louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00206037: Open Wedge High Tibia Osteotomy
Official title: Comparison of Open Wedge High Tibia Osteotomy Surgeries Using Colloss E and Tomofix and Tomofix Only, Regarding the Bone Healing
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: High Tibia Osteotomy
Keywords: Tibia osteotomy
Bone healing
Bone filler
Equine Protein
COLLOSS E
TomoFix
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
Collaborators: name: Ossacur Inc.
First posted: 2005-09-21
Enrollment: 49
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 this RCT is to show, that in a patient group receiving COLLOSS E combined with TomoFix for medical open wedge high tibial osteotomy, the onset of bone healing is earlier in time, compared to patients receiving TomoFix without COLLOSS E.

Detailed description: The healing effect should be demonstrated by using MRI pictures during the entire FU's in order to demonstrate the differences if COLLOSS E is applied or not.

Eligibility criteria: Inclusion Criteria:

* Adult and active patient
* Varus malalignment of the leg
* Intact lateral joint compartment
* Physiological age-appropriate ROM in hip, knee and ankle of affected leg

Exclusion Criteria:

* BMI\>35
* Drug or alcohol abuse
* Known equine protein allergy or immunological anormalities
* Immunosuppressive treatment
* Systemic or severe local inflammation or infections
* History of active malignancy or systemic disease
* Impossible to obtain informed consent
* Legal incompetence
* Pregnant and nursing women
* Patients before, during or one year after radio- or chemotherapy
* Patients with metal or metal implants near vulnerable structures
* Patients with pacemakers or other implanted devices

Primary outcomes:
measure: Percentage of the osteotomy gap volume filled with bone healing tissue as determined on the MRI at 2 and 6 weeks postoperatively
timeFrame: 6 weeks
Secondary outcomes:
measure: Bone union
measure: Complication rate
measure: Pain asset on the VAS
measure: Deviation planing angle
measure: Immuno reaction on equine proteins
measure: Range of motion
measure: Ligament stability
measure: Time to pain free walking
measure: WOMAC osteoarthritis index
measure: SF36 Index
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Henriettenstiftung Hannover
city: Tuebingen
country: Germany
facility: BGU Tuebingen
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern
Study officials:
affiliation: Klinik Gut, St. Moritz
name: René K Marti, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03604237: Targeted Forceps Biopsy for Colorectal Tumors
Official title: Concordance Rate of Pathology Between Targeted Forceps Biopsy and Resected Specimen for Large Colorectal Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Neoplasms
Keywords: forceps biopsy
colorectal tumors
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 64
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study evaluates whether targeted forceps biopsy with careful tumor surface evaluation can improve diagnostic accuracy of colorectal tumors larger than 2 cm during colonoscopy.


Eligibility criteria: Inclusion Criteria:

* Patients with colorectal neoplasms of the size larger than 2 cm

Exclusion Criteria:

* Patients who deny the participation in the study

Primary outcomes:
measure: pathologic diagnosis
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
Study officials:
References:
Clinical trial NCT04801537: Temperature of Extremities and Necrotizing Enterocolitis
Official title: Association of Temperature of Extremities and Necrotizing Enterocolitis(NEC)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neutral Temperature
Bloody Stool
Necrotizing Enterocolitis
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Chongqing Medical University
First posted: 2021-03-17
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: an infant's body weight \> 2500 grams and/or gestational age \>35 weeks is included in the present study.

Brief summary: Bloody stool and necrotizing enterocolitis(NEC) is two main focus in non-neonatal intensive care unit ward and usually lead to longed duration of hospitalization.

Neutral temperature is a environmental temperature where the infant's body temperature is normal under resting state, and the changes of body temperature and skin temperature are less than 0.2-0.3 centigrade. According the definition, a suggested temperature range is set. For example, if an infant's body weight is more than 2500 gram, the initial set of environmental temperature is 31.3 centigrade with a range of 29.8-32.8 centigrade.

low environmental temperature is a risk factor for Bloody stool and NEC. Therefore, how to set the optimal environmental temperature is a challenge.

Detailed description: After birth, newborns must adapt to their relatively cold environment by the metabolic production of heat because they are not able to generate an adequate shivering response. Under the condition, environment temperature should be given to protect an infant from cold stress and cold injury, even NEC.

Therefore, the setting of the optimal environment temperature is a key focus in neonatal ward. Here, the investigators suggest a hypothesis that environment temperature should be set to keep warmth of extremities temperature and infant's body temperature is between 36.7-37.3 centigrade.

In the present study, the investigators will test the hypothesis.

Eligibility criteria: Inclusion Criteria:

* body weight \>2500 grams and/or gestational age \>35 weeks
* an infant is diagnosed with hyperbilirubinemia and/or pneumonia without need for oxygen inhalation

Exclusion Criteria:

* congenital deformities
* refusal of parents' consent

Primary outcomes:
measure: bloody stool
timeFrame: before discharge
measure: necrotizing entercolitis(NEC)
timeFrame: before discharge
Secondary outcomes:
measure: late-onset sepsis(LOS)
timeFrame: before discharge
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chen
state: Chongqing
Study officials:
References:
Clinical trial NCT05376137: Personal Therapy Comfort Settings Pilot Clinical Study
Official title: Personal Therapy Comfort Settings Pilot Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Continuous Positive Airway Pressure
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2022-05-17
Enrollment: 66
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: 350 participants will be enrolled in this study. The target population are patients newly diagnosed with OSA and starting CPAP treatment.

User accessible customizable comfort settings (Response setting, expiratory pressure relief (EPR) on/off and EPR level, and Ramp) will be set to either default (control group), or personalized for that participant (active treatment group).

Usage will be recorded for the first 1 month of CPAP treatment, to determine if customizing comfort settings can improve CPAP compliance


Eligibility criteria: Inclusion Criteria:

* Patients willing to give written informed consent
* Patients who can read and comprehend English
* Patients who are ≥ 18 years of age
* Patients newly diagnosed with OSA and indicated for CPAP therapy.

Exclusion Criteria:

* Patients who have previously used PAP therapy
* Patients who require a bilevel device
* Patients who are or may be pregnant

  \* Patients who are unable to attend follow up appointments
* Patients with a preexisting lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury
* Patients believed to be unsuitable for inclusion by the researcher

Primary outcomes:
measure: Comparison of treatment continuance between the control group and active treatment group.
timeFrame: 4 weeks after commencement of CPAP
Secondary outcomes:
measure: comparison of compliance between the control group and active treatment group
timeFrame: 4 weeks after commencement of CPAP
measure: Treatment efficacy
timeFrame: 4 weeks after commencement of CPAP
measure: Mask leak
timeFrame: 4 weeks after commencement of CPAP
measure: Settings changes
timeFrame: 4 weeks after commencement of CPAP
measure: Ad hoc contacts
timeFrame: 4 weeks after commencement of CPAP
Other outcomes:
measure: Exploratory analysis of long term usage
timeFrame: 3,6,9, 12 months after commencement of CPAP
Locations:
city: Bella Vista
country: Australia
facility: ResMed Centre for Healthy Sleep
state: New South Wales
Study officials:
affiliation: ResMed
name: Jeff Armitstead, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01454037: Immune Profiles and Circulating Tumor Cell Status Following Prostate Cryotherapy
Official title: Immune Profiles and Circulating Tumor Cell Status Following Prostate Cryotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Immune Profile
Circulating Cancer Cells
Clinical Corelation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2011-10-18
Enrollment: 160
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Taiwanese organ-confined or locally advanced prostate cancer patients

Brief summary: The change of immune profiles and existence of circulating tumor cells following prostate cryotherapy may be correlated with the clinical outcome.


Eligibility criteria: Inclusion Criteria:

* Age\>20 years
* Histopathology-proven prostate adenocarcinoma
* Non-metastatic localized disease
* Subjects have chosen their curative, definitive treatments for prostate cancer prior to enrolling for the study
* Subjects are willing to sign the informed consent and agree to comply with the study procedures

Exclusion Criteria:

* Chronic use (\> 2 weeks) of \> 10 mg/day of prednisone or prednisolone within 2 months of the screening (topical or inhalational corticosteroids are permitted)
* Concurrent use of immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 3 months of study entry
* Other conditions the investigators think may affect subjects' compliance

Primary outcomes:
measure: Cancer recurrence
timeFrame: 3, 6, 12, 24 months after treatments
Secondary outcomes:
measure: Quality of life
timeFrame: 3, 6, 12, 24months after treatments
Other outcomes:
Locations:
city: Taipei
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 NCT03860337: The Effect of Alginate on Carbohydrate and Fat Digestion in a Mixed Meal
Official title: The Effect of Alginate on Carbohydrate and Fat Digestion in a Mixed Meal - A Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Triacylglycerol Digestion
Keywords: fat digestion
alginate
sausages
Lead sponsor: Newcastle University
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double blind randomised controlled trial
Primary purpose: BASIC_SCIENCE

Brief summary: This study will investigate the effect of an extract of brown seaweed, called alginate, on fat digestion. The extract has been cooked into sausages and the alginate sausages will be compared to the same sausages that do not contain alginate. People taking part in the study will come to the study centre twice. Once to have the alginate sausage meal or the normal sausage meal and on the second visit they will have the other meal so then end up having had both types of sausages. The level of fat in their blood will be monitored over the four hours after the meal. The rate and amount of fat that moves into the blood after a meal is an indication of the amount of fat digestion. We believe that less fat will be digested and move into the blood when the volunteers eat the alginate sausages compared to the normal sausages.

Detailed description: Alginate is an extract of brown seaweed and has been shown to reduce lipase activity in vitro. Lipase is a valid target for anti-obesity products as shown by the pharmaceutical drug orlistat which targets the same enzyme. Reducing the amount of lipase activity will reduce the amount of triacylglycerol (TAG) that will be digested and therefore absorbed and will be seen as a reduction in the level of circulating TAG in the blood. Adding alginate to a range of food products that are simple to include into the diet could help with the management of obesity. In this study, sausages containing alginate have been manufactured for us along with matched control sausage. The circulating TAG in the blood will be measured via fingerpick blood samples every 30 minutes for four hours after the volunteers have eaten either alginate sausages or normal sausages. The volunteers will come for two visits and consume the other sausage meal at the second so they will have had both types of sausage.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* pregnant or lactating.

Primary outcomes:
measure: Concentration of circulating TAG in blood
timeFrame: 4 hours after the test meal
Secondary outcomes:
measure: Concentration of circulating glucose in blood
timeFrame: 4 hours after the test meal
Other outcomes:
Locations:
city: Newcastle
country: United Kingdom
facility: Newcastle University
state: Tyne And Wear
Study officials:
affiliation: Newcastle University
name: Jeffrey P Pearson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05065437: Virtual Reality and Spinal Stimulation to Improve Arm Function
Official title: Immersive Virtual Reality and Noninvasive Spinal Stimulation to Promote Arm Function in Individuals With Tetraplegia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tetraplegia
Keywords: upper limb function
virtual reality
spinal cord stimulation
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of our work is to develop and test the safety and feasibility of a home-based upper limb rehabilitation program for individuals with tetraplegia. The program will consist of simultaneous non-invasive spinal cord stimulation and immersive virtual exercises of the upper limbs, with a focus on shoulder and elbow function.


Eligibility criteria: Inclusion Criteria:

1. incomplete low tetraplegia (C5-8; \[ASIA\] classification B-D),
2. free of contraindications to transspinal stimulation,
3. more than one-year post-injury,
4. stable medication regimen for the past month,
5. utilization of wheelchair as a primary mode of mobility (\>75% of the time). -

Exclusion Criteria:

1. Neurologic injury other than spinal cord injury
2. severe medical illness.

Primary outcomes:
measure: Change in medical status
timeFrame: Baseline to post intervention, approximately 4 weeks
measure: Acceptability of the treatment
timeFrame: Post intervention, approximately 4 weeks
measure: Usability of the treatment
timeFrame: Post intervention, approximately 4 weeks
Secondary outcomes:
measure: Change in affect
timeFrame: Baseline to post intervention, approximately 4 weeks
measure: Change in current pain intensity
timeFrame: Baseline to post intervention, approximately 4 weeks
measure: Change in clinical muscle strength
timeFrame: Baseline to post intervention, approximately 4 weeks
measure: Change in upper limb function
timeFrame: Baseline to post intervention, approximately 4 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Carrie Peterson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00164515: Increasing Physical Activity Among Overweight Women With Mobility Disabilities.
Official title: Personalized Exercise Programme (PEP) I: Physician Referral Approach to Increasing Awareness and Sustainability of Physical Activity for Overweight Adults With Mobility Limitations.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: obesity, mobility limitations, women, physical activity
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: University of Illinois, Center on Health Promotion Research for Persons with Disabilities
First posted: 2005-09-14
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to increase physical activity among overweight African-American women with mobility limitations.

Detailed description: Regular, sustainable physical activity can have a dramatic effect on reducing obesity and other secondary conditions and increasing quality of life. People with mobility limitations have a higher level of physical inactivity resulting from numerous personal and environmental barriers to physical activity participation. This project will evaluate the feasibility of increasing physical activity among overweight individuals with mobility limitations through physician-referrals to a personalized exercise programme at the Chicago-based National Center on Physical Activity and Disability (NCPAD).

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* English speaking
* Self-reported mobility limitation
* BMI greater than or equal to 27
* Receiving care at the University of Illinois, Chicago (UIC) Medical Center
* Sedentary

Exclusion Criteria:

* did not receive physician approval to participate

Primary outcomes:
measure: Physical activity
timeFrame: 24 months
measure: Body mass index (BMI)
timeFrame: 24 months
measure: Blood lipids
timeFrame: 24 months
measure: Weight
timeFrame: 24 months
measure: Blood Pressure
timeFrame: 24 months
Secondary outcomes:
measure: Psychosocial Health
timeFrame: 24 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois, Chicago
state: Illinois
Study officials:
affiliation: UIChicago
name: James Rimmer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rimmer JH, Rauworth A, Wang E, Heckerling PS, Gerber BS. A randomized controlled trial to increase physical activity and reduce obesity in a predominantly African American group of women with mobility disabilities and severe obesity. Prev Med. 2009 May;48(5):473-9. doi: 10.1016/j.ypmed.2009.02.008.
Clinical trial NCT05673915: Study of Transcranial Direct Current Stimulation to Treat Epilepsy
Official title: Pilot Study of Transcranial Direct Current Stimulation (tDCS) to Treat Epilepsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Focal Epilepsy
Generalized Onset Epilepsy
Sleep-related Epileptic Encephalopathy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to see to what extent electrical stimulation applied to the scalp (transcranial direct current stimulation or tDCS) can reduce the number and intensity of epileptic seizures.

Detailed description: tDCS for treatment of epilepsy has been studied previously with results suggesting that it can lead to a notable seizure reduction for a limited time period after the cessation of stimulation, e.g., about one month. Here, we assess further aspects of tDCS treatment protocols, including the feasibility and safety of at-home use.

Eligibility criteria: Inclusion Criteria

* Clinical diagnosis of generalized onset or focal epilepsy or sleep-related epileptic encephalopathy.
* Estimated to have at least 2 countable seizures per month or spike-wave index ≥50%.
* Has not had control with at least 2 anti-seizure medicines.
* Able to maintain a constant medication for duration of the study (rescue meds allowed).
* Subject or legally authorized representative is able to understand consent and keep a seizure diary in English.

Exclusion Criteria:

* A disease likely to progress over course of the study.
* Psychogenic non-epileptic seizures.
* Suicide attempt or psychiatric hospitalization past 2 years.
* A skin condition interfering with scalp electrodes or allergy to silver.
* Women will verify not pregnant, and if applicable, have a serum pregnancy test.
* Implanted devices (e.g. pacemakers)-except VNS, which is allowed.

Primary outcomes:
measure: Seizure Count
timeFrame: 2 months
Secondary outcomes:
measure: EEG interictal discharge frequency
timeFrame: 2 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Brian Lundstrom, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: