigenesis.

According to High Authority of Health clinical good practice guidelines, the risk does not justify more screening than the organized screening. We do not have information about awareness level of workers in health structures, specially in the Hospices Civils de Lyon.

Investigators would like to know how employees take part to breast cancer screening, specially in night workers.

This study, as a survey, is a first step to evaluate the need for specific actions to increase the participation to breast cancer screening.


Eligibility criteria: Inclusion Criteria:

* employees HCL
* women

Exclusion Criteria:

* \<18 years old

Primary outcomes:
measure: Participation of HCL female staff in mammography screening for breast cancer
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de Gynécologie - Hôpital de la Croix-Rousse - Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT04286997: VARA (Virtual and Augmented Reality Applications in Rehabilitation): Motor Rehabilitation Protocol With GRAIL for Patients Affected by Hemiparesis
Official title: VARA: Motor Rehabilitation Protocol With GRAIL for Patients Affected by Hemiparesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiparesis
Keywords: GRAIL
children
rehabilitation
virtual reality
hemiparesis
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main goal of the study is to verify the efficacy of the GRAIL system in respect to the walking pattern improvement in a population of hemiparetic subjects.

In particular, the specific goals will be:

* increase in walking symmetry and a better distribution among the time of stance and swing.
* Kinematics and Kinetics correction, with incentive of more corrected activation timing.
* Recruitment of the muscles most involved by the paresis, with the help of visual feedback.
* walking speed increase (but with the priority of the walking pattern)
* increase in the resistance
* Stregthening of the support reaction


Eligibility criteria: Inclusion Criteria:

* hemiparetic patients as a consequence of acquired brain injury

Exclusion Criteria:

* excessive muscular spasticity or contractures.
* recent (under 6 months) lower limbs surgery
* cognitive or emotional/relational obstacles to the therapy

Primary outcomes:
measure: Gait Analysis
timeFrame: 1 month
measure: Gross Motor Functional Movement
timeFrame: 1 month
Secondary outcomes:
measure: 6 Minute Walking Test
timeFrame: 1 month
measure: Functional Assessment Questionaire
timeFrame: 1 month
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS E.Medea
state: Lecco
Study officials:
References:
Clinical trial NCT03620305: Septic Pseudarthrosis Of Long Bone : Experience In A Regional Reference Center
Official title: Septic Pseudarthrosis Of Long Bone : Experience In A Regional Reference Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pseudoarthrosis of Bone
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: : patients having septic pseudarthrosis managed with 2 steps chirurgical treatment

Brief summary: Description of septic pseudarthrosis with chirurgical treatment in two steps (first step : Implementation of cement, second step : bone reconstruction, with or without device)


Eligibility criteria: Inclusion Criteria:

* patients having septic pseudarthrosis of long bone treated at the CRIOAc LYON

Exclusion Criteria:

-

Primary outcomes:
measure: Description of treatment of septic pseudarthrosis : chirurgical treatment - rate of use of this type of chirurgical treatment among patients with septic pseudarthrosis
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Secondary outcomes:
measure: Description of treatment of septic pseudarthrosis : medical treatment - duration of treatment in patients having sepstic pseudarthrosis
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
measure: Treatment failure : rate of failure with this 2 times chirurgical treatment
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon - Hôpital Croix-Rousse
name: Tristan Ferry
role: PRINCIPAL_INVESTIGATOR
References: