louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06958250: Novel Endoscopic Bite Block
Official title: Novel Endoscopic Bite Block
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gastric Disease
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study will test a novel endoscopic bite block during upper endoscopy.

Detailed description: This study will feasibility and comfort of the novel endoscopic bite block that contains a compressible addition to the traditional endoscopic bite block offering cushioning for the teeth and the ability to resist mispositioning when a patient opens their mouth (ie, during a yawn).

Eligibility criteria: Inclusion Criteria

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, \> 18 years of age
4. Deemed appropriate for scheduled upper endoscopy by endoscopy and anesthesia staff

Exclusion Criteria:

1. Known allergic reactions to components of the novel endoscopic bite block

Primary outcomes:
measure: Feasibility of successful completion of upper endoscopy procedures with novel bite block
timeFrame: Day 1
Secondary outcomes:
measure: Endoscopist satisfaction
timeFrame: Day 1
measure: Absence of dental injury during endoscopy
timeFrame: Day 1
measure: Decreased need for manual bite block securing during endoscopy
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00832650: Multiple Dose Study To Investigate The Effects Of Fesoterodine And Solifenacin On Gastrointestinal Transit
Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose Study To Investigate The Effects Of 8 Mg Fesoterodine SR Tablets And 10 Mg Solifenacin Tablet On Gastrointestinal Transit In Healthy Female Subjects.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy; Fesoterodine; Solifenacin
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the effect of fesoterodine 8 mg as compared to solifenacin 10 mg on colonic transit.


Eligibility criteria: Inclusion Criteria:

* Healthy female subjects

Exclusion Criteria:

* Evidence or history of clinically significant findings at screening

Primary outcomes:
measure: Colonic Transit at 24 Hours
timeFrame: Day 13 (Day 12 24 hours post-meal)
Secondary outcomes:
measure: Proximal Colonic Emptying Time
timeFrame: Day 12 to 14
measure: Colonic Transit at 48 Hours
timeFrame: Day 14 (Day 12 48 hours post-meal)
measure: Colonic Filling at 6 Hours
timeFrame: Day 12
measure: Time to Gastric Emptying
timeFrame: Day 12: 2 hours, 4 hours
measure: Mean Number of Stools Per Day
timeFrame: Day 11 to 13
measure: Mean Score of Stool Consistency Per Day
timeFrame: Day 11 to 13
measure: Average Score of Ease of Passage During Defecation Per Day
timeFrame: Day 11 to 13
measure: Mean Proportion of Bowel Movements With Satisfaction Per Day
timeFrame: Day 11 to 13
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: Minnesota
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Bharucha AE, Isowa H, Hiro S, Guan Z. Differential effects of selective and non-selective muscarinic antagonists on gastrointestinal transit and bowel function in healthy women. Neurogastroenterol Motil. 2013 Jan;25(1):e35-43. doi: 10.1111/nmo.12043. Epub 2012 Nov 21.
Clinical trial NCT03227250: Effects of Bilateral GPI DBS on Freezing of Gait in PD
Official title: Effects of Bilateral Pallidal Deep Brain Stimulation on Freezing of Gait in Parkinson's Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: freezing of gait
Parkinson disease
GPi
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Parkinson's Disease who underwent GPI DBS.

Brief summary: This study aims to evaluate the effect of deep brain stimulation in the the globus pallidus (Gpi) on freezing of gait in patients with Parkinson's disease.


Eligibility criteria: Inclusion criteria: (1) idiopathic PD, according to the MDS Parkinson's Disease Society Diagnostic Criteria17; (2) bilateral GPi-DBS implant according to a careful consideration of patients' symptom profiles (e.g., existence and severity of dyskinesia, dystonia, axial symptoms, or cognitive and mood problems); (3) onset of PD at or before 70 years of age; and (4) disease duration of more than 3 years at the time of surgery.

Patients were excluded if they had unstable vital signs or medical and psychiatric comorbidities at the time of the study.

Primary outcomes:
measure: Changs in the score of Timed Up and Go Test
timeFrame: baseline, 12 month
Secondary outcomes:
measure: Change of the score in GFQ
timeFrame: baseline, 12 month
measure: Change of the score in FoG total time of TUG test
timeFrame: baseline, 12 month
measure: Change of the score in FoG Episodes of TUG test
timeFrame: baseline, 12 month
measure: Change of the score in Proportion of FoG of TUG test
timeFrame: baseline, 12 month
measure: Change of the score in Longest FoG duration of TUG test
timeFrame: baseline, 12 month
Other outcomes:
measure: Change of the scores in MDS-UPDRS
timeFrame: baseline, 12 month
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
name: Haiyan Zhou
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
name: Shengdi Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
name: Dianyou Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
name: Bomin Sun
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Wei Hu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00710450: Effect of Montelukast on Basophils, In-vitro
Official title: The Effect of Montelukast In-vitro on Basophil Histamine and Leukotriene, IL-4 Adn IL-13 Release in Subjects With Allergic Rhinitis or Allergic Asthma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Allergic Asthma
Allergic Rhinitis
Keywords: IL13
leukotriene
histamine
IL4
Must be allergic asthma or allergic rhinitis
Lead sponsor: Creighton University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-07-04
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Allergic rhinitis or allergic asthma, age 13+

Brief summary: Subjects with either allergic asthma or allergic rhinitis will be recruited to obtain blood. This blood will be used to be stimulated with to whatever the patient allergic. In the laboratory, this stimulated blood will be measured for histamine, leukotrienes, IL-13 and IL-3. These are chemicals responsible for allergy symptoms.


Eligibility criteria: Inclusion Criteria:

* Allergic asthma or allergic rhinitis
* age 12+

Exclusion Criteria:

* smokers

Primary outcomes:
measure: Histamine Release
timeFrame: during the assay portion.
Secondary outcomes:
measure: Cytokine release. IL-13, IL-4 and leukotriene
timeFrame: assay portion
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
Study officials:
References:
Clinical trial NCT00636350: Bioavailability of Pepper Carotenoids in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pepper carotenoids
xanthophylls
healthy volunteers
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2008-03-14
Enrollment: 5
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: - list item one, Peppers

We propose to evaluate bio absorption of pepper carotenoids in a red bell-pepper or non-pungent green jalapeno pepper. The pepper will be provided in a cooked dish. The specific aims of this study are: 1) to determine blood response kinetics of lutein following multiple doses of non-pungent green jalapeno pepper with meals. 2) to determine blood response kinetics of zeaxanthin/capsanthin following multiple doses of red bell pepper with meals. We will feed 16 healthy man and women (50 - 65 y, females were at least one year post menopause), each cooked green jalapeno pepper or red pepper for 4 days and donate blood samples up to 21 days to determine blood response kinetics of xanthophylls following multiple doses of pepper dishes.

Detailed description: - list item one, Peppers

Epidemiological data show that carotenoids and ß-C are health promoting when taken at physiologic levels in foods. However, human absorption and metabolism of carotenoids contained in various food matrices has not been studied well. It is important to investigate the characteristics of absorption and disposal kinetics after eating carotenoid rich foods in order to gain a basic understanding of the biological characteristics of lutein, zeaxanthin, and other carotenoids in food sources.

We propose to evaluate bio absorption of pepper carotenoids in a 2-phase research study: phase 1 will utilize red bell-pepper and phase 2 will utilize non-pungent green jalapeno pepper. The pepper will be provided as a dish in a meal. We will feed 16 healthy man and women (50 - 70 y, females were at least one year post menopause), each with red pepper (phase 1) and/or green jalapeno pepper (phase 2) for \~ 4 days and donate blood samples up to 21 days. Volunteers will be randomly assigned to one of the following two phases: phase 1 and phase 2.

The study will provide us the information on the bioavailability of pepper carotenoids.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* GI track problems

Primary outcomes:
measure: The enrichment of labeled pepper carotenoids in the serum samples after the meals.
timeFrame: upto 21 days after the start of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University
state: Massachusetts
Study officials:
References:
Clinical trial NCT00004450: Randomized Study of Beta Interferon and Thalidomide in Patients With Adrenoleukodystrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adrenoleukodystrophy
Keywords: adrenoleukodystrophy
inborn errors of metabolism
rare disease
sphingolipidoses
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
Collaborators: name: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
First posted: 1999-10-19
Enrollment: 60
Sex: MALE
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Evaluate the efficacy of interferon beta and thalidomide in male patients with adrenoleukodystrophy who show evidence of brain inflammatory response and are receiving concurrent glyceryl trierucate and glyceryl trioleate (Lorenzo's oil).

II. Evaluate the progress of the disease and possible side effects of the medication in these patients.

Detailed description: PROTOCOL OUTLINE: This is randomized, double blind, placebo controlled study. Patients are randomized to receive beta interferon and thalidomide placebo (arm I), thalidomide and beta interferon placebo (arm II), or placebo for both beta interferon and thalidomide (arm III). Patients receive interferon beta by subcutaneous injection and thalidomide orally. All patients are maintained on glyceryl trierucate and glyceryl trioleate (Lorenzo's oil) therapy.

Patients are followed at 3, 6, and 12 months and then may be followed every 6 months thereafter.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Adrenoleukodystrophy (ALD) diagnosis based on history and examination, MRI, and biochemical assay

Clinical evidence of rapidly progressive phase of cerebral ALD must include 2 or more of the following during the preceding year:

Significant and progressive impairment of school performance Significant loss of cognitive function leading to an IQ of 75 or less Progressive impairment of the ability to understand spoken words Progressive impairment of vision Progressive deterioration of handwriting Progressive difficulty in walking Progressive impairment in speech articulation, and vocabulary Progressive weakness of one or more limbs

Must have MRI abnormalities characteristic of cerebral ALD, especially evidence of the breakdown of the blood-brain barrier using gadolinium contrast medium and magnetization transfer technique Evidence of brain white matter inflammatory response Must not meet criteria for bone marrow transplantation Not in an apparent vegetative state --Prior/Concurrent Therapy-- Concurrent glyceryl trierucate and glyceryl trioleate (Lorenzo's oil) therapy required --Patient Characteristics-- Effective contraception required of all patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: Hugo Wolfgang Moser
role: STUDY_CHAIR
References:
Clinical trial NCT00432250: The Use of Cervical Length to Reduce Hospital Stay in Women Admitted Because of Preterm Labor.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Labor, Premature
Cervical Length
Keywords: Preterm labor
Cervical ultrasonography
Hospital stay
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2007-02-07
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this study was to investigate the effect of the use of sonographic cervical length (CL) on the hospital stay in women admitted because of preterm labor.

Detailed description: Eligible women who agreed to participate in the study were randomized by means of a central randomization office into two groups:

CONTROL group: cervical length was measured but the result was blinded to the physician in charge and women was managed according to the standard protocol.

STUDY group: cervical length was measured and the result was reported to the physician in charge. If cervical length was of 25 mm or more, discharge in 12-24 h was recommended. If cervical length was less than 25 mm, decision on discharge was made following clinical criteria.

Eligibility criteria: Inclusion Criteria:

* Admitted because of preterm labor
* Not delivered after 24-48 h of admission
* Single pregnancy
* Intact membranes
* Gestational age between 24.0 and less tahn 36.0 weeks
* Bishop score \< 6

Exclusion Criteria:

* Fetal death or malformation
* Signs of chorioamnionitis
* Non-reassuring fetal test

Primary outcomes:
measure: Length of hospital stay
measure: Gestational age at delivery
Secondary outcomes:
measure: Rate of hospital stay below 3 days
measure: Interval admission-to-delivery < 7 days
measure: Rate of preterm delivery before 37 weeks
measure: Rate of preterm delivery before 34 weeks
Other outcomes:
Locations:
city: Sabino de Arana 1
country: Spain
facility: Hospital Clínic of Barcelona
state: Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Montse Palacio
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínic of Barcelona
name: Vicenç Cararach
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05218850: The Use of Butyrate Therapy in Pediatric Ulcerative Colitis
Official title: Butyrate Therapy in Hispanic Children With Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Ulcerative Colitis
Keywords: ulcerative colitis
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 10
Sex: ALL
Minimum age (years): 7
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Butyrate is an important metabolite produced by the gut microbiome and has been shown as a helpful therapy in ulcerative colitis. This is a feasibility study to determine the efficacy of butryate enemas in pediatric ulcerative colitis.

Detailed description: butyrate enemas will be administered for 12 weeks to children ages 7 to 21 with mild to moderate ulcerative colitis to determine if butyrate therapy can help improve the clinical disease in those children. standard management of the disease will be performed during these 12 weeks including routine laboratory studies and endoscopy.

Eligibility criteria: Inclusion Criteria:

* 7-21 years, mild to moderate ulcerative colitis

Exclusion Criteria:

* UC therapy within 4 weeks of study medication initiation
* infectious colitis, -pregnancy

Primary outcomes:
measure: remission of clinical disease
timeFrame: 12 weeks
Secondary outcomes:
measure: improvement of inflammatory markers including ESR, CRP, Calprotectin
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Sonia Michail, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00224250: Ultrasound Study of the Uterine Healing Process After Cesarean Delivery
Official title: Ultrasonographic Assessment of the Uterine Scarring Process Following Closure of the Uterus in One Versus Two Layer Technique.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myometrial Remodeling
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Our hypothesis is that there is no difference in the healing process in those women who have a one- or two-layer uterine closure at the time of cesarean delivery.

Detailed description: We are recruiting women who are presenting for their first (primary) cesarean delivery. They will be randomized to one- or two-layer myometrial closure at the time of their cesarean delivery. Ultrasound will be used to serially assess the myometrial thickness and myometrial remodeling process.

Eligibility criteria: Inclusion Criteria:

* singleton gestation
* term pregnancy
* Kerr uterine incision employed
* age \> 18

Exclusion Criteria:

* Pain score \> 4
* Current cesarean delivery for non-reassuring fetal status or other emergent situation (eg. maternal bleeding, etc.)
* Prior cesarean section
* Prior uterine surgery
* Hysterotomy other than Kerr (low transverse) incision in current cesarean
* Extension of the uterine incision in current cesarean
* Multifetal pregnancy
* Maternal diabetes mellitus
* Maternal connective tissue disorder
* Uterine malformation
* Uterine myomas (fibroids) in the anterior lower uterine segment
* Chorioamnionitis
* Non-English speaking

Primary outcomes:
measure: myometrial thickness
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Benjamin Hamar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hamar BD, Saber SB, Cackovic M, Magloire LK, Pettker CM, Abdel-Razeq SS, Rosenberg VA, Buhimschi IA, Buhimschi CS. Ultrasound evaluation of the uterine scar after cesarean delivery: a randomized controlled trial of one- and two-layer closure. Obstet Gynecol. 2007 Oct;110(4):808-13. doi: 10.1097/01.AOG.0000284628.29796.80.
Clinical trial NCT06611150: Concurrent Nab-paclitaxel with Intensity-modulated Radiation Therapy in Patients with Stage III-IVa Nasopharyngeal Carcinoma
Official title: A Phase I Study of Concurrent Nab-paclitaxel with Intensity-modulated Radiation Therapy in Patients with Stage III-IVa Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Nasopharyngeal Carcinoma (NPC)
Keywords: nasopharyngeal carcinoma
nab-paclitaxel
concurrent chemotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to determine the maximum tolerated dose and the recommended phase II dose for nab-paclitaxel when administered concurrently with radiotherapy in nasopharyngeal carcinoma. Researchers will observe the toxicity response of patients receiving nab-paclitaxel at 180 mg/m², 200 mg/m², 230 mg/m², and 260 mg/m².


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed nasopharyngeal carcinoma
* III-IVa (AJCC8th)
* age 18-70
* PS score 0-1
* normal functions to tolerate chemotherapy and radiotherapy

Exclusion Criteria:

* The presence of other malignant neoplasms within the preceding five years, with the exception of carcinoma in situ, adequately treated non-melanoma skin cancer and papillary thyroid cancer, is permitted.
* Symptomatic heart failure, unstable angina, myocardial infarction, active infections requiring systemic therapy, psychiatric disorders, or family and social factors

Primary outcomes:
measure: The maximum tolerated dose and the recommended phase II dose
timeFrame: From start of radiotherapy to 2 weeks after completion of radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References: