louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02394925: Acceptance & Tolerance Study of Multifocal Contact Lenses by Functional Emmetropes
Official title: Acceptance & Tolerance Study of Multifocal Contact Lenses by Functional Emmetropes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vision Correction
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-20
Enrollment: 113
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine the retention rate over a two month period of vision correction in emmetropic, presbyopes fitted with multifocal contact lenses.


Eligibility criteria: Inclusion Criteria:

1. The subject must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. The subject must be between 40 and 70 years of age.
4. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to +2.00 in each eye.
5. The subject's refractive cylinder must be less than or equal to -0.75 D in each eye.
6. The subject's ADD power must be in the range of +0.75 D to +2.50.
7. The subject must have best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
2. Any ocular or systemic allergies that contraindicate contact lens wear.
3. Any ocular or systemic disease, autoimmune disease, or use of medication, that contraindicates contact lens wear.
4. Any ocular abnormality that may interfere with contact lens wear.
5. Use of any ocular medication, with the exception of rewetting drops.
6. Any previous intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
7. Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
8. History of herpetic keratitis.
9. Any ocular infection or inflammation.
10. Any corneal distortion or irregular cornea.
11. History of binocular vision abnormality or strabismus.
12. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV).
13. History of diabetes.
14. Current or previous history of being prescribed a correction for distance vision.
15. Current or previous history of contact lens wear.
16. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.

Primary outcomes:
measure: Proportion of Successful Contact Lens Wearers
timeFrame: 2 months post wear
Secondary outcomes:
Other outcomes:
Locations:
city: Pensacola
country: United States
facility: Tallahassee Eye Center
state: Florida
city: London
country: United Kingdom
facility: Ocular Technology Group-International
Study officials:
References:
Clinical trial NCT00645125: A Comparative, Single-Center, Pediatric Taste Test Study of Omnicef Versus Amoxicillin Antibiotic Suspension Medications
Official title: A Comparative, Single-Center, Pediatric Taste Test Study of Omnicef Versus Amoxicillin Antibiotic Suspension Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: pediatric taste test
antibiotic taste test
cefdinir
amoxicillin
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 154
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To compare the taste and smell acceptability scores of cefdinir (Omnicef) versus amoxicillin oral antibiotic suspension medications in pediatric subjects. It is designed to determine if Omnicef or amoxicillin is preferred to the other with regard to taste or smell.

Detailed description: The Primary Purpose for the study is "Other". Per ClinicalTrials.gov, more information regarding the primary purpose is described here; the primary purpose for the study is to determine whether cefdinir possesses preferred taste and smell characteristics when compared to amoxicillin, a pediatric taste test.

Eligibility criteria: Inclusion Criteria:

* Female or male child age 4 through 8 years in good general health.
* Minimum weight of 16.3 kg (36 lb).
* Willing to comply with appropriate instructions provided to complete the study.
* Written informed consent from parent/legal guardian.

Exclusion Criteria:

* Current medical condition, that in the opinion of the Investigator or designee, could interfere with the ability to discriminate taste (e.g., common cold, sinus infection, bronchial infection, etc.).
* History of allergic reaction to cefdinir, prescription (e.g. penicillins or cephalosporins) and/or OTC medications, and/or food products.
* History of significant medical condition (e.g., GI disorders, hematological or bleeding disorders, renal or hepatic diseases).
* Use of any oral medication, vitamins or herbal supplements within 6 hours prior to tasting.
* Temperature \> than 99.2°F.
* Participation in a clinical or marketing research study within the past 3 months.
* Sibling of another subject on the study, or living in the same household as another subject that has participated in a clinical or marketing research study within the past 3 months.
* Family member or close friend employed by an advertising agency, market research company and/or a company that processes or manufacturers medical or health care products.

Primary outcomes:
measure: Taste and smell acceptability assessment
timeFrame: 2 hours
Secondary outcomes:
measure: Adverse events assessment
timeFrame: 72 hours with follow-up to a satisfactory conclusion
measure: Concomitant medications
timeFrame: 72 hours
measure: Vital signs
timeFrame: 2 hours
measure: Any clinically abnormal observations
timeFrame: 2 hours with follow-up to a satisfactory conclusion
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
Study officials:
References:
Clinical trial NCT05014425: Risk Factors for Post Whipple Pancreatic Fistula
Official title: Risk Factors Predicting Development of Pancreatic Fistula Following Pancreaticoduodenectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Fistula
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 96
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients underwent pancreaticoduodenectomy at Al-Rajhi liver Hospital, Assiut university from January 2017 to December 2020

Brief summary: Postoperative pancreatic fistula (POPF) following pancreaticoduodenectomy is considered a life-threatening complication. This study was designed to analyze the risk factors for development of such fistula in a tertiary care center (Al-Rajhi Liver Hospital/ Assiut University).


Eligibility criteria: Inclusion Criteria:

* All patients underwent pancreaticoduodenectomy for pancreatic cancer

Exclusion Criteria:

* All types of pancreatic resection other than pancreaticoduodenectomy

Primary outcomes:
measure: Development of pancreatic fistula following pancreaticoduodenectomy
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00612625: Near Normalisation of BG Improves the Potentiating Effect of GLP-1
Official title: Near Normalisation of Blood Glucose Improves the Potentiating Effect of GLP-1 on Glucose Induced Insulin Secretion in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2008-02-12
Enrollment: 9
Sex: ALL
Minimum age (years): 18
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: The ability of glucagon-like peptide 1 to enhance beta-cell responsiveness to I.v. glucose is impaired in patients with type 2 diabetes mellitus compared with healthy individuals. We investigated whether 4 weeks of near-normalisation og blood glucose improves the potentiation of glucose-stimulated insulin secretion by GLP-1


Eligibility criteria: Inclusion Criteria:

* Age 18-70 years
* Type 2 diabetes diagnosed after 30 years of age
* BMI \> 25

Exclusion Criteria:

* Severe complications to diabetes
* Abnormal liver og kidney function
* Haemoglobin below the lower limit
* Macroalbuminuria
* Systemic disease
* Pregnancy

Primary outcomes:
measure: insulin secretion rate (ISR) were derived by deconvolution of c-peptide. ISR is expressed as pmol/kg/min
timeFrame: 180 minutes
Secondary outcomes:
measure: The calculated ISR values was plotted against the ambient plasma glucose. The slopes of this linear relationships were calculated by cross-correlation analysis and is and estimation of beta-cell responsiveness (pmol/kg/min)/mmol/l
timeFrame: 180 minutes
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept. of Endocrinology, Hvidovre Hospital
Study officials:
affiliation: University Hospital Hvidovre
name: Patricia V Højberg, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hojberg PV, Zander M, Vilsboll T, Knop FK, Krarup T, Volund A, Holst JJ, Madsbad S. Near normalisation of blood glucose improves the potentiating effect of GLP-1 on glucose-induced insulin secretion in patients with type 2 diabetes. Diabetologia. 2008 Apr;51(4):632-40. doi: 10.1007/s00125-008-0943-x. Epub 2008 Feb 22.
Clinical trial NCT05847725: Effects of Bandaging and Kinesiotaping® in Patients With Total Knee Arthroplasty
Official title: Effects of Bandaging and Kinesiotaping® on Pain, Edema, and Functional Level in Patients With Total Knee Arthroplasty in the Early Postoperative Period: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee arthroplasty
edema
elastic bandages
short stretch bandages
kinesio tape
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study included a three parallel group of blinded evaluators. These cases were followed up with a planned follow-up program between preoperative and postoperative three months.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study aimed to compare the effectiveness of elastic bandaging, Kinesio taping, and short stretch bandaging techniques on postoperative pain, edema, and functional level in the early stage after total knee arthroplasty.

Detailed description: The study was conducted on 30 volunteer subjects who underwent unilateral total knee arthroplasty surgery. Thirty participants who underwent unilateral total knee arthroplasty were divided into the Elastic Bandage Group (n=10), Kinesio Tape group (n=10), and Short Stretch Bandage group (n=10). All treatments were stopped on the eighth day. All measurements taken preoperatively were repeated postoperative 1st, 3rd, 5th, 8th, 14th, 28th days, 6th week, and 3rd month. The functional level was measured in the sixth week and third month.

Eligibility criteria: Inclusion Criteria:

* 60 years or older patients who had undergone unilateral TKA surgery for primary knee osteoarthritis, rheumatoid arthritis, and posttraumatic arthritis.

Exclusion Criteria:

* Body mass index greater than or equal to 35 kg/m2,
* Having a neurological or peripheral vascular disease,
* Having a contraindication condition for compression application (e.g., acute cellulitis, arterial insufficiency, unstable heart disease, acute deep vein thrombosis), and kinesio taping application (e.g., presence of active infectious, lymphedema and/ or cancer history)

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: up to sixth weeks
Secondary outcomes:
measure: Measuring Tape Measure
timeFrame: up to sixth weeks
measure: The Knee Society Clinical Scoring System
timeFrame: up to sixth weeks
Other outcomes:
Locations:
Study officials:
affiliation: Hacettepe University
name: Gürsoy Coşkun, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04467125: Nexplanon Removal: Subcutaneous vs. Topical Lidocaine
Official title: Nexplanon Removal: Subcutaneous vs. Topical Lidocaine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Contraception
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A randomized trial of using EMLA cream for anesthesia to remove Nexplanon versus the standard route of subcutaneous lidocaine for anesthesia. Primary endpoints are pain during procedure and time to removal.


Eligibility criteria: Inclusion Criteria:

* Females with Nexplanon implant in place, desiring removal No allergy to lidocaine or any component of EMLA cream Age greater than or equal to 18years English as primary language Not pregnant

Exclusion Criteria:

* pregnant non-emglish speaking age less than 18 yo Allergy to lidocaine or EMLA

Primary outcomes:
measure: pain of procedure
timeFrame: during procedure
measure: time to perform procedure
timeFrame: procedure
Secondary outcomes:
measure: How likely to recommend their anesthetic?
timeFrame: procedure
measure: Provider's sense of ease of removal?
timeFrame: procedure
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University Ob/Gyn Resident Continuity Clinic
state: Georgia
Study officials:
References:
Clinical trial NCT05759325: An Exploratory Study of ctDNA-MRD in Predicting the Efficacy of Esophageal Squamous Cell Carcinoma
Official title: Application of ctDNA-MRD in the Prediction of Curative Effect, Recurrence Monitoring and Prognosis Evaluation of Esophageal Squamous Cell Carcinoma (ESCC) During Perioperative Treatment
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Squamous Cell Carcinoma of Esophagus
Keywords: ESCC
ctDNA
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 100
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: Esophageal squamous cell carcinoma patients who were initially diagnosed as stage II-IVA (TNM V8) and planned to undergo radical surgery

Brief summary: The purpose of this study is to observe and evaluate the correlation between ctDNA-MRD and the therapeutic effect and prognosis of stage II-IVA operable esophageal squamous cell carcinoma.

Detailed description: ESCC patients with II-IVA resection will undergo MRD examination at the following time: the first examination is before the operation, the second examination is 7-10 days after the operation, and then 1 month after the operation, 2 weeks after the end of adjuvant treatment (if available), the follow-up period (every 3 months if there is no postoperative treatment) and the progress (the progress of the disease confirmed by the researcher), the patients will receive close MRD monitoring to evaluate the correlation between ctDNA-MRD and therapeutic efficacy and prognosis.

Eligibility criteria: Inclusion Criteria:

1. Patients with stage II-IVA Esophageal squamous cell carcinoma confirmed by clinical pathological staging;
2. ≥18 years;
3. Eastern Cooperative Oncology Group performance status score (ECOG PS) is 0 \~ 1 points;
4. Expected survival time ≥ 6 months;
5. Patients agree and have the ability to follow the planned study visits, laboratory tests and other research steps.

Exclusion Criteria:

1. Patients with other malignant tumors;
2. Patient had undergone surgery before admission;
3. Pregnant or lactating women;
4. Patients with other serious diseases;
5. Patients who could not understand the experiment content and could not cooperate with them and refused to sign the informed consent form;
6. Patients with contraindications to radiotherapy and chemotherapy;
7. Other researchers think it is not suitable.

Primary outcomes:
measure: Progression-free survival
timeFrame: up to 2 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04476225: Induced Pluripotent Stem Cells for Disease Research
Official title: Induced Pluripotent Stem Cells for Disease Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hirschsprung Disease
Keywords: Hirschsprung Disease
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 1
Sex: ALL
Minimum age (years): 13
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with Hirschsprung disease and their unaffacted family members

Brief summary: The aim of this study is to determine the contribution of genetic factors to the pathogenesis of diseases, including diseases such as Parkinson's disease, Hirschsprung's disease, and autism. Patient-derived cellular models of diseases will be developed, which will require the collection of blood samples from patients and healthy individuals in order to generate induced pluripotent stem cells (iPSCs) for the development of iPSC-derived human cell cultures. These human cellular models will be phenotyped using a variety of methods, including cellular, molecular, and biochemical assays. Because these human cellular models will retain the genetic background from the patients and control subjects, this will allow us to determine the contribution of genetics to disease phenotypes. Such disease-specific pluripotent stem cell lines will be invaluable tools for many basic and translational research applications, including pathophysiological studies in a developmental context, and innovation and screening of small molecule drugs capable of reversing the disease phenotype and potentially leading to a cure for a broad range of diseases, where appropriate in vitro or in vivo disease models do not exist.


Eligibility criteria: Inclusion Criteria:

* Individuals with Hirschsprung disease
* Any disease severity accepted
* Individuals with or without other health issues accepted
* Unaffected / healthy relatives of individuals with Hirschsprung disease

Exclusion Criteria:

* Individuals who are unwilling or unable to provide blood sample
* Individuals who are unwilling or unable to provide informed consent
* Individuals who are outside the age range permitted for our study will be excluded. Our study will only perform blood draws from individuals ages 13 and above.

Primary outcomes:
measure: Whole blood sample collection
timeFrame: 52 weeks after sample collection
measure: iPSC disease modeling
timeFrame: 200 weeks after sample collection
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Steve Finkbeiner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03243825: Comparative Study of Different Neoadjuvant Therapies Before Radical Hysterectomy in Stage Ib2-IIa2 Cervical Cancer
Official title: Comparative Study of Neoadjuvant Chemo/Brachytherapy and Chemotherapy Alone Before Radical Hysterectomy in Stage Ib2-IIa2 Cervical Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: neoadjuvant chemotherapy
brachytherapy
radiotherapy
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2017-08-09
Enrollment: 120
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: For stage Ib2-IIa2 cervical cancer patients, neoadjuvant therapy followed by radical hysterectomy and pelvic lymphadenectomy is one of the managements. Post-operative concurrent chemo-radiotherapy is necessary if the patients have high-risk factors, including positive surgical margin, parametrium and pelvic nodes. Our previous retrospective study showed that combination of neoadjuvant chemotherapy and brachytherapy reduced the proportion of post-operative concurrent chemo-radiotherapy compared to neoadjuvant chemotherapy alone.

Detailed description: In the present study, the patients with stage Ib2-IIa2 cervical cancer will receive either neoadjuvant chemo/brachytherapy or neoadjuvant chemotherapy before radical hysterectomy and pelvic+/- para-aortic lymph node dissection. According to the surgical findings, post-operative chemo-radiotherapy will be performed.

Eligibility criteria: Inclusion Criteria:

* Histology confirmed cervical cancer
* Clinical stage Ib2 or IIa2 (FIGO 2009)

Exclusion Criteria:

* Patients who not suitable for surgery
* Personal history of pelvic radiotherapy

Primary outcomes:
measure: proportion of post-operative chemo-radiotherapy
timeFrame: 2 months
Secondary outcomes:
measure: 3-year disease-free survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Acadamy of Medical Sceinces
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Ning Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01236222: Health Effects of Commuter Cycling
Official title: Health Effects of Commuter Cycling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention
Keywords: commuter cycling
fitness
metabolic syndrome
children
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
First posted: 2010-11-07
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether cycling to school is effective in the prevention of the metabolic syndrome.

Detailed description: Physical activity plays a crucial role in relation to prevent a clustering of risk factors. In adults a lower all-cause mortality has been found in those cycling to work compared to inactive commuters. It thus seems possible that cycling to school will entail health beneficial effects for children.

Eligibility criteria: Inclusion Criteria:

* passive commuted to school last 6 months, own a bike

Exclusion Criteria:

* less than 2 km to school

Primary outcomes:
measure: Fitness
timeFrame: Day 0, Day 120
Secondary outcomes:
measure: Metabolic syndrome
timeFrame: Day 0, Day 120
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark
Study officials:
References:
citation: Ostergaard L, Borrestad LA, Tarp J, Andersen LB. Bicycling to school improves the cardiometabolic risk factor profile: a randomised controlled trial. BMJ Open. 2012 Oct 31;2(6):e001307. doi: 10.1136/bmjopen-2012-001307. Print 2012.