louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05439772: Examining the Effect of Ondansetron on Bowel Prep Success
Official title: Examining the Effect of Ondansetron on Bowel Prep Success
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abdominal Pain
Inflammatory Bowel Diseases
Eosinophilic Gastroenteritis
Diarrhea
Hematochezia
Weight Loss
Keywords: colonoscopy
bowel preparation
ondansetron
Lead sponsor: State University of New York - Downstate Medical Center
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 41
Sex: ALL
Minimum age (years): 2
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: non-blinded randomized control trial
Primary purpose: OTHER

Brief summary: This is a pilot randomized-controlled trial assessing the utility of ondansetron for improving pediatric pre-colonoscopy bowel prep outcomes using the boston bowel preparation score, as well as assessing the impact on patient experience of bowel preparation.

Detailed description: The study will compare two approaches to pre-colonoscopy cleanout, one with traditional laxatives only, and one with laxatives + anti-emetic therapy. The medication to be added will be Ondansetron (brand name: Zofran). Classically, the bowel prep entails drinking large amounts of water with an osmotic laxative and being only on a liquid diet the day prior to the procedure. Drinking this mixture of water with an osmotic laxative may cause nausea and discomfort in some patients that may prevent them from finishing the bowel prep. This will therefore affect the visualization of the colon during the procedure, as there will still be retained, hard stool. Having large amounts of stool in the colon during the procedure can make the colonoscopy more difficult, takes a longer time to complete, can make the study inconclusive, unable to properly diagnose, and difficult to take biopsies. This study assesses the impact of anti-emetic medication (ondansetron) on the bowel prep experience with the goal of improving participant tolerance and preparation success. This will eliminate concern for retained stool and less chance of cancelling a procedure due to improper bowel prep.

Eligibility criteria: Inclusion Criteria:

* Age \>2, \<20
* clinically indicated for a colonoscopy

Exclusion Criteria:

* known arrhythmia or long QT

Primary outcomes:
measure: Boston Bowel Preparation Scale
timeFrame: 24 hours after dose
Secondary outcomes:
measure: Symptoms associated with Bowel Prep
timeFrame: 24 hours after dose
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: SUNY Downstate University Hospital of Brooklyn
state: New York
Study officials:
affiliation: SUNY Downstate HSU
name: Thomas Wallach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04485572: Diagnostic Validity of the Neurodynamic or Orthopedic Tension Tests
Official title: Use of Neurodynamic or Orthopedic Tension Tests for the Diagnosis of Lumbar-Sacral and Lumbar Radiculopathies: Study of the Diagnostic Validity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiculopathy, Lumbosacral Region
Keywords: Lumbar radiculopathy
Neurodynamic tension tests
Orthopaedic tension tests
Lumbosacral radiculopathy
Lead sponsor: University of Extremadura
Sponsor class: OTHER
Collaborators: name: University of Cadiz
First posted: 2020-07-24
Enrollment: 1887
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The target population were all the patients referred to the Radiology Department of the 'Puerta del Mar University Hospital' in Cádiz (Spain) to undertake a MRI scan of the lumbar or lumbosacral spine

Brief summary: The objective of the present study is to analyse the diagnostic validity of 8 neurodynamic and/or orthopedic tension tests using magnetic resonance imaging as the Gold Standard.

Detailed description: Lumbar radiculopathy is a nerve root disorder which affects quality of life of the patient and it is considered as an important health problem. Therefore, its correct diagnosis is essential. The objective of the present study is to analyse the diagnostic validity of 8 neurodynamic and/or orthopedic tension tests using magnetic resonance imaging as the Gold Standard.

This is an epidemiological study of randomized consecutive cases which was observational, descriptive, transversal, double blinded and followed the STARD (Standards for Reporting Diagnostic accuracy studies) declaration.

Eligibility criteria: Inclusion Criteria:

* Clinical suspicion of lumbar or lumbosacral radiculopathy

Exclusion Criteria:

* Healthy subjects or with a radiculopathy already diagnosed
* subjects with Diabetes, alcoholism, HIV+, herpes zoster infection, cancer, multiple sclerosis, hereditary neuropathy or lumbar surgery
* persons with pacemaker or stent
* known pregnancy
* persons that refused to participate in the study or undergo the MRI scan.

Primary outcomes:
measure: Sensitivity of the tests
timeFrame: Through study completion, an average of 2 years
measure: Specificity of the tests
timeFrame: Through study completion, an average of 2 years
measure: Positive and negative predictive values (PV+ and PV-)
timeFrame: Through study completion, an average of 2 years
measure: Likelihood Ratio (LR+ y LR-).
timeFrame: Through study completion, an average of 2 years
measure: Kappa index (K)
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05301972: Expanded Access for Bromodomain and Extra-Terminal (BET) Inhibitor
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-03-31
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This is an expanded access designed to provide access to Bromodomain and Extra-Terminal (BET) Inhibitor for eligible participants.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05883072: Exploring the Effectiveness of AI Generative Models for Diabetic Patients
Official title: Exploring the Effectiveness of AI Generative Models for Diabetic Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus, Type 2
Diabetic Retinopathy
Diabetes
Lead sponsor: Pakistan Council of Scientific and Industrial Research
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People affected with diabetes in Pakistan

Brief summary: We plan to explore the usability of Generative AI-Chatbot for Diabetic Patient

Detailed description: Diabetes is rapidly spreading, affecting a significant number of adults, with a staggering total of 537 million diabetic individuals. This condition gives rise to various complications that can lead to diabetic retinopathy, foot ulcers, cardiac problems, and kidney damage. However, many of these complications can be mitigated by providing patients with accurate information concerning their diet, stress management, and weight control.

The recent advancements in Generative Artificial Intelligence-based chatbots have demonstrated their efficacy as intelligent assistants across various aspects of human life. In this study, we aim to assess the effectiveness of these Language Models in assisting patients. Our research plan entails the interaction between patients and chatbots like ChatGPT, both with and without human support, followed by evaluations of these interactions by specialists. Additionally, we will gather feedback from patients regarding their experiences and perceptions of the chatbot interactions.

Eligibility criteria: Inclusion Criteria:

* Present physically in Pakistan
* Adults (18 years or older)
* Diabetic Patient

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Prisoners

Primary outcomes:
measure: Usability of the Chatbot for diabetic patient
timeFrame: One time
measure: Internet Speed
timeFrame: One time
Secondary outcomes:
measure: Analyzing Chat response generated by AI Chatbot
timeFrame: One time
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: CDLE, PCSIR Lbas Complex
state: Sindh
Study officials:
affiliation: Pakistan Council of Scientific and Industrial Research
name: Ghulam Mustafa
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02279472: Optical Coherence Tomography Quantitative Analysis of Changes in Anterior Chamber After Laser Peripheral Lridotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Angle Closure Glaucoma
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2014-10-31
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to analysis changes in anterior segment morphology after laser peripheral lrldotomy measured by optical coherence tomography, and to evaluate treatment effectiveness

Detailed description: In the study ,primary angle closure(PAC) and primary angle closure glaucoma (PACG) will be recruited. Anterior segment optical coherence tomography images captured before and after laser peripheral iridotomy will be analysed to provide objective and reproducible quantification of anterior segment biometric parameters.The outcomes can provide useful information for clinical strategies in the treatment and management of pathology related to angle closure.

Eligibility criteria: Inclusion Criteria:

1 .The gonioscopy or UBM examination has confirmed the diagnosis of PACS or PAC 2. Intraocular pressure within 10 to 21 mmHg ，C/D≤0.6 3. Visual field is normal or only show paracentral scotoma 4. Vision or corrected visual acuity ≥0.8 5. Refractive degree no more than 200D 6. Exclude other ocular and systemic diseases

-

Exclusion Criteria:

1. Corneal macula and other corneal diseases, ocular surface disease or corneal edema
2. Iridocyclitis
3. Ocular trauma and intraocular operation history
4. No fixationFundus lesions such as diabetic retinopathy or retinal detachment
5. No fixation
6. Ocular or systemic application of cortical steroids -

Primary outcomes:
measure: Changes in anterior chamber after LPI at 1 month
timeFrame: 1month
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University,
state: Hunan
Study officials:
affiliation: Central South University
name: Xuanchu Duan, Ph.D
role: STUDY_DIRECTOR
References:
citation: Memarzadeh F, Li Y, Chopra V, Varma R, Francis BA, Huang D. Anterior segment optical coherence tomography for imaging the anterior chamber after laser peripheral iridotomy. Am J Ophthalmol. 2007 May;143(5):877-9. doi: 10.1016/j.ajo.2006.11.055. Epub 2006 Dec 29.
citation: Lee KS, Sung KR, Shon K, Sun JH, Lee JR. Longitudinal changes in anterior segment parameters after laser peripheral iridotomy assessed by anterior segment optical coherence tomography. Invest Ophthalmol Vis Sci. 2013 May 3;54(5):3166-70. doi: 10.1167/iovs.13-11630.
Clinical trial NCT01615172: Cannulation of the Artery Axiliaris for Extracorporeal Circulation
Official title: Cannulation of the Artery Axiliaris for Extracorporeal Circulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neurologic Manifestations
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
Collaborators: name: Pitzer Stiftung
First posted: 2012-06-08
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparision of two different cannulation techniques on the neurological outcome in cardiac surcical procedures. Study hypothesis: Cannulation of the axilaris artery can reduce neurolocical side effects.


Eligibility criteria: Inclusion Criteria:

* Cardiac procedure with ecc Age 40-85 years CABG and/or valve

Exclusion Criteria:

* Stenosis of a.subclavia

Primary outcomes:
measure: Surrogat endpoint: Number of participants with change from baseline in Neurolocial events at 5th postoperative day (POD) and 3 month after operation
timeFrame: Participants will be followed for the duration of hospital stay (5 POD) and a follow up visit 3 months after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Goethe Universität
state: Hessen
Study officials:
affiliation: Goethe University
name: Andreas Zierer, PD.Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01884272: NSAID Drug Interaction Study
Official title: A Phase 1 Study to Evaluate the Potential Two-Way Pharmacokinetic Interaction Between Lesinurad and Naproxen and Between Lesinurad and Indomethacin in Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gout
Lead sponsor: Ardea Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-24
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a drug-drug interaction study in healthy volunteers to evaluate the potential pharmacokinetic (PK) effects of non-steroidal anti-inflammatory drugs on lesinurad and leinurad on the non-steroidal anti-inflammatory drugs.

Detailed description: Naproxen and indomethacin are non-steroidal anti-inflammatory drugs (NSAIDs) used both prophylactically for the prevention of, and as a treatment for, acute gout flares. RDEA594-126 is an open-label study designed to assess the potential effect of multiple doses of naproxen and indomethacin on the single-dose PK of lesinurad, and to assess the potential effect of multiple doses of lesinurad on the multiple-dose PK of naproxen and indomethacin.

Eligibility criteria: Inclusion Criteria:

* Subject has a body weight ≥ 50 kg (110 lbs) and a body mass index (BMI) ≥ 18 and ≤ 30 kg/m2.
* Subject is free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations or procedures.
* Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination or safety laboratory values.

Exclusion Criteria:

* Subject has clinically significant pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders.
* Subject has a history or suspicion of kidney stones.
* Subject has a history of asthma.
* Subject has undergone major surgery within 3 months prior to Day 1.
* Subject has donated blood or experienced significant blood loss (\> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to the Screening visit.
* Subject has inadequate venous access or unsuitable veins for repeated venipuncture.

Primary outcomes:
measure: PK profile of lesinurad from plasma and urine
timeFrame: Day 1, Day 6 (urine only), Day 7, Day 14
measure: PK profile of naproxen and indomethacin from plasma and urine
timeFrame: Day 1, Day 6 (urine only), Day 7, Day 14
Secondary outcomes:
measure: Incidence of Adverse Events and Changes in Laboratory, Electrocardiogram, and Vital Signs Parameters
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Kalamazoo
country: United States
state: Michigan
Study officials:
affiliation: Ardea Biosciences, Inc.
name: S Bradley, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02285972: Efficacy of Intravenous Dexketoprofen and Tenoxicam on Propofol Associated Injection Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Injection Pain
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2014-11-07
Enrollment: 118
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: PREVENTION

Brief summary: Propofol remains the most common drug for induction of general anaesthesia, although it causes considerable pain or discomfort on injection. Anesthesia providers have attempted a large number of remedies to prevent this pain on injection. Previously explored ideas include injecting propofol into larger veins, warming of the hand with hot packs, and intravenous pretreatment with numerous other medications. No studies to date have looked at the dexketoprofen and tenoxicam for the pretreatment of pain on injection caused by propofol. The investigators propose studying the use of dexketoprofen and tenoxicam for pretreatment of propofol related pain on injection.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status 1 and 2
* 18 - 65 years
* general anesthesia scheduled for elective surgery

Exclusion Criteria:

* age \< 18 years, \> 65 years
* pregnancy
* patients requiring a rapid sequence induction
* refusal to participate and patients already participating in another study
* allergy to study drugs
* communication difficulty
* psychiatric and neurolojic disorders
* use of analgesics or sedative drugs within 24 hours before surgery.
* emergency surgery
* history of drug or alcohol abuse
* ASA 3 and above

Primary outcomes:
measure: Verbal Pain Score
timeFrame: Approximately one minute following administration of propofol.
measure: Facial Pain Score
timeFrame: Approximately one minute following administration of propofol.
Secondary outcomes:
Other outcomes:
Locations:
city: Altınordu
country: Turkey
facility: Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital
state: Ordu
Study officials:
References:
Clinical trial NCT04540172: The Effect of Music Therapy and Progressive Muscle Relaxation Exercise on Anxiety Before the First Clinical Practice
Official title: Music Therapy and Progressive Muscle Relaxation Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Stress
Lead sponsor: Istanbul Saglik Bilimleri University
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was carried out to evaluate the effect of music therapy and progressive muscle relaxation exercise on the state and trait anxiety levels before their first clinical practice in nursing students.

Detailed description: This randomized controlled experimental study sample consisted of 86 nursing students who will be firstly applied to clinical practice. The students were randomly assigned to music (n=30), exercise (n=28), and control (n=28) groups. The data of the study were collected with Student Information Form and State-Trait Anxiety Scale. The music therapy intervention was applied to the experimental groups three times a week for the first 2 weeks.

Eligibility criteria: Inclusion Criteria:

* being 18 years or older,
* being enrolled in the Nursing Fundamentals theoretical course,
* participating fully in the attempts being applied in the study,
* volunteering to participate in the study.

Exclusion Criteria:

* be graduating from Health Vocational High School
* not being in the field of application determined on the first clinical application day.

Primary outcomes:
measure: Anxiety
timeFrame: Change from baseline in 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Demet İnangil
Study officials:
affiliation: Saglik Bilimleri University
name: Merdiye Şendir, PhD
role: STUDY_CHAIR
References:
citation: Dehghan-Nayeri N, Adib-Hajbaghery M. Effects of progressive relaxation on anxiety and quality of life in female students: a non-randomized controlled trial. Complement Ther Med. 2011 Aug;19(4):194-200. doi: 10.1016/j.ctim.2011.06.002. Epub 2011 Jul 12.
citation: Chen Y, Yang X, Wang L, Zhang X. A randomized controlled trial of the effects of brief mindfulness meditation on anxiety symptoms and systolic blood pressure in Chinese nursing students. Nurse Educ Today. 2013 Oct;33(10):1166-72. doi: 10.1016/j.nedt.2012.11.014. Epub 2012 Dec 20.
citation: Inangil D, Sendir M, Kabuk A, Turkoglu I. The Effect of Music Therapy and Progressive Muscle Relaxation Exercise on Anxiety Before the First Clinical Practice in Nursing Students: A Randomized Controlled Study. Florence Nightingale J Nurs. 2020 Oct 26;28(3):341-349. doi: 10.5152/FNJN.2020.19075. eCollection 2020 Oct.
Clinical trial NCT01626872: Long-Term Study of MP-214 in Patients With Schizophrenia
Official title: Long-Term Extension Study of MP-214 in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Antipsychotic Agents
Mental Disorder
Psychotropic Drugs
Dopamine Agents
Risperidone
Central Nervous System Agents
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2012-06-25
Enrollment: 254
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: The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained from the patient before the completion of Study A002-A4
* Patients who have completed the A002-A4 study

Exclusion Criteria:

* Patients who are experiencing ongoing, uncontrolled, clinically significant adverse events (AEs), as judged by the investigator (or subinvestigator)

The information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to 60 weeks (Treatment Period (48 weeks) and Follow-up Period (12 weeks))
Secondary outcomes:
Other outcomes:
Locations:
city: Sapporo
country: Japan
state: Hokkaido
city: Seoul
country: Korea, Republic of
city: Taipei
country: Taiwan
Study officials:
References: