louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06638879: Tacrolimus Toothpaste for Management of Oral Chronic Graft vs. Host Disease (cGVHD)
Official title: Prospective Study of Tacrolimus Toothpaste for Management of Oral Chronic Graft vs. Host Disease (cGVHD) in Stem Cell Transplant Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Chronic Graft Versus Host Disease Oral
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 13
Sex: ALL
Minimum age (years): 1
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the use of a novel formulation of tacrolimus, as a toothpaste, in a population of patients with oral chronic graft vs. host disease (cGVHD) as an adjunctive therapy in addition to standard-of-care systemic therapy.

The investigators plan to summarize our findings to add to the current body of literature regarding managing cGVHD, specifically those with oral involvement. Additionally, establishing effective topical application of tacrolimus in the oral cavity will allow for future prospective studies comparing outcomes for these patients with a more traditional standard of care.


Eligibility criteria: Inclusion Criteria:

* Patients with oral chronic graft vs. host disease (cGVHD)
* Stable immune suppression within two weeks of enrollment
* Ages \> 1 year and \< 40 years

Exclusion Criteria:

* Clinically confirmed or suspected herpes simplex virus (HSV) stomatitis
* A recent (within 2 weeks of enrollment) escalation in immune suppression or change in systemic immune suppression of ongoing chronic graft vs. host disease (cGVHD)

Primary outcomes:
measure: The presence of mucosal ulcerations
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Allison Bartlett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01583179: Duration of Analgesic Effect for Ultrasound Guided Supraclavicular Blocks With the Addition of Buprenorphine to Local Anesthetic Solution
Official title: Duration of Analgesic Effect for Ultrasound Guided Supraclavicular Blocks With the Addition of Buprenorphine to Local Anesthetic Solution
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Regional Block for Pain Control
Supraclavicular Block
Ultrasound Guided Block
Block Additive
Keywords: nerve block
outpatient surgery
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2012-04-23
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The patients included will be those who have already agreed to have a brachial plexus nerve block for surgery. A flip of the coin will decide who gets and additive called buprenorphine in their block or not. They will both contain the same amount and type of numbing medicine. The goal will be to see if the additive extends the life of the pain control portion of the ultrasound guided supraclavicular nerve block.


Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status 1-3
2. Age 18-79, inclusive
3. BMI \<36 kg/m\^2
4. Patient consenting to single injection brachial plexus nerve block as primary anesthetic for a procedure

Exclusion Criteria:

1. Patients with coagulation disorders
2. Clinically significant pulmonary disease
3. Clinically significant cardiac disease
4. Neurologic deficit in surgical extremity
5. Allergy to bupivacaine or buprenorphine
6. Intolerance of narcotics
7. Local infection over intended area of needle insertion
8. Hepatic failure or renal failure
9. Significant psychiatric disease, including drug abuse
10. Seizure disorder
11. Possible pregnancy or lactation by patient report
12. Use of narcotic medication greater than 2 times a week for greater than 1 week.
13. Patients for whom the surgeon requests a shorter-acting block

Primary outcomes:
measure: Time Until First Pain Medication Post-operatively
timeFrame: 48 hrs
Secondary outcomes:
measure: Pain Score on Post Operative Day 1
timeFrame: 1 day postoperative
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin School of Medicine and Public Health, Madison
name: Melanie Donnelly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01219179: Use of Sterile Water Feeds for Treatment of Hypernatremia in Extremely Low Birth Weight Infants
Official title: The Use of Enteral Sterile Water Feeds for the Treatment of Hypernatremia in Extremely Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extremely Low Birth Weight Infants
Hypernatremia
Keywords: Extremely Low Birth Weight Infants
Hypernatremia
Enteral Sterile Water Feeds
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 19
Sex: ALL
Minimum age (years): 24
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The improved survival rate of extremely low birth weight(ELBW)infants has resulted in new fluid and electrolyte problems that have not been encountered previously,in particular electrolyte imbalance. ELBW infants are especially vulnerable to hypernatremia(serum sodium value \>150 mEq/L). Hypernatremia may be due to rapid dehydration or excessive administration of intravenous fluids(IV)that contain sodium. The current treatment modality for hypernatremia is to increase IV fluids above daily requirements.Enteral sterile water feeds(ESWF)are theorized as an endogenous source of fluids that may decrease elevated electrolytes such as sodium and potassium in premature infants. By giving ESWF to decrease elevated electrolytes, there would be less need for large volumes of IVF that contribute to the co-morbidities of prematurity: bronchopulmonary dysplasia (BPD),intraventricular hemorrhage(IVH)and patent ductus arteriosus(PDA).

The purpose of this proposed study is to determine whether enteral sterile water feedings is effective in decreasing the incidence, duration and severity of hypernatremia in ELBW infants.


Eligibility criteria: Inclusion Criteria:

* Infants less than or equal to 1,100 grams birth weight
* Less than or equal to 28 weeks gestational age

Exclusion Criteria:

* \* Congenital heart disease, other than a PDA

  * Major congenital anomalies
  * A surgical condition (gastroschisis,omphalocele)
  * Renal disease
  * Hypotension treated with pressor support
  * Reverse end diastolic flow on Doppler study prior to delivery
  * Emergency medication received in the delivery room,except fluid boluses
  * Apgar scores recorded at 10 minutes of life \< or up to 5 and/or pH less than 7.0 on the first blood gas upon admission to the NICU

Primary outcomes:
measure: serum sodium values
timeFrame: Every 12 hours for 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Donna Dowling, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05052879: Efficacy and Safety of Toronto Association in the Treatment of Erectile Dysfunction and Premature Ejaculation
Official title: National, Multicenter, Randomized, Double-blind, Double-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Toronto Association in the Treatment of Erectile Dysfunction and Premature Ejaculation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Erectile Dysfunction
Premature Ejaculation
Keywords: Erectile dysfunction
Premature Ejaculation
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2021-09-22
Enrollment: 232
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of Toronto association in the treatment of both sexual dysfunction: erectile dysfunction and premature ejaculation.


Eligibility criteria: Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Male participants, with age greater than or equal to 18 years;
* Heterosexual, sexually active participants in a stable and monogamous relationship for at least 6 months before screening and who plan to maintain this relationship throughout the study period;
* Participants with erectile dysfunction, in stable and effective treatment with PDE-5 inhibitors;
* Participants diagnosed with premature ejaculation;
* Participants with IELT ≤ 2 minutes;
* Participants with score ≥ 25 points in the erectile function questionnaire;
* Participants (or partners) who use at least one contraceptive method.

Exclusion Criteria:

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* Participation in a clinical trial in the year prior to this study;
* Known hypersensitivity to any of the formula compounds;
* Participants with cardiovascular disease for whom sexual activity is inadvisable
* History or current experience of surgical interventions or radiotherapy in the pelvic region, neurological conditions, trauma or infections that are associated with the symptoms premature ejaculation;
* Diagnosis of other diseases or conditions in the urinary tract;
* Participants with conditions that may predispose them to priapism;
* History of severe psychiatric or psychosocial disorders;
* Participant whose partner has clinically important sexual dysfunctions.

Primary outcomes:
measure: Percentage of participants with treatment response after 4 weeks of treatment.
timeFrame: 4 weeks
measure: Percentage of participants with treatment response after 8 weeks of treatment.
timeFrame: 8 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: 103 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02963779: A Study of LY2775240 in Healthy Participants
Official title: A 2-Part, Safety, Tolerability, and Pharmacokinetic Study of LY2775240 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2016-11-15
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is conducted to determine the side effects related to LY2775240 given orally to healthy participants. Blood tests will be done to check how much LY2775240 is absorbed into the bloodstream and how long the body takes to get rid of it. Each participant will enroll in either Part A or Part B of the study, which will last about 14 weeks and 8 weeks respectively, including screening.


Eligibility criteria: Inclusion Criteria:

* Overtly healthy adult male or a female who cannot get pregnant
* Have a screening body mass index (BMI) of greater than 18 and less than or equal to 32 kilograms per meter square (kg/m²), inclusive
* Have normal blood pressure, pulse rate, electrocardiogram (ECG) and medical test results that are acceptable for the study

Exclusion Criteria:

* Are currently participating in or completed a clinical trial within the last 30 days from a clinical trial or any other type of medical research judged to be incompatible with this study
* Have known allergies to compounds or drugs similar to LY2775240 or apremilast
* Have previously participated or withdrawn from this study
* Have or used to have health problems or medical test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through to final follow-up at approximately Week 14
Secondary outcomes:
measure: Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2775240
timeFrame: Baseline through Day 5
measure: Pharmacokinetics: Time to Maximal Blood Concentration of LY2775240
timeFrame: Baseline through Day 5
measure: Pharmacokinetics: Maximum Concentration of LY2775240 in Blood
timeFrame: Baseline through Day 5
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03676179: The Comparison of Anterior Knee Pain in Patella With or Without Denervation in Medial Unicompartmental Knee Arthroplasty
Official title: The Comparison of Anterior Knee Pain in Patella With or Without Denervation in Medial Unicompartmental Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
Collaborators: name: Pranungkraw General Hospital
First posted: 2018-09-18
Enrollment: 66
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: unicompartment knee arthroplasty with patella denervation
Primary purpose: TREATMENT

Brief summary: the present study will conduct to assess anterior knee pain and complications after medial UKA with or without patella denervation in medial compartment arthritis and severe lateral facet patellofemoral arthritis patients.

Detailed description: In this prospective cohort study, the investigators will conduct to compare the clinical result of 70 patients of unicompartment knee arthroplasty with and without patella denervation between April, 2018 and April, 2019 for the patients with osteoarthritis.

Eligibility criteria: Inclusion Criteria:

* Patients who diagnose with medial osteoarthritis (OA) of the knee with an Alhback score of 2, 3 and 4 (Ahlback 1968) and with any Kujala score for pre-operative anterior knee pain.
* Older than 40 years of age.
* pain on the medial joint line.
* primary medial compartment osteoarthritis with a well preserved lateral compartment with competent cruciate ligaments with correctable intraarticular varus deformity.
* ROM flexion up to 110° under anesthesia.

Exclusion Criteria:

* Patients with fixed varus deformity \> 15°
* Inflammatory arthritis
* Previous high tibial osteotomy or ACL reconstruction

Primary outcomes:
measure: Kujala score
timeFrame: 6 months
Secondary outcomes:
measure: complication
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Pranungkraw General Hospital
Study officials:
References:
citation: Suwankomonkul P, Arirachakaran A, Kongtharvonskul J. Short-term improvement of patellofemoral pain in medial unicompartmental knee arthroplasty with patellar denervation: a prospective comparative study. Musculoskelet Surg. 2022 Mar;106(1):75-82. doi: 10.1007/s12306-020-00675-7. Epub 2020 Aug 2.
Clinical trial NCT01635179: Laryngeal View With Videolaryngoscopy
Official title: Laryngeal View With Intubation by Videolaryngoscopy With and Without Sellicks Maneuver.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Aspiration
Hypoxemia
Keywords: Videolaryngoscopy
Bronchial Aspiration
Hypoxia
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2012-07-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To prevent bronchial aspiration during induction of anaesthesia it has been a common procedure to perform a cricoid pressure, called Sellicks Maneuver, to occlude esophagus, and thereby prevent aspiration. During the last ten years the efficiency of this maneuver has been discussed, since it probably prolong the intubation time and do not significantly reduces the risk of aspiration.

The hypothesis is that Sellicks Maneuver prolong the time of intubation and reduces the view of the laryngeal inlet, during intubation with a videolaryngoscopy.

The hypothesis is tested by a double-blinded randomized study where patients is intubated twice, with and without Sellicks Maneuver, in a randomized order. The specific cricoid pressure is blinded to the personal performing the intubation.


Eligibility criteria: Inclusion Criteria:

* ASA 1-2, BMI \< 35,
* no indication for rapid sequence induction,
* age \> 18,
* able to give consent.

Exclusion Criteria:

* ASA \> 2,
* BMI \> 35,
* RSI

Primary outcomes:
measure: Completed intubation within 120 seconds
timeFrame: 120 seconds
Secondary outcomes:
measure: A description of the laryngeal inlet
timeFrame: 120 seconds
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Glostrup University Hospital
Study officials:
affiliation: GlustrupUH dept of Anaesthesia
name: Bjørn Arenkiel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01613079: Efficacy and Safety of Tripterygium Wilfordii in Patients With Rheumatoid Arthritis
Official title: Evaluation of Oral T2 (Chloroform/Methanol Extract of Tripterygium Wilfordii Hook F) in the Treatment of RA Patients With Clinical Efficacy and Safety.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Arthritis, Rheumatoid
Keywords: Rheumatoid Arthritis
Methotrexate
Tripterygium
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2012-06-06
Enrollment: 201
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: Evaluation of oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F) in the treatment of RA patients with clinical efficacy and safety.Open-labeled, randomized, prospective multi-center clinical trial. Observation period of 24 weeks.


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years with informed consent
* Diagnosed with rheumatoid arthritis as determined by meeting the 2010 ACR/EULAR classification criteria and has had rheumatoid arthritis for at least 6 weeks
* Swollen joint (SJC)≥3 and tender joint count(TJC)≥5
* ESR \>28 mm/hr or C-reactive protein \> 20 mg/L

Exclusion Criteria:

* Pregnant, lactating or further fertility requirements
* Previous treated with methotrexate or biologic DMARD.
* Active or chronic infection, including HIV, HCV, HBV, tuberculosis
* Patient with cancer

Primary outcomes:
measure: ACR50
timeFrame: 24 weeks.
Secondary outcomes:
measure: Radiology outcome
timeFrame: 24 weeks
measure: DAS28
timeFrame: 24 weeks
measure: ACR20/70
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Deptment of Rheumatology, Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Xuan Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou YZ, Zhao LD, Chen H, Zhang Y, Wang DF, Huang LF, Lv QW, Liu B, Li Z, Wei W, Li H, Liao X, Liu H, Liu X, Jin H, Wang J, Fei YY, Wu QJ, Zhang W, Shi Q, Zheng WJ, Zhang FC, Tang FL, Lipsky PE, Zhang X. Comparison of the impact of Tripterygium wilfordii Hook F and Methotrexate treatment on radiological progression in active rheumatoid arthritis: 2-year follow up of a randomized, non-blinded, controlled study. Arthritis Res Ther. 2018 Apr 10;20(1):70. doi: 10.1186/s13075-018-1563-6.
citation: Lv QW, Zhang W, Shi Q, Zheng WJ, Li X, Chen H, Wu QJ, Jiang WL, Li HB, Gong L, Wei W, Liu H, Liu AJ, Jin HT, Wang JX, Liu XM, Li ZB, Liu B, Shen M, Wang Q, Wu XN, Liang D, Yin YF, Fei YY, Su JM, Zhao LD, Jiang Y, Li J, Tang FL, Zhang FC, Lipsky PE, Zhang X. Comparison of Tripterygium wilfordii Hook F with methotrexate in the treatment of active rheumatoid arthritis (TRIFRA): a randomised, controlled clinical trial. Ann Rheum Dis. 2015 Jun;74(6):1078-86. doi: 10.1136/annrheumdis-2013-204807. Epub 2014 Apr 14.
Clinical trial NCT04246879: MRI Following Stereotactic Radiosurgery (SRS) for Brain Metastases
Official title: Diagnostic Accuracy of Delayed MRI Contrast Enhancement Characteristics and Radiation Necrosis Following Stereotactic Radiosurgery (SRS) for Brain Metastases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Metastases
Keywords: Laser Interstitial Thermal Therapy (LITT)
Stereotactic radiosurgery (SRS)
Magnetic resonance image (MRI)
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to test whether an additional magnetic resonance image (MRI) sequence can improve the ability to distinguish radiation damage from tumor recurrence in participants with brain metastasis who have previously been treated with stereotactic radiosurgery (SRS).


Eligibility criteria: Inclusion Criteria:

* Adult patients, age ≥18
* Metastatic malignancy with at least 1 brain metastasis previously treated with SRS
* Patients may have also received whole brain radiation therapy (WBRT) for management of brain metastatic disease but this is not required for study participation
* Patients must have been diagnosed with a metastatic solid tumor of any histological type except small cell lung cancer (SCLC), or lymphoma.
* Radiographic progression on post-SRS imaging at previously treated SRS site(s)
* Must be a candidate for brain surgery as determined by treating neurosurgeon and/or anesthesia team
* Patients must sign study-specific informed consent prior to study entry

Exclusion Criteria:

* Poor surgical candidate as determined by treating neurosurgeon and/or anesthesia team
* Unable to undergo contrasted MRI (e.g. incompatible medical device, inadequate renal function per standard institutional clinical protocol, contrast allergy)
* Small cell lung cancer (SCLC) or lymphoma histology

Primary outcomes:
measure: number of positive MRI sequences along with positive tumor biopsies
timeFrame: baseline
measure: number of negative MRI sequences along with negative tumor biopsies
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke Health
name: Scott Floyd, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: