louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02160418: Incentives for Daily Tooth Brushing to Reduce Gingivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2014-06-10
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: In this randomized controlled study, the investigators compare two classes of behavioral approaches to change habits and health outcomes with an application to dental health: cognitive vs. behavioral financial incentives. Under cognitive incentives subjects are paid to correctly answer health-related quizzes. Under behavioral incentives subjects earn money for making healthy choices. The investigators apply these incentives to toothbrushing, a daily health-related behavior critical to the prevention of dental caries and periodontal disease, two high-burden conditions among US adults.


Eligibility criteria: Inclusion Criteria:

* Male or female older than 18 years, with at least 10 teeth present.

Exclusion Criteria:

* Pregnancy, uncontrolled diabetes, systemic antibiotics taken within the previous 2 months, need for referral for periodontal treatment.

Primary outcomes:
measure: Follow-up Gingival Index
timeFrame: 6 months
Secondary outcomes:
measure: Frequency and duration of toothbrushing
timeFrame: 3 months
measure: End of treatment Gingival Index
timeFrame: 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05735418: The Effect of GI Biome #7 on Gut Microbiome and Health of the Elderly
Official title: A Study on the Effects of Oral Intake of GI Biome #7 on the Intestinal Microbiome and Health in the Elderly Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Weakness
Keywords: gut microbiome
probiotics
muscle strength
intervention
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: GI Biome
First posted: 2023-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A double-blind, randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effects of probiotics named GI Biome #7 on the gut microbiome and muscle strength in older adults aged 60 years or older.

Detailed description: This study is a double-blind, randomized controlled trial. A total of 60 healthy adults aged 60 years or older will be recruited, and they will be randomly assigned to the intervention group or the control group. The intervention group will be given GI Biome #7 pills, and the control group will be given the placebo pills for four weeks. The participants will visit the research laboratory four times as follows: A day before starting to take the pills, two weeks later after starting to take the pills, the last day of taking the pills, and four weeks later after the end of taking the pills. Participants' stool, blood, and urine will be sampled every visit, and grip strength and body composition will also be checked.

Eligibility criteria: Inclusion Criteria:

* 60 years old or older
* Those who have no difficulties in daily living
* Willing to commit throughout the study

Exclusion Criteria:

* Antibiotics medication in the last month.
* Probiotics used in the last months.
* Those who are in the treatment of the following diseases: Liver disease, Neurological disease, Respiratory disease, Tumors, Psychiatric disorders, Angina, Myocardial infarction, and Stroke

Primary outcomes:
measure: Hand Grip Strength Change
timeFrame: 4 weeks
Secondary outcomes:
measure: Bacteroidetes/Firmicutes Ratio Change
timeFrame: 4 weeks
measure: Fasting blood glucose
timeFrame: 4 weeks
Other outcomes:
measure: Walking speed
timeFrame: 0, 2, 4, 8 weeks
measure: Gut quotient
timeFrame: 0, 2, 4, 8 weeks
measure: IGF-1
timeFrame: 0, 2, 4, 8 weeks
measure: Myostatin
timeFrame: 0, 2, 4, 8 weeks
measure: 8-OHdG
timeFrame: 0, 2, 4, 8 weeks
measure: Fecal acetate level
timeFrame: 0, 2, 4, 8 weeks
measure: Fecal butyrate level
timeFrame: 0, 2, 4, 8 weeks
measure: Fecal propionate level
timeFrame: 0, 2, 4, 8 weeks
measure: Fecal calproate level
timeFrame: 0, 2, 4, 8 weeks
measure: Fecal valerate level
timeFrame: 0, 2, 4, 8 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University College of Medicine
Study officials:
affiliation: Seoul National University
name: Yun-Chul Hong, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00925418: Evaluation of the Cryotherapy in the Prevention of Nails Toxicity Induced by Taxotere® in Breast or Prostate Cancer
Official title: Randomized Trial Evaluating the Cryotherapy in the Prevention of Nails Toxicity Induced by Taxotere® in Patient Treated for Breast or Prostate Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Neoplasms
Prostate Cancer
Nail Diseases
Keywords: Neoplasm
breast Neoplasm
docetaxel
Glove
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2009-06-22
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Taxotere® can induce nails changes like dyschromia, hematoma, lines of Beau-Reil (signing the stop of the epithelial proliferation), abscess, or pain. In this context, this randomized, monocentric phase III trial evaluates the cryotherapy, using frozen glove, in the prevention of nails toxicity induced by Taxotere® in patient treated for breast or prostate cancer.

Primary objective:

Demonstrate a reduction of the nails toxicity using frozen glove during chemotherapy with Taxotere®.

Secondary objectives:

Analysis of time of protection against onycholysis Estimation of the efficiency of cryotherapy, and impact on quality of life Tolerance and compliance of the frozen glove


Eligibility criteria: Inclusion Criteria:

* Patients with hormono-resistant breast cancer or metastatic prostate cancer treated by chemotherapy with Taxotere®.
* Patients aged 18 and older
* Nail toxicity \< grade 2 (CTC-AE version 3.0)
* Informed patients with signed consent

Exclusion Criteria:

* History of treatment with taxane
* Raynaud syndrome
* Distal metastasis in superior extremity
* Nail diseases
* Distal arteriopathy
* Cold intolerance
* Peripheral neuropathy\>=2
* Pregnancy, breast feeding
* Unable to give informed consent
* Unable to have a medical follow-up for social, geographical, family or psychological reasons

Primary outcomes:
measure: Number of patients treated by Taxotere® with nail toxicity >= 2 (CTC-AE version 3.0)
timeFrame: 4 months
Secondary outcomes:
measure: Number of day between inclusion and apparition of nail toxicity
timeFrame: 4 months
measure: Necessity of local care, existence of pains
timeFrame: 4 months
measure: Tolerance and compliance for the frozen glove
timeFrame: 4 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut PAOLI-CALMETTES
Study officials:
affiliation: Institut Paoli-Calmettes
name: Carole TARPIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02906618: Study of LY3039478 in Healthy Participants
Official title: An Absolute Bioavailability Study of LY3039478 in Healthy Subjects Using the Intravenous Tracer Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2016-09-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study involves one dose of LY3039478 given by mouth followed by an intravenous infusion (IV) (via a tube linked to a small needle in the vein) of LY3039478. The results of this study will help to answer the following research questions:

* How much LY3039478 gets into the blood stream when given by mouth as a capsule compared to when given by an IV
* How long it takes the body to remove the study drug
* The safety of LY3039478 and any side effects that might be associated with it

Participation in the study is expected to last up to 7 weeks. There will be screening, a single study period, and a follow-up.


Eligibility criteria: Inclusion Criteria:

- Have a body mass index (BMI) of 18.5 to 32.0 kilogram per meter square (kg/m²) inclusive

Exclusion Criteria:

- Have previously completed or withdrawn from this study or any other study investigating LY3039478, and have previously received the investigational product

• Have known allergies to LY3039478, related compounds or any components of the formulation, or history of significant atopy in the opinion of the investigator

Primary outcomes:
measure: Pharmacokinetics: Area Under the Concentration versus Time Curve (AUC) from Time Zero to the Last Time Point with a Measurable Concentration (AUC[0 tlast]) of LY3039478 and 3C 15N 2H-LY3039478
timeFrame: Predose through 48 hours after administration of study drug
measure: Pharmacokinetics: AUC from Zero to Infinity (AUC[0 - inf]) of LY3039478 and 3C 15N 2H-LY3039478
timeFrame: Predose through 48 hours after administration of study drug
Secondary outcomes:
measure: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of LY3039478
timeFrame: Predose through 48 hours after administration of study drug
measure: Pharmacokinetics: Time of Cmax (tmax) of LY3039478
timeFrame: Predose through 48 hours after administration of study drug
measure: Pharmacokinetics: Half Life Associated With The Terminal Rate Constant (t1/2) of LY3039478
timeFrame: Predose through 48 hours after administration of study drug
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
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 NCT01667718: Bismuth Improves the Efficacy of Levofloxacin-containing Triple Therapy for Helicobacter Pylori Treatment
Official title: Levofloxacin-containing Therapy for Helicobacter Pylori Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Functional Dyspepsia
Peptic Ulcer
Keywords: eradication
helicobacter pylori
bismuth
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2012-08-17
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To examine and compare the efficacy of 2 week Levofloxacin-containing therapies with and without Bismuth for H.pylori treatment.

Detailed description: The success rate of the standard triple therapy for H. pylori infection is decreasing recently.Fluoroquinolone has been proposed to replace clarithromycin as an alternative in the treatment. However prevalence of H.pylori resistance to Levofloxacin has increased rapidly in our area. The purpose of this study is to observe the efficacy of 14 day Levofloxacin triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment.

Eligibility criteria: Inclusion Criteria:

* patients who presented with upper gastrointestinal symptoms and endoscopically proven H.pylori-positive functional dyspepsia and scarred peptic ulcer

Exclusion Criteria:

* patients with peptic ulcer, previous H.pylori eradication therapy, previous gastric surgery, pregnancy, lactation, major systemic diseases, receipt of anti-secretory therapy, antibiotics or bismuth in the preceding 4 weeks, or allergy to any one of the medications

Primary outcomes:
measure: eradication rate of Helicobacter pylori
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao-Tong University School of Medicine Renji Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Jiao-Tong University School of Medicine Renji Hospital
name: Hong Lu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01663818: Tack Optimized Balloon Angioplasty (TOBA) Study
Official title: Tack Optimized Balloon Angioplasty (TOBA) Study for Femoropopliteal Arteries Using the Tack-IT Endovascular Stapler
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vascular Disease
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2012-08-13
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A multi-center, post-CE Mark study designed to evaluate the performance of the Intact Vascular Tack-IT Endovascular Stapler™ in subjects with vascular flaps (e.g.; post-angioplasty dissection) resulting from percutaneous transluminal balloon angioplasty (PTA) of superficial femoral or popliteal artery(ies).

Detailed description: Intact Vascular intends to conduct a prospective, single arm, multi-center, post-CE Mark study designed to evaluate the performance of the Intact Vascular Tack-IT Endovascular Stapler™ in subjects with vascular flaps (e.g.; post-angioplasty dissection) resulting from percutaneous transluminal balloon angioplasty (PTA) of superficial femoral or popliteal artery(ies).

Eligibility criteria: Inclusion Criteria:

* Rutherford clinical category 2, 3 or 4
* ABI less than or equal to 0.90
* Reference vessel diameter is between 2.5mm and 5.5mm
* Target lesion has stenosis greater than or equal to 70% or is occluded
* Target lesion is less than or equal to 10cm in length

Exclusion Criteria:

* Previously implanted stent in the ipsilateral superficial femoral or popliteal artery
* Target treatment area is severly calcified (e.g. circumferential calcification or calcium plaque visible on plain fluoroscopy that extends far more than 5.0cm continuously)

Primary outcomes:
measure: Safety
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Patrick Peeters, MD
Study officials:
affiliation: St. Blasius Hospital
name: Marc Bosiers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Park Hospital, Leipzig
name: Dierk Scheinert, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00496418: Peristomal Mesh for Prophylaxis of Parastomal Hernia
Official title: Randomized Controlled Open Interventional Study for Evaluation of Use of Peristomal Mesh for Prophylaxis of Parastomal Hernia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hernia
Keywords: colostomy
parastomal
peristomal
hernia
mesh
surgery
Indication for permanent end colostomy
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2007-07-04
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to prove differences or equalities in outcome for patients operated with or without a peristomal mesh in the sublay position when establishing a permanent colostomy.

Detailed description: Patients are randomized to 2 groups equal in number: a group with mesh implantation and a control group without mesh implantation.

Primary endpoint is Parastomal hernia. Secondary endpoints are operating time, infection, obstruction, stenosis, retraction, fistulae, skin related problems and reoperations. Endpoints are correlated to body mass index, previous hernia, age, concurrent illness and cause for colostomy. Patients are followed 4 years after operation with clinical examination

Eligibility criteria: Inclusion Criteria:

* Condition with indication for establishing a permanent end-colostomy.

Exclusion Criteria:

* Age under 18
* ASA score above 3

Primary outcomes:
measure: Parastomal hernia
timeFrame: at 3, 12, 24, 36 and 48 months
Secondary outcomes:
measure: Operating time, infection, obstruction, stenosis, retraction, fistulae, skin related problems and reoperations. Endpoints are correlated to body mass index, previous hernia, age, concurrent illness and cause for colostomy
timeFrame: 4 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet-Radiumhospitalet HF
Study officials:
affiliation: Rikshospitalet-Radiumhospitalet HF, Medical Center
name: Jan Lambrecht, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lambrecht JR. Diagnostic methods in parastomal hernia; research and clinical relevance. Hernia. 2021 Jun;25(3):817-820. doi: 10.1007/s10029-020-02177-8. Epub 2020 Mar 28. No abstract available.
Clinical trial NCT00874718: Impact in Life Quality of a Educational Program for Prevention of Occupational Musculoskeletal Disorders in Workers
Official title: Impact in Life Quality of a Educational Program for Prevention of Occupational Musculoskeletal Disorders in Workers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Occupational Musculoskeletal Disorders
Healthy
Keywords: repetitive strain injury
quality of life
functional capacity
workers
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
First posted: 2009-04-02
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study consists of evaluating the efficacy of an Educational Program for prevention of occupational musculoskeletal problems in workers. It is a randomized clinical trial with parallel groups and blinded evaluator, with a control group not submitted to the educational program, but that received a program for general orientation in health. The primary outcome was the change of the quality of life measured by means of Medical Outcomes Study 36-Term Short Health Survey (SF-36), that it is a generic instrument of evaluation of the quality of life, translated and validated in Portuguese of Brazil.


Eligibility criteria: Inclusion Criteria:

* All workers from a specific company, including administrative and production sections.

Exclusion Criteria:

* Workers absent from the workplace during all the study period.

Primary outcomes:
measure: Medical Outcomes Study 36-Item Short Form Health Survey - (SF-36)
timeFrame: 6 months
Secondary outcomes:
measure: Work Limitation Questionnaire
timeFrame: 6 months
measure: Work absenteeism
timeFrame: 6 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Rio Grande do Sul
state: RS
Study officials:
affiliation: Associate Professor
name: Ricardo M Xavier, MD
role: STUDY_DIRECTOR
affiliation: Associate Professor
name: Antonio C dos Santos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Santos AC, Bredemeier M, Rosa KF, Amantea VA, Xavier RM. Impact on the Quality of Life of an Educational Program for the Prevention of Work-Related Musculoskeletal Disorders: a randomized controlled trial. BMC Public Health. 2011 Jan 28;11:60. doi: 10.1186/1471-2458-11-60.
Clinical trial NCT04952818: The Value of Preoperative Diagnosis and Prognostic Prediction Based on Radiomics of Giant Cell Tumor of Spine
Official title: Radiomics Based on Preoperative Imaging of Giant Cell Tumor of the Spine to Predict the Early Recurrence and Survival of Giant Cell Tumor of the Spine After Surgery, and the Expression Levels of P53, VEGF, RANK, RANKL and Other Prognostic-related Molecular Markers.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Tumor
Keywords: giant cell tumor of bone
radiomics
recurrence
spine tumor
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with spinal GCTB

Brief summary: 1. Exploit CT (plain scan), enhanced CT and fMRI based radiomic biomarkers, explore their correlation with the prognostic molecular markers of spinal GCTB(p53/vegf/rank/rankl...), and help accurate diagnosis of GCTB.
2. Exploring a new method of preoperative risk stratification for spinal GCTB, and establishing radiomic model combined with clinical features. Exploring the GCTB biological behavior prediction model and the prognosis prediction of GCTB.

Detailed description: This study intends to conduct a systematic review of patients with spinal GCTB who have undergone standardized imaging (CT or MRI) in our hospital since 2006 to obtain case samples, conduct standardized clinical and imaging data extraction and analysis, and fully integrate histopathology and clinical follow-up results. To preliminarily explore the value of postoperative imaging-based radiomics markers in the preoperative precise diagnosis of spinal GCTB, risk stratification and prediction of tumor biological behavior.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with spinal GCTB who underwent surgical resection or biopsy without preoperative chemotherapy or radiotherapy were included in this study.

Exclusion Criteria:

* i) The CT scan was performed more than 1 week before surgery ii) Poor image quality. Such as surrounding structure artifacts; iii) The remaining tumor tissue in the postoperative paraffin specimen is too little to be used for reanalysis; iv) Cases with negative H3F3A (H3 histone, family 3A) staining were excluded; v) Incomplete clinical information.

Primary outcomes:
measure: RANK/RANKL
timeFrame: 2020
measure: VEGF
timeFrame: 2020
measure: p53
timeFrame: 2020
Secondary outcomes:
measure: Recurrence
timeFrame: 2020
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University third hospital
state: Please Select An Option Below
Study officials:
affiliation: Peking University Third Hospital
name: Ning Lang
role: STUDY_CHAIR
References: