louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02072447: Absolute Bioavailability of YH4808 With Accelerator Mass Spectrometry(AMS)-Based Microdose Study
Official title: A Study to Determine the Absolute Bioavailability of YH4808 Using Simultaneous Oral Therapeutic- and [14C]-Labeled Intravenous Microdoses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Gastroesophageal Reflux Disease
Keywords: absolute bioavailability,
microdose,
AMS
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-02-26
Enrollment: 8
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to determine the absolute bioavailability of YH4808 using simultaneous oral therapeutic- and \[14C\]-labeled intravenous microdoses.


Eligibility criteria: Inclusion Criteria:

* healthy male subject aged 20 to 45 at screening
* subjects who have weight over 55 kg with BMI ranged from 20.0 to 25.0
* subjects who decide to participate voluntarily and write a informed consent form

Exclusion Criteria:

* subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
* clinically significant allergic disease (except for mild allergic rhinitis)
* subjects who have determined not eligible by screening test (medical history, physical examination, 12-lead ECG, laboratory test, etc) within 28 days of study start
* subjects considered unsuitable for inclusion by the investigator

Primary outcomes:
measure: Absolute bioavailability (Fpo)
timeFrame: predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 12, 13, 24, 48, 96, 144, 216 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT02697747: Identification of L3-L4 Interspace in Parturients
Official title: Identification of L3-L4 Interspace in Parturients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Ultrasound
Palpation
Analgesia
Epidural
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2016-03-03
Enrollment: 18
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant female patients.

Brief summary: The investigators hypothesize that teaching ultrasound sonoanatomy to identify the L3-L4 interspace will improve resident's long term skill to correctly identify the interspace as compared to palpation alone.

Detailed description: This will be an observational education based study to improve anesthesiology resident's ability to correctly identify the L3-L4 interspace. Residents who agree to participate in the study will be trained using ultrasound to identify the L3-L4 interspace during their rotation on the obstetric anesthesia service. Training will include using the ultrasound to correlate the surface palpation with the underlying structures. This will be supplemented with teaching videos and literature. The training will be performed for the first three weeks of the four week rotation.

After undergoing this training program, during the fourth week of the rotation, the residents will be asked to perform palpation identification of the L3-L4 interspace on parturients. Ultrasound will be used to assess the accuracy of the identified level. These assessments will repeated at six and 12 months to assess whether the skill has been retained.

Eligibility criteria: Inclusion Criteria:

* term gestation (at least 38 weeks gestation)

Exclusion Criteria:

* Prior back surgery
* Previously diagnosed skeletal deformities such as scoliosis
* BMI greater than 40
* Height less than 60 inches
* Patient discomfort requiring immediate analgesia

Primary outcomes:
measure: Accuracy measured as percentage of cases where the L3-4 vertebral interspace is identified correctly
timeFrame: 1 month
Secondary outcomes:
measure: Durability measured as percentage of cases where the L3-4 vertebral interspace is identified correctly
timeFrame: 6 months and 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Philip E Hess, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00607347: Atenolol Exposure as Risk for Adverse Metabolic Responses to Beta Blockers
Official title: Atenolol Exposure as Risk for Adverse Metabolic Responses to Beta Blockers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Keywords by National Institute of General Medical Sciences
Hypertension
Adverse metabolic effects
Beta blockers
Dyslipidemia
Atenolol
New onset diabetes
Pharmacokinetic study
Oral glucose tolerance test
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2008-02-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The researchers hypothesize that the impact of increasing systemic exposure to atenolol leads to increased risk for adverse metabolic effects from atenolol therapy in hypertension. This will be accomplished through a 24-hour pharmacokinetic (PK) study and oral glucose tolerance test in hypertensive patients taking chronic atenolol 100 mg daily.

Detailed description: The current study is a sub-study of Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR - NCT00246519). The primary objective of this pharmacokinetic (PK) study is to investigate the correlation of atenolol Cp with hypertriglyceridemia and insulin sensitivity in mild to moderate hypertensive patients after 6-8 weeks of atenolol treatment.

Participants will undergo the PK study when they have been on atenolol 100 mg once daily for at least 4 weeks and on atenolol therapy (50 mg or 100 mg) for ≥ 7 weeks. They will undergo a two hour Oral Glucose Tolerance Test (OGTT), 1 hour after atenolol dosing. Blood will be drawn at 12 time points for 24 hours. Atenolol Cp will be measured in all 12 blood samples and will be correlated with the glucose/insulin measured during the OGTT.

Eligibility criteria: Inclusion Criteria:

* Subjects from PEAR who are on atenolol 100 mg once daily will be invited to participate
* Other inclusion criteria from PEAR

Exclusion Criteria:

* Patients with BMI \>35 kg/m2 will be excluded
* Other exclusion criteria from PEAR

Primary outcomes:
measure: Correlation of area under curve (AUC) up to 24 hour time point of atenolol plasma drug concentrations and glucose/insulin values obtained from OGTT and triglycerides
timeFrame: Glucose/insulin will be measured during 2 hour Oral Glucose Tolerance Test and from baseline measurements from PEAR, triglycerides will be measured from baseline lab measurements from PEAR and during the pharmacokinetic study
Secondary outcomes:
measure: HDL-cholesterol, fatty acids, total cholesterol
timeFrame: Baseline lab values from PEAR and before the start of pharmacokinetic study
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Julie A. Johnson, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05308147: Assessment of the Glycemic Responses to Nutritional Products (v2.0)
Official title: Determination of the Postprandial Glycemic Response and Glycemic Index of Nutritional Products: A Randomized Controlled Clinical Trial in Healthy Individuals (v2.0)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glycemic Response
Keywords: Glycemic response
Glycemic index
Nutritional products
Healthy individuals
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
First posted: 2022-04-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study assesses the glycemic responses to nutritional products. During a study visit fasted subjects will consume one serving of the reference product or the test product. Capillary blood samples will be taken at baseline and at several time-points over a 2-hr period. Several nutritional products will be tested over time.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 and ≤ 65 years
* Body mass index (BMI) between 18.5 and 27 kg/m²

Exclusion Criteria:

* Known history of gastrointestinal disease, bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), or any condition which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2)affect the results.
* Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
* Major trauma or surgical event within 3 months of screening.
* Known intolerance, sensitivity or allergy to test products.
* Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.).
* History of cancer in the prior two years, except for non-melanoma skin cancer.

Primary outcomes:
measure: The glycemic index of nutritional products
timeFrame: 3 months
Secondary outcomes:
measure: The postprandial glucose levels at each time point after each test product compared with the mean of the 3 references
timeFrame: 3 months
measure: The postprandial incremental area under the curve (iAUC) after each test product compared with the mean of the 3 references
timeFrame: 3 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: INQUIS Clinical Research, Ltd
state: Ontario
Study officials:
References:
Clinical trial NCT01902147: Postoperative Quality Recovery Scale (PQRS)
Official title: Measuring Recovery in Patients Undergoing Major Abdominal, Thoracic, and Arthroplasty Surgery Using an Enhanced Recovery Program.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Recovery
Keywords: abdominal
thoracic
arthroplasty
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2013-07-18
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective major abdominal, thoracic, and arthroplasty surgery

Brief summary: Recovery following general anesthesia and surgery is a complex issue confounded by the type of surgery, surgical care, inflammation, different anesthetic drugs and techniques, patient co-morbidities, and differing patient and clinician perceptions of what constitutes good recovery. In this observational study, quality of recovery and patient satisfaction will be measured using the Postoperative Quality Recovery Scale (PQRS). This tool includes six domains of recovery: physiological, nociceptive (pain and nausea), emotive (anxiety and depression), functional recovery (return of activities of daily living), self-assessed recovery, and cognitive recovery.


Eligibility criteria: Inclusion Criteria:

* elective major abdominal, thoracic, and arthroplasty surgery

Exclusion Criteria:

* Poor comprehension of English or French

Primary outcomes:
measure: Incidence of recovery (return to baseline or better) in the cognitive domain of the PQRS
timeFrame: postoperative day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Franco Carli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Royse CF, Newman S, Chung F, Stygall J, McKay RE, Boldt J, Servin FS, Hurtado I, Hannallah R, Yu B, Wilkinson DJ. Development and feasibility of a scale to assess postoperative recovery: the post-operative quality recovery scale. Anesthesiology. 2010 Oct;113(4):892-905. doi: 10.1097/ALN.0b013e3181d960a9.
Clinical trial NCT06705647: Analyzing Acoustic Properties of the Vowel "a" Collected Via Mobile Phone From Individuals Diagnosed With Chronic Obstructive Pulmonary Disease and Health Control Groups
Official title: Analyzing Acoustic Properties of the Vowel "a" Collected Via Mobile Phone From Individuals Diagnosed With Chronic Obstructive Pulmonary Disease and Health Control Groups
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Acoustic features
Statistic analysis
Mel frequency cepstral coefficients
Vowel quadrilateral
Lead sponsor: Blekinge Institute of Technology
Sponsor class: OTHER
Collaborators: name: Excellence Center at Linköping - Lund in Information Technology (ELLIIT)
First posted: 2024-11-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data collected from participants 18 years old and older with and without COPD diagnosis will be used. The participants will be balanced on a gender and age basis.

Brief summary: The Study aims to identify the changes in voice caused by Chronic Obstructive Pulmonary Disease (COPD) statistically for identifying the potential digital voice biomarkers.

Detailed description: 1058 voice recordings collected via mobile phones over time in form of the Swedish utterance of vowel "a" will be analysed using vowel quadrilateral space and the Mann-Whitney U test.

The significance threshold p-value will be set to 0.05, and vocal features consisting of 101 base line acoustic features and MFCC features will be analysed between the COPD and HC groups. The most significant features that remain under the significance threshold will be reported.

Eligibility criteria: Inclusion Criteria:

* being 18 years old and older.

Exclusion Criteria:

* being under 18 years old and older.

Primary outcomes:
measure: Difference in Acoustic Voice Features Between COPD and Healthy Control Participants Difference in Acoustic Voice Features Between COPD and Healthy Control Participants
timeFrame: 30 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karlskrona
country: Sweden
facility: Blekinge Institute of Technology
state: Blekinge
Study officials:
References:
Clinical trial NCT00801047: Intravenous Remifentanil Patient-controlled Analgesia (PCA) and Epidural Patient Controlled Epidural Analgesia (PCEA) for Labor Analgesia
Official title: Comparison of the Efficacy Intravenous Remifentanil PCA and Epidural PCEA for Labor Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Labor
Pain
Keywords: Epidural
Labor
Remifentanil
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2008-12-03
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Women requesting analgesia do not always wish to receive a potent analgesic method, and may fear the risks of epidural analgesia.

Study Aim: To determine whether remifentanil is effective for labor analgesia when compared with standard treatment (epidural analgesia).


Eligibility criteria: Inclusion criteria:

* Healthy women
* American Society of Anesthesiologists physical status class I or II
* Body weight less than 110 kg
* In active labor (including induced labor and premature rupture of membranes)
* Cervical dilatation at 2-6 cm
* Regular contractions
* Age between 18 and 40 years old
* Gestational age greater than 36 completed weeks
* Singleton pregnancy and vertex presentation

Exclusion criteria:

* Contraindication for epidural analgesia (bleeding diathesis, neuropathy, severe scoliosis, previous spine surgery, local anesthetic allergy)
* Narcotic administration in the previous 2 hours
* Previous uterine surgery
* Pre-eclampsia and the inability to adequately understand the consent form
* Blocked nose, and any indication patient for whom epidural analgesia is medically indicated (cardiac disease, suspected difficult airway)

Primary outcomes:
measure: Primary analgesia end-point: VAS pain Score
timeFrame: 1-6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah HMO
name: Carolyn F Weiniger, MB ChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hill D. Remifentanil patient-controlled analgesia should be routinely available for use in labour. Int J Obstet Anesth. 2008 Oct;17(4):336-9. doi: 10.1016/j.ijoa.2008.03.005. No abstract available.
Clinical trial NCT04179747: Psychotherapy and Pharmacotherapy in the Treatment of Erectile Dysfunction: A Pilot Study
Official title: A Comparison of Psychotherapy and Pharmacotherapy in the Treatment of Erectile Dysfunction: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erectile Dysfunction
Keywords: Sexual Dysfunctions, Men Health
Lead sponsor: International Islamic University, Islamabad
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The study involved the administration of pharmacotherapy and cognitive behavior psychotherapy to individuals suffering from erectile dysfunction. The study was randomized controlled trial with two arms involving a control group. The study was conducted with an aim of pilot and feasibility study to evaluate the efficacy and suitability of cognitive behavior psychotherapy with individuals suffering from erectile dysfunction.


Eligibility criteria: Inclusion Criteria:

1. Men diagnosed with erectile dysfunction
2. Must be in the age range of 18 to 39 years
3. Must be in a stable heterosexual relationship
4. Must not be suffering from any medical or psychiatric illness

Exclusion Criteria:

1. Men not meeting criteria of diagnosis of erectile dysfunction
2. Men not in a heterosexual relationship
3. Men of or above the age of 40 years
4. Men diagnosed with any medical or psychiatric illness or obese men

Primary outcomes:
measure: International Index of Erectile Functioning-5
timeFrame: 3 months maximum
Secondary outcomes:
measure: Depression, Anxiety, and Stress Scale-21
timeFrame: 3 months maximum
Other outcomes:
Locations:
city: Bahāwalpur
country: Pakistan
facility: Ahmad Bilal Private Practice
state: South Punjab
Study officials:
affiliation: International Islamic University, Islamabad, Pakistan
name: Ahmad Bilal, MPhil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bilal A, Abbasi NUH. Development of an indigenous manual of cognitive behavior sex therapy for young men. J Family Med Prim Care. 2022 Aug;11(8):4127-4130. doi: 10.4103/jfmpc.jfmpc_1892_21. Epub 2022 Aug 30.
Clinical trial NCT01773447: Set-back Suture Versus Traditional Vertical Mattress Suture
Official title: Comparing Wound Eversion and Clinical Outcomes in Surgical Wound Repair With Subcuticular Set-back Versus Traditional Vertical Mattress Suturing Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Basal Cell Carcinoma
Squamous Cell Carcinoma
Melanoma
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2013-01-23
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators hope to compare two different methods of closing skin wounds using sutures. One of these methods (the set-back technique) was recently described in 2010 and has been reported to be technically easier and reduces the chance of spitting sutures (deep sutures that are pushed to the surface of the skin as the wound heals). The other method (the vertical mattress technique) has been used for many years with good results. However, no controlled studies have been performed to clearly demonstrate a difference between the two methods. We hope to find differences in the height of the wound edges immediately after surgery(5 minutes following the procedure) as well as the appearance of the scar and symptoms associated with the scar 3 months after surgery.


Eligibility criteria: Inclusion Criteria:

* Elliptical surgical wound that needs to be closed with a layered closure
* Wound 3 cm in length or longer

Exclusion Criteria:

* Incarceration
* Active pregnancy
* Less than 18 years of age
* Unable to give informed consent
* Non-English or Dutch speaking (the scar assessment scale described below has only been validated in the English and Dutch languages)
* Wound closure projected to be less than 3 cm in length
* Skin less than 3 mm in thickness (dermis and epidermis combined)

Primary outcomes:
measure: Mean of sum of 2 blinded reviewers Physician Observer Assessment scores
timeFrame: 3 months
measure: Scar width
timeFrame: 3 months
Secondary outcomes:
measure: Height of scar immediately following wound closure
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis, Department of Dermatology
state: California
Study officials:
affiliation: University of California, Davis
name: Daniel Eisen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: