louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04563832: Self-administered Hyperinsufflation Chest on the Risk of Low Respiratory Infection in Patients With Multiple Sclerosis With Sputum Capacity Deficit
Official title: Self-administered Hyperinsufflation Chest Mobilization Randomized Study on the Risk of Low Respiratory Infection in Patients With Multiple Sclerosis With Sputum Capacity Deficit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Control group: standardized respiratory management.
* Experimental group: same program, associated with the daily use of a hyperinsufflation technique.
Primary purpose: SUPPORTIVE_CARE

Brief summary: In patients with neuromuscular disease, chest mobilization by hyperinsufflation slows respiratory decline by almost 80% compared to controls, and prevents complications like pneumonia, atelectasis and respiratory distress.

This insufflation technique improves the airway clearance and reduces the need for invasive ventilation. It also improves CV and DEPtoux in patients with neuromuscular pathology

Detailed description: During multiple sclerosis (MS), although expiratory involvement and reduced sputum capacity are predominant, automated techniques of hyperinsufflation and in-exsufflation remain underused and undervalued. A single retrospective study suggests a decrease in the decline in respiratory function with regular manual hyperinsufflation.

Evidence of a benefit of chest mobilization by hyperinsufflation by a controlled trial is therefore necessary before recommending its use in MS.

Eligibility criteria: Inclusion Criteria:

* Confirmed MS diagnosis (McDonald criteria)
* EDSS ≥ 7
* Age greater than or equal to 18 years.
* Expiratory flow during a coughing effort (DEPtoux) ˂4.5L / s.

Exclusion Criteria:

* ENT and / or thoracic surgery less than 6 months old
* Progressive or past pneumothorax / pneumomediastinum
* Severe swallowing disorders.
* Inability to use the device under study

Primary outcomes:
measure: Effectiveness of a self-administered automated hyperinsufflation technique for 2 years, versus standard management, on respiratory infection risk within 2 years after randomization, in patients with MS.
timeFrame: 24 months
Secondary outcomes:
measure: Effect of COUGH-ASSIST on slowing the decline in respiratory function,
timeFrame: 12 months and 24 months
measure: Functional effectiveness of COUGH-ASSIST
timeFrame: 12 months and 24 months
measure: Tolerance and compliance with COUGH-ASSIST,
timeFrame: 24 months
measure: Effectiveness of COUGH-ASSIST in reducing the risk of serious respiratory infection
timeFrame: 24 months
Other outcomes:
Locations:
city: Garches
country: France
facility: Hôpital Raymond Poincaré
state: Haut De Seine
Study officials:
References:
Clinical trial NCT02984332: Timecourse of Immobilization Experiment
Official title: Short-term Muscle Disuse Induces a Rapid and Sustained Decline in Daily Myofibrillar Protein Synthesis Rates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscular Atrophy
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 13
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The effect of unilateral lower limb immobilisation over one week on muscle atrophy

Detailed description: This study aims to assess the effect of one week of unilateral leg immobilization on quadriceps muscle volume and muscle protein synthesis rates. Participants wore a leg brace on one leg and ambulated on crutches during the immobilization period. Thirteen healthy young males were recruited to undertake this study.

It is currently understood that unilateral leg immobilization will result in a reduction in muscle size (Berg et al., 1996, Wall et al., 2015) and muscle protein synthesis rates after a period of disuse (de Boer et al., 2015, Glover et al., 2008). Recent research in this area has shown that even short term periods of leg immobilization (i.e. \<1 week) will result in reductions in muscle size and muscle protein synthesis rates after the period of disuse (Wall et al., 2015). However we currently do not have detailed information on how muscle disuse affects muscle size and muscle protein synthesis over time during short term disuse (e.g. the first week).

The stable isotope tracer deuterium oxide (D2O) will be applied to assess cumulative muscle protein synthesis between days 0-2, 2-7 and 0-7 of the immobilization period in both the immobilized and non immobilized legs. This will be in-conjunction with bilateral vastus lateralis muscle biopsies before and after 2 and 7 days of immobilization. Furthremore, quadriceps muscle volume was assessed via MRI scans that again occured before and after 2 and 7 days of immobilization. To gain a mechanistic insight on the molecular changes during disuse a custom designed 48 well Taqman low density microarray genecard was applied to assess the transcriptional response on genes involved in muscle protein synthesis and breakdown.

Eligibility criteria: Inclusion Criteria:

BMI \>18 and \<28 no prescription medications or current illness -

Exclusion Criteria:

BMI \<18 and \>28 current prescription medication no history of leg injury

Primary outcomes:
measure: Muscle size
timeFrame: Days 0, 2 and 7
Secondary outcomes:
measure: Muscle protein synthesis
timeFrame: days 0-2, 2-7 and 0-7
measure: Muscle strength
timeFrame: Pre and post immobilization
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Sport & Health Sciences
state: Devon
Study officials:
References:
Clinical trial NCT04466332: Comparison of Two ECG Guided PICC Insertion Techniques
Official title: Comparison of Two ECG Guided PICC Insertion Techniques, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Venous Access
Long Term Antibiotics
Chemotherapy
Total Parenteral Nutrition
Keywords: PICC
ECG guidance
Central Venous Catheter
Catheterization
Lead sponsor: University of Lausanne
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Vaudois
First posted: 2020-07-10
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of our study is to compare two ECG techniques for guiding Peripherally Inserted Central Venous Cather (PICC) in terms of accuracy of the final position of the catheter tip.

Detailed description: One technique uses ECG signal transmission with saline water and allows external catheter length adjustment while the other technique uses a guidewire for signal transmission thus requiring prior catheter length adjustment

Eligibility criteria: Inclusion Criteria:

* Informed Consent as documented by signature (Appendix Informed Consent Form)
* Adult \> 18 years
* Referred to the interventional radiology department for PICC insertion

Exclusion Criteria:

* Known or suspected non-compliance
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Previous enrolment into the current study
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Impairment of the heart rhythm changing the presentation of the P wave (atrial fibrillation, atrial flutter, severe tachycardia, pacemaker driven rhythm)
* Enrolled in conflicting research study
* Weight\> 150 kg, technical limit for the fluoroscopy table
* Impossibility of obtaining informed consent
* Refusal to be informed in the event of a chance discovery

Primary outcomes:
measure: Distance from catheter tip to cavo-atrial junction (CAJ)
timeFrame: At the end of intervention
Secondary outcomes:
measure: Length of the outgoing catheter
timeFrame: At the end of intervention
measure: Haemostasis time
timeFrame: At the end of intervention
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV
state: Vaud
Study officials:
affiliation: UNIL-CHUV
name: Salah Dine Qanadli, Prof. MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00463632: Schistosomiasis in Women of Reproductive Age in Burkina Faso: Implications for Control
Official title: Schistosomiasis in Women of Reproductive Age in Burkina Faso: Implications for Control
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schistosomiasis
Anaemia
Pregnancy
Keywords: schistosomiasis
anaemia
pregnancy
Lead sponsor: DBL -Institute for Health Research and Development
Sponsor class: OTHER
Collaborators: name: Centre Muraz
First posted: 2007-04-20
Enrollment: 200
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: antenatal care clinics child immunization program

Brief summary: Cross-sectional study of prevalence and intensity of schistosome infection in pregnant women, follow-up into postpartum, and the association of schistosome infection with haemoglobin concentration, compared to a group of non-pregnant women.

Detailed description: The objective of this study is to investigate the epidemiology of schistosomiasis and anaemia among pregnant and non-pregnant women in Burkina Faso and explore the implications for the national schistosomiasis control programme and future studies.

Specific objectives are:

* to determine the prevalence and intensity of schistosome infection in pregnant women attending for antenatal care and in non-pregnant women of reproductive age in an area which is hyperendemic for S.haematobium infection and in which there is little or no S.mansoni infection
* to determine the prevalence and intensity of schistosome infection in pregnant women attending for antenatal care and in non-pregnant women of reproductive age in an area in which S.mansoni infection is common
* to determine Haemoglobin concentration in pregnant women attending for antenatal care and in non-pregnant women of reproductive age in the regions described above
* to investigate the association between infection and haemoglobin concentration in pregnant and non-pregnant women
* to determine the prevalence of other parasitic infections in pregnant women and non-pregnant women including hookworms, ascaris, trichuris and malaria
* to demonstrate the research team's ability to follow-up pregnant women recruited at antenatal care clinics onto the postpartum period

Eligibility criteria: Inclusion Criteria:

* Pregnant women attending for ANC
* Non-pregnant women age 15-45 years accompanying relatives or children to the health centres or for immunization

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dori
country: Burkina Faso
facility: Dori Health Centre
city: Ouagadougou
country: Burkina Faso
facility: National Schistosomiasis Control Program
Study officials:
affiliation: The National Schistosomiasis Control Program Burkina Faso
name: Seydou Touré, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03881332: Measurement of Perioperative Glomerular Filtration Rate
Official title: Clinical Observational Study Using Iohexol to Measure Perioperative Glomerular Filtration Rate in Patients Undergoing Robotic Surgery for Rectum or Large Bowel Cancers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Colon Cancer
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive elective rectum and colonic cancer patients due for robot surgery

Brief summary: Our objective is to monitor glomerular filtration rate (GFR)during the perioperative phase of patients undergoing robotic surgery for rectum or large bowel cancers. We will use both a single injection and a continuous infusion of iohexol to measure kidney function for 72 hours after surgery.

Detailed description: The considerable morbidity and mortality associated with perioperative acute kidney injury (AKI) is well documented and known to complicate recovery from surgery.

Accurate, direct measurements of glomerular filtration rate (GFR) may provide a tool to monitor perioperative onset of rapidly changing renal function. This may subsequently lead to design of randomized controlled trials examining the effects of earlier intervention with the aim to reduce the incidence of perioperative AKI.

Recently a protocol for continuous infusion of low-dose iohexol (CILDI) as a measure of GFR in stable patients over a range of GFR (28-128 mL/min/1.73 m2) has been developed. Accuracy of this infusion protocol was confirmed with the single bolus injection (SBI) method. Data also showed that the continuous infusion protocol of low-dose iohexol is an accurate and precise method when measuring changing GFR even in critical ill patients with variable AKI risks. Accordingly, SBI and CILDI together now allow us to explore unanswered research questions related to perioperative change in renal function.

Eligibility criteria: Inclusion Criteria:

* Rectum or colon cancer

Exclusion Criteria:

* Acute kidney injury grade 3 or higher

Primary outcomes:
measure: Glomerular filtration rate
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
state: Troms
Study officials:
affiliation: University Hospital of North Norway
name: Lars Marius Ytrebo, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02071732: Therapeutic Effect of Repetitive Transcranial Magnetic Stimulaton on Tinnitus
Official title: Repetitive Transcranial Magnetic Stimulation (rTMS) Effect on Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Subjective Tinnitus
Lead sponsor: Dongtan Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2014-02-26
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether repetitive transcranial magnetic stimulation (rTMS) is effective in the treatment of tinnitus.


Eligibility criteria: Inclusion Criteria:

* Subjective tinnitus
* Age 18 years and older

Exclusion Criteria:

* Meniere, conductive hearing loss, objective tinnitus
* History of seizure disorder or epilepsy
* Clinically relevant psychiatric comorbidity
* Previous symptomatic stroke
* Surgically or traumatically implanted foreign bodies such as a pacemaker, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings), intracardiac lines that may pose a physical hazard during magnetic stimulation

Primary outcomes:
measure: Tinnitus handicap inventory score
timeFrame: Before (- six months) and after (+ 5 days) rTMS interventions
Secondary outcomes:
Other outcomes:
Locations:
city: Hwaseong-si
country: Korea, Republic of
facility: Department of Neurology, and Department of Otorhinolaryngology-Head & Neck Surgery Dongtan Sacred Heart Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT02443532: Effects of Structured Group Education on Quality of Life and Glycemic Control in Type 1 Diabetes
Official title: Quality of Life, Treatment Satisfaction, Fear of Hypoglycemia, Eating Habits, Ang Glucose Control in Patients With Type 1 Diabetes: Effects of Structured Group Education Versus Group Care.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2015-05-14
Enrollment: 72
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with type 1 diabetes aged 15-65 years without major complications will be randomized either to usual care or to a structured group education program, with 6 four-hour weekly interactive sessions devoted to diabetes management. The principal endpoint will be the variation of HbA1c at 12 months from enrolment. Secondary endpoints will include quality of life, treatment satisfaction, fear of hypoglycemia, incidence of hypoglycemia.

Detailed description: The group intervention consists of interactive sessions for groups of 5-7 patients, dealing with different aspects of management of type 1 diabetes: insulin therapy and hypoglycemia, management of insulin doses, diet, physical exercise, sick days, etc. The intervention is designed for the acquisition of specific skills of self-management. This intervention is provided by a team including physicians, dietitians, and nurses.

The control group will receive individual education during routine clinic visits, following usual care, complying with the recommendations of national (Italian) guidelines.

HbA1c will be assessed every three months for all the duration of the study. The principal endpoint will be variation from baseline of HbA1c at 12 weeks from the beginning of the intervention.

Eligibility criteria: Inclusion Criteria:

* type 1 diabetes

Exclusion Criteria:

* serious diabetic complications, such as to interfere with physical functioning (e.g., lower limb amputation, renal failure requiring dialysis, blindness)
* Illiteracy

Primary outcomes:
measure: HbA1c (between-group difference in variation from baseline)
timeFrame: 12 months
Secondary outcomes:
measure: Quality of life (Well-being enquiry in Diabetics [WED] questionnaire)
timeFrame: 12 months
measure: Treatment satisfaction (Diabetes Treatment Satisfaction [DTS] questionnaire)
timeFrame: 12 months
measure: Fear of hypoglycemia (Fear of Hypoglycemia [FH-15] questionnaire)
timeFrame: 12 months
measure: Severe hypoglycemia (incidence of episodes of hypoglycemia requiring hospitalization and/or help from third parties, self-reported)
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01805232: Intravenous Artesunate and Malaria
Official title: Intravenous Artesunate Versus Quinine in Severe Malaria at Kassla, Sudan
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Malaria
Keywords: severe
Falciaparum
Malaria
Lead sponsor: University of Khartoum
Sponsor class: OTHER
Collaborators: name: University of Kassala, Sudan
name: Kassala
name: Sudan
First posted: 2013-03-06
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intravenous artesunate is egual to quinine in the treatment of severe malaria

Detailed description: Intravenous artesunate is egual to quinine in the treatment of severe malaria in the form of fever clearance time and parasite clearance time

Eligibility criteria: Inclusion Criteria:

severe P.falciparum malaria-

Exclusion Criteria:

mixed infection Pregnant women -

Primary outcomes:
measure: clearance of the parasite and fever
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kassala
country: Sudan
facility: Kassala
Study officials:
References:
citation: Eltahir HG, Omer AA, Mohamed AA, Adam I. Comparison of artesunate and quinine in the treatment of Sudanese children with severe Plasmodium falciparum malaria. Trans R Soc Trop Med Hyg. 2010 Oct;104(10):684-6. doi: 10.1016/j.trstmh.2010.05.009. Epub 2010 Jun 17.
Clinical trial NCT02139332: A Primary Prevention Trial to Strengthen Child Attachment in a Native Community
Official title: A Primary Prevention Trial to Strengthen Child Attachment in a Native Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parent-child Interaction
Keywords: Attachment theory
Parent- child relationship
Child mental health
Behavioral health
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2014-05-15
Enrollment: 225
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to to conduct a randomized controlled trial comparing an intervention group and a control group to evaluate the feasibility of the Promoting First Relationships method in an American Indian community through their tribal Health Promotion program, and to assess the efficacy of the method in this community.


Eligibility criteria: Inclusion Criteria:

1. Primary caregiver for a child aged 10 to 30 months
2. Caregiver lives with the child full time for the past three months and plans to continue for at least 6 more months.
3. Child is an American Indian or Alaska Native living on or near the Tribe's reservation.
4. Caregiver has telephone access
5. Caregiver is willing to have researchers come to their house
6. Caregiver is English speaking
7. Caregiver is willing to participate in a home-visiting program which includes video-recorded sessions of caregivers and their children playing

Exclusion Criteria: Caregiver is

1. Hospitalized or imprisoned
2. Living in a Treatment facility or shelter
3. Unable to give consent
4. Live in a household that already has a dyad enrolled in the study.

Primary outcomes:
measure: Change in Quality of caregiver-child interactions from baseline at 3 months and 6 months
timeFrame: Baseline, 3-month and 6-month follow-ups
Secondary outcomes:
measure: Change in Caregiver helplessness from baseline at 3 months and 6 months
timeFrame: Baseline, 3-month and 6-month follow-ups
measure: Change in Caregiver stress from baseline at 3 months and 6 months
timeFrame: Baseline, 3-month and 6-month follow-ups
measure: Change in Child Social-emotional Competence from baseline at 3 months and 6 months
timeFrame: Baseline, 3-month and 6-month follow ups
Other outcomes:
Locations:
city: Eagle Butte
country: United States
facility: MBIRI
state: South Dakota
Study officials:
affiliation: University of Washington
name: Cathryn Booth-LaForce, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oxford M, Booth-LaForce C, Echo-Hawk A, Madesclaire O, Parrish L, Widner M, Petras A, Abrahamson-Richards T, Nelson K, Buchwald D; CATCH Project Team. Promoting First Relationships(R): Implementing a Home Visiting Research Program in Two American Indian Communities. Can J Nurs Res. 2020 Jun;52(2):149-156. doi: 10.1177/0844562120914424. Epub 2020 Mar 26.