louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02726516: Effects of PRJ-205 on Performance in Trained Young Subjects
Official title: Effects of PRJ-205 on Performance in Trained Young Subjects After Acute and Chronic Intake of the Study Product
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Performance
Lead sponsor: Bioiberica
Sponsor class: INDUSTRY
Collaborators: name: University of Valencia
First posted: 2016-04-01
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Compare a dietary supplement (PRJ-205) and placebo during 1 or 4 days on aerobic exercise performance, oxidative stress and muscle damage.

The hypothesis is that supplementation with PRJ-205 improve aerobic performance

Detailed description: Twenty young active males will be recruited and randomized to either placebo or PRJ-205. Subjects will take the designated treatment in an acute dosage and chronically, 4 days of treatment.

They will undergo 3 exercise tasks (before the administration of the product, 1.5h after the acute administration of the product and after 4 days of treatment). VO2max and anaerobic threshold will be measured during the tests. Blood samples will be taken to measure muscle damage and oxidative stress.

Eligibility criteria: Inclusion Criteria:

* Male
* Healthy
* Physically active

Exclusion Criteria:

* known cardiovascular, pulmonary or metabolic disease
* any medical condition that could affect the development and safety of the exercise task

Primary outcomes:
measure: Aerobic performance determined by VO2max
timeFrame: 4 days
Secondary outcomes:
measure: Pressure pain threshold of calf muscle
timeFrame: 4 days
measure: Serum markers of muscular damage
timeFrame: 4 days
measure: Oxidative stress parameters
timeFrame: 4 days
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Universidad de Valencia
state: Comunidad Valenciana
Study officials:
affiliation: University of Valencia
name: Jose Viña, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03178916: Breast Feeding Practice in High Risk Pregnant Women
Official title: Breast Feeding Practice in High Risk Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Feeding
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 140
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients attending Sohag general hospital

Brief summary: The American Academy of Paediatrics recognizes multiple benefits of breastfeeding to both the term and premature newborn, particularly with regard to protection from infectious agents. Studies have demonstrated decreased rates of bacteraemia, meningitis, respiratory and urinary tract infections, necrotizing enterocolitis, and otitis media among breastfed infants


Eligibility criteria: Inclusion Criteria:

1. Diabetes mellitus.
2. Cardiac disease.
3. Essential hypertension.
4. Chronic chest disease, and/or chronic TB infection.
5. Chronic hepatitis.
6. Neurologic disease.
7. Anaemia (Hemoglobin \<10 gm/dL).
8. Thyroid disease.
9. Multiple pregnancy.

Exclusion Criteria:

* pregnant women \< 34 weeks.

Primary outcomes:
measure: The number of breast feeding women during pregnancy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Faculty of Medicine
Study officials:
References:
Clinical trial NCT02081716: Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Bone Marrow Transplant Recipients (ACE-BMT)
Official title: Assessment of CMV-specific ELISPOT Assay for Predicting CMV Infection in Bone Marrow Transplant Recipients (ACE-BMT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Marrow Transplantation
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2014-03-07
Enrollment: 88
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: bone marrow transplant recipients

Brief summary: CMV is one of the most important opportunistic infection in transplant recipients. In South Korea, more than 95% of adults reveal sero-positivity for CMV IgG. Until now, sero-positivity for CMV IgG before bone marrow organ transplantation is a laboratory test of choice to stratify the risk of CMV reactivation after solid organ transplantation. Theoretically, CMV-specific cell-mediate immune response before and after bone marrow transplantation will further categorize the patients into high or low risk of CMV development after bone marrow transplantation. The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in bone marrow transplant candidates to predict the development of CMV infection after transplantation.

Detailed description: We will evaluate whether CMV-specific cell-mediated immune response before transplant, 1 month, 3 months, and 6 months after transplantation will predict CMV infection after bone marrow transplantation.

Eligibility criteria: Inclusion Criteria:

* age 16 or more
* agree with written informed consent

Exclusion Criteria:

* no exclusion criteria

Primary outcomes:
measure: CMV infection
timeFrame: 6 months after transplantation
Secondary outcomes:
measure: mortality
timeFrame: 6 months after transplantation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Sung-Han Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00061516: Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension
Official title: Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Ocular Hypertension
Keywords: Glaucoma
Ocular Hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2003-05-30
Enrollment: 78
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of both BETAXON and AZOPT in pediatric patients. Patients will dose with study drug at 8 am and 8 pm daily for twelve weeks. Patients will have vision tested, slit lamp exam, blood pressure and pulse checks at each visit. Patients will have a dilated fundus exam and corneal measurements taken at first and last visit.


Eligibility criteria: INCLUSION:

* Children 5 years old and younger
* require treatment for glaucoma or ocular hypertension
* vision is 20/80 or better
* cup-to-disc ratio of 0.8 or less

EXCLUSION:

* do not have abnormal fixation
* IOP greater than 36 mm Hg
* significant retinal disease
* penetrating keratoplasty
* severe ocular pathology
* optic atrophy
* eye surgery in the past 30 days
* cardiovascular abnormalities
* hypersensitivity to beta blockers, carbonic anhydrase inhibitors or sulfa drugs

Primary outcomes:
measure: Mean Change from Baseline IOP
timeFrame: Up to Week 12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Whitson JT, Roarty JD, Vijaya L, Robin AL, Gross RD, Landry TA, Dickerson JE, Scheib SA, Scott H, Hua SY, Woodside AM, Bergamini MV; Brinzolamide Pediatric Study Group. Efficacy of brinzolamide and levobetaxolol in pediatric glaucomas: a randomized clinical trial. J AAPOS. 2008 Jun;12(3):239-246.e3. doi: 10.1016/j.jaapos.2007.11.004. Epub 2008 Mar 4.
Clinical trial NCT02781324: Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis
Official title: Use of Ultrasonic Bone Scalpel in Adolescent Idiopathic Scoliosis - Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Posterior Spinal Fusion
Keywords: Ultrasonic Bone Scalpel
Adolescent Idiopathic Scoliosis
Posterior Spinal Fusion
Estimated Blood Loss
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2016-05-24
Enrollment: 66
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this randomized trial is to compare the efficacy of an ultrasonic bone scalpel (or osteotome device) with standard of care surgical instruments during posterior spine fusion with instrumentation.


Eligibility criteria: Inclusion Criteria:

1. 10-18 years of age
2. Diagnosis of Adolescent Idiopathic Scoliosis (AIS)
3. Scheduled for a posterior spinal fusion (without Schwab Grade II or higher osteotomy)

Exclusion Criteria:

1. Plan for a posterior column osteotomy of Schwab Grade II or higher
2. Prior spinal surgery
3. Magnetic Resonance Imaging (MRI) abnormalities (such as syrinx and/or chiari malformations)
4. Subjects with medical comorbidities (e.g. heart, lung, kidney disease)
5. Subjects with bleeding diatheses
6. Non-idiopathic etiology for scoliosis

Primary outcomes:
measure: Estimated Blood Loss/Level
timeFrame: Intraoperative
Secondary outcomes:
measure: Number of Patients With Intraoperative and Postoperative Blood Transfusions in the Ultrasonic Bone Scalpel Group and Standard of Care Group
timeFrame: Intraoperative, Short Term Postoperative (end of procedure until hospital discharge, up to 7 days after surgery)
measure: Procedure Time (Minutes)
timeFrame: Intraoperative (for duration of the procedure)
Other outcomes:
measure: Preoperative Major Cobb Angle (Degrees)
timeFrame: Preoperative (up to 1 month before scheduled date of surgery)
measure: Postoperative Major Cobb Angle (Degrees)
timeFrame: Short Term Postoperative (3 month), Long Term Postoperative (1 year)
measure: Number of Vertebral Levels Fused
timeFrame: Intraoperative
measure: BMI Percentile at Surgery
timeFrame: Preoperative (on day of surgery)
measure: Weight (kg) at Surgery
timeFrame: Preoperative (on day of surgery)
measure: Percent of Participants With Lenke 1 Curve Pattern
timeFrame: Preoperative (up to 1 month before scheduled date of surgery)
measure: Preoperative Hematocrit
timeFrame: Preoperative (prior to first incision)
measure: Postoperative Hematocrit
timeFrame: Short Term Postoperative (12-18 hours after procedure)
measure: Intraoperative Use of Antifibrinolytic
timeFrame: Intraoperative
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Sumeet Garg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03820024: MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback
Official title: The MOVES Trial: MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Overweight and obese endometrial cancer (EC) survivors at the University of North Carolina (UNC) at Chapel Hill will be approached for tailored feedback fitness intervention. The investigators plan to enroll 36 women (18 in each arm) to evaluate if receipt of weekly tailored feedback messages can improve physical activity in EC survivors. It is hypothesized that women receiving the feedback message intervention will increase step counts from baseline more than 2,000 steps compared to women in the non-intervention arm.

Detailed description: Objectives:

* To assess if a tailored feedback fitness intervention can increase physical activity in EC survivors from baseline to 12 weeks post-baseline
* To determine the acceptability of the fitness intervention in EC survivors through a completion survey.
* To assess if a tailored feedback message fitness intervention can (1) decrease BMI, (2) reduce waitst to hip (W.H) ratios, (3) improve quality of life (QOL) and (4) improve serum metabolic markers (insulin, glucose and low density lipoprotein (LDL) in EC survivors.

Eligibility criteria: Inclusion Criteria:

* Be over the age of 18 years
* Have a confirmed diagnosis of endometrial cancer and have completed therapy (surgery, chemotherapy or radiation) within the past 6 months
* Have no current evidence of endometrial cancer
* Have a BMI 25 kg/m2 or greater
* Have approval from their treating physician to engage in moderate-intensity physical activity.
* Have a smart phone with Bluetooth capabilities turned on
* Have access to email

Exclusion Criteria:

* Are currently undergoing treatment for their cancer
* Are unable to read a sample message aloud
* Do not have a computer or smart phone with Bluetooth capabilities
* Are pregnant
* Have a history of angina or palpitations with exertion
* Have a history of uncontrolled pulmonary disease (COPD or asthma)
* Have one or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention.

Primary outcomes:
measure: Change in Steps in Endometrial Cancer Survivors During 12 Week Intervention
timeFrame: 13 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: North Carolina Cancer Hospital
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Leslie Clark, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02406924: Bone Augmentation Using Particulated Biomaterial and Autogenous Bone, Stabilized by Collagen Membrane and Pins (PaMP)
Official title: Maxillary Horizontal and Vertical Bone Augmentation Using Particulated Biomaterial Associated With Autogenous Bone, Covered and Stabilized by a Collagen Membrane and Pins
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alveolar Bone Grafting
Bone Augmentation
Keywords: pin
particulated graft
bone augmentation
vertical augmentation
horizontal augmentation
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-04-02
Enrollment: 24
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: Twenty four patients with bone resorption on the anterior maxilla will be divided into two groups with different kinds of grafting: bone block associated with particulated biomaterial and particulated mixture of autogenous bone and biomaterial stabilized by collagen membrane and pins. The techniques will be compared according to volume gain, quality of graft osseointegration, implant survival and maintenance of the level of soft tissues.

Detailed description: Twenty four patients will be selected analysing the resorption on the front maxilla and will be divided into two groups. Experimental group will receive a particulated mixture of autogenous and lyophilized bovine bone, stabilized with a collagen membrane and pins over the vertical and/or horizontal defect, while Control group will receive a bone block graft, stabilized with fixation screws , covered with lyophilized bone and a collagen membrane. After a period of nine months, the volume increase will be measured trough the difference found between the initial computerized tomography and the final computerized tomography.

Dental implants will be placed according to the prosthetic need and bone cylinders will be removed from the respective location. The cylinders will be histologically analysed in order to verify the quality of the graft osteointegration. After the prosthesis installation, the implant survival and the soft and hard tissues will be followed up for a minimum period of 24 months.

Eligibility criteria: Inclusion Criteria:

* absence of teeth at anterior maxilla
* need of vertical or horizontal bone reconstruction at anterior maxilla

Exclusion Criteria:

* smoking habits
* diabetes
* systemic diseases which interfere with osseous metabolism
* active periodontal disease

Primary outcomes:
measure: vertical gain
timeFrame: 9 months
measure: horizontal gain
timeFrame: 9 months
measure: implants survival
timeFrame: 24 months
measure: soft tissue volume
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Pedro Tortamano, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02041624: International Registry on the Quality of Life of Patients With Grass-pollen-induced Allergic Rhinitis
Official title: An International Non-Interventional Registry on the Quality of Life of Patients With Grass-pollen-induced Allergic Rhinitis Treated With Oralair®.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Allergic Rhinitis Due to Grass Pollens
Keywords: allergic
rhinitis
conjunctivitis
grass pollen
Allergen ImmunoTherapy (AIT)
grass mix
Lead sponsor: Stallergenes Greer
Sponsor class: INDUSTRY
Collaborators: name: Registrat-Mapi
First posted: 2014-01-22
Enrollment: 740
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with allergic rhino-conjunctivitis are visiting their allergist during grass-pollen season when symptoms are strong. In accordance with the terms of the Marketing Authorization, ORALAIR® treatment has to be set-up "at the right moment" about 4 months before the next grass-pollen season.

Brief summary: The purpose of the present study is to describe patient's perception of quality of life and effectiveness of ORALAIR® over a follow-up period up to 5 years, in real-life settings.

Detailed description: Primary objective:

To describe the patient's perception of the impact of ORALAIR® on his/her health related generic and disease specific quality of life during the grass pollen season in real-life settings.

Secondary objectives:

- To describe the patient's perceived effectiveness of ORALAIR® in allergic rhinoconjunctivitis management in terms of disease intensity, satisfaction and rescue medication

Eligibility criteria: Inclusion Criteria:

* Patient of 5 years of age and older at the date of the screening visit
* Patient with proven allergic rhino-conjunctivitis due to grass pollen
* Patient eligible for a grass-pollen Allergen ImmunoTherapy (AIT)
* Patient whose physician prescribed ORALAIR® independently of the study, before the beginning of the grass-pollen season

Exclusion Criteria:

* Patient participating in a clinical trial or in an epidemiological study

Primary outcomes:
measure: Health related quality of life
timeFrame: patients will be followed for the duration of the treatment, an expected average of 6 months/year
Secondary outcomes:
measure: Treatment Effectiveness
timeFrame: patients will be followed for the duration of the treatment, an expected average of 6 months/year
Other outcomes:
Locations:
city: Antony
country: France
facility: Laboratoire Stallergenes
Study officials:
affiliation: Hôpital Larrey, Toulouse, France
name: Alain DIDIER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02754024: Humeral Head Implants: Radiological and Clinical Evaluation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Idiopathic Osteoarthritis
Posttraumatic Osteoarthritis
Humeral Head Necrosis
Instability Arthritis
Keywords: Stemless shoulder prosthesis
Lead sponsor: Austrian Research Group for Regenerative and Orthopedic Medicine
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients requiring hemi- or total shoulder arthroplasty

Brief summary: In the past years several shoulder reconstruction systems with different types of prostheses and fixation methods have been developed to improve shoulder arthroplasty, trying to cover a wide range of pathologies and revision situations. The aim of the present study is to report radiological and clinical outcome with a stemless shoulder implant with hollow screw fixation.


Eligibility criteria: Inclusion Criteria:

* Age 40 to 85 years at time of surgery
* Patients with primary or secondary osteoarthritis of the shoulder

Exclusion Criteria:

* Patients with cuff tear arthropathy and axillary nerve lesions

Primary outcomes:
measure: the Constant score
timeFrame: 5 years
measure: Radiological assessment to determine radiolucent areas and osteolysis around the humeral head
timeFrame: 5 years
Secondary outcomes:
measure: the Constant score
timeFrame: Change from baseline to 2 years postimplantation
measure: Radiological assessment to determine radiolucent areas and osteolysis around the humeral head
timeFrame: 2 years
measure: the Constant score
timeFrame: Change from baseline to 5 years postimplantation
measure: the Constant score
timeFrame: 10 years
measure: Radiological assessment to determine radiolucent areas and osteolysis around the humeral head
timeFrame: 10 years
measure: the Constant score
timeFrame: 15-20 years
measure: Radiological assessment to determine radiolucent areas and osteolysis around the humeral head
timeFrame: 15-20 years
Other outcomes:
Locations:
Study officials:
References:
citation: Heuberer PR, Brandl G, Pauzenberger L, Laky B, Kriegleder B, Anderl W. Radiological changes do not influence clinical mid-term outcome in stemless humeral head replacements with hollow screw fixation: a prospective radiological and clinical evaluation. BMC Musculoskelet Disord. 2018 Jan 22;19(1):28. doi: 10.1186/s12891-018-1945-6.
Clinical trial NCT01071824: Comparison of Limb Size of Transverse Coloplasty Pouch
Official title: Prospective Randomised Study for Comparison of the Size of Limb of Transverse Coloplasty Pouch After Low Rectal Resection With Total Mesorectal Excision
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Cancer
Keywords: size
limb
transverse coloplasty pouch
rectal resection
mesorectal excision
treatment outcome
Lead sponsor: Kantonsspital Liestal
Sponsor class: OTHER
First posted: 2010-02-19
Enrollment: 52
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 aim of the study is the comparison of pouch function with two different sizes of limb of transverse coloplasty pouch after rectal resection and total mesorectal excision.

Detailed description: No detailed description necessary, see brief summary.

Eligibility criteria: Inclusion Criteria:

* all patients in need of rectal resection due to benign or malign disease
* \>=18 years

Exclusion Criteria:

* anamnestic rectal resection
* life expectancy of less than 2 years
* pregnancy
* \<18 years
* missing informed consent

Primary outcomes:
measure: Pouch function 4 month after closure of protective ileostomy.
timeFrame: 4 month
Secondary outcomes:
measure: Pouch function 2 and 12 month respectively after closure of protective ileostomy.
timeFrame: 1 year
Other outcomes:
Locations:
city: Liestal
country: Switzerland
facility: KS Liestal
state: BL
Study officials:
affiliation: Kantonsspital Liestal
name: Christoph A Maurer, Prof
role: PRINCIPAL_INVESTIGATOR
References: