louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05916040: Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy
Official title: Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Cancer
Keywords: Radiation therapy
MR-guided radiotherapy
Stereotactic body radiotherapy
Total Neo-adjuvant Treatment
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with rectal cancer aged 18 years or older.

Brief summary: The TNTRect trial is a prospective observational study that will evaluate the outcome of MR-guided stereotactic body radiotherapy (SBRT) with a simultaneous integrated boost in a hypofractionated treatment of rectum cancer. Patients will be treated in 5 daily fractions of 5 Gy within an overall treatment time (OTT) of 5 days. A simultaneous integrated boost (SIB) till 30Gy will be delivered to the gross tumor volume. Patients will be treated with daily adaptive radiotherapy and online tumor gating on the MRIdian system (ViewRay Inc.). The aim of the study is to improve the complete clinical response rate to offer more patients an organ preserving approach.

The primary endpoint is patient response to the treatment, assessed by endoscopy and MRI, or by medical pathology reports after potential resection was performed. As secondary endpoints local control, disease-free survival, overall survival and the patient's quality of life \& hospital anxiety and depression will be measured.


Eligibility criteria: Inclusion Criteria:

* Locally advanced rectal cancer

Exclusion Criteria:

* Patients with unresectable metastatic disease at diagnosis
* Patients with an ECOG performance status \> 2
* Patients not deemed fit for radiotherapy, chemotherapy or surgery

Primary outcomes:
measure: Response to therapy
timeFrame: up to 25 weeks after start of radiotherapy
Secondary outcomes:
measure: Quality of life assessment via QLQ-C30
timeFrame: from the start of radiotherapy until 5 years after treatment
measure: Colorectal specific quality of life assessment via QLQ-CR29
timeFrame: from the start of radiotherapy until 5 years after treatment
measure: Bowel functioning specific quality of life assessment via LARS score
timeFrame: from the start of radiotherapy until 5 years after treatment
measure: Anxiety and depression state via HADS
timeFrame: from the start of radiotherapy until 5 years after treatment
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel - Dienst Radiotherapie
state: Brussels Capital Region
Study officials:
affiliation: Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel
name: Mark De Ridder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04250740: The Morning Coffee Study
Official title: The Morning Coffee Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetitive Behavior
Lead sponsor: University of Guelph
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The liking of a breakfast meal has been shown to influence food choice throughout the day. This study will investigate the effects that liking of different coffee beverages has on daily food intake.

Detailed description: This is a postprandial acute meal crossover blinded study in which 30 fasted young healthy women will consume one of 3 butter-rich coffees, in random order, at each of three study sessions separated by at least 4 days. Participants will rate the coffee characteristics and complete paper visual analogue scale ratings of alertness, fatigue, nausea, satiety, and comfort for 180 minutes and consume a pasta lunch meal. A subset of 10 participants will be invited to attend 3 additional study visits where gastric emptying following consumption of each coffee will be assess using gastric ultrasound.

Eligibility criteria: Inclusion Criteria:

* Generally healthy women
* 20-35 yrs
* BMI of 18.5-26.1 kg/m2 and waist circumference \<88cm
* Non-smoking
* Non to moderate alcohol drinkers
* Regular coffee consumers
* Regularly consumes dairy products
* Pre-menopausal with regular monthly periods
* Stable medication use
* Have not gained or lost significant weight during the past 3 months
* Not pregnant or lactating
* Enjoy and be willing to consume pasta with tomato sauce

Exclusion Criteria:

* Any food sensitivity or intolerance
* Any anaphylactic allergy or gastrointestinal disorder
* History of any major disease or medical condition
* Elite or training athletes
* Three Factor Eating Questionnaire restraint score \>16
* Taking any natural health products or dietary supplements, other than a multivitamin, that interfere with fat or caffeine digestion

Primary outcomes:
measure: Please indicate how much you liked or disliked the coffee
timeFrame: 30-180 minutes
Secondary outcomes:
measure: Please indicate on the line the creaminess of the coffee
timeFrame: 0 - 180 minutes
measure: Please indicate on the line how hungry you are
timeFrame: 30 - 180 minutes
measure: Lunch meal food intake
timeFrame: 180 minutes
Other outcomes:
measure: Gastric emptying
timeFrame: 0, 30, 60, 90, 120, 150, and 180 minutes
Locations:
city: Guelph
country: Canada
facility: University of Guelph
state: Ontario
Study officials:
References:
Clinical trial NCT02175940: VEGF and PEDF in Patients With Myopic Choroidal Neovascularization
Official title: Effect of Intravitreal Ranibizumab Injection on Aqueous Humor Concentrations of Vascular Endothelial Growth Factor and Pigment Epithelium-derived Factor in Patients With Myopic Choroidal Neovascularization.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopic Choroidal Neovascularization
VEGF Aqueous Level
PEDF Aqueous Level
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
Collaborators: name: Ciro Costagliola
name: Francesco Semeraro
name: Roberto dell'Omo
name: Mario R Romano
name: Fabiana Aceto
name: Rodolfo Mastropasqua
name: Antonio Porcellini
First posted: 2014-06-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with myopic Choroidal Neovascularization treated with intravitreal ranibizumab at the Medical Retina Department, University of Molise, Campobasso, Italy

Brief summary: This was a prospective, case-control study investigating aqueous levels of VEGF and PEDF in eyes with mCNV treated with IVB.


Eligibility criteria: Inclusion Criteria:

* pathologic myopia, defined as spherical equivalent \>6 diopters and axial length \>26 mm
* posterior pole myopic retinal changes (posterior staphyloma, chorioretinal atrophy, papillary crescent);
* fluorescein angiography, indocyanine green angiography and optical coherence tomography detection of the subfoveal or juxtafoveal choroidal neovascularization
* clear ocular media;

Exclusion Criteria:

* previous treatment for choroidal neovascularization, including the previous intravitreal drug injection or PDT
* presence of other maculopathy as diabetic retinopathy or retinal vascular occlusion
* history of recent myocardial infarction or other thromboembolic events
* ongoing uncontrolled hypertension or glaucoma
* refractive media opacities
* previous eye surgery

Primary outcomes:
measure: vascular endothelial growth factor (VEGF) aqueous levels
timeFrame: 2 months
measure: pigment epithelium-derived factor (PEDF) aqueous levels
timeFrame: 2 months
Secondary outcomes:
measure: best-corrected visual acuity
timeFrame: 2 months
measure: central retinal thickness
timeFrame: 2 months
Other outcomes:
Locations:
city: Cambpobasso
country: Italy
facility: Medical Retina Department, University of Molise
state: CB
Study officials:
References:
citation: Costagliola C, Semeraro F, dell'Omo R, Romano MR, Russo A, Aceto F, Mastropasqua R, Porcellini A. Effect of intravitreal ranibizumab injections on aqueous humour concentrations of vascular endothelial growth factor and pigment epithelium-derived factor in patients with myopic choroidal neovascularisation. Br J Ophthalmol. 2015 Jul;99(7):1004-8. doi: 10.1136/bjophthalmol-2014-306465. Epub 2015 Mar 13.
Clinical trial NCT00786240: Phase1, Single Dose, Crossover Study to Determine Bioequivalence
Official title: A Phase 1, Open-Label, Randomized, Single-Dose, 2-Way Crossover Study To Determine Bioequivalence Of 4 Mg Fesoterodine SR Tablet Between Formulation D And Formulation E(1) In Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
Therapeutic Equivalency
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-06
Enrollment: 37
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to demonstrate bioequivalence of 4 mg tablet of formulation D and formulation E(1).


Eligibility criteria: Inclusion Criteria:

* Healthy male or female Chinese or Japanese subjects

Exclusion Criteria:

* Evidence or history of clinically significant findings at screening

Primary outcomes:
measure: AUCt and Cmax of 5-HMT after single oral administration of 4 mg fesoterodine SR tablets in formulation D under fasted conditions
timeFrame: Day 1 and 2
measure: AUCt and Cmax of 5-HMT after single oral administration of 4 mg fesoterodine SR tablets in formulation E(1) under fasted conditions
timeFrame: Day 1 and 2
Secondary outcomes:
measure: Tmax, AUClast, AUCinf, kel, t½ and MRT after single oral administration of 4 mg fesoterodine SR tablets in formulation D under fasted conditions
timeFrame: Day 1 and 2
measure: Tmax, AUClast, AUCinf, kel, t½ and MRT after single oral administration of 4 mg fesoterodine SR tablets in formulation E(1) under fasted conditions
timeFrame: Day 1 and 2
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05535140: A Chatbot-Powered G8 Screening Intervention to Facilitate Referrals to a Comprehensive Geriatric Assessment Among Older Adults With Cancer
Official title: Chatbot Powered G8 Screening Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Geriatric Cancer Patients
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-09-10
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients who are 65 years of age or older coming to the medical oncology department at Thomas Jefferson University for care.

Brief summary: In this prospective quality improvement study, we will develop and evaluate the feasibility and acceptability of an online patient self-reported G8 screening tool which will allow us to efficiently identify G8 positive older cancer patients to be referred to our Senior Adult Oncology Center (SAOC) for a Comprehensive Geriatric Assessment (CGA).

Detailed description: We will test the feasibility and acceptability of the online G8 screening tool developed. 100 older new established cancer patients who had used the MyChart G8 will be recruited to provide their feedback on the usability of the screening tool and any related referral and SAOC appointment experience. Among patients with G8 scores ≤ 14, they will be referred to a CGA. We will examine CGA attendance compliance, predictive value of the online collected G8 score with the final frailty designation determined by the CGA, and perceived barriers among CGA non-adherent patients via a brief follow up inquiry.

Eligibility criteria: Inclusion Criteria:

* 65 years and older
* New Patient Visit scheduled for Medical Oncology

Exclusion Criteria:

• Inability to answer or have caregiver answer questions on screening tool.

Primary outcomes:
measure: Agree to using the G8 assessment
timeFrame: At time of visit
measure: Complete the G8 assessment
timeFrame: At time of visit
measure: 3. Complete the referred SAOC visits if they complete the G8 assessment and are screened positive
timeFrame: After visit
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06985940: Visual and Acoustic Effects of Human Thermal Comfort and Perception in a Micro-Climatically Steady Environment
Official title: Visual and Acoustic Effects of Human Thermal Comfort and Perception in a Micro-Climatically Steady Environment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Thermal Perception
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to understand how environmental factors influence comfort and health. The main question it aims to answer is:

* do temperature, visuals, and sounds affect a person's physiology and perception?

Participants will watch short videos in 2 different climate-controlled environments and provide feedback on their thermal experiences.

Detailed description: Participants will engage in a series of sessions in a climate-controlled environment, where researchers will manipulate temperature, visuals, and sounds to study their effects on various physiological measurements, including blood pressure, pulse rate, core temperature, and skin temperature. The study will take place in two distinct chambers, with each chamber designed to allow for precise control of environmental variables. Participants will be asked to watch short video clips in different thermal environments and provide feedback on their thermal experiences.

Eligibility criteria: Inclusion Criteria:

* Age 18-40 years
* BMI between 18-27.5 kg/m²
* No history of color blindness or sensory impairments
* Normal chronotype (consistent sleep-wake patterns)
* Must have lived in or near Guangzhou, China for at least two months prior to participation

Exclusion Criteria:

* Children (age under 18), elders (age \> 60)
* People with obesity
* People with a history of color blindness
* People without a consistent sleep-awake pattern
* People with limited English proficiency

Primary outcomes:
measure: Change in thermal perception
timeFrame: Baseline to 90 minutes
measure: Change in pulse rate
timeFrame: Baseline to 90 minutes
measure: Change in skin temperature
timeFrame: Baseline to 90 minutes
measure: Change in blood pressure
timeFrame: Baseline to 90 minutes
measure: Change in core temperature
timeFrame: Baseline to 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
References:
Clinical trial NCT04122040: Effects of Roxithromycin on Quality of Life and Physiological Outcomes in Bronchiectasis
Official title: Effects of Roxithromycin on Quality of Life and Physiologic Outcomes in Bronchiectasis Patients During Treatment and Posttreatment Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Quality of Life
Respiratory Function Tests
Keywords: Bronchiectasis
quality of life
pulmonary function tests
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised control study
Primary purpose: TREATMENT

Brief summary: roxithormycin 300 mg per day for 12 weeks could improve quality of life and physiological outcomes in bronchiectasis

Detailed description: A randomized, double blinded, placebo controlled study was conducted to evaluate the effects of a 12-week administration of roxithromycin 300 mg once daily and a 12-week follow-up period in symptomatic stable bronchiectasis

Eligibility criteria: minimum 15 year maximum 75 years

Criteria inclusion Criteria:

Symptomatic bronchiectasis Stable clinical bronchiectasis

Exclusion Criteria:

Adverse drug reaction to macrolide Recent exacerbation within 2 weeks History of macrolide therapy within 2 weeks active malignancy and end stage diseases 5. not perform lung function tests Females who were lactating

Primary outcomes:
measure: SGRQ scores
timeFrame: for 12 weeks
Secondary outcomes:
measure: pulmonary function tests
timeFrame: 24 weeks
measure: sputum volumes
timeFrame: 24 wekse
Other outcomes:
Locations:
Study officials:
affiliation: Prince of Songkla University
name: Kanung Saejiam, MS
role: STUDY_DIRECTOR
References:
citation: Nakamura H, Fujishima S, Inoue T, Ohkubo Y, Soejima K, Waki Y, Mori M, Urano T, Sakamaki F, Tasaka S, Ishizaka A, Kanazawa M, Yamaguchi K. Clinical and immunoregulatory effects of roxithromycin therapy for chronic respiratory tract infection. Eur Respir J. 1999 Jun;13(6):1371-9. doi: 10.1183/09031936.99.13613809.
Clinical trial NCT01359540: Femoral Remodeling Following Total Hip Arthroplasty With OMNI Apex Modular™ and OMNI Apex ARC™ Stem Compared to Competitive Designs
Official title: A Dual Energy X-Ray Absorptiometry (DXA) Evaluation Of Bone Density Changes After Hip Replacement. Performance Of The OMNI Apex Modular™ Hip Stem And The OMNI Apex ARC™ Hip Stem In Primary Total Hip Arthroplasty, Five-Year Clinical And DXA Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Hip
Keywords: Total Hip Arthroplasty
Bone Loss
Femoral Remodeling
Bone mineral density
THA
DXA
DEXA
Dual Energy X-Ray Absorptiometry
Lead sponsor: Spokane Joint Replacement Center
Sponsor class: OTHER
First posted: 2011-05-24
Enrollment: 73
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing elective total hip arthroplasty

Brief summary: This study compares the change in bone density which occurs after hip replacement with different femoral stem devices.


Eligibility criteria: Inclusion Criteria:

* Minimum age 20 years, maximum age 80 years
* Osteoarthritis of the hip
* Elective THA
* Signed Informed Consent

Exclusion Criteria:

* Osteoporosis
* Revisions
* Clinically obese (\>40 body mass index \[BMI\])
* Femoral dysplasia
* Trochanteric osteotomy
* Inflammatory arthritis
* Breast-feeding, pregnancy, or women of childbearing potential without documentation of a negative pregnancy test and not utilizing contraception
* Patients with a history of having taken or currently taking bisphosphonates, PTH, fluoride therapy or strontium ranelate or patients taking other chronic medications that in the investigator's opinion are known to affect bone mineral density in a substantial way
* Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
* Use of other investigational agent in the last 30 days
* Unable to sign Informed Consent

Primary outcomes:
measure: Femoral bone mineral density
timeFrame: Baseline, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative
Secondary outcomes:
measure: Harris Hip Score (HHS)
timeFrame: Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Spokane Joint Replacement Center
state: Washington
Study officials:
affiliation: Spokane Joint Replacement Center
name: David F Scott, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01107340: AMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study
Official title: AMIStem Primary Hip System Prospective Post-marketing Multi-centre Surveillance Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis
Arthritis
Avascular Necrosis
Fracture of the Femoral Neck or Head
Congenital Hip Dysplasia
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2010-04-20
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicentre post-marketing prospective study to evaluate performance and clinical outcomes of AMIIStem primary hip system.


Eligibility criteria: Inclusion Criteria:

* Patient is a good candidate for a primary hip arthroplasty using AMIStem Hip System
* Patient is willing and able to give informed consent to participate in the follow-up program
* Patient is suitable for surgery and able to participate in the follow-up program.
* Those presenting with disease that meets the indication for use for Medacta implants defined in the study (on-label use)

Exclusion Criteria:

* Acute systemic or chronic infection
* Skeletal immaturity
* Severe muscular, neurological, vascular deficiency or other pathologies of the affected limb that may compromise the stability of the implant.
* Bone condition that may compromise the stability of the implant.
* Patient who are unwilling or unable to give consent, or to comply with the protocol and the follow-up program.

Primary outcomes:
measure: Assessment of implant survivorship using Kaplan Meier curve
timeFrame: 10 years after surgery
Secondary outcomes:
measure: Assessment of the patient's physical level of activity using the Oxford Hip Score
timeFrame: pre-op, annually post-op up to 10 years
measure: Assessment of the improvement in quality of life and joint movement using the EuroQol-5D score
timeFrame: pre-op, annually post-op up to 10 years
measure: Assessment of implant survivorship as a measure of safety using Kaplan Meier curve
timeFrame: 6 months, 3 years, 5 years, 7.5 years, 10 years after surgery
measure: Assessment of the clinical outcome following total hip replacement using the Harris Hip Score
timeFrame: pre-op, 6 months, 3 years, 5 years, 7.5 years, 10 years after surgery
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Uniklinik Balgrist
city: Epsom
country: United Kingdom
facility: The Elective Orthopaedic Centre (EOC)
state: Surrey
Study officials:
affiliation: British Orthopaedic Association
name: Richard E Field, PhD FRCS
role: PRINCIPAL_INVESTIGATOR
References: