louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05223764: Why Are Fertility Preservation Patients Not Coming Back?
Official title: Why Are They Not Coming Back? A Single-center Follow-up Study in Fertility Preservation in Oncological Women.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fertility Issues
Cancer
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 172
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with an oncological diagnosis who underwent ovarian stimulation and oocytes retrivial and cryopreservation for fertility preservation

Brief summary: This is a single-center retrospective study carried out with a phone call follow-up to investigate women's decision not to return for criopreserved ovocytes use after cancer treatment. The study database includes all women who underwent fertility preservation cycles at a third-level university-affiliated center from January 2001 to December 2017.

Patients were asked a set of standardized questions whose purpose was to investigate their present health conditions, cancer treatment and any potential relapses, their family projects and sentimental status, any spontaneous conception, and why they had not yet returned for embryo transfer.

All data were recorded anonymously in our dataset.

Detailed description: All women who underwent oocyte cryopreservation cycles for oncological purposes from January 2001 to December 2017 at Fertility Center of Humanitas Research Hospital, Rozzano (Milano), Italy, were contacted.

The survey's purpose was to investigate their present health conditions, cancer treatment and any potential relapses, their family projects and sentimental status, any spontaneous conception, and why they had not yet returned for oocytes use.

Eligibility criteria: Inclusion Criteria:

The study database includes all women who underwent fertility preservation cycles at a third-level university-affiliated center

Primary outcomes:
measure: return rate
timeFrame: from January 2001 to December 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Valentina Immediata
state: MI
Study officials:
References:
Clinical trial NCT02952664: Pressure Ulcer Monitoring Platform (PUMP)
Official title: Pressure Ulcer Monitoring Platform (PUMP): A Device to Monitor Patient Positioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-11-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will employ two monitoring device prototypes. The devices are sensors containing accelerometers and gyroscope. The raw output data will be analyzed to determine when patients are moved or are repositioned in their beds. The data is captured within a modem which will correlate these movements with video recordings for interpretation by the research team. One sensor is wearable on the patient gown or sleepwear, and the other is placed underneath the frame of the hospital bed. The investigators propose a non-blinded trial with n=10 where all subjects will undergo the two devices. A video camera will be placed in each subject room for recording the repositioning events to correlate the monitor signals with the actual subject repositioning captured by the video. The goal of the trial is to validate the ability of each of the sensor prototypes to accurately detect when subjects are turned, in order to reduce stationary positioning which contributes to the incidence of pressure ulcers and to improve compliance with patient repositioning trials.

Detailed description: The investigators propose a non-blinded trial with n=10 where all subjects will undergo the two devices. A video camera will be placed in each subject room for recording the repositioning events to correlate the monitor signals with the actual subject repositioning captured by the video. The goal of the trial is to validate the ability of each of the sensor prototypes to accurately detect when subjects are turned, in order to reduce stationary positioning which contributes to the incidence of pressure ulcers and to improve compliance with patient repositioning trials. The repositioning events recorded by the sensor devices will be automatically uploaded and abstracted by the research team, along with the events captured by the simultaneous video recording of patient repositioning.

Eligibility criteria: Inclusion Criteria:

* Subject is over 18 years of age
* Subject is immobile and/or unable to independently re-position self

Exclusion Criteria:

* Subject is under the age of 18 years
* Subject is able to independently re-position self

Primary outcomes:
measure: Comparison of sensor output with video-recorded data
timeFrame: 10 hours of monitoring
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Mercy
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Patsy Simon, RN,BS,CCRC
role: STUDY_DIRECTOR
affiliation: University of Pittsburgh
name: Joseph P Rubin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00798564: Exercise Induced Asthma and Airway Reactivity in Athletes
Official title: Explorative Study "Exercise Induced Asthma and Airway Reactivity in Athletes"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Function Tests
Keywords: Exercise
Mannitol
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
Collaborators: name: Swedish Heart Lung Foundation
First posted: 2008-11-26
Enrollment: 300
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 100 elite swimmers 100 elite tennis players 100 aged matched non-atletic subjects, 30 aged-matcked healthy non-atopic controls

Brief summary: The overall aim is to explore pathophysiological factors related to airway hyperresponsiveness to direct and indirect provocation stimuli in athletes with different sport activities, with special focus on epithelial reaction linked to CC16 and to eicosanoid related inflammatory response. The investigators also wish to compare indirect testing done as hyper osmotic challenge with Mannitol compared to a defined sport specific exercise challenge.

Detailed description: By non-invasive tools the investigators wish to characterize type of airway reaction to various provocative stimuli in athletes doing two different sort activities, Tennis or swimming. As controls are being used sedentary age-matched controls from the same region, exposed to the same school environment. Thus we wish to:

* explore the prevalence of positive mannitol reactivity among swimmers and tennis player and how this relates to symptoms, disease history and to a sport specific exercise provocation test.
* compare the results from sport specific testing with a standardized eucapnic hyperventilation test (EHV)
* compare the overall reactivity to mannitol or EHV among swimmers and tennis players compared to aged matched controls.
* explore the role by CC16 in airway reactivity to different provocative stimuli and to see whether there is a difference between different sport activities, different test protocols and between athletes and controls.
* explore evidence of eicosanoid related inflammatory reaction in athletes and controls in relation to different provocative stimuli

The study population consists of 100 elite swimmers, 100 elite tennis players and 100 non-elite, eged matched controls. In the latter group, 30 are aged matched non-atopic non-asthmatic controls.

Eligibility criteria: Inclusion Criteria:

* Subjects aged 16-19 from Skåne.
* All should approve attendance in the study by signing an informed consent. Igf they are aged under 18, parents should also sign.
* Three groups are included
* Elite aspiring swimmers with an average training intensity of at least hours per week the last year.

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Lund University
name: Leif H Bjermer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02504164: Effect of Midazolam Premedication on the Satisfaction Levels of Patients After Endoscopic Submucosal Dissection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Gastric Cancer
Gastric Adenoma
Keywords: midazolam
satisfaction
endoscopic submucosal dissection
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-07-21
Enrollment: 72
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Endoscopic submucosal dissection is commonly performed under light to moderate sedation, and minimizing patient movement is of key importance for successful outcome. Propofol has widely replaced benzodiazepines as sedative drug of choice, and has been reported to enhance the quality of procedure in our past study. However, despite higher satisfaction scores of the endoscopists and faster post-procedural recovery, patient satisfaction scores were found to be higher in patients that received midazolam and meperidine instead of propofol and remifentanil. This seems to be due to the anterograde amnestic effects of midazolam rather than the quality of sedation itself. Investigator hypothesized that by premedicating the patient with low lose midazolam before receiving sedation for ESD with propofol and fentanyl, patient satisfaction would be enhanced without affecting endoscopic performance.


Eligibility criteria: Inclusion Criteria:

1. Adult patients over the age of 19 diagnosed with early gastric cancer or gastric adenoma that are scheduled for endoscopic submucosal dissection
2. American society of anesthesiologist physical status 1\~3

Exclusion Criteria:

1. Patient refusal
2. Patients that received sedatives within 24 hours prior to endoscopic submucosal dissection
3. History of gastrectomy or previous endoscopic submucosal dissection at same site
4. Allergies to propofol or its ingredients, soybeans or peanuts
5. Pregnant or breastfeeding patients
6. Patients with severe debilitating underlying medical conditions
7. Patients with altered mental status
8. Illiterate patients or foreigners

Primary outcomes:
measure: Overall patient satisfaction scores on a scale from 0 to 10
timeFrame: 24 hours after ESD
measure: Willingness to receive same method of sedation for ESD in the future as yes or no
timeFrame: 24 hours after ESD
measure: Post-procedural pain on a VAS scale of 0 to 10
timeFrame: at 1 hour and 24 hours after ESD
measure: Any recall of the ESD procedure on a scale from 0 to 2 (0; no recall, 1; partial recall, 2; can recall most of procedure)
timeFrame: 24 hours after ESD
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Study officials:
References:
Clinical trial NCT02298764: Back Pain and PostTraumaticStressDisorder. A Randomized Clinical Trial
Official title: Somatic Experiencing for Patients With Comorbid Posttraumatic Stress and Back Pain - A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
PTSD
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Spine Centre of Southern Denmark
First posted: 2014-11-24
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim The aim is to test whether a short psychotherapeutic intervention targeting Post Traumatic Stress Disorder (PTSD) symptoms will have an additional positive effect on the outcomes of the Standard Multidisciplinary Program (SMP) against chronic back pain development.

Detailed description: Focus Patients with back pain often demonstrate symptoms of PTSD measured via the Harvard Trauma Questionnaire Scale (HTQ). It has been found that PTSD and pain may maintain each other.

Methods Thousand consecutive patients with Low Back Pain (LBP) referred to the Spine Center are screened for PTSD. It is expected that 100 patients will meet the inclusion criteria and be randomized to SMP or to SMP plus 10 psychotherapeutic sessions, that will include the shock-trauma method 'Somatic Experiencing'.

Conclusion The project started in 2013, so there have not yet been any results. Currently total reached 65 back pain patients; 34 patients in the SMP + sessions intervention arm.

Effect parameters are: Pain, daily function, EuroQOL and (HTQ), anxiety and depression, fear avoidance (Tampa Scale for Kinesiophobia) on entry, and at 6/12 months.

This "Nested Randomized Trial in a Cohort Design" is one of the very first studies targeting both PTSD and chronic pain-related symptomatology.

Eligibility criteria: Inclusion Criteria:

* Back pain: from 1/2 Y duration or longer
* Trauma according to HTQ

Exclusion Criteria:

-

Primary outcomes:
measure: Functional status, Roland Morris Scale
timeFrame: 0, 1 year
Secondary outcomes:
measure: Harvard Trauma Questionnaire
timeFrame: 0, 1 year
measure: Back pain intensity, numeric rating scale
timeFrame: 0, 1 year
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark
state: Fyn
Study officials:
affiliation: University of Southern Denmark, Department of Psychology
name: Tonny E Andersen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03750721: Staphylococcal Acute Post-Operative PJI Treated With 'DAIR' And Impact Of Rifampin
Official title: Staphylococcal Acute Post-Operative Prosthetic Joint Infection Treated With 'DAIR' (Debridement and Implant Retention) And Impact Of Rifampin: A Retrospective Cohort Study In France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone and Joint Infection
Antibiotic Resistant Staphylococcus Aureus Infection
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 79
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: retrospective cohort study in 4 hospitals : patients with staphylococcal acute post-operative (\< 1 month) PJI treated with DAIR in 2011-2016 period

Brief summary: S. aureus and coagulase-negative staphylococci are the most frequent bacteria responsible for PJI (prosthetic joint infection). The aim of this study is to describe the use of rifampicin.


Eligibility criteria: Inclusion Criteria:

patients having had acute PJI (i.e. \<1 month following the implantation), DAIR with exchange of removal components) due to S. aureus and coagulase-negative staphylococci (2011-2016)

Exclusion Criteria:

None

Primary outcomes:
measure: description of the use of rifampicin : rate of use
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Secondary outcomes:
measure: rate of failure for treatment using rifampin
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
measure: rate of adverse event with rifampin
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 de la Croix-Rousse
name: Tristan FERRY, Md,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00919321: The Duration of Humoral Immunity and the Memory Cell Function After Vaccination With 7-valent Pneumococcal Conjugate Vaccine in CLL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Lymphocytic Leukemia (CLL)
Keywords: CLL
PPV
PCV
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Turku University Hospital
name: Finnish Institute for Health and Welfare
First posted: 2009-06-12
Enrollment: 32
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Patients with chronic lymphocytic leukemia (CLL)have had very poor humoral responses to pneumococcal polysaccharide vaccine (PPV). The vaccine in which pneumococcal polysaccharide antigens are conjugated to protein (PCV) have been immunogenic in CLL patients in our previous studies.

The purpose of this study is to evaluate the duration of these vaccine-induced antibodies and the function of memory cells by giving a one dose of PPV-vaccine after several years of PCV-vaccination.


Eligibility criteria: Inclusion Criteria:

* CLL patients and controls who have been vaccinated with PCV in our previous study

Exclusion Criteria:

* Vaccinated with PPV-vaccine within the last 5 years, immunoglobulin substitution, corticosteroid treatment (equivalent of 20mg prednisolone per day)

Primary outcomes:
measure: Antibody response
timeFrame: 1-3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
References:
citation: Sinisalo M, Vilpo J, Itala M, Vakevainen M, Taurio J, Aittoniemi J. Antibody response to 7-valent conjugated pneumococcal vaccine in patients with chronic lymphocytic leukaemia. Vaccine. 2007 Dec 21;26(1):82-7. doi: 10.1016/j.vaccine.2007.10.053. Epub 2007 Nov 12.
citation: Sinisalo M, Aittoniemi J, Oivanen P, Kayhty H, Olander RM, Vilpo J. Response to vaccination against different types of antigens in patients with chronic lymphocytic leukaemia. Br J Haematol. 2001 Jul;114(1):107-10. doi: 10.1046/j.1365-2141.2001.02882.x.
citation: Lindstrom V, Aittoniemi J, Salmenniemi U, Kayhty H, Huhtala H, Itala-Remes M, Sinisalo M. Antibody persistence after pneumococcal conjugate vaccination in patients with chronic lymphocytic leukemia. Hum Vaccin Immunother. 2018 Jun 3;14(6):1471-1474. doi: 10.1080/21645515.2018.1436424. Epub 2018 Feb 23.
Clinical trial NCT00000221: Alternate-Day Buprenorphine Administration. Phase I - 3
Official title: Alternate-Day Buprenorphine Administration. Phase I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Opioid-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Vermont
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 28
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if two times a subject's daily maintenance dose will hold for 48 hours without changes in agonist and antagonist effects.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Drug use
measure: Opioid withdrawal
measure: Opioid agonist effects
measure: Dose identification
measure: Pupil diameter
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Treatment Research Center
state: Vermont
Study officials:
affiliation: University of Vermont
name: Warren Bickel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amass L, Bickel WK, Higgins ST, Badger GJ. Alternate-day dosing during buprenorphine treatment of opioid dependence. Life Sci. 1994;54(17):1215-28. doi: 10.1016/0024-3205(94)00848-5.
Clinical trial NCT04768621: Health Consequences of Wintering in the French Southern and Antarctic Territories
Official title: Health Consequences of Wintering in the French Southern and Antarctic Territories
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Environmental Exposure
Winter Depression
Endocrine System Diseases
Sleep Disorder
Immunologic Activity Alteration
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Questionnaire
Primary purpose: PREVENTION

Brief summary: Polar stays expose people to extreme climate, isolation and confinement. The combination of these factors induces psychological disorders, sleep disorders, immune and endocrine disturbances, and deficiencies. In the TAAF, (French Southern and Antarctic Lands) two types of population coexist: winter residents, exposed to these stressors over long periods, and country people, who benefit from milder conditions and only make short stays. In this context, the investigators have decided to set up this cohort study with the objective of comparing the state of health of the winterers of the TAAF from 2012 to 2017 with that of the country people of the same period, before their stay, during and the year following their return.

Detailed description: Participants will answer to a questionnaire. This questionnaire will determinate participants health about following areas : psychological disorders, sleep disorders, immune and endocrine disturbances, and any deficiencies.

Eligibility criteria: Inclusion Criteria:

for the exposed group are:

* To have carried out one or more wintering in one of the districts of the TAAF, that means a stay of at least six consecutive months including winter;
* Have started their first wintering between 01jan2012 and 31dec2017;
* Know how to read and write French.

for the non-exposed group are:

* To have taken part in one or more summer campaigns between 01jan2012 and 31dec2017;
* Never have overwintered;
* Not having been refused wintering for health reasons or following psychological tests;
* Knowing how to read and write French.

Exclusion Criteria:

* Persons under guardianship or guardianship, deceased persons, persons refusing to participate in the study

Primary outcomes:
measure: Evaluate incidence health disorders and sociological consequences of wintering of health of winterers (exposed) of TAAF from 2012 to 2017 with that of country people (not exposed) of the same period
timeFrame: between 4 years and 9 years after polar exposure
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Denis
country: Réunion
facility: CHU de la Réunion
Study officials:
affiliation: CIC 1410
name: Nicolas BOUSCAREN
role: PRINCIPAL_INVESTIGATOR
References: