louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04765163: Research on Operating Handle of Colonoscope
Official title: Research on Intelligent Assist System of Colonoscope Operating Handle
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colonic Disease
Keywords: Intelligence; Colonocope; Handle
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: After full informed consent, outpatients undergoing a physical examination for colonoscopy

Brief summary: Artificial intelligence is deeply integrated with medical diagnosis, and intelligent colonoscopy technology has broad room for development. At present, the assist device of colonoscopy is insufficiently studied. It is the part that needs to be further explored in the development of artificial intelligence colon diagnosis and treatment technology. The study will be conducted at the Digestive Endoscopy Center and it is expected that 380 subjects will participate voluntarily. Subjects met: 1) routine colonoscopy; 2) willing to provide relevant information required by the experiment; 3) signed informed consent for the study. This topic focuses on the colonoscope assist device, through the combination of power assisting device, dynamic analysis, and migration expert skills, to achieve a combination of intelligent power and precise treatment, and establish a prototype of the patient-colonoscopy-assisted assist system-doctor's four-in-one diagnosis and treatment system.


Eligibility criteria: Inclusion Criteria:

1. routine colonoscopy;
2. Willing to provide relevant information required by this experiment;
3. Sign the informed consent form for this study.

Exclusion Criteria:

1. can not tolerate colonoscopy;
2. Information about the requirements of this study cannot be provided;
3. Questionnaires cannot be conducted.

Primary outcomes:
measure: Colonoscope operating handle model
timeFrame: January 21, 2021
Secondary outcomes:
measure: Patents
timeFrame: November 11, 2020
Other outcomes:
Locations:
city: Beijing
country: China
facility: Wang Ruigang
Study officials:
References:
Clinical trial NCT02396563: Effect of Epidural Analgesia on the Length of Labor and Delivery and Fetal Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Labor
Epidural Analgesia
Nulliparous
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who come to the Gynecological nd obstetric Department of University Hospital to deliver

Brief summary: The purpose of this study is to determine if there is a difference in the duration of the first and second stage of labor in nulliparous women , with or without epidural analgesia. The investigators hypothesize that the duration of the first stage of labor will be no different in nulliparous patients, while the duration of the second stage will be longer in patient with analgesia.


Eligibility criteria: Inclusion Criteria:

* Nulliparous
* \> 18 years old
* term (\>37 weeks gestation)
* singleton
* vertex pregnancies

Exclusion Criteria:

* Non-vertex presentation
* cervical dilation \> 4.0cm

Primary outcomes:
measure: duration of labor
timeFrame: Onset of contractions or rupture of membrances to delivery
Secondary outcomes:
measure: Presence or absence of fetal heart rate decelerations
timeFrame: Time of first analgesic dose to 60 minutes
measure: fetal tachycardia
timeFrame: Time of first analgesic dose to 60 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01187563: A Study of Tocilizumab in Patients With Rheumatoid Arthritis
Official title: A Phase 4, Open-label, Repeat-Dose Study of the Safety and Pharmacodynamic Profile of Tocilizumab and Concomitant Methotrexate in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis, tocilizumab
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-08-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult rheumatoid arthritis patients with indication for treatment with tocilizumab.

Brief summary: This is an open-label, uncontrolled, observational study in patients with rheumatoid arthritis (RA) who are receiving tocilizumab concomitantly with methotrexate as part of their standard of care.

Detailed description: This single arm, open label study evaluates the safety and pharmacodynamic profile of tocilizumab in RA patients. Participating patients are among those for whom tocilizumab is indicated and who are scheduled to receive tocilizumab as part of their normal care, in full compliance with the FDA-approved prescribing information. Study assessments consist of clinical evaluations and laboratory tests conducted in conjunction with the first three monthly intravenous infusions of tocilizumab. These assessments are designed to provide a better understanding of the pharmacodynamic effects and mechanistic actions of tocilizumab and help guide the clinical development of other therapeutic agents for RA. A total of 15 patients are expected to participate for approximately 10 weeks.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age
* Moderately to severely active rheumatoid arthritis
* Inadequate response to previous treatment with an anti-TNF agent
* Receiving methotrexate for at least 12 wks before study

Exclusion Criteria:

* Previous treatment with tocilizumab
* Previous treatment with other IL-6 receptor inhibitors
* Treatment with corticosteroids (oral prednisone \>10 mg/day or equivalent) within 4 wks
* Conditions noted in the tocilizumab prescribing information

Primary outcomes:
measure: Safety (clinical and laboratory parameters)
timeFrame: Throughout the study until week 10
Secondary outcomes:
measure: Treatment emergent adverse events
timeFrame: Throughout the study until week 10
Other outcomes:
Locations:
city: Worcester
country: United States
state: Massachusetts
city: Duncansville
country: United States
state: Pennsylvania
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
Clinical trial NCT06799663: Comparison the Effect of Smart Phones Addiction Between Children and Adolescents on Posture Deviations , Physical Fitness and Intelligence in Egypt
Official title: Comparison the Effect of Smart Phones Addiction Between Children and Adolescents on Posture Deviations , Physical Fitness and Intelligence in Egypt
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Smart Phone Addiction
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 60
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents from 9 years to 18 years

Brief summary: Comparison the effect of smart phones addiction between children and Adolescents on posture deviations , physical fitness and intelligence in Egypt


Eligibility criteria: Inclusion Criteria:

* Subjects with the following criteria will be enrolled in this study :

The participants will be from middle childhood to adolescents and their age will be ranged from 9to 18 years.

They had Body Mass Index (BMI) = 18.5 :40 . They have a score of 24 or more on the Smart phones addiction scale-short version.

Exclusion Criteria:

* Subjects will be excluded from the study if the participant has the followings that affect that study:

visual or hearing defects, cachexia, any neurological disorders and musculoskeletal problems, any congenital abnormalities .

Primary outcomes:
measure: Physical fitness
timeFrame: 2 months
measure: Postural deviation on head and neck
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kafrelsheikh
country: Egypt
facility: Kafrelsheikh university
Study officials:
References:
Clinical trial NCT03112863: Comparison of the Cosmetic Effects of Bakuchiol and Retinol
Official title: Comparison of the Cosmetic Effects of Bakuchiol and Retinol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Wrinkle
Photoaging
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 44
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind randomized study comparing the effect of bakuchiol and retinoid
Primary purpose: TREATMENT

Brief summary: Subjects will be assigned to a retinoid cream or bakuchiol to compare the cosmetic effects. This will take place over a 12 week period.

Detailed description: Bakuchiol is a phytochemical that has demonstrated cutaneous antiageing effects when applied topically. Early studies have suggested that bakuchiol is a functional analogue of topical retinoids, as both compounds have been shown to induce similar gene expression in the skin and lead to improvement of cutaneous photodamage. No in vivo studies have compared the two compounds for efficacy and side-effects.

The aim of this study is to compare the cosmetic effects of Bakuchiol to Retinol over a 12-week period.

Eligibility criteria: Inclusion Criteria:

• Individuals aged 30-55

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant or breast feeding women
* Prisoners
* Those with acne, eczema, seborrheic dermatitis, rosacea or polycystic ovarian syndrome
* Those who have used isotretinoin in the last 6 months
* Those who have used products containing salicylic acid, beta hydroxyl acids or vitamins A, C, or E in the last 14 days
* Those who have used topical antibiotics or topical retinoids in the last 30 days
* Those who are currently smoking or have smoked within the past 3 years.
* Those who have had a recent surgical or cosmetic procedure in the last 3 months that can affect facial wrinkles or facial hyperpigmentation, such as botulinum toxin injections, chemical peels, laser based therapies to the face, or face lift surgeries

Primary outcomes:
measure: Change in Wrinkle Appearance
timeFrame: 12 week
measure: Percentage of Participants With Change in Appearance of Skin Pigmentation
timeFrame: 12 week
Secondary outcomes:
measure: Number of Reports of Stinging, Burning, Itching
timeFrame: Assessed at Week 4, 8, and 12.
measure: Number of Reports of Facial Erythema Assessment
timeFrame: week 4, week 8 and week 12
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Department of Dermatology
state: California
Study officials:
affiliation: UC Davis
name: Raja Sivamani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00126763: Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Chronic, Moderate to Severe Non-Malignant Pain
Official title: An Open-Label, Long-Term Safety Study to Evaluate the Safety of the ZR-02-01 Matrix Transdermal Fentanyl Patch for the Treatment of Moderate to Severe Non-Malignant Chronic Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pain
Keywords: Chronic Pain
Pain
Lead sponsor: ZARS Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2005-08-04
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 evaluate the safety of the matrix fentanyl patch ZR-02-01 in providing relief of non-malignant chronic pain.

Detailed description: This study will evaluate the safety of the matrix fentanyl patch. The study will be conducted in opioid-tolerant patients with moderate to severe non-malignant chronic pain currently taking an around-the-clock opioid. Patients will discontinue their current opioid regimen and begin using ZR-02-01 as soon as possible under the direction of the physician investigator upon entry into the study. Patient's dose of ZR 02 01 will be determined by the investigator using sponsor-provided conversion. Pain therapy will be under the supervision of the physician investigator.

Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 and no older than 75 years of age
* Patient has moderate to severe, non-malignant chronic pain that is expected to last for at least 12 months and is currently taking an around-the-clock opioid to treat his/her pain
* Patient is already receiving opioid therapy, has demonstrated opioid tolerance, and requires a total daily dose of opioids at least equivalent to 25 mcg/hr of transdermal fentanyl. Patients who are considered opioid-tolerant are those who have been taking a daily dose of at least 30 mg of oral morphine or morphine equivalent opioid for at least 2 weeks.

Exclusion Criteria:

* Patient has active cancer
* Patient has a history of substance abuse or has a substance abuse disorder

Primary outcomes:
measure: Number of participants with adverse eventsTo
timeFrame: 12 months
Secondary outcomes:
measure: Pain Intensity
timeFrame: 12 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Reserach Center
state: Arizona
city: Loma Linda
country: United States
facility: Loma Linda Center for Pain Management
state: California
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: Overland Park
country: United States
facility: Pain Management Institute
state: Kansas
city: Kansas City
country: United States
facility: Pain Management Associates
state: Missouri
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
Study officials:
affiliation: The Center for Clinical Research
name: Richard Rauck, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00645463: Effect of Diltiazem Administration on CP-945,598 Pharmacokinetics
Official title: A Phase 1, Randomized, Fixed Sequence Study To Evaluate The Effect Of Multiple Dose Administration Of Modified Release Diltiazem On The Multiple Dose Pharmacokinetics Of CP-945,598 In Healthy Overweight And Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A recently completed clinical drug interaction study of CP-945,598 with ketoconazole, a potent CYP3A inhibitor, showed that coadministration of CP-945,598 with ketoconazole results in an approximately 5-fold increase in CP-945,598 total exposure (AUC) and 4-fold increase in Cmax. Therefore, the sensitivity of CP-945,598 pharmacokinetics (PK) to less potent CYP3A inhibitors needs to be characterized to support labeling and registration.

Diltiazem is a known substrate and moderate mechanism-based inhibitor of the CYP3A enzyme system and was chosen as the moderate CYP3A inhibitor for this study as it is a clinically relevant medication likely to be prescribed concomitantly with CP-945,598 given the increased risk of hypertension and cardiovascular disease in the obese patient population.


Eligibility criteria: Inclusion Criteria:

* No clinically relevant abnormalities based upon medical history, physical exam, 12-lead ECG, and clinical lab tests
* Body Mass Index (BMI) \~ 27-40 kg/m2, inclusive
* Personally signed inform consent document

Exclusion Criteria:

* Evidence or history of significant acute or chronic disease
* Pregnant or nursing females
* Screening PR interval \> 220 msec
* Sitting blood pressure \<= 90 mmHg systolic or \<= 60 mmHg diastolic

Primary outcomes:
measure: Pharmacokinetic parameters of CP-945,598 and its metabolite, CE-156,706, (AUCtau, Cmax and Tmax)
timeFrame: Days 7 and 28
measure: Safety endpoints including adverse event monitoring, physical examinations, vital signs, ECGs, and clinical laboratory tests.
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04737863: Minimally Invasive Management During Endodontic Retreatment
Official title: Minimally Invasive Management of Separated Instruments in Vertucci Type ii Canals: A Radomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Teeth, Endodontically-Treated
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study compares the prognosis of cases treated with "selective root retreatment" to the cases treated with traditional retreatment approach

Detailed description: Post-treatment apical periodontitis is an inflammatory disorder of peri-radicular tissues caused by either persistent or secondary intra-radicular infection .Conventionally, nonsurgical retreatment has been believed to be an ''all or none'' treatment approach in which the endodontist has to remove all restorations from the tooth and to remove the obturation materials from all the canals in order to perform thorough disinfection of the entire root canal system. Nowadays, All operations in the medical field are aimed basically at the conservation of the human body. The alternative concept allows the endodontist to formulate clinical treatment decisions with respect to the presence of periapical pathosis related to individual roots rather than the tooth as a whole.

The literature is lacking the clinical outcome studies dealing with the prognosis of cases treated with "selective root retreatment" concept so the aim of this study was to compare the prognosis of such cases in comparison to the traditional retreatment approach.

Eligibility criteria: Inclusion Criteria:

* endodontically treated teeth
* multirooted teeth
* radiographic evidence of periradicular infection related to one root

Exclusion Criteria:

* medically compromised patients
* fused roots
* root resorption
* root fracture

Primary outcomes:
measure: volumetric change of periapical lesion size in CBCT
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Ainshams University
Study officials:
affiliation: Associate professor of Endodontics, Ain Shams University
name: Mohamed M Nagy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nudera WJ. Selective Root Retreatment: A Novel Approach. J Endod. 2015 Aug;41(8):1382-8. doi: 10.1016/j.joen.2015.02.035. Epub 2015 Apr 21.
citation: Liang YH, Li G, Wesselink PR, Wu MK. Endodontic outcome predictors identified with periapical radiographs and cone-beam computed tomography scans. J Endod. 2011 Mar;37(3):326-31. doi: 10.1016/j.joen.2010.11.032.
Clinical trial NCT05274763: Chaplain-Delivered Compassion Meditation to Improve Quality of Life in Patients Receiving a Stem Cell Transplant
Official title: A Feasibility Study of Chaplain-Delivered Compassion Meditation for Patients Receiving Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoma
Plasma Cell Myeloma
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Center for Complementary and Integrative Health (NCCIH)
name: National Institutes of Health (NIH)
First posted: 2022-03-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial tests whether chaplain-delivered compassion centered spiritual health (CCSH) works to improve quality of life in patients receiving a stem cell transplant. Compassion Centered Spiritual Health (CCSH) is a secularized, research-based mindfulness and compassion meditation program designed to expand and strengthen compassion for self and others. Practices include training in attentional stability and increased emotional awareness, as well as targeted reflections to appreciate one's relationship with self and others. By centering the mind, controlling negative thoughts, and cultivating personal resiliency and an inclusive and more accurate understanding of others, Compassion Centered Spiritual Health (CCSH) may help improve response to stress and reduce inflammation.

Detailed description: PRIMARY OBJECTIVE:

I. To examine the feasibility, adoption, extent of implementation, and fidelity of chaplain-delivered Compassion Centered Spiritual Health (CCSH).

OUTLINE:

Patients undergo 4 to 8 sessions (2-4 per week) of Compassion Centered Spiritual Health (CCSH) over 30 minutes with a chaplain while impatient.

Eligibility criteria: Inclusion Criteria:

* PATIENT: Within 6 weeks of scheduled hematopoietic stem cell transplant (HSCT)
* PATIENT: \> 18 years of age
* PATIENT: Speak and read English
* CHAPLAIN: Emory Healthcare Chaplain

Exclusion Criteria:

* CHAPLAIN: There will be no exclusion criteria and no consequence to the chaplains for refusing to volunteer
* PATIENT: Neurologic or cognitive problems that preclude chaplain-delivered Compassion Centered Spiritual Health (CCSH)

Primary outcomes:
measure: Fidelity to Intervention Delivery
timeFrame: 3 months
Secondary outcomes:
measure: Number of Sessions Completed
timeFrame: Up to 3 months
measure: Percentage of Cognitive Based Compassion Training
timeFrame: Up to 3 months
measure: Responsiveness
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital/Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University Hospital/Winship Cancer Institute
name: Jennifer Mascaro, PhD
role: PRINCIPAL_INVESTIGATOR
References: