louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02635958: InBody Validation Study
Official title: Validation of the InBody 770® for the Assessment of Body Composition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Validation Study
Keywords: Body Mass Index
BMI
InBody
iDXA
validation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: BioSpace, Inc.
First posted: 2015-12-21
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with a BMI greater than 18.5 and weigh no more than 450 lbs.

Brief summary: With, one in three Americans now having a body mass index (BMI) greater than 30, and the fastest growing segment of the population having a BMI greater than 40, it is paramount to conduct validation of approaches to measure body composition. Currently the dual-energy x-ray absorptiometry (iDXA) is the gold standard for measuring the body composition. But it is often difficult to perform since it is limited to specific height, weight and BMI's. InBody is a tool which uses bio electric impedance to measure the body composition. This study will compare both approaches. Validation is necessary as it is clinically quite pertinent to accurately assess a patients' body fat percentage, fat free mass, and total body water and changes that are occurring with nutritional support.

Detailed description: This study will use a stratified design. Eligible participants will be categorized with BMI category to receive InBody followed by iDXA. A total of 176 participants will be placed in 1 of 4 arms (n = 44 per arm) based on their BMI: 1) 18.5-24.9; 2) 25-29.9; 3) 30-34.9; and 4) ≥ 35. Within these arms, the 44 participants will participate in an InBody 770® body composition measure as well as an iDXA body composition measure.

Eligibility criteria: Inclusion Criteria:

* Between 18 and 65 years of age
* Have a Body Mass Index ≥ 18.5 kg/m2

Exclusion Criteria:

* Are not English speaking
* Are younger than 18 years of age
* Weigh more than 450 lbs
* Taller than 6'6" due to size constraints of the iDXA
* Have a pacemaker, defibrillator, artificial lung, artificial heart, electrocardiograph, or nerve simulator
* People having radioactive iodine thyroid treatment.
* People who have had a nuclear medicine study or a barium X-ray within the last 5 days.
* People with large amounts of metal in their bodies.
* People with arthritis of the spine recorded in the medical record.
* Are pregnant

Primary outcomes:
measure: Body Composition Measures
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ryan T Hurt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06689358: Thoracic Paravertebral Block for Postoperative Pain Management After VATS
Official title: Thoracic Paravertebral Block for Postoperative Pain Management in PACU After VATS Surgeries: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: Opioids, Pain Management,
Thoracic Paravertebral Block. VATS
Regional Anesthesia
Lead sponsor: King Hussein Cancer Center
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1: General anesthesia with TPVB; Type: Experimental Intervention: 0.4 ml/kg of 0.5% bupivacaine injected into the thoracic paravertebral space.

Arm 2: General anesthesia alone (control group). Type: No intervention (control) Intervention: No intervention
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial evaluated the efficacy of a thoracic paravertebral block (TPVB) in reducing opioid requirements and pain intensity in the PACU after video-assisted thoracoscopic surgery (VATS).

Detailed description: This randomized controlled trial evaluated the efficacy of a thoracic paravertebral block (TPVB) in reducing opioid requirements and pain intensity in the PACU after video-assisted thoracoscopic surgery (VATS). Adult patients scheduled for elective VATS who meet the eligibility criteria will be randomized to either Arm:

Arm 1: General anesthesia with TPVB;

Arm 2: General anesthesia alone (control group).

Primary Outcome: to assess Opioid requirement in the PACU

Eligibility criteria: Inclusion Criteria:

* Adult patients scheduled for elective VATS, ASA physical status II-III, BMI 19-40.

Exclusion Criteria:

* Patient refusal, coagulation disorders, contraindications to TPVB, chronic analgesic use, mental illness

Primary outcomes:
measure: Opioid requirement in the PACU
timeFrame: Opioid requirement assessed at 5 minutes, 15 minutes, 30 minutes post-PACU admission, and at PACU discharge (up to 4 hours)
Secondary outcomes:
measure: Pain intensity measured by Numeric Rating Scale -NRS
timeFrame: Pain intensity measured using the Numeric Rating Scale (NRS) at 5 minutes, 15 minutes, 30 minutes post-PACU admission, and at PACU discharge (up to 4 hours)
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: King Hussein Cancer Center
Study officials:
affiliation: KHCC
name: Ahed Al-Edwan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01471158: Patient Preference Comparison of AZARGA Versus COSOPT in Patients With Glaucoma
Official title: Patient Preference Comparison of AZARGA Versus COSOPT After Single Doses in Patients With Open-Angled Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: Primary open-angle glaucoma
ocular hypertension
pigment dispersion glaucoma
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-11-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess patient preference of AZARGA® compared to COSOPT® after a single drop of each medication is administered to both eyes, in patients with open-angled glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
* On a stable regimen intraocular pressure (IOP) lowering medication within 30 days of screening visit.
* IOP considered to be safe (in the opinion of the investigator) in both eyes in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
* Willing to discontinue use of all other ocular drugs (prescribed and over-the-counter) prior to receiving the screening dose during Screening Visit and for the course of the study.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in this study that is deemed clinical significant in the opinion of the Principal Investigator.
* Corneal dystrophies in either eye.
* Risk of visual field or visual acuity worsening as a consequence of participating in this study, in the investigator's best judgment.
* Bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
* History of severe allergic rhinitis.
* Participation in any other investigational study within 30 days prior to the Screening/Baseline Visit.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Discomfort
timeFrame: One minute after instillation
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Centro Oftalmológico
Study officials:
affiliation: Alcon Research
name: Abayomi Ogundele, PharmD
role: STUDY_DIRECTOR
References:
citation: https://www.dovepress.com/preference-for-a-fixed-combination-of-brinzolamidetimolol-versus-dorzo-peer-reviewed-article-OPTH
Clinical trial NCT04700358: Characterization of Antibacterial Antibodies in Patients With Cystic Fibrosis
Official title: Identification and Characterization of Antibacterial Antibodies in Sera of Patients With Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Cystic Fibrosis
Neutralizing Antibodies
Lead sponsor: University Hospital of Cologne
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the University Hospital Cologne

Brief summary: Most of the cystic fibrosis (CF) patients are or have been pulmonary colonized with bacteria such as Pseudomonas aeruginosa or Staphylococcus aureus. Aim of this study is to detect virulence factor neutralizing antibodies in the sera of the study population followed by B cell repertoire analyses to design B cell-derived neutralizing monoclonal antibodies. The functionality of neutralizing antibodies rests on inhibition of virulence factors by binding of crucial epitopes rather than merely the induction of opsonization. Focusing on patients with bacterial colonization/chronic infections or a history of an acute infection in the past, will increase the likelihood for identification of serum with neutralizing activity as in vivo antigen contact is a prerequisite for antibody development and maturation. Since virulence factors are essential for infection, dissemination and tissue damage, inhibition of these factors by developed neutralizing antibodies might contribute to a favorable outcome of life-threatening infections.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Ability to give consent
* Normal vital signs including:
* Blood pressure systolic value 150 - 100 mmHg, diastolic value \< 90 mmHg
* Respiratory rate \< 20/min
* Oxygen saturation \>92%
* Heart rate 50 - 110/min
* Body temperature \<38°C

Exclusion Criteria:

* Cytopenia (leukocytes \< 1.500/µl, thrombocytes \< 50.000/µl, Hemoglobin \< 12 g/dl)
* Heart disease or pulmonary hypertension
* Body weight \<50 kg (exclusion of blood sampling for B cell isolation)
* Blood donation, larger blood loss and/or major surgery in the last 8 (male) or 12 (female) weeks
* Any decline of the general state of health in the last 3 month including weight loss \> 2kg, pulmonal exacerbation or increased impairment of pulmonary function (FEV1 \< 50%)

Primary outcomes:
measure: Prevalence of antibacterial antibodies
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: CF Study Center, University Hospital Cologne
Study officials:
affiliation: University Hospital Cologne
name: Silke van Koningsbruggen-Rietschel, MD, PhD
role: STUDY_DIRECTOR
affiliation: University Hospital Cologne
name: Jan Rybniker, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02052258: Oxytocin in Opiate Dependence: A Pilot Study of the Effects of Intranasal Oxytocin on Emotional Processes and Stress Responses in Patients With Opiate Dependence
Official title: Oxytocin in Opiate Dependence: A Double-blind, Within-subjects, Placebo-controlled Pilot Study of the Effects of Intranasal Oxytocin on Emotional Processes and Stress Responses in Patients With Opiate Dependence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Opiate Dependence
Keywords: oxytocin
Lead sponsor: MacDonald, Kai, M.D.
Sponsor class: INDIV
First posted: 2014-02-03
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Opiate dependence is a serious problem, and oxytocin has many properties which make it attractive as a treatment for this type of substance dependence. This experiment will test the effects of oxytocin on a variety of brain-based processes in patients with opiate dependence. The investigators hypothesize that intranasal oxytocin in these conditions will enhance emotional processing and will have beneficial effects on stress responses in opiate-dependent patients.


Eligibility criteria: Inclusion Criteria:

* adult men 18 years or older
* meet DSM-IV criteria for opiate dependence, and no other active substance dependence disorder save nicotine dependence
* clinically stable, and low risk for suicide as determined by principal investigator and screening questionnaire
* abstinent from non-prescribed opiate use for at least two weeks from Baseline 1 and free from opiate withdrawal symptoms. If on agonist therapy, dose must be stable for 2 weeks before study visit.
* must be able to use nasal spray
* negative salivary drug screen, save for opiates

Exclusion Criteria:

* any active medical condition that in the opinion of the investigator will interfere with the objectives of the study
* any active, severe mental illness, neurological disorder, including schizophrenia, autism, Asperger's syndrome
* are unsuitable in any way to participate in this study, in the opinion of the investigator
* hospitalizations due to complications of an Axis 1 disorder for the past 12 months, excluding drug or alcohol rehabilitation
* any clinically significant chronic pain condition, as determined by the principal investigator
* positive salivary drug screen at the time of the visit, for any substance other than opiates or another prescribed medication

Primary outcomes:
measure: Cold Pressor Task
timeFrame: up to 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
Study officials:
References:
Clinical trial NCT02574858: Study of the Safety of QRH-882260 Heptapeptide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adults
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2015-10-14
Enrollment: 25
Sex: ALL
Minimum age (years): 25
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the safety of orally administered QRH-882260, a topically administered Cy5-labeled heptapeptide specific for epithelial growth factor receptor (EGFR).

Detailed description: This is a Phase IA study of the safety of an orally administered QRH-882260 heptapeptide for detection of neoplastic tissues in multiple areas of the gastrointestinal tract in humans. The investigators intend to enroll 10 evaluable subjects. The investigators expect to be able to enroll about 1-2 subjects per week, so the study should take about 1-2 months to complete.

Interested, healthy subjects ages 25-100 who respond to recruitment advertising and appear to be eligible based on a screening questionnaire will be scheduled for a study visit at MCRU. At the study visit, the subjects will review and sign the informed consent and eligibility will be confirmed. If eligible, subjects will provide a blood sample for clinical labs and a urine sample for urinalysis. A baseline EKG will be recorded. A negative urine pregnancy test for women of child-bearing potential is required to be eligible. Eligible subjects will consume the reconstituted QRH-882260 heptapeptide. After 5 minutes, subjects will drink a minimum 4-8 ounces of tap water. Subjects will remain in MCRU for observation for 30 minutes. Vital signs and an EKG will be recorded after 30 minutes. Subjects are required to have repeat blood draw for clinical labs and urinalysis within 24 to 48 hours after QRH-882260 heptapeptide ingestion. The study team will conduct a follow up phone call to verbally assess toxicity after post-ingestion labs (within 7 days).

Eligibility criteria: Inclusion Criteria

* Adults age 25 to 100 years
* Not pregnant (willing to have pregnancy test if applicable)
* No recent illness (infection, URI, virus or flu) within 2 weeks,
* Stable health status (i.e. no medication changes within 2 months, no recent surgery, etc. per PI)
* Willing and able to sign informed consent
* Willing and able to drink the peptide and a tap water chaser
* Willing and able to get baseline and 24-48 hours post ingestion labs Exclusion Criteria
* Known allergy to Cy5 or derivatives, such as indocyanine green (ICG)
* Subjects on active chemotherapy or radiation therapy
* Diabetics on insulin/hypoglycemic (due to fasting requirements)

Primary outcomes:
measure: Number of Subjects With Abnormal Lab Values
timeFrame: 48 hours
measure: Number of Subjects With Abnormal EKG
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
References:
Clinical trial NCT00893958: Bioequivalency Study of Mycophenolate Mofetil 500 mg Tablets Under Fed Conditions
Official title: A Single Dose, 2-Period, 2-Treatment 2-Way Crossover Bioequivalency Study of Mycophenolate Mofetil 500 mg Tablets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prophylaxis of Organ Rejection
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2009-05-06
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 500 mg tablets under fed conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to mycophenolate mofetil or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: baseline, 2-period, 14 day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: CEDRA Clinical Research
state: Texas
Study officials:
affiliation: CEDRA Clinical Research
name: William Allan Alexander, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06693258: Study of Transaxillary Robotic Thyroidectomy Versus Standard Open Thyroidectomy: Prospective, Comparative Single-Center Study
Official title: A Comparative Study of Transaxillary Robotic Thyroidectomy Versus Standard Open Thyroidectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carpal Tunnel Surgery
Lead sponsor: Clinique Bizet
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Comparative, Monocentric Study
Primary purpose: OTHER

Brief summary: The aim of our study is to evaluate the two surgical approaches, standard thyroidectomy and robotic thyroidectomy, in terms of postoperative pain management, scar quality, quality of life, as well as the occurrence of postoperative complications (hypocalcemia, compressive cervical hematoma and nerve stimulation)


Eligibility criteria: Inclusion Criteria:

* Subject aged over 20 years
* Referred for a thyroidectomy (total or partial)
* Absence of participation in another clinical study
* Subject affiliated to a social security scheme or beneficiary of such a scheme
* Accepts the completion of the various study questionnaires

Exclusion Criteria:

* Patient under 20 years of age.
* Patients who have undergone combined radical cervical lymph node dissection
* Patient with a postoperative wound problem
* Patient with an underlying systemic disease that may influence the wound healing process
* Unable to undergo medical follow-up for the study.

Primary outcomes:
measure: Evaluate the post-operative quality of life at D30 between the two groups
timeFrame: day 30
Secondary outcomes:
measure: Total dysphagia score between the two groups
timeFrame: Day7, Day30 and 3 months
measure: Quality of the scar between the two groups
timeFrame: day 30
measure: Assess the functional recovery of the vocal cords
timeFrame: day 7 and day 30
Other outcomes:
Locations:
city: Paris
country: France
facility: clinique Bizet
Study officials:
References:
Clinical trial NCT02751658: Tap to "Tap", Pathobiome Associates Health Care
Official title: Pathobiomes Training in the Care of Water Sources and Dynamics of Water-borne Pathogens Involved in Healthcare Associated Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Otorhinolaryngologic Diseases
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-04-26
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The bacteria live in community and in some cases it is the combination of several microorganisms that facilitates transmission and pathogenicity. The concept of pathobiome follows from this finding. Investigators hypothesize that the microbial community water point is a pathobiome influencing installation and transmission of pathogens associated with care

Detailed description: Goals :

Key: To study the impact of bacterial communities on the risk of transmission of waterborne pathogenic bacterium Pseudomonas aeruginosa in patients hospitalized from a contaminated water source by this bacterium.

secondary:

1. Assess the role of communities on installing the water points in P. aeruginosa by comparing contaminated and uncontaminated water sources.
2. To evaluate the effect of the quality of water and the conditions of use of water points network on the composition of bacterial communities associated or not with P. aeruginosa.

Experimental Study conducted from 6 points of water, contaminated deliberately experimental backs onto the project to assess conventional and alternative measures decontamination network and water points

Eligibility criteria: Inclusion Criteria:

* Patients in the Otorhinolaryngology department

Exclusion Criteria:

* Immunocompromised patients
* Patient Opposition to enter the research protocol

Primary outcomes:
measure: Presence of Pseudomonas aeruginosa
timeFrame: Entrance hospitalization (Day 1)
Secondary outcomes:
measure: Presence of infection with Pseudomonas aeruginosa
timeFrame: Exit hospitalization (Day 10)
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Montpellier
name: Sara ROMANO-BERTRAND, MCU-PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Virieux-Petit M, Hammer-Dedet F, Aujoulat F, Jumas-Bilak E, Romano-Bertrand S. From Copper Tolerance to Resistance in Pseudomonas aeruginosa towards Patho-Adaptation and Hospital Success. Genes (Basel). 2022 Feb 4;13(2):301. doi: 10.3390/genes13020301.