louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04777864: Developing a Tool to Support Shared Decision Making Post-Concussion Between Adolescents, Parents and Clinicians
Official title: Developing a Tool to Support Shared Decision Making Post-Concussion Between Adolescents, Parents and Clinicians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion, Brain
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 106
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Investigators will conduct a pilot efficacy test of a decision aid about contact sport participation post-concussion.

Detailed description: The clinical trial portion of this study will enroll 40 adolescents and their parent/caregiver who are seen in the Sports Medicine clinic with a diagnosis of concussion. 20 will receive usual care, and 20 will receive a decision aid to facilitate the decision making process about sport participation post-concussion. Adolescents and their parent/caregiver will complete separate surveys at a minimum of three timepoints: before their initial clinic visit, after each clinic visit (up until a decision regarding sports participation post-concussion is made), and three months after their first clinic visit. The study team will also conduct surveys with clinicians about their experiences with implementation.

Eligibility criteria: Participants in the clinical trial component of this study will be adolescents, parents, and healthcare providers:

Adolescent Inclusion Criteria:

* Age 11-17
* Sustained at least 1 concussion and is scheduled for a concussion injury visit

Parent Inclusion Criteria:

* Age 18 or older
* Parent of a child between the age of 11 and 17 (inclusive) who has sustained at least 1 concussion and is scheduled for a concussion injury visit

Healthcare Provider Inclusion Criteria:

* Age 18 or older
* Seattle Children's affiliated healthcare provider who provides patient care to youth with concussion

Primary outcomes:
measure: Decisional Regret
timeFrame: 3 months after initial clinic visit
measure: Change in Quality of Choice Made
timeFrame: 1 week before clinic visit, Immediately after clinic visit
measure: Decision Self-Efficacy
timeFrame: 1 week before clinic visit
measure: Patient-Parent-Provider Engagement
timeFrame: Immediately after clinic visit
Secondary outcomes:
measure: Change in Adolescent Psychosocial Functioning
timeFrame: 1 week before clinic visit, Immediately after clinic visit(s), 3 months after initial clinic visit
measure: Change in Adolescent Physical Activity
timeFrame: 1 week before clinic visit, Immediately after clinic visit(s), 3 months after initial clinic visit
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
References:
Clinical trial NCT03055364: Cognitive Function After Treatment of Primary CNS Malignancy
Official title: Observational Study Evaluating Neurocognitive Function in Patients With Primary CNS Malignancy Receiving Radiation Treatment to the Brain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CNS Malignancy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-02-16
Enrollment: 129
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary CNS malignancy

Brief summary: In this study, the investigators propose to evaluate cognitive function and determine the feasibility of neurocognitive assessment using a select CogState test battery in patients with primary intracranial malignancies receiving photon- or proton-based cranial irradiation with curative intent. The investigators will use the CogState software to quantify changes in verbal learning, memory, and executive function over the initial months and years following radiation treatment. Cognitive changes and temporal patterns of function will be compared to baseline performance for each patient. Data regarding cognitive function, fatigue, quality of life, and standard patient reported outcomes will be collected to characterize the daily impact of treatment. In addition, observed outcomes will be correlated with dosimetry values, radiation dose volumes, and anatomic dose distribution.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 4 years with primary CNS malignancy
* Able to use computer for assessment battery
* Receiving photon- or proton-based radiation for primary intracranial malignancy
* Demonstrates the capacity to sign informed consent

Exclusion Criteria:

* Patients with WHO Grade IV tumors

Primary outcomes:
measure: characterize the rate and magnitude of change in cognitive performance within 12 months of completion of therapy in patients with intracranial malignancies receiving photon- or proton-based cranial irradiation with curative intent
timeFrame: baseline, completion of treatment, 3 months, 6 months, 1 year and 2 years after radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Nadia N. Laack, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01070264: A Pilot Observational Clinical Survey: Impacts of Tahitian Noni Juice on the Quality of Life of Patients With Osteoarthritis
Official title: A Pilot Observational Clinical Survey: Impacts of Tahitian Noni Juice on the Quality of Life of Patients With Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Excellence in Academic Medicine (EAM) Grant
First posted: 2010-02-17
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Tahitian Noni Juice (TNJ) made from Morinda citrifolia (noni) fruits may provide a safe adjunctive treatment for osteoarthritis (OA) due to its anti-inflammatory and analgesic properties. In this study the investigators examined whether TNJ was able to improve the symptoms and quality of life (QOL) of OA patients. The investigators also sought to evaluate the tolerability and safety of TNJ.

This was an open label three-month intervention pilot study. Data were collected by pre and post intervention survey as well as laboratory testing. Inclusion criteria were: adults of both sexes aged 40 to 75, with a diagnosis of OA on the hip or knee by their primary care physician, not on prescription medicine for OA, and who were willing to drink 3 oz of TNJ a day.


Eligibility criteria: Inclusion Criteria:

* adults aged 40 to 75 of both sexes with a physician diagnosis of OA of the hip or knee who were not taking prescription medicine for arthritis and were willing to drink 3 oz of TNJ daily for 12 weeks

Exclusion Criteria:

* all others

Primary outcomes:
measure: Quality of Life
Secondary outcomes:
Other outcomes:
Locations:
city: Rockford
country: United States
facility: University of Illinois-Chicago College of Medicine at Rockford
state: Illinois
Study officials:
References:
Clinical trial NCT02088164: Long-Term Outcome of Subjects With Elevated PSA in Healthy Taiwanese Men
Official title: Long-Term Outcome of Subjects With Elevated PSA in Healthy Taiwanese Men
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: PSA,
asian men,
survival
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-03-14
Enrollment: 27741
Sex: MALE
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Taiwanese healthy men who are older than 40 years

Brief summary: To determine the long-term survival outcome of subjects who had various PSA levels at screening


Eligibility criteria: Inclusion Criteria:

* Health men who received PSA screening at NTUH and CGMH

Exclusion Criteria:

* Prior history of prostate cancer

Primary outcomes:
measure: Diagnosis of prostate cancer
timeFrame: 20 years (average)
Secondary outcomes:
measure: Cancer-specific death
timeFrame: 20 years (average)
measure: Overall survival
timeFrame: 20 years (average)
Other outcomes:
Locations:
city: Taipei city
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yeong-Shiau Pu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06616064: Evaluation of a Procedure for Identification and Brief Intervention of Lifestyle Advice Assisted by Application in a Care Setting
Official title: Evaluation of a Procedure for Identification and Brief Intervention of Lifestyle Advice Assisted by Application in a Care Setting
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Disease
Keywords: brief intervention of lifestyle advice
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 164
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: Chronic diseases share similar risk factors associated with four daily behaviours: unbalanced diet, sedentary lifestyle (physical inactivity and time spent sitting down), smoking and alcohol consumption. These diseases are responsible for 74% of deaths worldwide. Despite the frequency with which practitioners witness these bad habits in their patients, little time is devoted to lifestyle advice during medical visits, and even less to using effective techniques to discuss their behaviour. Yet medical and paramedical consultations could be an essential educational opportunity to promote a healthy lifestyle. But advice is often limited during medical check-ups, due to a lack of time and suitable tools, and is often focused on a particular risk factor. To date, there is no procedure for screening and behavioural intervention to deal with harmful lifestyle habits in patients.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Treated for a stabilised chronic disease OR person treated for localised cancer, after the end of heavy treatment during the follow-up period within 5 years of the date of diagnosis of the cancer.
3. Contactable by telephone
4. Affiliated to a social security scheme
5. Having signed a free, informed and written consent.

Exclusion Criteria:

1. Requiring psychiatric assessment
2. Suffering from eating disorders
3. Undergoing dietetic treatment or therapeutic education for dietetic purposes (at least two consultations at the same facility in the previous year)
4. Suffering from a life-threatening condition within 5 years
5. Suffering from a disabling condition (reduced activity with major restrictions)
6. Unable to read
7. Taking part in another psycho-behavioural nutritional intervention study
8. Protected person (adult subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty, pregnant woman (declaratory), breast-feeding woman and minor).

Primary outcomes:
measure: Number of green criteria on application feedback
timeFrame: between Day 0 and Month 1
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes cedex 9
country: France
facility: CHU Rennes
Study officials:
affiliation: CHU Rennes
name: Romain Moirand
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02809664: Feasibility and Safety of Ultrasound Guided Installation Central Subclavian Catheter Through Supraclavicular Way
Official title: Feasibility and Safety of Ultrasound Guided Installation Central Subclavian Catheter Through Supraclavicular Way
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Diseases
Diseases, Metabolic
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 20
Sex: ALL
Minimum age (years): 43
Maximum age (years): 44
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in the neonatal intensive care or neonatal intensive care.

The 3 types of taken most often encountered load are:

1. support for prematurity at birth or poor adaptation at birth requiring intensive care or ventilatory support.
2. management of congenital heart diseases including ducto-dependent, awaiting surgery.
3. care for severe medical condition exposing one or more organ failure, between 0 and 28 days of life (severe infections, metabolic diseases, severe dehydration ...)

Brief summary: Our goal is to demonstrate the feasibility of laying uncomplicated ultrasound-guided central subclavian catheter by supraclavicular route in the newborn.


Eligibility criteria: Inclusion Criteria:

* Patient hospitalized in the neonatal intensive care or neonatal intensive care at the University Hospital of Hautepierre
* All infants less than 44 weeks corrected age who require a surgical approach
* In the first line if neonate over 34 weeks corrected age requiring dual carriageway catheter
* After Failure or inability laying KTEC for children between 30 and 34 weeks of age corrected and heavy over 1000

Exclusion Criteria:

* Nouveau-né de poids \< 1000g
* Nouveau-né de moins de 30 semaines d'âge corrigé
* Choix d'une autre voie d'abord plus judicieux (KTVO, KTC broviac)
* Sortie avant retrait du KTC

Primary outcomes:
measure: success rate without complications laying catheter ultrasound guided subclavian by supraclavicular route in newborn
timeFrame: 1h after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de réanimation néonatale - HOPITAL DE HAUTEPIERRE
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Pierre Kuhn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00370864: Study of a Pandemic Influenza Vaccine in Children
Official title: Phase II Study of a Pandemic Influenza Vaccine in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Pandemic
Influenza
Prevention
Vaccine
Prevention of Pandemic Influenza
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2006-09-01
Enrollment: 220
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza strain H5N1 is one of the leading candidates to cause the next influenza pandemic. Children are likely to be a special target group for vaccination; therefore, this study will test the safety and immunogenicity of an H5N1 pandemic influenza vaccine in healthy children.


Eligibility criteria: Inclusion Criteria:

* Healthy children aged greater or equal to 6 months to less than 9 years
* Normal gestation period

Exclusion Criteria:

* History of clinically significant medical conditions
* History of Guillain Barre syndrome or active neurological disease

Primary outcomes:
measure: Safety and immunogenicity
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Murdoch Childrens Research Institute
state: Victoria
city: Perth
country: Australia
facility: Princess Margaret Hospital for Children
state: Western Australia
Study officials:
affiliation: Murdoch Childrens Research Institute
name: Terry M Nolan, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nolan T, Richmond PC, Formica NT, Hoschler K, Skeljo MV, Stoney T, McVernon J, Hartel G, Sawlwin DC, Bennet J, Ryan D, Basser RL, Zambon MC. Safety and immunogenicity of a prototype adjuvanted inactivated split-virus influenza A (H5N1) vaccine in infants and children. Vaccine. 2008 Nov 25;26(50):6383-91. doi: 10.1016/j.vaccine.2008.08.046. Epub 2008 Sep 16.
Clinical trial NCT00940264: Laparoscopic Transvaginal Hybrid Cholecystectomy: a Prospective Data Collection.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholecystolithiasis
Cholecystitis
Keywords: symptomatic cholecystolithiasis
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2009-07-15
Enrollment: 200
Sex: FEMALE
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: female patiens with given indication for cholcystectomy

Brief summary: Transvaginal hybrid procedures especially the transvaginal hybrid cholecystectomy are of interest as an available NOTES-Procedure for the clinical routine. Few authors have demonstrated the feasibility and safety in a selected patient collective. The aim of this prospective data collection is to evaluate the feasibility in the clinical routine in a non select patient collective.

Therefore all patients giving the informed consent to the transvaginal hybrid cholecystectomy will be included and assessed concerning feasibility to perform the transvaginal approach and complete the operation transvaginally.


Eligibility criteria: Inclusion Criteria:

* given informed consent for transvaginal hybrid cholecystectomy

Exclusion Criteria:

* pregnancy
* malignoma
* present choledocholithiasis

Primary outcomes:
measure: Feasibility and safety of the transvaginal operation
timeFrame: 30 days
Secondary outcomes:
measure: Long-term life quality and sexual dysfunction
timeFrame: 3 year
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Department of surgery
Study officials:
affiliation: Cantonal Hospital St. Gallen
name: Andreas Zerz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02266264: Hyperglycemia and Effects of Daily 100 mg Versus 200 mg of Hydrocortisone Therapy in Patients With Septic Shock
Official title: Hyperglycemia and Effects of Daily 100 Milligrams Versus 200 Milligrams of Hydrocortisone Therapy in Patients With Septic Shock: A Double-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperglycemia
Lead sponsor: Srinakharinwirot University
Sponsor class: OTHER
First posted: 2014-10-17
Enrollment: 80
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 compare hyperglycemia and other effects, include 28-day mortality and time to reversal of shock between 100 milligrams and 200 milligrams of hydrocortisone as initial dosage in patients with septic shock.

Detailed description: The intervention group will be received 100 milligrams per day of hydrocortisone on the first three day the taper off, whereas the control group will be received 200 milligrams per day of hydrocortisone on the first three day the taper off. Hyperglycemia rate will be monitored every 6 hours after hydrocortisone is started until 24 hours after it is stopped.

Also, 28-day mortality will be follow after hydrocortisone is started.

Eligibility criteria: Inclusion Criteria:

* Septic shock
* Adequate fluid resuscitation and vasopressor therapy are unable to maintain hemodynamic stability

Exclusion Criteria:

* Receive systemic steroid in past 3 months
* Established adrenal insufficiency
* Currently used in chemotherapy or immunosuppressive agents
* Radiotherapy currently received
* Known HIV infection
* Pregnancy

Primary outcomes:
measure: Hyperglycemia
timeFrame: two years
Secondary outcomes:
measure: 28-day mortality
timeFrame: two years
measure: Time to shock reversal
timeFrame: two years
Other outcomes:
Locations:
city: Ongkharak
country: Thailand
facility: Department of Medicine, Faculty of Medicine, Srinakharinwirot University
state: Nakhon nayok
Study officials:
affiliation: Department of Medicine, Faculty of Medicine, Srinakharinwirot University
name: Kanchana Ngaosuwan, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06196164: A RCT of Low MBO Drainage Strategies
Official title: A Randomized Controlled Trial of Malignancy Low Biliary Tract Obstruction Drainage Strategies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Jaundice, Obstructive
Cholangiopancreatography, Endoscopic Retrograde
Endoscopic Ultrasound-Guided Drainage
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 40
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 evaluate the efficacy and safety of EUS-BD compared with ERCP-BD in low biliary obstruction caused by periampullary cancer, pancreatic cancer or low bile duct cancer. This is a single center, prospective, randomized-controlled study. The primary endpoint of this study is stent patency time, and secondary endpoints include technical success rate, clinical success rate, operation time, operation related complications rate, reintervention rate, stent patency rate at 6 months, and 1-year postoperative survival rate.


Eligibility criteria: Inclusion Criteria:

1. Age:18 years old or above;
2. Periampullary cancer/pancreatic cancer according to pathology or clinical judgment of more than 2 senior doctors;
3. Distal malignant bile duct obstruction (2cm away from the hepatic hilum);
4. Ultrasound evaluation shows that the accessible part of the bile duct has a width of ≥ 12mm;
5. The patient or family member is able to understand the research protocol and is willing to participate in this study, providing written informed consent.

Exclusion Criteria:

1. Patients suffer from severe cardiovascular or pulmonary diseases who are unable to tolerate anesthesia or endoscopic examination;
2. Uncorrectable coagulation abnormalities or bleeding tendencies (INR\>1.5 or platelets\<50) × 109 /L);
3. There is a plan for subsequent surgical resection of the tumor, accompanied by severe infection or an expected survival period of less than 3 months;
4. Successful biliary drainage measures have been implemented, including but not limited to ERCP, ENBD, PTCD, and surgical procedures;
5. Previous surgical changes to the anatomical structure of the pancreas, gallbladder, stomach, and duodenum;
6. Pregnancy, lactation, or planned pregnancy;
7. Refusal to join or inability to provide informed consent;
8. Other researchers evaluated the unsuitability of enrollment.

Primary outcomes:
measure: stent patency time
timeFrame: 0-24months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Xi WU
role: STUDY_DIRECTOR
References: