louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03584100: Effect of Pneumatic Tourniquet on Arm Swelling After Lymph Node Removal
Official title: The Effect of Pneumatic Tourniquet Use on Upper Extremity Edema Following Axillary Lymph Node Dissection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subject
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the proposed study is to evaluate the acute impact of swelling caused by low-pressure tourniquet use in the setting of ipsilateral prior axillary lymph node dissection and the change in swelling reduction following tourniquet use in three limb postures versus healthy volunteers.

Detailed description: PRIMARY OBJECTIVES:

I. To evaluate reduction in swelling and safety of tourniquet use in patients with prior axillary lymph node dissection

OUTLINE:

Participants raise their arm for 15 minutes, then wear a tourniquet inflated for 25 minutes. Hand volume is measured by aqueous volumeter at baseline, after use of the tourniquet and every 5 minutes for 30 minutes, while the arm is placed at a raised on head position, shoulder-level brace position, or at waist in a sling position.

PROCEDURE:

Participants raise their arm for 15 minutes, then wear a tourniquet 8000 inflated for 25 minutes. Hand volume is measured by aqueous volumeter at baseline, after use of the tourniquet and every 5 minutes for 30 minutes, while the arm is placed at a raised on head position, shoulder-level brace position, or at waist in a sling position.

Eligibility criteria: Inclusion Criteria:

* Have previously undergone axillary lymph node dissection
* Or healthy volunteers

Exclusion Criteria:

* Have new-onset lymphedema of the involved limb.
* Infection including cellulitis
* Trauma or planned axillary surgery within 6 months of participation
* Any prior axillary radiation

Primary outcomes:
measure: Change in Hand Volume Following Tourniquet Use
timeFrame: 30 minutes after tourniquet use
Secondary outcomes:
measure: Difference in Hand Volume Following Tourniquet Use, Between ALND and Control Limbs
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford Cancer Institute
name: Jeffrey Yao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04704700: Evaluate the Rotator Cuff Repair With "InSpace" VS Without "InSpace"
Official title: Evaluate the Rotator Cuff Repair With "InSpace" VS Without "InSpace"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Repair of a Cuff Tear
Lead sponsor: Clinique Bizet
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Evaluate the re-rupture rate 12 months following the intervention in a group with and a group without a spacer


Eligibility criteria: Inclusion Criteria:

* First intention of the rotator cuff
* Repairable supraspinatus and infraspinatus type 2 rupture (according to the PATTE classification, tendon retraction at the top of the humeral head)
* No surgical history
* Patient who has given his participation agreement to participate in the observational study after information by the surgeon,
* Patient living in France and having the capacity to answer alone to the survey.
* Subject affiliated to a social security scheme
* Lack of participation in another clinical study

Exclusion Criteria:

* Major subject protected by law, under curatorship or tutorship
* Known allergy to Inspace medical device materials (PLA and -θ-caprolactone copolymer)
* Osteoporosis
* Damaged cartilage
* Isolated rupture of the suprascapularis
* Glenohumeral instability
* Pseudo-paralytic shoulder- Infection
* Necrosis
* Major joint trauma
* Pregnant or breastfeeding women

Primary outcomes:
measure: Evaluate the re-rupture rate
timeFrame: 12 months
Secondary outcomes:
measure: Evaluate mobility
timeFrame: up to 12 months
measure: Assess shoulder pain
timeFrame: up to 12 months
measure: the quality of life assessed
timeFrame: up to 12 months
measure: resumption of work
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinique Bizet
Study officials:
affiliation: Clinique Bizet
name: philippe VALENTI, DOCTOR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00569400: Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes
Official title: Comparison of Efficacy and Safety of Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-12-07
Enrollment: 241
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: This trial is conducted in Asia and Oceania. The aim of this trial is to compare the efficacy and safety of human insulin produced by the current process and the NN729 process in type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Duration of diabetes for at least 12 months
* Basal/bolus treatment with human insulin for at least 2 months preceding trial start
* Body Mass Index (BMI) lesser than or equal to 35.0 kg/m2
* HbA1c lesser than or equal to 12.0%

Exclusion Criteria:

* Proliferative retinopathy or maculopathy requiring acute treatment or laser treatment within the last 6 months
* Any condition that the investigator and/or sponsor feel would interfere with trial participation
* Known or suspected allergy against trial product or related products

Primary outcomes:
measure: Change of human insulin antibodies
timeFrame: after 26 weeks of treatment
Secondary outcomes:
measure: Change of human insulin antibodies
measure: Frequency of adverse events
Other outcomes:
Locations:
city: Broadmeadow
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Keswick
country: Australia
facility: Novo Nordisk Investigational Site
state: South Australia
city: Dunedin
country: Australia
facility: Novo Nordisk Investigational Site
city: Hamilton
country: Australia
facility: Novo Nordisk Investigational Site
city: Kippa Ring
country: Australia
facility: Novo Nordisk Investigational Site
city: Miranda
country: Australia
facility: Novo Nordisk Investigational Site
city: Stones Corner
country: Australia
facility: Novo Nordisk Investigational Site
city: Shatin, New Territories
country: Hong Kong
facility: Novo Nordisk Investigational Site
city: Cheras
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Georgetown, Penang
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Kota Bharu, Kelantan
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Cebu City
country: Philippines
facility: Novo Nordisk Investigational Site
city: Iloilo
country: Philippines
facility: Novo Nordisk Investigational Site
city: Makati City
country: Philippines
facility: Novo Nordisk Investigational Site
city: Marikina City
country: Philippines
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00685100: Retinal Effects After Combined Photodynamic Therapy (PDT) With Intravitreal Triamcinolone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neovascular Age Related Macular Degeneration
Keywords: IVTA; CNV; age-related macular degeneration; PDT
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2008-05-28
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background: To identify characteristic morphological changes of the retina, their change over time and the association with visual function after combined photodynamic therapy (PDT) and intravitreal triamcinolone (IVTA).

Methods: In this retrospective study, 40 patients (40 eyes) were treated with PDT and same day IVTA. Optical coherence tomography (OCT), fluorescein angiography (FA) and evaluation of distance visual acuity (VA) were performed. Main outcome measures were the anatomical changes within intra- and subretinal compartments and their detailed analysis and grading.


Eligibility criteria: Inclusion Criteria:

* cnv secondary to age related macular degeneration

Exclusion Criteria:

* glaucoma, diabetic retinopathy

Primary outcomes:
measure: visual acuity, central retinal thickness (CRT), choroidal perfusion and macular sensitivity (MS)
timeFrame: Day 1, Week 1, 4 and 12
measure: visual acuity, central retinal thickness (CRT), choroidal perfusion and macular sensitivity (MS)
timeFrame: Day 1, week 1, 4 and 12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01201200: Right Ventricular Function in Patients With Obstructive Sleep Apnea
Official title: Right Ventricular Function in Patients With Obstructive Sleep Apnea Assessed by Real-time Three-dimensional Echocardiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea
Right Ventricular Function
Pulmonary Hypertension
Lead sponsor: Associação Fundo de Incentivo à Pesquisa
Sponsor class: OTHER
First posted: 2010-09-14
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Initially, 56 patients with obstructive sleep apnea (OSA) and 50 non-OSA controls underwent real-time three-dimensional echocardiography. 30 Patients with moderate and severe OSA underwent to continuous positive airway pressure treatment over 6 months. Echocardiogram will be repeated on the third and sixth months from the treatment onset.

Brief summary: The purpose of this study is to determine whether patients with obstructive sleep apnea have any changes in right ventricular function evaluated by three dimensional echocardiography.

Detailed description: Several studies have reported the association between sleep disorders to an increased risk to the development of cardiac disease. However, there is no substantial that about the influence of Obstructive Sleep Apnea on the right ventricular function. Objective: to analyse the right ventricular function in patients with Obstructive Sleep Apnea by means of Real-Time Three dimensional Echocardiography.

Eligibility criteria: Inclusion Criteria:

* Individuals \> 18 years old and \< 70.

Exclusion Criteria:

* Body mass index greater than 35
* Past of clinically significant cardiac conditions

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Escola Paulista de Medicina
Study officials:
affiliation: Escola Paulista de Medicina
name: Orlando Campos, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02433600: The Effect of Feeding Infant Formula With Enriched Protein Fractions in the US
Official title: The Effect of Feeding Infant Formula With Enriched Protein Fractions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Declarative Memory
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2015-05-05
Enrollment: 2
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study is intended to measure declarative or stored memory and behavior between infants who consume one of two infant formulas through approximately one year of age.


Eligibility criteria: Inclusion Criteria:

* Singleton, 0-90 days of age at randomization
* Term infant with birth weight of a minimum of 2500 grams
* Receiving at least 75% of the recommended caloric intake from cow's milk-based infant formula
* Parent or legally authorized representative attending study visits reads, understands, and speaks English
* Signed Informed Consent and Protected Health Information authorization

Exclusion Criteria:

* History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
* Feeding difficulties or formula intolerance
* Infant born small for gestational age
* Infant born from a mother who was diabetic at childbirth
* History of seizures or neurological disorders or infant with known head/brain disease/injury

Primary outcomes:
measure: Sequence Recall using 3-dimensional props
timeFrame: 365 days of age
Secondary outcomes:
measure: Electroencephalogram response to stimuli
timeFrame: 180 days of age
measure: Sequence Recall using 3-dimensional props
timeFrame: 300 days of age
measure: Infant Behavior Questionnaire Revised, Short
timeFrame: 240 days of age
measure: MacArthur-Bates Communication Development Inventory
timeFrame: 365 days of age
measure: Bayley Scales of Infant and Toddler Development, Third Edition
timeFrame: 365 days of age
measure: Achieved Weight
timeFrame: 52 weeks
measure: Achieved Length
timeFrame: 52 weeks
measure: Achieved Head Circumference
timeFrame: 52 weeks
measure: Formula Intake
timeFrame: 52 weeks
measure: Medically-confirmed Adverse Events
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Kannapolis
country: United States
facility: University or North Carolina Nutrition Research Instutite
state: North Carolina
Study officials:
affiliation: Mead Johnson Nutrition
name: Carol Lynn Berseth, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06826300: Application of Elbow Manipulation in Archers
Official title: Analysis of Muscle Strength and Stiffness and the Effect of Manual Therapy on the Time Travel Speed of Kart Drivers
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Health
Keywords: go-kart drivers
muscle fatigue
recovery
manipulation
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study was to: (i) assess the impact of maximal muscle strength and stiffness on EMG and Myoton parameters for selected upper limb muscles; and (ii) assess how manipulation of the initial 2-s tension phase, in particular involving muscle stretching, affects these EMG and Myoton parameters during karting training.

Detailed description: EMG and Myoton measurements will be performed on selected muscles of the shoulder joint and forearm during karting drivers' training, initially at the beginning, after the athletes perform their first 8-minute run, after manipulation and after another 8-minute run.

Eligibility criteria: Inclusion Criteria:

* Healthy persons aged 18,
* A license to drive a kart,
* A competitor who regularly competes in the league,
* Expressing informed consent to participate in the study and undertakes to comply with the regulations on the track and wear a helmet.

Exclusion Criteria:

* Lack of volunteer consent,
* Previous upper, lower limb and spine surgeries,
* Other upper limb injuries in the last 6 months,
* Pain limiting participation in the study,
* Neurological diseases,
* Connective tissue diseases.

Primary outcomes:
measure: Assessment of MVC.
timeFrame: The study will be conducted 4 times during one training session (before the intervention, after the intervention, after race 1 and after race 2). Each isometric muscle test lasts 3 seconds.
measure: 2 Assessment of MVC.
timeFrame: The study will be conducted 4 times during one training session (before the intervention, after the intervention, after race 1 and after race 2).Each isometric muscle test lasts 3 seconds.
measure: 3. Muscle stiffness
timeFrame: The study will be conducted 4 times during one training session (before the intervention, after the intervention, after race 1 and after race 2). Each Myoton application lasts 1 sec for one point.
Secondary outcomes:
Other outcomes:
Locations:
city: Gdansk
country: Poland
facility: Go-Kart Track E1GOKARTS
Study officials:
References:
Clinical trial NCT05549700: The Application of Neuromodulation in Sciatic Nerve
Official title: The Fascicular Anatomy of Nerve May Influence the Muscular Activity of the Biceps Femoris After Applying Ultrasound-guided Percutaneous Neuromodulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this study will be to analyze the muscle activity of the short head (SHBF) and long head of the biceps femoris (LHBF) after the application of ultrasound-guided percutaneous neuromodulation (NMP) in the tibial or common fibular nerve compartment of the sciatic nerve.

Authors will recruit healthy subjects and they will receive asymmetric biphasic rectangular current through a needle into the sciatic nerve. The sample was divided into two groups: one to which the technique was applied in the lateral compartment and another group, in the medial compartment of the nerve. The protocol used was 5 seconds of stimulation, 55 seconds of rest for 5 minutes at a frequency of 100 Hz and a phase duration of 350 microseconds. The electrical activity (recruitment of muscle fibers and maximum contraction) of the SHBF and LHBF and the muscle strength of the knee flexors were recorded by requesting the participants isometric flexion of the knee in the prone position. The percentage of change of each variable was also analyzed.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteer

Exclusion Criteria:

* Subjects that have lumbar area of the back, scoliosis, lower limb dysmetria
* Subjects undergone any surgical intervention in the lumbar area or lower limbs
* Subjects that present acute or unresolved injury in the last 6 months in the lower limbs
* Subjects under treatment drug treatment
* Subjects that they are afraid of needles or electric current
* Subjects with epileptic
* Pregnant.

Primary outcomes:
measure: Electrical muscular activity
timeFrame: 3 months
measure: muscle strength of the knee flexors
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Blanca
state: Sevile
Study officials:
References:
Clinical trial NCT01721070: Effect of Ketoconazole on Sufentanil NanoTab Pharmacokinetics
Official title: IAP104 - Assessment of Pharmacokinetic Changes Following Concurrent Administration of Sufentanil NanoTab and Ketoconazole in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Keywords: Area under curve, time to maximum concentration
Lead sponsor: Talphera, Inc
Sponsor class: INDUSTRY
First posted: 2012-11-04
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Evaluate the effect of taking ketoconazole on sufentanil plasma concentrations following sublingual administration of sufentanil NanoTab.


Eligibility criteria: Inclusion Criteria:

* Non smoking
* Ages 18 to 45 year, inclusive
* BMI between 18 and 30

Exclusion Criteria:

* subjects taking any prescription or OTC medications or vitamins or supplements
* pregnant females
* subjects with pulmonary disease or sleep apnea

Primary outcomes:
measure: AUC (0-inf)
timeFrame: 0 (pre-dose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes, and 24 hours after dosing.24 hours
measure: Cmax
timeFrame: 0 (pre-dose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes, and 24 hours after dosing.
Secondary outcomes:
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: PRA
state: Kansas
Study officials:
affiliation: Talphera, Inc
name: Pamela P. Palmer, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05735470: An Exploratory Clinical Trial to Evaluate the Efficacy and Safety of a Novel Antibacterial Bone Traction Needle
Official title: An Exploratory Clinical Trial to Evaluate the Efficacy and Safety of a Novel Antibacterial Bone Traction Needle
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wound Infection
Keywords: external fixation, implant
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to test in wound infection. The main question it aims to answer is: Whether this antibacterial bone traction needle is safe and has a good effect on wound infection. Participants will be implanted with an antibacterial bone traction needles and the infection grade of wound after surgery will be observed. If there is a comparison group: Researchers will compare the control group without antibacterial ability to see if the experimental group Can effectively inhibit wound infection.


Eligibility criteria: Inclusion Criteria:

1. Limb fractures, infections, defects and deformities caused by various congenital or acquired factors, such as multiple fractures of tibia and fibula, infectious bone defects of tibia, knee varus, horseshoe varus foot, etc.;
2. The subject understands the significance of this project, voluntarily acts as the subject and signs the informed consent.

Exclusion Criteria:

1. The subjects are pregnant or lactating women;
2. Pathological fractures (such as primary or metastatic tumors);
3. The patient is allergic to iodine and its compounds;
4. The patient is allergic to metal implants;
5. Patients with coagulopathy (such as hemophilia, vitamin K deficiency, severe liver disease, etc.);
6. The patient had participated in other clinical trials in the past 3 months;
7. The patient had contraindications to anesthesia and surgery;
8. The patient is currently receiving chemotherapy or radiotherapy, systemic corticosteroid use (continuous use for more than 3 months);
9. The patient had poor compliance and was judged by the researchers to be unable to complete the experiment according to the research plan, such as alcohol addiction, drug abuse, schizophrenia, dementia, and did not provide consent for voluntary participation in the clinical study.

Primary outcomes:
measure: Wound healing grading
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhaoming Ye
state: Zhejiang
Study officials:
affiliation: 2' affiliated Hospital, Schoolc of Medcine, Zhejiang University, China
name: Zhaoming Ye, Doctor
role: STUDY_CHAIR
References: