louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00994084: Healthy Kids-Houston: A Community Childhood Obesity Intervention Program
Official title: Healthy Kids-Houston: An Integrated Community Program for the Prevention of Obesity Among Minority Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Minority children
Community intervention program
Lifestyle changes
Physical activities
Nutrition lessons
Behavior modification
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2009-10-14
Enrollment: 1094
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The collaborative study is to determine the effectiveness of an after-school community-based program to prevent obesity among minority children.

Detailed description: Childhood obesity is a major health issue in the United States, particularly among minority children. An integrated after-school program that offers structured and fun physical activities with nutrition and behavior lessons in community centers operated by the Houston Parks and Recreation Department might prevent obesity among minority children who live in the neighborhood.

Eligibility criteria: Inclusion Criteria:

* Live in close proximity of the community centers

Exclusion Criteria:

* Medical or physical conditions that prevent the child from participating in the physical activities

Primary outcomes:
measure: Body mass index
timeFrame: One school year
Secondary outcomes:
measure: Agility
timeFrame: One school year
measure: Muscular strength and endurance
timeFrame: One school year
measure: Self esteem
timeFrame: One school year
measure: Physical activity level
timeFrame: One school year
measure: Flexibility
timeFrame: One school year
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Parks and Recreation Department Community Centers
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: William W Wong, PhD
role: STUDY_DIRECTOR
References:
citation: Wong WW, Mikhail C, Ortiz CL, Lathan D, Moore LA, Konzelmann KL, Smith EO. Body weight has no impact on self-esteem of minority children living in inner city, low-income neighborhoods: a cross-sectional study. BMC Pediatr. 2014 Jan 24;14:19. doi: 10.1186/1471-2431-14-19.
citation: Wong WW, Ortiz CL, Lathan D, Moore LA, Konzelmann KL, Adolph AL, Smith EO, Butte NF. Sleep duration of underserved minority children in a cross-sectional study. BMC Public Health. 2013 Jul 12;13:648. doi: 10.1186/1471-2458-13-648.
citation: Wong WW, Ortiz CL, Stuff JE, Mikhail C, Lathan D, Moore LA, Alejandro ME, Butte NF, Smith EO. A Community-based Healthy Living Promotion Program Improved Self-esteem Among Minority Children. J Pediatr Gastroenterol Nutr. 2016 Jul;63(1):106-12. doi: 10.1097/MPG.0000000000001088.
Clinical trial NCT05731284: Platelet Rich Plasma as an Adjunct Therapy at the Time of Transvaginal Native Tissue Prolapse Surgery
Official title: Platelet Rich Plasma as an Adjunct Therapy at the Time of Transvaginal Native Tissue Prolapse Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 60
Sex: FEMALE
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 the study is to evaluate the surgical outcomes of injecting platelet-rich plasma (PRP) into the vaginal tissue as an adjunct therapy at the time of prolapse surgery

Detailed description: Platelet rich plasma (PRP) is an autologous product with high levels of platelets which are concentrated with bioactive growth factors responsible for accelerating tissue healing by stimulating the number of reparative cells to create collagen production, angiogenesis and neurogenesis. The overarching goal is to evaluate the effectiveness and safety of the adjunct application of PRP in the fibromuscular connective tissue (the site of anterior tissue plication) at the time of anterior colporrhaphy (the site of highest recurrence risk) in women undergoing native tissue vaginal prolapse repair, to promote tissue healing and regeneration, thus to improve surgical outcomes.

Eligibility criteria: Inclusion Criteria:

* Desire surgical treatment via a transvaginal native tissue approach.
* Completed child-bearing

Exclusion Criteria:

* Unable to follow-up, not willing to, or unable to participate in the proposed study
* Prior pelvic surgery within the past 12 months
* Prior anterior/apical suspension procedures
* Prior graft augmented prolapse surgery
* Pelvic/abdominal radiation
* Pelvic mass
* History of solid organ malignancy

Primary outcomes:
measure: Anterior wall descensus measured by the POP-Q System, Ba point
timeFrame: 12 month
Secondary outcomes:
measure: Apical wall descensus measured by the POP-Q System, C point
timeFrame: 12 months
measure: Posterior wall descensus
timeFrame: 12 months
measure: Leading edge
timeFrame: 12 months
measure: Safety outcomes
timeFrame: 12 months
measure: Subjective
timeFrame: 12 months
measure: Retreatment
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: The University of Alabama at Birmingham
name: Isuzu Meyer, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01897584: Effect Inverse Ratio Ventilation on Arterial Oxygenation and Respiratory Mechanics During lapaLAR
Official title: Effect of Inverse Ratioventilation on Laparoscopic Low Anterior Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Keywords: laparoscopy, Trendelenburg Position, ventilation
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2013-07-12
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Changes of inspiration: expiration ration from 1:2 to 1:1 could improve the arterial oxygenation and respiratory mechanics

Detailed description: Inverse ratio ventilation already known as effective to improve the oxygenation and respiratory mechanics in the ARDS patients. Recently, there were report of decrease in airway pressure and improve in respiratory compliance during inverse ration ventilation undergoing one lung ventilation. We hypothesized that changes of inspiration and expiration ratio from 1:2 to 1:1 could improve the arterial oxygenation and respiratory mechanics in the patients who undergoing laparoscopic low anterior resection. However, prolonged inspiratory time might compromise cerebral perfusion pressure due to an elevation in central venous pressure and concomitant reductions in mean arterial pressure.

Eligibility criteria: Inclusion Criteria:

* colorectal cancer

Exclusion Criteria:

* obesity (BMI\>35), uncontrolled hypertension, coronary artery disease, uncompensated cardiovascular disease, current respiratory disease, open procedure

Primary outcomes:
measure: arterial oxygenation (PaO2)
timeFrame: baseline PaO2- 2 hour after pneumoperitoneum
Secondary outcomes:
measure: cerebral perfusion pressure
timeFrame: immediately before pneumoperitoneum in the Trendelenburg position, every 5 min up to 20 after I:E ratio 1:1
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Kyung Cheon Lee
Study officials:
affiliation: Gachon University Gil Medical Center
name: Hyun Jeong Kwak, M.D., Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT01354184: CRD007 for the Treatment of Abdominal Aorta Aneurysm (The AORTA Trial)
Official title: An International, Multi-centre, Randomised, Stratified, Double-blinded, Placebo-controlled, 4-parallel Group Trial Investigating the Efficacy and Safety of Three Different Dose Levels of CRD007 (The AORTA Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Abdominal Aortic Aneurysm
Lead sponsor: RSPR Pharma AB
Sponsor class: INDUSTRY
First posted: 2011-05-16
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is an investigation of the efficacy and safety of CRD007 compared to placebo in the treatment of patients with abdominal aortic aneurysm.


Eligibility criteria: Inclusion Criteria:

* Infra-renal abdominal aortic aneurysm

Exclusion Criteria:

* Previous infra-renal aortic surgery
* Known diabetes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Hospital, Department of Vascular Surgery V
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital Skejby, Hjerte-Lunge-Kar kir. afd. T
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Karkirurgisk afdeling RK 3111
city: Kolding
country: Denmark
facility: Sygehus Lillebælt, Karkirurgisk Forskningsenhed
city: Viborg
country: Denmark
facility: Regionshospitalet Viborg, Karkiurgisk Forskningssektion
city: Borås
country: Sweden
facility: Borås Hospital, Department of Surgery
city: Eskilstuna
country: Sweden
facility: Mälarsjukhuset, Team Kärl Kir. Klin.
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Malmo
country: Sweden
facility: Skånes Universitets Sjukhus, Institution of Surgical Science
city: Orebro
country: Sweden
facility: Universitetssjukhuset Örebro, Kirurgkliniken, Kärlsektionen
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Kärlkirurgiska Kliniken
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Västerås
country: Sweden
facility: Centrallaserettet, Kärlkirurgiska Kliniken
city: London
country: United Kingdom
facility: St George's Hospital NHS Trust
city: Manchester
country: United Kingdom
facility: University Hospital of South Manchester
Study officials:
affiliation: Rigshospitalet, University of Copenhagen, Denmark
name: Henrik Sillesen, MD DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sillesen H, Eldrup N, Hultgren R, Lindeman J, Bredahl K, Thompson M, Wanhainen A, Wingren U, Swedenborg J; AORTA Trial Investigators. Randomized clinical trial of mast cell inhibition in patients with a medium-sized abdominal aortic aneurysm. Br J Surg. 2015 Jul;102(8):894-901. doi: 10.1002/bjs.9824. Epub 2015 May 12.
Clinical trial NCT02521584: Ischemia Time and Graft Survival
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Transplant
Keywords: Liver transplant recipient
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 150
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: recipients of living donor liver transplantation

Brief summary: Study the effect of ischemia time on patient and graft survival.

Detailed description: Study the effect of cold ischemia and warm ischemia on graft function after one year and patient one year survival.

Eligibility criteria: Inclusion Criteria:

* recipients of living donor liver transplantation

Exclusion Criteria:

* early mortality

Primary outcomes:
measure: one year graft survival
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
state: Dakahleya
Study officials:
References:
Clinical trial NCT04423484: Therapeutic Recommendations for Nephroblastoma
Official title: Therapeutic Recommendations for the Treatment of Children With Nephroblastoma in Africa.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nephroblastoma
Lead sponsor: French Africa Pediatric Oncology Group
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children with local Nephroblastoma in all participating units

Brief summary: The study is based on results form 2 previous studies carried out by the GFAOP. The aim of this study is to evaluate the capacity of units to follow the recommendations in the protocol.

Detailed description: The study is based on results form 2 previous studies carried out by the GFAOP. This study aims to evaluate the capacity of units to follow the recommendations in the protocol. It will look mainly at treatment compliance and outcome for the children treated. The study will also evaluate the improvement in treatment compliance and reporting. This work will help the group to evaluate future needs in participating units and help us adapt treatment programmes to local conditions.

Eligibility criteria: Inclusion Criteria:

Unilateral Nephroblastoma Tumor Not previously treated The general health of the child will permit treatment.

.

Exclusion Criteria:

Bilateral Nephroblastoma tumor Previously treated Disease too advanced Doubt concerning the diagnosis Treatment Refusal

Primary outcomes:
measure: Evaluation of the number of cases with local disease.
timeFrame: 5 years
measure: Evaluation of the number of cases with stage IV disease.
timeFrame: 5 Years
measure: Evaluating the treatment given.
timeFrame: 5 Years
measure: Evaluating the follow up after treatment.
timeFrame: 5 Years
Secondary outcomes:
measure: Why has treatment failed
timeFrame: 5 years
Other outcomes:
Locations:
city: Ouagadougou
country: Burkina Faso
facility: Centre Hospitalier Universitaire Pédiatrique Charles De Gaulle
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: CUK (Cliniques Universitaires de Kinshasa)
city: Lubumbashi
country: Congo, The Democratic Republic of the
facility: Cliniques Universitaires de Lubumbashi (CUL)
city: Abidjan
country: Côte D'Ivoire
facility: CHU de Treichville à ABIDJAN
city: Antananarivo
country: Madagascar
facility: HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona
city: Bamako
country: Mali
facility: CHU Gabriel Touré (HGT)
city: Dakar
country: Senegal
facility: Hôpital Aristide Le Dantec, Avenue Pasteur, BP 3001
Study officials:
affiliation: French Africa Pediatric Oncology Group
name: Fatou Binetou Ms DIAGNE AKONDE, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04784884: Hyperspectral Imaging in Thoracic Surgery
Official title: Pilot Study of Intraoperative Tissue Differentiation and Vascular Perfusion Using Intraoperative Hyperspectral Imaging (HSI) in Benign and Malignant Diseases of the Lung, Pleura and Mediastinum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchus Anastomosis
Bronchus Stump
Tissue Oxygenation
Lead sponsor: LungenClinic Grosshansdorf
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to find out whether hyperspectral imaging enables bronchus stump and bronchus anastomosis oxygenation.

Detailed description: The bronchus before lung resection and the bronchus stump or bronchus anastomosis, respectively, are investigated. The hyperspectral imaging camera head is placed and aligned over the surgical (camera and object distance: 30 cm for all measurements). The Field of view is illuminated by 8 halogen spots (20 W each) and 100 wavelengths in the wavelength range from 500 to 1000 nm were applied. The software calculates the tissue oxygenation \[%\] , organ-hemoglobin-index, near-infrared-Index and the tissue-water-index of the investigated tissue. The study was designed to investigate tissue oxygenation in the superficial (app. 1mm) and deeper layers (app. 4-6mm) of the bronchus before and after lung resection.

Eligibility criteria: Inclusion Criteria:

* lung resection or other resection via thoracotomy

Exclusion Criteria:

* Restriction of the ability to consent

Primary outcomes:
measure: Oxygenation: Bronchus before lung resection
timeFrame: directly before lung resection
measure: Oxygenation: Bronchus stump or bronchus anastomosis after lung resection
timeFrame: 10-15 minutes after lung resection
measure: Near Infrared Perfusion Index: Bronchus before lung resection
timeFrame: directly before lung resection
measure: Near Infrared Perfusion Index: Bronchus stump or bronchus anastomosis after lung resection
timeFrame: 10-15 minutes after lung resection
measure: Tissue-Hemoglobin index: Bronchus before lung resection
timeFrame: directly before lung resection
measure: Tissue-Hemoglobin index: Bronchus stump or bronchus anastomosis after lung resection
timeFrame: 10-15 minutes after lung resection
measure: Tissue-Water-Index: Bronchus before lung resection
timeFrame: directly before lung resection
measure: Tissue-Water-Index: Bronchus stump or bronchus anastomosis after lung resection
timeFrame: 10-15 minutes after lung resection
Secondary outcomes:
Other outcomes:
Locations:
city: Großhansdorf
country: Germany
facility: LungenClinic Großhansdorf
Study officials:
affiliation: LungenClinic Grosshansdorf
name: David B. Ellebrecht, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03540784: Effects of WB-EMS and High Protein Diet in IBD Patients
Official title: Effect of Whole-body Electromyostimulation Combined With a High Protein Diet in Malnourished Patients With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Diseases
Keywords: muscle weakness
muscle mass
whole-body electromyostimulation
WB-EMS
nutrition
protein
crohn's disease
ulcerative colitis
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients with inflammatory bowel disease (IBD) often suffer from muscle weakness and a low bone mineral density as a consequence of systemic Inflammation and disease treatment limiting Quality of life in a considerable way. Exercise interventions to build up muscle mass and increasing physical function are promising Tools to improve the whole muscular Status of those patients. However, in the acute Phase of IBDs conventional Training methods may be too strenous, also because patients are suffering from acute gastrointestinal symptoms and feel fatigued. Due to those symptoms, patients present low Food intake and great loss of nutrients and energy especially by diarrhea. Individualized nutritional Support may be helpful to avoid malnutrition. The aim of this pilot study is to investigate the effect of a combined exercise and Nutrition Intervention using the gentle Training method of whole-body electromyostimulation (WB-EMS) combined with a individual high Protein nutritional Support on muscle mass, Body composition, physical function, Quality of life and gastrointestinal symptoms in outpatients with IBD.


Eligibility criteria: Inclusion Criteria:

* outpatients with inflammatory bowel disease (Crohn's disease, ulcerative Colitis)
* adults (18 years and older)

Exclusion Criteria:

* simultaneous participation in other nutritional or exercise intervention Trials
* acute cardiovascular events
* use of anabolic medications
* epilepsy
* severe neurological diseases
* skin lesions in the area of electrodes
* energy active metals in body
* pregnancy
* acute vein thrombosis

Primary outcomes:
measure: Skeletal muscle mass
timeFrame: 12 weeks
Secondary outcomes:
measure: Body composition
timeFrame: 12 weeks
measure: Physical function - isometric muscle strength
timeFrame: 12 weeks
measure: Physical function - Endurance
timeFrame: 12 weeks
measure: Physical function - lower limb strength
timeFrame: 12 weeks
measure: Quality of Life
timeFrame: 12 weeks
measure: Physical activity
timeFrame: 12 weeks
measure: Disease activity (Crohn's disease)
timeFrame: 12 weeks
measure: Disease activity (ulcerative colitis)
timeFrame: 12 weeks
measure: Inflammation status
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen, Medizinische Klinik 1
state: Bavaria
Study officials:
References:
Clinical trial NCT01274884: Tightrope Fixation of Acromioclavicular Joint Dislocation - a Prospective Series
Official title: Prospective Series of Acute Acromioclavicular Dislocations Grade III+. Arthroscopic Fixation With Tightrope (R).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acromioclavicular Joint Dislocation
Keywords: Acromioclavicular
Injury
Dislocation
Surgery
Lead sponsor: Sykehuset Asker og Baerum
Sponsor class: OTHER
First posted: 2011-01-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Several surgical techniques are used for the treatment of acute acromioclavicular joint dislocations. The investigators investigate a new method using arthroscopic repair using the Tightrope fixation device.

Detailed description: The Tightrope consists of a suspension system with a strong suture thread intertwined between an oval button and a round button, which is inserted through drilling holes in the clavicula and the coracoid. The investigators want to prospectively evaluate the results in a series of 25 patients.

Eligibility criteria: Inclusion Criteria:

* Acute acromioclavicular joint dislocation
* 18 years or older

Exclusion Criteria:

* Unable to sign informed consent

Primary outcomes:
measure: Constant score
timeFrame: 1 Year
Secondary outcomes:
measure: Plain radiographs
timeFrame: 1 Year
measure: VAS Pain
timeFrame: 1 Year
measure: VAS Satisfaction
timeFrame: 1 Year
Other outcomes:
Locations:
city: Baerum
country: Norway
facility: Asker and Baerum Hospital
state: Rud
Study officials:
affiliation: Baerum Hospital, Vestre Viken, Norway
name: Wender Figved, MD, PhD
role: STUDY_DIRECTOR
affiliation: Baerum Hospital, Vestre Viken, Norway
name: Odd A Lien, MD
role: PRINCIPAL_INVESTIGATOR
References: