louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05768659: Fear Conditioning Paradigm in Obesity
Official title: Implicit Reactions to Threats in Individuals With Obesity: Primary Evidence From Fear Conditioning Paradigm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: fear conditioning
fear processing
anxiety
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with obesity will be recruited at the beginning of a rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy). Controls will be recruited out of the hospital.

Brief summary: Fear processing in obesity and specifically the ability to i) learn and remember threatening stimuli, and ii) implicitly (i.e., unconsciously) and explicitly (consciously) discriminate them from neutral ones, will be investigated in affected individuals through the fear-conditioning paradigm.


Eligibility criteria: Inclusion criteria:

* Right-handed
* diagnosis of obesity (the level of body mass index - BMI - higher or equal to 30).

Exclusion criteria:

• concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders.

Primary outcomes:
measure: SCRs)
timeFrame: Baseline
Secondary outcomes:
measure: Recognition %
timeFrame: baseline
Other outcomes:
Locations:
city: Piancavallo
country: Italy
facility: IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe
state: VCO
Study officials:
References:
Clinical trial NCT00673959: Acute Comfort of Lubricant Eye Drop FID 111421
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Dry eye
artificial tears
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-05-07
Enrollment: 20
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: To evaluate the acute comfort and blurring profile between two artificial tears products in dry eye patients


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of dry eye
* Must not have worn contact lenses for 1 week preceding enrollment

Exclusion Criteria:

* Age related

Primary outcomes:
measure: Drop Comfort Upon Instillation
timeFrame: upon instillation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03046459: A First-in-Human Study of BNZ132-1-40
Official title: A First-in-human Study to Characterize the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of BNZ132-1-40
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: cytokines
interleukin-2
Safety Issues
Lead sponsor: Bioniz Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Celerion
First posted: 2017-02-08
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is an open-label, single ascending dose study to characterize the safety and PK/PD profile of IV BNZ132-1-40, a novel peptide inhibitor of multiple cytokines in the IL-2 family.

Detailed description: This is a open-label study of single doses of intravenous BNZ132-1-40 administered to healthy adult subjects. Subjects are followed for 30 days after treatment for collection of safety, PK and PD data. Cohorts of up to 6 subjects will be enrolled for each dose level.

Eligibility criteria: Inclusion Criteria:

* males and non-pregnant, non-lactating females
* no ongoing clinically significant medical condition
* willing and able to provide informed consent
* no use of Rx or OTC medications, other than oral contraceptives

Exclusion Criteria:

* Recent systemic infections
* Clinically-significant abnormal clinical labs, ECG or physical examination
* Immunization 30 days prior to study

Primary outcomes:
measure: The proportion of subjects with related, treatment-emergent adverse events
timeFrame: 30 days
Secondary outcomes:
measure: PK: Exposure as determined by maximum plasma concentration (Cmax)
timeFrame: 1 Day
measure: PK: Exposure as determined by area under the concentration-time curve (AUC)
timeFrame: 30 days
measure: PD: Effects of BNZ132-1-40 on the expression of T cells as determined by FACS analysis
timeFrame: 30 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Celerion
state: Arizona
Study officials:
affiliation: Bioniz Therapeutics, Inc.
name: Paul A Frohna, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Nata T, Basheer A, Cocchi F, van Besien R, Massoud R, Jacobson S, Azimi N, Tagaya Y. Targeting the binding interface on a shared receptor subunit of a cytokine family enables the inhibition of multiple member cytokines with selectable target spectrum. J Biol Chem. 2015 Sep 11;290(37):22338-51. doi: 10.1074/jbc.M115.661074. Epub 2015 Jul 16.
Clinical trial NCT02321059: Validation of the Goodstrength System for Assessment of Abdominal Wall Strength in Patients With Incisional Hernia
Official title: Validation of the Goodstrength System for Assessment of Abdominal Wall Strength in Patients With Incisional Hernia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incisional Hernia
Keywords: incisional hernia
hernia
abdominal wall strength
validation
physical activity
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2014-12-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients on waiting list for repair of a ventral incisional hernia and healthy volunteers.

Brief summary: Patients with an incisional hernia in the midline and controls with an intact abdominal wall are examined twice with one week apart, in order to establish the test-retest reliability and internal and external validity of the Goodstrength trunk dynamometer.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists score 1-3
* Age equal to or above 18
* Ventral incisional hernia OR intact abdominal wall

Exclusion Criteria:

* Pregnancy
* Severe heart disease (New York Heart Association class III-IV)
* Severe pulmonary disease
* Severe musculoskeletal disease
* Systemic treatment with glucocorticoid

Primary outcomes:
measure: Abdominal wall strength measured by the Goodstrength system
timeFrame: One week
Secondary outcomes:
measure: Physical activity the last week, assessed by the International Physical Activity Questionnaire
timeFrame: Once, at baseline examination
measure: Self-assessed abdominal wall strength, as measured on a visual analogue scale
timeFrame: Once, at baseline examination
measure: Trunk extensor strength measured by the Goodstrength system
timeFrame: One week
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Bispebjerg Hospital
state: Copenhagen
Study officials:
affiliation: Bispebjerg Hospital
name: Kristian K Jensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03410459: Long-term Adverse Effects After Bariatric Surgery on Bone Density
Official title: Long-term Adverse Effects After Laparoscopic Sleeve Gastrectomy and Roux en Y Gastric Bypass (Part A)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-01-25
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this trial is to examine long-term effects of laparoscopic gastric bypass (LRYGB) and sleeve gastrectomy (LSG) on bone mineral density, fracture risk, and body composition ≥ 5 years post-surgery.

Detailed description: Bariatric surgery shows impressive results in terms of weight loss and resolution of comorbidities. Still, there are questions as to the frequency of long-term adverse effects: data on alterations in bone health are missing,

The goal of this trial is to examine long-term effects of laparoscopic gastric bypass (LRYGB) and sleeve gastrectomy (LSG) on bone mineral density, fracture risk, and body composition ≥ 5 years post-surgery.

Eligibility criteria: Inclusion Criteria:

* Patients who received laparoscopic sleeve gastrectomy (LSG) or laparoscopic gastric bypass (LRYGB) ≥ 5 years ago as a primary bariatric procedure will be eligible for this study.

Exclusion Criteria:

* LSG or LRYGB as a secondary bariatric procedure (e.g. after gastric banding), patients receiving secondary bariatric operation after LSG resp LRYGB (e.g. biliopancreatic diversion), pregnancy (due to radiation exposition)

Primary outcomes:
measure: Total hip T-Score measured with dual-energy x-ray absorptiometry
timeFrame: 5-7 years after bariatric surgery
Secondary outcomes:
measure: Total vertebral T-Score measured with dual-energy x-ray absorptiometry
timeFrame: 5-7 years after bariatric surgery
measure: fracture risk assessed by FRAX score
timeFrame: 5-7 years after bariatric surgery
measure: plasma concentration of C-terminal telopeptide (CTX)
timeFrame: 5-7 years after bariatric surgery
measure: plasma concentration of vitamin D3
timeFrame: 5-7 years after bariatric surgery
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: St Claraspital
Study officials:
affiliation: Clinical Research St. Claraspital Basel
name: Bettina K Wölnerhanssen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04550559: Rate of Spontaneous Stone Passage as Assessed Using Urinary Ultrasonography and Direct Urinary System Radiography
Official title: Evaluation of the Effect of Masturbation on Distal Ureteral Stones: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ureteral Calculi
Masturbation
Lead sponsor: Avrasya University
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 149
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of masturbation on the spontaneous expulsion of distal ureteral stones 5-10 mm in size.

Detailed description: This prospective randomized controlled study was performed between February 2018 and March 2020 after obtaining ethics committee approval.A total of 128 men with distal ureteral stones were randomly divided into 3 groups. All patients received standard medical therapy. Patients in group 1 (n=43) were instructed to masturbate at least 3-4 times a week, patients in group 2 (n=41) received tamsulosin 0.4 mg/day, and patients in group 3 (controls, n=44) received standard medical therapy alone. Rates of expulsion, need for analgesic, and ureterorenoscopic lithotripsy were compared between the groups.

Eligibility criteria: Inclusion Criteria:

* age ≥18 years
* presenting with renal colic and inguinal or lumbar pain
* being diagnosed as having distal ureteral stones ≥5 mm and \<10 mm in size

Exclusion Criteria:

* age \<18 years,
* stones \<5 mm or ≥10 mm in size,
* intermediate (stones on the ureter-iliac artery cross)
* proximal ureteral stones, multiple ureteral stones,
* presence of urinary infection,
* renal insufficiency,
* high creatinine level,
* severe hydroureteronephrosis,
* history of open or endoscopic ureteral surgery,
* vesicoureteral reflux,
* neurogenic bladder,
* erectile dysfunction,
* inability or refusal to masturbate for any reason (such as religious beliefs)

Primary outcomes:
measure: The rates of spontaneous distal ureteral stone (5-10 mm size) passage after 4 weeks masturbation
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Hasan Turgut
Study officials:
affiliation: Avrasya University Health Science Faculty
name: Hasan Turgut, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01382459: Constructed Intervention by Home and School Diabetes Nurse Visits on Diabetic Control of Children With Type I Diabetes
Official title: The Efficacy of Constructed Intervention by Home and School Visits by Diabetes Nurses on Diabetic Control of Children With Type I Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 1 Diabetes Mellitus
Keywords: children
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
Collaborators: name: Clalit Health Services
First posted: 2011-06-27
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: type 1 DM children in the age of 4-18, living in Beer Sheva and the area, who are under treatment in the pediatric diabetes unit in Soroka.

Brief summary: The investigators assume that an intervention program that includes home visits and trainings of diabetes' nurse and dietitian will lead to an improvement of the patients' metabolic balance, a decrease in complications' rate, a reduction of hospitalizations and an economic streamlining.

Detailed description: The investigators assume that during the study, subjects from the intervention group will reach a better metabolic balance than the control group. In this group the following changes will occur:

* A decrease in HbA1C levels.
* A decrease in Hypoglycemia events.
* A decrease in DKA events.
* A decrease in patients' visits in ER and hospitalizations.
* An improvement in the knowledge of the patients and their families about the disease.

Eligibility criteria: Inclusion Criteria:

* Type 1 DM diagnosis from at least 8 months/
* HbA1C levels \>8
* Signed inform consent.

Exclusion Criteria:

- Children who are not in educational settings and are not hebrew or arabic speakers.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka medical center
Study officials:
References:
Clinical trial NCT05158959: Association Between Renal Reserve Function and Progression of Renal Function to Predict CKD Risk in Thai Elderly
Official title: Study of the Association Between Renal Reserve Function and Progression of Renal Function to Predict Chronic Kidney Disease Risk in Thai Elderly
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Elder
Renal Function Abnormal
Keywords: Renal functional reserve, CKD progression, Elderly
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elders age more than 60 years who are non-frail and has no limited life expectancy

Brief summary: This study investigates renal functional reserve in elderly.

Detailed description: The prevalence of CKD in elder is high as age has been a variable in eGFR equation. eGFR by calculation always declines in parallel with age. The assumption that a persistent over 3 months of eGFR less than 60 mL/min/1.73m2 define CKD with risk of progression and need refer to nephrologist may not necessary true in aging population. We study renal functional reserve in elderly population who risk of CKD progression and ESRD is the highest prevalence in human life cycle and explore whether renal functional reserve can be used as ad additional marker of CKD progression in elderly.

Eligibility criteria: Inclusion Criteria:

* Patient age \> 60 years at screening
* Patient willing to participate in the study and can provide inform consent
* Patient have residual kidney function ≤ 90 ml/min/1.73m2 by CKD-EPI equation

Exclusion Criteria:

* Patient active smoking
* Patient have Charlson comorbidity index \> .....
* Patient active cancer
* Patient contraindications for blood collection
* Patients with a history of hypersensitivity to cimetidine or amino acid IV solution

Primary outcomes:
measure: Change of renal functional reserve per 12 months (mL/min)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Kearkiat Praditpornsilpa
Study officials:
References:
Clinical trial NCT05707559: Knowledge Beliefs and Expectations of Chronic Musculoskeletal Patients About Their Physiotherapy Program
Official title: Knowledge Beliefs and Expectations of Chronic Musculoskeletal Patients About Their Physiotherapy Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Musculoskeletal Pain
Keywords: chronic musculoskeletal pain
pain education
patient expectations
communication skills
physiotherapy
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic Musculoskeletal Patients

Brief summary: The purpose of this study is to investigate the knowledge, beliefs and expectations of patients with chronic musculoskeletal pain about their physiotherapy program and the relationship that they built with physiotherapists.

Detailed description: The main questions of this study are:

Have patients with chronic pain educated in pain? To what extent physiotherapists use appropriate communication skills and show empathy? What expectations do the patients have of their rehabilitation program?

Eligibility criteria: Inclusion Criteria:

* Patients with chronic musculoskeletal pain more than 3 months and intensity more than 3/10 VAS.
* Greek speaking patients
* patients who are following or followed a physiotherapy treatment for their pain

Exclusion Criteria:

* None

Primary outcomes:
measure: Demographic characteristics
timeFrame: Baseline
measure: Knowledge about their pain
timeFrame: Baseline
measure: Pain (Neuroscience) Education
timeFrame: Baseline
measure: Patient's Experience about healthcare professional's communication skills
timeFrame: Baseline
measure: Patient's Expectations
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Lamia
country: Greece
facility: University of Thessaly
Study officials:
affiliation: University of Thessaly
name: Eleni Kapreli, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01032759: Memantine and Postoperative Pain
Official title: Memantine for Postoperative Analgesia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2009-12-15
Enrollment: 77
Sex: MALE
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: Memantine is associated with improvement in pain relief after surgery.

Detailed description: This prospective, randomized, controlled trial will investigate whether perioperative memantine has a postoperative analgesic effect following radical retropubic prostatectomy (RRP). 100-110 patients scheduled to undergo RRP at Duke will be assessed preoperatively for allodynia using Von Frey filaments, then stratified into two groups based on the presence or absence of allodynia. Patients in each group will then be randomized to receive either memantine 20 mg or placebo 30-60 minutes preoperatively, followed on postoperative day 1 with either memantine 10 mg in the morning and 10 mg in the evening for memantine patients, or placebo at the same intervals for placebo patients. Data such as morphine consumption, patient satisfaction and pain scores, opioid-related side effects, and the area of hyperalgesia around the surgical incision will be recorded for the initial 48 hours postoperatively, and patient satisfaction with their postoperative analgesia will be assessed after 1 week. At 1, 3, and 6 months postoperatively, patients will be asked about the presence and intensity of any persistent pain related to surgery.

Eligibility criteria: Inclusion Criteria:

* Male
* Age 18 to 75 years old

Exclusion Criteria:

* Chronic pain conditions or taking regular analgesics
* Taking psychotropic medications
* Parkinson's disease
* Narrow-angle glaucoma
* Known gastroduodenal ulcer
* History of seizure disorder
* Renal insufficiency, as defined by serum creatinine greater than 2 mg/dL
* Liver disease, including liver failure, cirrhosis, or acute hepatitis
* Significant coronary vascular disease or cardiac conduction system disease, as noted by ECG or history of cardiac symptoms, or cardiac ejection fraction less than 30%
* American Society of Anesthesiologists (ASA) score of 4 or higher
* Allergy to ketorolac or memantine

Primary outcomes:
measure: 24 hr Opioid Consumption
timeFrame: 24 hr
Secondary outcomes:
measure: Pain Scores
timeFrame: 48 hours
measure: Opioid Related Side Effects
timeFrame: 0-24 h
measure: Opioid Related Side Effects: Pruritus
timeFrame: 0-24 h
measure: Hyperalgesia
timeFrame: Within 48 h
measure: Patient Satisfaction
timeFrame: 48 hours
measure: Chronic Post-surgical Pain
timeFrame: 1 month, 3 month, 6 month
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
References: