louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04393597: Effects of Food on the Pharmacokinetics of DWJ1458 in Healthy Adults
Official title: A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Effects of Food on the Pharmacokinetics of Orally Administered DWJ1458 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2020-05-19
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the food effect on the pharmacokinetics of DWJ1458 after oral administration in healthy volunteers.

Detailed description: The purpose of this study is to evaluate the food effect on the pharmacokinetics of DWJ1458 after oral administration in healthy volunteers: Randomized, open-label, oral, single-dose, crossover study

Eligibility criteria: Inclusion Criteria:

* Age 19 to 55 years
* BMI 18.5≥ and ≤27.0 kg/m²
* Female subjects must be menopause or surgically infertility.
* Male subjects must consent to contraception for at least 60 days after the study period and the final administration of the study drug.
* Those who understand the requirements of the study and sign a written informed consent, and also accept all the restrictions imposed during the course of the study.

Exclusion Criteria:

* History of hypersensitivity to investigational product
* Participation in a clinical drug study or bioequivalence study 6 months prior to the present study
* The subject who is judged to be unsuitable as a test subject in a screening test.
* The subject who is judged to be unsuitable for participation in a clinical trial due to other reasons determined by the investigators.

Primary outcomes:
measure: Pharmacokinetic parameter of DWJ1458: AUC0-t
timeFrame: 0 - 144 hours after dosing
measure: Pharmacokinetic parameter of DWJ1458: Cmax
timeFrame: 0 - 144 hours after dosing
Secondary outcomes:
measure: Pharmacokinetic parameter of DWJ1458: AUCinf
timeFrame: 0 - 144 hours after dosing
measure: Pharmacokinetic parameter of DWJ1458: Tmax
timeFrame: 0 - 144 hours after dosing
measure: Pharmacokinetic parameter of DWJ1458: t1/2
timeFrame: 0 - 144 hours after dosing
measure: Pharmacokinetic parameter of DWJ1458: Vd/F
timeFrame: 0 - 144 hours after dosing
measure: Pharmacokinetic parameter of DWJ1458: Cl/F
timeFrame: 0 - 144 hours after dosing
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
References:
Clinical trial NCT02035397: Intragastric Injections of Botox for the Treatment of Obesity
Official title: Treatment of Morbid Obesity by Intragastric Injections of Botulinum Toxin A. A Randomized, Double-blind, Placebo Controlled, Phase II-trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Obesity, Morbid
Keywords: botulinum toxin
Endoscopy
Satiation
Diet
Weight Loss
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2014-01-14
Enrollment: 20
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: One possible angle for treating obesity could be slowing down the gastric emptying time. By prolonging the gastric emptying time, the person would ideally experience increased sensation of satiety, and in the long run reduce food intake. If such a treatment provides a clinically significant weight loss, this could be an alternative for surgical procedures, avoiding the risk for perioperative complications as well as complications in the long run.

There are now several pilot studies documenting that intragastric treatment with botulinum toxin A (BTA) can be effective, although the treatment perspective is short and do not include repeated injections. However, they demonstrate that BTA-injections are safe for the patient. The treatment is administered by endoscopy.


Eligibility criteria: Inclusion Criteria:

* BMI \> 35

Exclusion Criteria:

* Known hypersensitivity to medication
* Neuro muscular disease
* Dysphagia
* Tendency for aspiration
* Ulcus
* Use of aminoglycoside antibiotics and/or spectinomycin lately
* Previous side effects of botox injections
* Previous bariatric surgery
* Previous cancer in GI-tract
* Other obesity treatment last 12 months
* Severe eating disorder
* Hypothyroidism
* Pregnancy/brest feeding
* Reduced competence to consent

Primary outcomes:
measure: Body weight
timeFrame: Change from baseline to 6 months; 1 year; 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs Hospital, Trondheim University Hospital
Study officials:
affiliation: Norwegian University of Science and Technology, Fac MH, IKOM
name: Bård Kulseng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02174497: One-Day Versus Three-Day Bowel Preparation for Colonoscopy in Children
Official title: One-Day Bowel Preparation With Polyethylene Glycol 3350 (Miralax®) is as Effective and Safe as Three-Day Preparation for Colonoscopy in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bowel Preparation
Pediatric Colonoscopy
Keywords: Pediatric Colonoscopy
Bowel Preparation
Safety
Tolerability
Lead sponsor: St. John Health System, Michigan
Sponsor class: OTHER
First posted: 2014-06-25
Enrollment: 32
Sex: ALL
Minimum age (years): 2
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children between 2 and 21 years of age undergoing elective colonoscopy were enrolled into the study.

Brief summary: This was a blinded study conducted on the efficacy and safety of a one-day versus a three-day bowel preparation in a pediatric population. Limited data is available in this regard, and this study supports the use of a one-day bowel preparation, as this is both safe and effective.

Detailed description: Colonoscopy in children and young adults is performed by gastroenterologists for a variety of indications, including but not limited to evaluation of rectal bleeding, chronic diarrhea, family history of polyposis syndromes and surveillance for colon cancer in patients with inflammatory bowel disease. A successful bowel preparation that enables clear visualization of the intestinal mucosa is essential to diagnose and treat the underlying pathology. Currently, gastroenterologists use a variety of colon cleansing preparations, but Polyethylene Glycol (PEG) 3350 given for three to four days appears to be standard. Though it is well tolerated, safe and effective the duration of preparation may cause disruption to the routine and missed school days. To date, there is limited data that shows efficacy of a shorter duration of bowel preparation with PEG. This study aims to compare the efficacy and safety of a one-day preparation with that of a three-day preparation with PEG 3350 as preparation for colonoscopy in children and young adults.

Eligibility criteria: Inclusion Criteria:

* Pediatric Patients referred for an outpatient colonoscopy

Exclusion Criteria:

* None

Primary outcomes:
measure: Safety of a one day versus a three day colonoscopy preparation in a pediatric population
timeFrame: 02/08-06/10 (28 months)
Secondary outcomes:
measure: Tolerability of a one day versus a three day colonoscopy preparation in a pediatric population
timeFrame: 02/08-06/10 (28 months)
Other outcomes:
Locations:
city: Detroit
country: United States
facility: St. John Hospital and Medical Center
state: Michigan
Study officials:
References:
citation: Sorser SA, Konanki V, Hursh A, Hagglund K, Lyons H. 1-day bowel preparation with polyethylene glycol 3350 is as effective and safe as a 3-day preparation for colonoscopy in children. BMC Res Notes. 2014 Sep 15;7:648. doi: 10.1186/1756-0500-7-648.
Clinical trial NCT05614297: Agreement Between Rolimeter and Lachmeter in Patients With ACL Injury
Official title: Agreement Between Two Methods for Assessing Knee Joint Laxity in Patients With ACL Injuries
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anterior Cruciate Ligament Injuries
Laxity of Ligament
Lead sponsor: Region MidtJylland Denmark
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are recruited consecutively from either the orthopaedic outpatient clinic (patients with ACL-injury) or the physiotherapy outpatient clinic (patients who have previously undergone ACL surgery) at Aarhus University Hospital.

Brief summary: The study is a quality assurance study, aiming to determine the agreement between two different measurement instruments for assessing knee joint laxity in patients with ACL injuries.

The study aims to include 60 patients with previous ACL injury, recruited in an outpatient clinic at Aarhus University Hospital from September 2022 to March 2023. For patients who consent to participate in the study, their knee joint laxity in both the injured and the non-injured knee is assessed using both a Rolimeter and a Lachmeter. Subsequently, the collected data are examined to determined the agreement between the two measurement instruments.

Detailed description: Methods:

In connection with their visit at either the orthopaedic or physiotherapy outpatient clinic, patients are invited to participate in the study. Patients consenting to participate will undergo knee joint laxity tests with both the Rolimeter and the Lachmeter, and in addition health-related and demographic data are collected.

The two tests are performed in random order for each patient, and the same physiotherapist conducts the two tests in each individual patient. The physiotherapist performing the two tests reads and notes the score on the first test, while a different physiotherapist, blinded to the score of the first test, reads and notes the score on the second test.

Agreement between the two scores are investigated using a Bland-Altman plot, with calculation of bias and upper and lower limits of agreements with 95% CIs. A priori, an acceptable difference between the two methods is set at 1 millimeter.

Eligibility criteria: Inclusion Criteria:

* Patients with ACL injury awaiting potential ACL-surgery
* Patients with previous ACL-surgery

Exclusion Criteria:

* Multiligament injury
* PCL injury

Primary outcomes:
measure: Knee joint laxity (millimeters)
timeFrame: For surgicaly treated patients: Between 1 year and up to 5 years post-surgery. For non-surgically treated patients: Up to 12 weeks after ACL injury.
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Central Denmark Region
Study officials:
affiliation: Aarhus University Hospital
name: Nanna Rolving, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04821297: Linguistically-Tailored Mobile Intervention for the Improvement of Follow Up for Abnormal Pap Test Results
Official title: An Innovative and Linguistically-Tailored Mobile Intervention to Improve Follow-Up for Abnormal Pap Test Results: CervixChat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 30
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial evaluates the feasibility of a linguistically-tailored mobile intervention, called CervixChat in improving the follow-up of patients with abnormal Papanicolaou (pap) test results. A text messaging program, such as CervixChat may support patients who need a colposcopy.

Detailed description: PRIMARY OBJECTIVE:

I. To evaluate the feasibility of CervixChat intervention in a mix method design, through participants consent rate and the study completion rate.

SECONDARY OBJECTIVE:

I. To evaluate the acceptability of CervixChat intervention using a validated Likert-scale participant satisfaction questionnaire, as well as participant's interview data.

EXPLORATORY OBJECTIVE:

I. To evaluate the preliminary impact of CervixChat intervention, by comparing the colposcopy appointment adherence rate in the study cohort against a 1:1 matched control sample selected based on matching age, race and ethnicity, from participants at Jefferson Obstetrics and Gynecology (Ob-Gyn) department scheduled for a colposcopy in 2019.

OUTLINE:

Patients receive text messages for 1-2 months before scheduled appointment. Patients also complete a survey at baseline and after standard of care colposcopy and an interview after standard of care colposcopy.

After completion of study, patients are followed up periodically.

Eligibility criteria: Inclusion Criteria:

* Female, aged 21 to 65 years of age
* Had received an abnormal Pap smear result
* Scheduled colposcopy
* Able to communicate with ease in English or Spanish
* Have a cell phone with text (TXT) ability
* Competent to give consent

Exclusion Criteria:

* Are pregnant at the time of recruitment
* Display current evidence of positive invasive carcinoma of the cervix

Primary outcomes:
measure: Patient Consent Rate
timeFrame: Up to 12 months
measure: Study Completion Rate
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06207097: Compare the Effect of Exercise Program Plus Dry Needling Versus Elastic Taping
Official title: Effect of Dry Needling Plus Exercise Compared to Elastic Taping Plus Exercise on the Reduction of Nonspecific Low Back Pain and Functionality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: University of Americas
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 22
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: TREATMENT

Brief summary: Low back pain is a common musculoskeletal health condition in society. It is a leading cause of disability globally and has created a significant burden in terms of work disability and high healthcare costs.

Studies on the treatment of combined therapies for non-specific low back pain are scarce, so it is not known in depth which intervention is the best for reducing pain. For this reason, the objective of this study was to evaluate and compare the effect of physical exercise plus dry needling versus physical exercise plus elastic bandage. For this, a randomized clinical trial was carried out with a total of 22 people, where pain was evaluated using the ENA scale and functionality using the Oswestry test. Participants received CORE stabilization exercises. CORE stability training has become a popular training trend and has begun to be applied in rehabilitation programs and sports medicine (1).

The expected results of the study are that the group that receives the physical exercise intervention plus dry needling will have better results in reducing the pain and functionality variable, evaluated with ENA and Oswestry in 4 sessions.


Eligibility criteria: Inclusion Criteria:

* Workers of the University of the Americas, Santiago Centro Campus, Echaurren and República Headquarters

Exclusion Criteria:

Not having a diagnosis of cancer,

* Hernia of the nucleus pulposus with neural symptoms,
* Pregnant
* History of recent surgery (\<6 months)
* History of tumor
* History of spinal fracture
* People with belonephobia

Primary outcomes:
measure: Pain (pain scale (VAS) 1 to 109
timeFrame: 1 week
Secondary outcomes:
measure: dysfunction (percentage of disability due to low back pain (from 0 to 10%))
timeFrame: 1 week
Other outcomes:
Locations:
city: Santiago de Chile
country: Chile
facility: Universidad de las Americas
state: Santiago
Study officials:
affiliation: Universidad de las Americas
name: Ignacio Astudillo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04206397: Mechanisms of Affective Touch in Chronic Pain
Official title: Mechanisms of Affective Touch in Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2019-12-20
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study compares how different types of touch found in massage therapies impact pain perception, and whether these effects differ in individuals with and without chronic pain. This study also examines psychological factors that may predict differences in touch perception in individuals with chronic pain. This research will improve our understanding of whether and how massage therapies can benefit pain and health, and whether this differs in people who suffer from chronic pain.


Eligibility criteria: Inclusion Criteria:

1. ages 18-65
2. fluent in English
3. physician diagnosis of Fibromyalgia but no other chronic pain conditions (patients) or no evidence of chronic pain (healthy volunteers)

Exclusion Criteria:

1. Sensory, motor, or anatomic differences or injuries relevant to study procedures
2. Known anomalies of the central nervous system (including stroke, dementia, aneurysm, or personal history of psychosis)
3. Pregnancy
4. Inability to rate pain or sensations
5. Major medical conditions such as kidney, liver, cardiovascular (hypertension, preexisting cardiac arrhythmia), autonomic, pulmonary, or neurological problems (e.g., seizure disorder) or a chronic systemic disease (e.g., diabetes).
6. History of blood clots or first-degree family members with clotting disorders
7. Current use of opiate medication(s)
8. Contraindications to MRI if participating in pilot MRI study
9. Unable to identify a heat stimulus 50C or lower that generates a rating of a 7 on our VAS scale
10. History of fainting or seizures
11. History of frostbite
12. Open cut or sore on hand to be immersed in cold water bath
13. Fracture of limb to be immersed
14. History of Reynaud's phenomenon (hands get white, then blue on exposure to cold, then red on warming)

Primary outcomes:
measure: Chronic pain levels using the Chronic Pain Grade Questionnaire
timeFrame: Day 1
measure: Trauma history using the Childhood Trauma Questionnaire
timeFrame: Day 1
measure: Current depression using the Hospital Anxiety and Depression Scale without chronic pain
timeFrame: Day 1
measure: Ratings of affective touch
timeFrame: Day 1
measure: Ratings of Heat Pain Intensity
timeFrame: Day 1
measure: Ratings of Heat Pain Intensity
timeFrame: Day 2
measure: Ratings of Heat Pain Unpleasantness
timeFrame: Day 1
measure: Ratings of Heat Pain Unpleasantness
timeFrame: Day 2
Secondary outcomes:
measure: Breathing rate
timeFrame: Day 1 and 2
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: ACTRI
state: California
Study officials:
References:
Clinical trial NCT00632697: Pentoxifylline and Endometriosis
Official title: Combined Laparoscopic Surgery and Pentoxifylline Therapy for Treatment of Endometriosis-Associated Infertility: A Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endometriosis-Associated Infertility
Keywords: endometriosis
immunomodulation
infertility
laparoscopic surgery
pentoxifylline
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2008-03-11
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To prove efficacy of an immunomodulator called pentoxifylline in the treatment of endometriosis in infertile patients undergoing laparoscopy surgery


Eligibility criteria: Inclusion Criteria:

* Infertile patients having early endometriosis as the only factor of their infertility

Exclusion Criteria:

* Previous treatment for endometriosis or patients having pelvic disorders in addition to endometriosis

Primary outcomes:
measure: Pregnancy rate
timeFrame: 6 months follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
References:
citation: Creus M, Fabregues F, Carmona F, del Pino M, Manau D, Balasch J. Combined laparoscopic surgery and pentoxifylline therapy for treatment of endometriosis-associated infertility: a preliminary trial. Hum Reprod. 2008 Aug;23(8):1910-6. doi: 10.1093/humrep/den167. Epub 2008 May 16.
Clinical trial NCT00284297: Follow-up of Patients After Knee Arthrodesis With an Intramedullary Nail
Official title: Follow-up of Patients After Knee Arthrodesis With an Intramedullary Nail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthrodesis With Intramedullary Nail
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-01-31
Enrollment: 20
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: Follow-up of patients who underwent a knee arthrodesis with different types of intramedullary nails.


Eligibility criteria: Inclusion Criteria:

* All patients who underwent a knee arthrodesis with an intramedullary nail between 1994 and 2005

Exclusion Criteria:

-

Primary outcomes:
measure: Follow-up of patients who underwent a knee arthrodesis with different types of intramedullary nails
timeFrame: t0
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: René Verdonk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: