louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06400589: A Study to Evaluate the Efficacy and Safety of Tanfanercept (HL036) in Dry Eye Disease
Official title: A Phase 3, Multicenter, Randomized, Double-Masked and Vehicle-Controlled Study Evaluating the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution 0.25% and 1.0% Compared to Vehicle in Participants With Dry Eye Disease (VELOS-4)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Dry Eye
Lead sponsor: HanAll BioPharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-06
Enrollment: 750
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 objectives of this study are to compare the efficacy and safety of tanfanercept ophthalmic solution 0.25% and 1.0% to vehicle for the treatment of DED.

Detailed description: The purpose of this research study is to test the safety and effectiveness (how well the drug works) of Tanfanercept ophthalmic solution 0.25% and Tanfanercept ophthalmic solution 1% against vehicle (no active treatment). Effectiveness will be measured by the improvement in Schirmer Test results (a test to see how many tears you produce), reduction of dry eye symptoms, eye redness (conjunctival redness), and eye surface irritation (corneal staining, conjunctival staining). Eye safety assessments will also be performed.

Eligibility criteria: Inclusion Criteria:

1. Are at least 18 years of age
2. Provide written informed consent
3. Are willing to attend all study visits and able to comply with study procedures and assessments
4. Have a self-reported history of DED (OU) for at least 6 months prior to Visit 1

Exclusion Criteria:

1. Have an uncontrolled systemic disease
2. Have been exposed to an investigational drug or device within 30 days or 5 half-lives prior to Visit 1, whichever is longer

Primary outcomes:
measure: Schirmer Test
timeFrame: 12 weeks
Secondary outcomes:
measure: Schirmer Test
timeFrame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
measure: Symptom Assessment in Dry Eye
timeFrame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
measure: VAS
timeFrame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
measure: Conjunctival redness
timeFrame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
measure: Corneal staining
timeFrame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
Other outcomes:
measure: Comfort Score (Exploratory)
timeFrame: 2 weeks, 4 weeks, 8 weeks
Locations:
city: Delray Beach
country: United States
facility: HanAll Site #1
state: Florida
Study officials:
References:
Clinical trial NCT01617889: Healthy Term Infants Fed Milk-Based Formulas
Official title: Healthy Term Infants Fed Milk-Based Formulas With Different Fat Blends
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Term Infant
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2012-06-13
Enrollment: 17
Sex: ALL
Minimum age (years): 53
Maximum age (years): 115
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective is to assess the comparative fat and calcium absorption, and gastrointestinal (GI) tolerance in healthy normal term infants fed powdered milk-based formulas containing different fat blends.


Eligibility criteria: Inclusion Criteria:

* Infant is judged to be in good health.
* Infant is singleton from a full term birth
* Infant's birth weight was \> 2490 g.
* Infant is between 53 and 115 days of age
* Infant is on infant formula and tolerating infant formula feedings
* Parent(s) confirm they will not administer vitamin or mineral supplements, solid foods or juices for the duration of the study, unless instructed otherwise by their healthcare professional.
* Parent(s) and physician agree to discontinue the use of medications or home remedies, herbal preparations that might affect GI tolerance

Exclusion Criteria:

Infant has received human milk within 7 days prior to SDay 1.

Any adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development and includes maternal substance abuse

Infant has been treated with antibiotics within 5 days prior to SDay 1

Infant has received probiotics within 5 days prior to SDay 1.

Primary outcomes:
measure: calcium absorption
timeFrame: 8 days
Secondary outcomes:
measure: stool consistency
timeFrame: 28 days
measure: fat absorption
timeFrame: 8 days
measure: average number of stools per day
timeFrame: 28 days
measure: percent of feedings with spit up/vomit associated with feeding per day.
timeFrame: 28 days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: Abbott Nutrition
name: John Lasekan, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04446689: Biofeedback Effects on Nursing Personal at an University Hospital
Official title: Biofeedback Efects on Stress, Anxiety, and Quality of Professional Life on Nursing Staff of an University Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress (Psychology)
Biofeedback, Psychology
Keywords: nursing staff
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized Clinical Trial comparing two groups: placebo group without self-monitoring of heart rate variability (HRV) and biofeedback intervention that includes self-monitoring of HRV

Detailed description: Its main objective is to evaluate the effects of Biofeedback intervention on the stress, and anxiety levels, as well as the quality of professional life, and their coping mechanisms, of a nursing staff from de Hospital de Clínicas de Porto Alegre. The research will have two phases, first to select the nursing staff sample, and then to apply and evaluate the intervention. From 2.219 individuals will be randomly drawn a sample of 272 participants. All will respond a questionnaire (Vasconcelos Symptoms and Stress List) in order to obtain a general level of stress score greater than 1 (inclusion criteria to enter the RCT). The 272 group will be randomly split in two groups (136 subjects each) to compare the intervention vs placebo.

Eligibility criteria: Inclusion Criteria:

* Nursing staff
* Both sexes
* Working activities
* Admitted in the last 90 days
* Presenting a level stress greater then 1

Exclusion Criteria:

* Pregnant and breast feeding professionals
* Those away from work a long time, and or returning from vacations in the last 15 days. ----Participants with any kind of cardiac pathology

Primary outcomes:
measure: Stress
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Sônia Souza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01737489: Title: "Development and Implementation of Innovative Auditory Training Methods and Verification of These Training Methods"
Official title: Title: "Development and Implementation of Innovative Auditory Training Methods and Verification of These Training Methods"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cochlear Implant
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-11-29
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if aural rehabilitation adds measurable benefit and participant satisfaction to a cochlear implant recipient's overall treatment. Also, the study is designed to compare the efficacy of a commercially available aural rehabilitation program (LACE) and an electronic program which takes advantage of a traditional form of auditory training (NOOK) for cochlear implant users.

Detailed description: The primary objective of this study is to determine if aural rehabilitation adds measurable benefit and participant satisfaction to a cochlear implant recipient's overall treatment.

The secondary objective of this study is to compare the efficacy of a commercially available aural rehabilitation program (LACE) and an electronic program which takes advantage of a traditional form of auditory training (NOOK) for cochlear implant users.

Eligibility criteria: Criteria for Inclusion:

* Willingness to participate
* Ability to provide informed written consent
* Willingness to follow study protocol
* Eighteen years or older at the time of signing the consent form
* Cochlear implant experience for 12 months or greater
* Spoken English as the first language
* Access to a home computer which meets the minimal requirements to run appropriate program or the ability to use an electronic reader depending on which group the participant is assigned to.
* Reports being comfortable using a computer if in the LACE group

Criteria for Exclusion:

* Unable or unwillingness to sign informed written consent
* Unable or unwillingness to follow study protocol
* Non-English speaking or English as a second language
* No access to a computer if assigned to the LACE study group
* Reports not being comfortable using a computer if assigned to the LACE study group.

Primary outcomes:
measure: Word recognition
timeFrame: baseline to 6 months
measure: Signal-to-noise ratio
timeFrame: baseline to 6 months
Secondary outcomes:
measure: Percent of speech comprehension
timeFrame: baseline to 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Annamary Peterson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00757289: Platelet-rich-plasma Treating Tennis Elbow
Official title: Use of Platelet-rich-plasma to Treat Tennis Elbow, A Blinded and Randomized Single Center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Tennis Elbow
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-09-23
Enrollment: 106
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 study is to compare the efficacy of autologous platelet concentrate injections to corticosteroid injection in patients suffering from tennis elbow with respect to pain and function.

Detailed description: Patients with chronic plantar fasciitis will be allocated randomly to have a steroid injection or an autologous platelet concentrate injections. Data will be collected before the procedure, 4, 8, 12, 26 weeks and 1 year after the procedure. The main outcome measures of this study are pain and function measured with questionnaires.

Eligibility criteria: Inclusion Criteria:

* Patient with chronic epicondylitis lateralis who do not react to conservative treatment and therefore are send to the orthopedic surgeon

Exclusion Criteria:

Primary outcomes:
measure: Visual Analog Score - Pain
timeFrame: 4months,12 months,24months & 52 months
Secondary outcomes:
measure: DASH
timeFrame: 4months,12months,24months & 52 months
measure: Complications
timeFrame: Anytime
Other outcomes:
Locations:
city: Tilburg
country: Netherlands
facility: Elisabeth ziekenhuis
Study officials:
affiliation: Elisabeth ziekenhuis
name: Taco Gosens, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04121689: Time Course of Postprandial Protein Metabolism
Official title: Time-dependent Regulation of Postprandial Muscle Protein Synthesis After Milk Protein Ingestion in Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Protein Synthesis
Protein Metabolism
Keywords: Protein
Amino Acids
Anabolic Signaling
Muscle Mass
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The anabolic action of 'fast' whey protein on the regulation of postprandial muscle protein synthesis has been established to be short-lived in healthy young adults. Our aim was assess the time course of anabolic signaling events and stimulation of muscle protein synthesis rates (MPS) after ingestion of a food source that represents a more typical meal-induced pattern of aminoacidemia, namely milk protein concentrate, in healthy young males.


Eligibility criteria: Inclusion criteria

* Males
* Aged between 18-35 years
* Healthy, recreationally active
* BMI \< 30 kg/m2

Exclusion criteria

* Smoking
* Allergies to milk proteins
* Vegetarians
* Diagnosed GI tract diseases
* Female
* Arthritic conditions
* A history of neuromuscular problems
* Previous participation in amino acid tracer studies
* Predisposition to hypertrophic scarring or keloid formation
* Individuals on any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications).

Primary outcomes:
measure: Fractional synthesis rates of myofibrillar protein
timeFrame: 8 hours
Secondary outcomes:
measure: Phosphorylation of muscle anabolic signaling
timeFrame: 8 hours
measure: Exogenous rate of phenylalanine appearance
timeFrame: 5 hours
Other outcomes:
Locations:
city: Urbana
country: United States
facility: Freer Hall
state: Illinois
Study officials:
References:
Clinical trial NCT00091689: Safety and Efficacy of an Immune Response Modifier to Treat Inoperable Advanced Melanoma Skin Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Melanoma
Keywords: Advanced Metastatic Melanoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2004-09-17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study 1501-852A is a Phase 1 Study with the objective of determining safety and the highest tolerated dose of an immune response modifier cream directly applied to advanced, inoperable, melanoma skin lesions. The study will also measure blood levels of the drug and examine the potential anti-tumor activity of the cream.


Eligibility criteria: Inclusion Criteria:

* Have melanoma cutaneous metastasis or lentigo maligna melanoma unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
* Have a life expectancy of 4 months
* Have normal organ and bone marrow function

Exclusion Criteria:

* Need for non-steroidal anti-inflammatory drugs (NSAIDs) during the study
* Have a body mass index (BMI)\> 30 kg/m2
* Have a history of, or clinical evidence of, myocardial ischemia, congestive heart failure, or myocardial arrhythmias requiring treatment within the past 6 months
* Have uncontrolled intercurrent or chronic illness, but not limited to, ongoing or active infection such as hepatitis B or C, immune dysfunction such as autoimmune disease, endocrine dysfunction such as hypo- or hyperthyroidism, psychiatric illness such as depression or suicidal tendency or social situations that would limit compliance with study requirements
* Have a history of disease requiring ongoing steroid treatment
* Have a history of seizure disorder (other than febrile seizures in childhood)
* Have a history of clinically significant coagulation or bleeding disorders or abnormalities
* Are HIV positive. HIV positive subjects are excluded from the study because of possible interactions with the immunomodulatory effects of 852A and because of potential pharmacokinetic interactions associated with combination retroviral therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Oklahoma City
country: United States
facility: Oklahoma Medical Research Foundation
state: Oklahoma
Study officials:
References:
Clinical trial NCT03305289: FMRI Assessment After Radiofrequency in Trigeminal Neuralgia
Official title: Brain Activity Assessment by Functional MRI Before, After Radiofrequency of Gasserian Ganglia in Patient With Trigeminal Neuralgia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trigeminal Neuralgia
Pain, Neuropathic
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-10-09
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the brain activations related to TN, using fMRI, and to evaluate changes in these activations following the application of pulsed and thermal Radiofrequency lesioning to the gasserien ganglion.


Eligibility criteria: Inclusion Criteria:

* Age 20 - 65 years
* Primary trigeminal neuralgia
* Maxillary and/or mandibular affection only
* Failure of medical treatment

Exclusion Criteria:

* 2ry trigeminal neuralgia
* Recurrent trigeminal neuralgia
* Ophthalmic branch affection
* Contraindication for intervention (sepsis, coagulopathy, infection at entery point, local anesthetic allergy,...)
* Pregnancy

Primary outcomes:
measure: pain alleviation
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00580489: Lifeflight: Fentanyl Versus Morphine
Official title: Efficacy and Adverse Events of Morphine and Fentanyl in an Aeromedical Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Relief
Adverse Events
Keywords: helicopter
aeromedical
pain relief
analgesia
fentanyl
morphine
adverse events
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is exempt from informed consent by the MetroHealth Medical Center institutional review board (IRB), because two standards of care are used and there is no increased clinical risk to the patient due to the study. The researchers randomize either fentanyl or morphine to be given to trauma patients and record how their pain scale is treated along with observing for adverse events. They are looking to see if the hypothesized benefits of fentanyl (which is much more expensive than morphine) actually exist.

Detailed description: Periodic reports are made to the IRB.

Eligibility criteria: Inclusion Criteria:

* Trauma patient
* Able to speak/communicate a pain scale

Exclusion Criteria:

* Age \<18
* Age \>69
* Initially or any time hypotensive
* Prisoner

Primary outcomes:
measure: Mean Change in Numeric Pain Score (NPS) From First to Last Dose
timeFrame: Medication was administered over a mean transport time of 37 minutes in the Morphine group and 43 minutes in the Fentanyl group.
Secondary outcomes:
measure: Recording of Instance of Narcotic Side Effects.
timeFrame: Groups were observed a mean of 37 minutes in the Morphine Group and a mean of 43 minutes in the Fentanyl group for side effects.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: MetroHealth Medical Center
name: Michael D Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith MD, Wang Y, Cudnik M, Smith DA, Pakiela J, Emerman CL. The effectiveness and adverse events of morphine versus fentanyl on a physician-staffed helicopter. J Emerg Med. 2012 Jul;43(1):69-75. doi: 10.1016/j.jemermed.2011.05.018.
Clinical trial NCT03700489: Mycological Comparative Study on Maxillary Dentures of Two Different Materials
Official title: Mycological Comparative Study Between Single Maxillary Denture Fabricated From Rapid Heat Cure Acrylic Resin Material and Conventional Acrylic Resin Material Modified by Titanium Dioxide Nanoparticles
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Effect of Tio2 Nanoparticles on Candida Aggregation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 34
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Cross over design the investigator divide participants to two groups group (A) will receive rapid heat cured denture base material and group (b) will receive the acrylic denture modified by titanium dioxide nanoparticles and after washout period alternatively group (a) will receive the acrylic denture modified by titanium dioxide nanoparticles AND group (b) will receive rapid heat cured denture base material the investigator will take swaps from dentures to count the candida species


Eligibility criteria: Inclusion Criteria:

* Completely edentulous maxillary arch and partially dentate mandibular arch with adequate interarch space.
* The edentulous ridges should be covered by firm healthy mucosa.
* Angle class I maxillomandibular relation.
* Healthy and cooperative patient

Exclusion Criteria:

* Patients with bad habits as severe clenching or bruxism, drug or alcohol addiction, moderate or heavy smoking (greater than 10 cigarettes per day).
* Previous history of radiotherapy or chemotherapy.
* Any skeletal problem dictates surgical intervention

Primary outcomes:
measure: Mycological investigation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: