louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02294604: The Antiseptic Outcome of Traditional Hand Scrubbing Versus Hand Rubbing in Surgical Room
Official title: The Antiseptic Outcome of Traditional Hand Scrubbing Versus Hand Rubbing in Surgical Room
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Disinfection
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2014-11-19
Enrollment: 236
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hand hygiene is the cornerstone of aseptic techniques to reduce surgical site infection. The traditional surgical antisepsis involves scrubbing the skin with povidone-iodine or chlorhexidine gluconate. Recently, a waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers was developed to provide a comparable antiseptic effect. The investigators perform a randomized controlled trial to compare the antiseptic effectiveness of the waterless hand rubbing, the classic surgical handwashing with povidone-iodine and chlorhexidine solutions.

Detailed description: This single centre, randomized trial recruited surgical team members in Taipei Medical University-Shuang Ho Hospital at November 2014. 255 episodes of hand washing are enrolled. The participants are assigned equally to use either a waterless hand rub (Group R), or traditional scrub formation with 10 % povidone-iodine (Group I) and 4% chlorhexidine (Group C). Hand washing time, microorganisms on hands before and after scrubbing is recorded. The primary outcome is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates after hand washing. The secondary outcomes is hand microbial flora after surgery and duration of hand washing.

Eligibility criteria: Inclusion Criteria:

* Surgical staff members, both surgeons and scrub nurses

Exclusion Criteria:

* Participants were excluded if they were medical or nursing students
* Allergy to the experimental materials

Primary outcomes:
measure: Microorganisms on Hands Before Scrubbing
timeFrame: 2 days after sampling
Secondary outcomes:
measure: Microorganisms on Hands After Scrubbing
timeFrame: 2 days after sampling
measure: Microorganisms on Hands After Surgery
timeFrame: 2 days after sampling
measure: Duration of Hand Washing
timeFrame: Immediately
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Medical University Shuang Ho Hospital
name: Ka-Wai Tam, MD, MS
role: STUDY_CHAIR
References:
Clinical trial NCT01405404: Engaging Low-Income Families in Prevention Programs
Official title: Engaging Low-Income Families in Prevention Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parenting
Keywords: parenting childcare discounts child behavior
No Intervention Control
Intervention no childcare discount
Intervention with childcare discount
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2011-07-29
Enrollment: 323
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purposes of this study are to (1) study the cost-effectiveness of childcare discounts on increasing parent participation rates in a preventive parent training program called the Chicago Parent Program and (2) evaluate the efficacy of the Spanish-translated version of the Chicago Parent Program in childcare centers serving low-income families with young children.


Eligibility criteria: Inclusion Criteria:

* parent of 2-4 year old child enrolled in participating day care center

Exclusion Criteria:

* parent previously participated in parent training program

Primary outcomes:
measure: Change in child behavior problems
timeFrame: baseline, 3-months, 9-months, 15-months
Secondary outcomes:
measure: Changing in parenting behavior
timeFrame: baseline, 3-months, 9-months, 15-months
measure: Participation rate
timeFrame: baseline and 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Deborah A Gross, DNSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04343404: Place of ECMO in the Management of Severe Refractory ARDS Associated With Covid-19
Official title: STUDY ECMO-COVID-19 : Place of ECMO in the Management of Severe Refractory ARDS Associated With Covid-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Distress Syndrome
Keywords: Respiratory Distress Syndrome
ARDS
SARS-COV-2
Extracorporeal membrane oxygenation
ECMO
Veno-venous ECMO
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with a COVID-19 diagnosis by RT-PCR

Brief summary: Describe COVID-19 patients who are receiving ECMO-VV respiratory replacement and what happens to them.


Eligibility criteria: Inclusion Criteria:

* Patient over the age of 18;
* Diagnostic COVID-19 by RT-PCR;
* Hospitalisation in resuscitation for the management of complications related to COVID-19
* Implanted ECMO-VV during hospitalisation;
* Patient agreeing to participate in the study

Exclusion Criteria:

* Sujet under guardianship or trusteeship
* Sujet under safeguard of justice

Primary outcomes:
measure: Retrospective description of COVID-19 patients receiving respiratory ECMO-VV supplementation and what happens to them
timeFrame: Files analysed retrospectily from March 1st, 2020 to April 15, 2020 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Thoracique Nouvel Hôpital Civil Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service de Chirurgie Thoracique Nouvel Hôpital Civl Hôpitaux Univesitaires de Strasbourg
name: Pierre-Emmanuel FALCOZ, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04563104: Lung Ultrasound in Procalcitonin- Guided Antibiotic Discontinuation in Ventilator Associated Pneumonia
Official title: Lung Ultrasound in Procalcitonin- Guided Antibiotic Discontinuation in Ventilator Associated Pneumonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilator Associated Pneumonia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients having ventilator associated pneumonia (VAP) with positive sputum culture. VAP was considered if the onset occurred following intubation of the trachea for 48 h and the infection was absent before starting mechanical ventilation . Diagnosis of pneumonia was based on radiographic finding of pulmonary infiltrate; findings should be new and progressive and at least should satisfy two clinical criteria of the following: body temperature \>38°C or \<35.5°C; leukocyte count \> 12,000 cells/mm3 or \<4000 cells/mm3; and clinical evidence of pneumonia, such as purulent secretions and a decrease in oxygenation.

Diagnosis of VAP was confirmed microbiologically by positive bronchial secretion cultures

Brief summary: Ventilator Associated pneumonia (VAP) is associated with longer ICU length of stay, prolonged mechanical ventilation, and increased use of antimicrobials, health-care cost and mortality . Acute respiratory infections (ARIs) comprise a large and heterogeneous group of infections, including bacterial infections, viral infections, and infections of other etiologies. Early initiation of adequate antibiotic therapy is the cornerstone in the treatment. However, overuse of antibiotics and prolonged duration of antibiotic therapy in patients with bacterial ARIs in the hospital and intensive care setting is associated with increased resistance for common bacteria, high costs, and adverse drug reactions.


Eligibility criteria: Inclusion Criteria:

* 18 years old or greater
* Ventilator associated pneumonia (VAP) with positive sputum culture.

Exclusion Criteria:

* pregnancy,
* use of immunosuppressive agents except for steroids,
* neutropenia (white blood cell count ≤1000/mL)
* patients whose primary diagnosis was community acquired pneumonia and other source of infection.

Primary outcomes:
measure: correlation between lung ultrasound and procalcitonin.
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT06876701: The Treatment of Newly Diagnosed CD19+Mixed Phenotype Acute Leukemia in Adults
Official title: The Treatment of Newly Diagnosed CD19+Mixed Phenotype Acute Leukemia in Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Acute Leukemia
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation the efficacy and safety of the combination of injectable bevacizumab, low-intensity chemotherapy, and venula in the treatment of newly diagnosed CD19+mixed phenotype acute leukemia in adults


Eligibility criteria: Inclusion Criteria:

1. Patients fully understand this study, voluntarily participate and sign an informed consent form (ICF);
2. Age: 18-75 years old (including boundary values of 18 and 75);
3. Clinically diagnosed adult Mixed Phenotype Acute Leukemia (WHO 2016 criteria) patients with CD19 positivity

Exclusion Criteria:

The subject's previous history of anti-tumor treatment meets one of the following conditions:

1. Individuals who have previously received bevacizumab
2. Individuals who have received CAR-T therapy or other gene modified cell therapies prior to screening;
3. Within 5 half lives of the first use of the investigational drug, having received anti-tumor treatment including surgery, chemotherapy, targeted therapy, or participating in other clinical trials and receiving clinical trial medication;

Primary outcomes:
measure: Negative conversion rate of evaluable residual lesions (MRD)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Zhaxin integrated hospital of traditional Chinese and Western Medicine
Study officials:
References:
Clinical trial NCT01135901: Local Measures to Prevent Diabetes in the Værnes Region.
Official title: The VEND RISK-study. Preventing Diabetes Type 2 in Overweight Persons in the Værnes Region, Central-Norway.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2
Obesity
Keywords: prevention
public health
community health services
Norway
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2010-06-03
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a development project involving four different municipalities in Central Norway. The aim is to identify adults with overweight and with an increased risk of developing diabetes mellitus type 2, then to prevent the disease to develop by the means of a behaviour change programme. The programme is group based.


Eligibility criteria: Inclusion Criteria:

* Living in Central Norway
* Find Risc score \> 15
* Written, informed consent

Exclusion Criteria:

* Severe mental disorder
* Not being able to function in the group programme

Primary outcomes:
measure: Diabetes mellitus type 2
timeFrame: Visit 1 (baseline) till Visit 9 (5 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Stjørdal
country: Norway
facility: Vaernesregionen: Meraker, Stjørdal, Selbu, Tydal
Study officials:
affiliation: Norwegian University of Technology and Science
name: Bård Kulseng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Folling IS, Kulseng B, Midthjell K, Rangul V, Helvik AS. Individuals at high risk for type 2 diabetes invited to a lifestyle program: characteristics of participants versus non-participants (the HUNT Study) and 24-month follow-up of participants (the VEND-RISK Study). BMJ Open Diabetes Res Care. 2017 Jul 31;5(1):e000368. doi: 10.1136/bmjdrc-2016-000368. eCollection 2017.
citation: Folling IS, Klockner C, Devle MT, Kulseng B. Preventing type 2 diabetes, overweight and obesity in the Norwegian primary healthcare: a longitudinal design with 60 months follow-up results and a cross-sectional design with comparison of dropouts versus completers. BMJ Open. 2022 Mar 9;12(3):e054841. doi: 10.1136/bmjopen-2021-054841.
citation: Folling IS, Solbjor M, Midthjell K, Kulseng B, Helvik AS. Exploring lifestyle and risk in preventing type 2 diabetes-a nested qualitative study of older participants in a lifestyle intervention program (VEND-RISK). BMC Public Health. 2016 Aug 25;16(1):876. doi: 10.1186/s12889-016-3559-y.
Clinical trial NCT06736301: Double Pig Tail Stent-assisted Fixation of Fully Covered Metal Stents for the Treatment of Benign Duodenal Strictures
Official title: An Exploratory Clinical Study of Double Pig Tail Stent-assisted Fixation of Fully Covered Metal Stents for the Treatment of Benign Duodenal Strictures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Duodenal Stricture
Keywords: duodenal stricture
fully covered stent
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 5
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Double Pig Tail Stent-assisted Fixation of Fully-Covered Metal Stents for the Treatment of Benign Duodenal Strictures

Detailed description: This study uses a double pig-tail stent for cross fixation of a fully-covered stent in the duodenum to reduce the incidence of displacement and ensure the stent can effectively expand the narrowed area, thereby alleviating patient symptoms.

The aim of this study is to explore the safety and efficacy of a double pig-tail stent-assisted fixation of a fully-covered stent for the treatment of benign duodenal strictures, further clarifying its long-term efficacy and providing strong support for the placement of fully-covered stents in treating benign duodenal strictures.

Eligibility criteria: Inclusion Criteria:

1. The subjects voluntarily signed the informed consent form for this trial;
2. Patients diagnosed with benign duodenal stricture;
3. Symptoms of upper gastrointestinal obstruction, such as nausea, vomiting, abdominal pain, or changes in bowel habits, occurring before admission or during hospitalization;
4. Patients with refractory strictures who have failed multiple balloon dilations;
5. Age \< 75 years.

Exclusion Criteria:

1. Gastrointestinal perforation;
2. Distal small bowel obstruction or multiple segments of small bowel obstruction;
3. Coagulation disorders;
4. Strictures or obstructions caused by malignant tumors;
5. Severe comorbidities involving the heart, brain, lungs, kidneys, etc.

Primary outcomes:
measure: Clinical remission rate at 30 days post-operation
timeFrame: at 30 days post-operation
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Fully Covered Metal Stents
state: Jiangsu
Study officials:
References:
Clinical trial NCT01117701: Does a Safety Guidewire Increase the Forces Needed to Move the Ureteroscope up and Down the Ureter?
Official title: Does a Safety Guidewire Adjacent to the Ureteroscope Increase the Forces Needed to Move the Ureteroscope up and Down the Ureter?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ureteroscopy
Lead sponsor: Helse-Bergen HF
Sponsor class: OTHER
First posted: 2010-05-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to investigate to forces needed to passage the ureteroscope up and down the ureter with and without a safety guidewire in place.

Detailed description: Ureteroscopy may damage the ureter, and the complication risk is influenced by the forces needed to move the ureteroscope up and down the ureter.

Although a safety guidewire (SGW) is commonly recommended in order to reduce the complication rate it may well be that the SGW itself may inhibit the passage of the ureteroscope due to increased friction.

The forces needed to move the ureteroscope in the ureter have not been investigated properly.

The intention in this study is to measure the forces needed to advance and withdraw the ureteroscope in the ureter with and without the SGW in place.

Eligibility criteria: Inclusion Criteria:

* Patients planned for endoscopic kidney stone treatment

Exclusion Criteria:

* Known pathology in the ureter

Primary outcomes:
measure: The force needed to passage the ureteroscope up and down in the ureter with and without SGW.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Helse Bergen HF, Haukeland University Hospital
Study officials:
affiliation: Helse Bergen HF, Haukeland University Hospital
name: Øyvind Ulvik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02053701: High-field Brain Magnetic Resonance Spectroscopy
Official title: Technical Developments for High-field Brain Magnetic Resonance Spectroscopy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Healthy
Keywords: magnetic resonance spectroscopy
quantification precision
brain
brain metabolites
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2014-02-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: healthy subjects

Brief summary: Magnetic resonance spectroscopy (MRS) allows non-invasive measurement of the concentration of up to 18 metabolites in the brain ("neurochemical profile").

The objective of this proposal is to develop new methods for high-field brain MRS (3 to 7 Tesla).

Our main hypothesis is that higher magnetic fields lead to improved spatial and temporal resolution and improved quantification precision.

Aims

1. To obtain improved "neurochemical profiles" in the brain using single voxel proton MRS at very high field (3 Tesla to 7 Tesla).
2. To develop new methods for proton magnetic resonance spectroscopic imaging (MRSI) to obtain metabolic maps at very high field (3 Tesla to 7 Tesla).

Since this project is focused on technical development, only healthy volunteers will be recruited (no patients).


Eligibility criteria: Inclusion Criteria:

* over 18 years old

Exclusion Criteria:

* no metallic implant or other MRI-incompatible device

Primary outcomes:
measure: Precision of quantification of brain metabolites concentrations
timeFrame: One time only
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Center for Magnetic Resonance Research
state: Minnesota
Study officials:
affiliation: Center for Magnetic Resonance Research, University of Minnesota
name: Pierre-Gilles Henry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01137201: Internal Hernia After Laparoscopic Gastric Bypass
Official title: Internal Hernia After Laparoscopic Gastric Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Prevalence of Surgery for Small Bowel Obstruction After LGBP Procedure.
Keywords: Small bowel obstruction
Laparoscopic gastric bypass
Internal Hernia
Mesenteric defect
Morbid obesity
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2010-06-04
Enrollment: 2507
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To see if closing the mesenteric defects created at a Laparoscopic Gastric Bypass is better than leaving them open.

Detailed description: When the patients who has undergone a Laparoscopic Gastric Bypass lose weight, the mesenteric defects that are inevitable to cause, gets bigger and can cause an internal hernia (IH). This study will observe whether it is better to close the defects or leave them open. The patients will be randomized into two groups. One, where the defects are closed with sutures and one where the defects are left alone. The primary endpoint of the study is the prevalence of surgery for obstruction. Information about this will be gathered through the national register for obesity surgery in Sweden, SOReg. Each arm in the study will include 1200 patients and the follow up period will be three years. Since the register mentioned above is an ongoing register, the results can be studied over a longer period if wanted. The national hospital registry will further improve the follow-up.

Eligibility criteria: Inclusion Criteria:

* Any patient accepted for a Laparoscopic Gastric Bypass that has given a written consent

Exclusion Criteria:

* Conversion to open surgery prior to the randomization
* Patients not giving a written consent

Primary outcomes:
measure: Surgery for small bowel obstruction after a LGBP procedure.
timeFrame: 2 years
Secondary outcomes:
measure: Serious Complications
timeFrame: within 2 years after surgery
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Department of Surgery, Örebro University Hospital
Study officials:
affiliation: Scandinavian Obesity Surgery Registry
name: Ingmar Näslund, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Stenberg E, Szabo E, Ottosson J, Thorell A, Naslund I. Health-Related Quality-of-Life after Laparoscopic Gastric Bypass Surgery with or Without Closure of the Mesenteric Defects: a Post-hoc Analysis of Data from a Randomized Clinical Trial. Obes Surg. 2018 Jan;28(1):31-36. doi: 10.1007/s11695-017-2798-z.
citation: Stenberg E, Szabo E, Agren G, Ottosson J, Marsk R, Lonroth H, Boman L, Magnuson A, Thorell A, Naslund I. Closure of mesenteric defects in laparoscopic gastric bypass: a multicentre, randomised, parallel, open-label trial. Lancet. 2016 Apr 2;387(10026):1397-1404. doi: 10.1016/S0140-6736(15)01126-5. Epub 2016 Feb 16.