louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00003654: Diagnostic Study to Identify Sentinel Lymph Nodes in Women With Stage I or Stage II Breast Cancer
Official title: Diagnostic Study of Patent Blue V Dye to Identify Sentinel Lymph Nodes in Patients With Stage I or IIA Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Keywords: stage I breast cancer
stage II breast cancer
Lead sponsor: UNICANCER
Sponsor class: OTHER
First posted: 2004-08-26
Enrollment: 200
Sex: FEMALE
Minimum age (years): 0
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: RATIONALE: Diagnostic procedures, such as blue dye or imaging to identify sentinel lymph nodes, may improve the ability to detect the extent of disease and help plan effective surgery for removing breast tumors.

PURPOSE: Diagnostic trial to study the effectiveness of blue dye and an imaging procedure to identify the sentinel lymph node under the arm in women with stage I or stage II breast cancer.

Detailed description: OBJECTIVES: I. Determine whether the concept of a sentinel lymph node within the axillary nodal basin is valid in staging breast cancer. II. Determine the sensitivity of combined methods of identification of sentinel lymph nodes by patent blue V dye and gamma probe detection in these women.

OUTLINE: Patients receive patent blue V dye injection peritumorally prior to surgery. Preoperative lymphoscintigraphy is performed using technetium Tc 99 sulfur rhenium colloid injected around the tumor associated with intraoperative gamma probe detection. Nonpalpable tumors receive a localized injection using stereotactic injection techniques. Patients then undergo standard axillary (level I and II) lymph node dissection.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study within 1 year.

Eligibility criteria: DISEASE CHARACTERISTICS: Histologically or cytologically proven stage I or IIA invasive breast cancer T0, T1, or T2 (no greater than 3 cm), N0 Noninflammatory Nonmetastatic No ductal carcinoma in situ Eligible for breast-conserving surgery Hormone receptor status: Positive or negative

PATIENT CHARACTERISTICS: Age: Any age Sex: Female Menopausal status: Pre- and postmenopausal Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant No allergy or sensitivity to radiopharmaceuticals or patent blue V dye

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior neoadjuvant chemotherapy Endocrine therapy: No prior endocrine therapy Radiotherapy: No prior neoadjuvant radiotherapy Surgery: No prior breast surgical biopsy or axillary surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Centre Paul Strauss
Study officials:
affiliation: Centre Paul Strauss
name: Jean-Francois Rodier, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02686554: Identification of Proteostasis-related Biomarkers in Alzheimer´s Dementia
Official title: Elucidating the Proteostatis Network to Control Alzheimer's Disease - Identification of Proteostasis-related Biomarkers in Alzheimer´s Dementia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alzheimer Disease
Keywords: Biomarker
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2016-02-19
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients reporting to a memory clinic

Brief summary: At the time of biomarker-substantiated diagnosis for a given AD patient it remains unclear to what extent the disease will devastate cognitive abilities within the next years. This is not only unsatisfying for the patient and the attending physician but also a major problem in the context of clinical trials that aim to establish new therapeutic agents. In clinical trials it is critically important to foresee as precisely as possible the course of the disease. The overall aim of the subproject is to identify a panel of CSF biomarkers to further improve specificity of diagnosis ("disease markers"), to measure disease activity and to predict AD progression ("stage and progression markers").

Detailed description: Within the last years, protein analyses of Aβ-species in the cerebrospinal fluid (CSF) and amyloid-imaging using F18-based PET-tracers have become a part of the diagnostic repertoire in specialized memory clinics allowing a neurobiological, biomarker-based validation of Alzheimer´s disease (AD) diagnosis. This has led to a substantial increase in the specificity of the diagnostic procedure. However, the problem remains that the diverse factors, which influence disease progression are largely unknown, while tools for diagnosis have improved substantially.

We will identify patients for participation in a long-term clinical follow up study. Biomaterial (CSF, blood) will be obtained at baseline and subjected to a detailed protein analysis. In a subset of patients, a lumbar puncture will be repeated to compare baseline and follow up CSF. Within this study, a panel of proteins, comprising Aβ- and Tau-species as well as inflammation, glial and synaptic markers, potentially involved in disease progression will be measured in biomaterial from baseline and from follow up assessment. Clinical data will be correlated with the panel of disease and progression markers.

Eligibility criteria: Inclusion Criteria:

Diagnosis of Alzheimer´s Disease

Exclusion Criteria:

Other neurological or psychiatric diseases Stroke

Primary outcomes:
measure: Cognitive Performance
timeFrame: 3-5 years
Secondary outcomes:
measure: Biomarker
timeFrame: 3-5 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University Medicine
Study officials:
affiliation: Charité University Medicine, Psychiatry, CBF
name: Oliver Peters, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00393354: Effect of Etoricoxib to Treat Chronic Low Back Pain (0663-041)
Official title: A Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Trial to Assess the Efficacy and Safety of MK0663 in Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Recurrent Low Back Pain
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2006-10-27
Enrollment: 325
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: Study the effect of etoricoxib 60 mg and 90 mg compared to placebo to treat chronic low back pain.


Eligibility criteria: Inclusion Criteria:

* Low back pain for previous 3 months and majority of days in last month
* Regular use of acetaminophen or NSAID to treat low back pain in past month
* Judged to be in otherwise good health

Exclusion Criteria:

* Low back pain that is due to secondary causes
* Radicular/myelopathic pain
* Surgery for low back pain within the past 6 months
* Active lawsuit or claim pertaining to their low back pain
* Disease that may confound the results of the study or pose risk to the patients
* Corticosteroid use in past month
* Previous participation in MK0663 study

Primary outcomes:
measure: Low back pain intensity scale (0-100 mm VAS) over 4 weeks compared to placebo
Secondary outcomes:
measure: Low back pain intensity scale (0-100 mm VAS) over 12 weeks compared to placebo
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Pallay RM, Seger W, Adler JL, Ettlinger RE, Quaidoo EA, Lipetz R, O'Brien K, Mucciola L, Skalky CS, Petruschke RA, Bohidar NR, Geba GP. Etoricoxib reduced pain and disability and improved quality of life in patients with chronic low back pain: a 3 month, randomized, controlled trial. Scand J Rheumatol. 2004;33(4):257-66. doi: 10.1080/03009740410005728.
citation: Curtis SP, Ng J, Yu Q, Shingo S, Bergman G, McCormick CL, Reicin AS. Renal effects of etoricoxib and comparator nonsteroidal anti-inflammatory drugs in controlled clinical trials. Clin Ther. 2004 Jan;26(1):70-83. doi: 10.1016/s0149-2918(04)90007-0.
citation: Sheldon EA, Bird SR, Smugar SS, Tershakovec AM. Correlation of measures of pain, function, and overall response: results pooled from two identical studies of etoricoxib in chronic low back pain. Spine (Phila Pa 1976). 2008 Mar 1;33(5):533-8. doi: 10.1097/BRS.0b013e3181657d24.
Clinical trial NCT03642054: Advanced Biomarker Assessment in Pelvic Organ Prolapse
Official title: Advanced Biomarker Assessment of Adipose Derived Stem Cells and Fibroblasts in Patients With and Without Pelvic Organ Prolapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 6 patients with pelvic organ prolapse and 6 patients without pelvic organ prolapse.

Brief summary: This study will assess advanced biomarkers in patients with and without vaginal prolapse. Assessments will be directed at vaginal fibroblasts and adipose derived stem cells.

Detailed description: Vaginal biopsies and abdominal adipose harvest will be accomplished in patients undergoing vaginal hysterectomy for non-prolapse benign conditions (6) and pelvic organ prolapse (6). Samples of tissues will be divided and portions will be snap-frozen, placed into transport medium for subsequent tissue digestion, and receive paraffin processing. Cells in transport medium will be transported to the Mayo Collaborative Research building (lab of Dr. David Lott) for isolation of fibroblasts and adipose derived stem cells.

The other samples will be transported to the lab of Dr. Andre van Wijnen (RST) to isolate RNA and protein for mRNA, microRNA and additional protein analysis.

Isolated fibroblasts and ASC's from the lab of Dr. Lott (MCA) will be expanded and passaged 3-5 times. ASCs phenotype will be confirmed by flow cytometry. Cells lines will be duplicated and biobanked at the Mayo Clinic Rochester Biotrust and separately biobanked at the Arizona State University lab of scaffold collaborator, Dr. Stephen Massia. Additional frozen cell lines will transported to the lab of Dr. Andre van Wijnen for further processing. . All cells and materials will be used for testing and to advance the science of regenerative medicine. No biobanked cells or materials from this specific project will be used for any future intervention or treatment in humans.

Eligibility criteria: Inclusion Criteria-

* Patients undergoing vaginal hysterectomy for non-prolapse benign conditions and pelvic organ prolapse
* at least 18 years old
* Mayo Clinic patient

Exclusion Criteria-

°Patients who have a history of a recognized classic connective tissue disease

Primary outcomes:
measure: Advanced biomarker assessments will include messenger RNA sequencing.
timeFrame: one year
Secondary outcomes:
measure: 2. Assess 3-D Biomaterial nanoscaffolds as potential carriers of ASC's to treat prolapse.
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Johnny Yi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03142854: Efficacy of Tailored Bowel Preparation Strategy Guided by a Predictive Model
Official title: Efficacy of Tailored Bowel Preparation Strategy Guided by a Predictive Model: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowel Cleansing Quality
Colonoscopy
Keywords: bowel preparation
colonoscopy
predictive model
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 429
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to group A or B. Participants of group A are given normal bowel preparation, while participants of group B are given personalized regimens according to a predictive model we have established.
Primary purpose: SUPPORTIVE_CARE

Brief summary: About 30% of patients were reported to suffer inadequate bowel preparation. So, it is desirable to prescribe personalized regimen according to patient's personal characteristics.

Detailed description: Colonoscopy is currently the main approach for detecting mucosal abnormalities in the whole colon. Inadequate bowel preparation is the predominant threaten to the efficacy of colonoscopy.Unfortunately, about 30% of patients were reported to suffer inadequate bowel preparation. In order to improve adequate bowel preparation rate, it is desirable to prescribe personalized regimen according to patient characteristics. We intend to create and verify a predictive model for inadequate bowel preparation. Then, in order to improve adequate bowel preparation rate, we aim to establish a bowel preparation strategy guided by the predicted model and verify it.

Eligibility criteria: Inclusion Criteria:

* patients aged 18 or older
* patients undergoing colonoscopy

Exclusion Criteria:

* patients with a history of colorectal surgery
* patients with severe colonic stricture or obstructing tumor
* patients with dysphagia
* patients with compromised swallowing reflex or mental status
* patients with significant gastroparesis or gastric outlet obstruction
* patients with known or suspected bowel obstruction or perforation
* patients with severe chronic renal failure (creatinine clearance\<30 ml/min)
* patients with severe chronic renal failure (creatinine clearance\<30 ml/min)
* patients with uncontrolled hypertension (systolic blood pressure\>170 mm Hg, diastolic blood pressure\>100 mm Hg)
* patients with inflammatory bowel disease or megacolon
* patients with dehydration
* patients with dehydration
* patients with pregnancy or lactation
* patients hemodynamically unstable
* patients unable to give informed consent

Primary outcomes:
measure: adequate bowel preparation rates between 2 groups.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ji'nan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Li Yanqing, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02960633: Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Corail Prosthesis With or Without Collar Design
Official title: Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Corail Prosthesis With or Without Collar Design
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coxarthritis
Lead sponsor: ZOL
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Corail prosthesis with or without collar design. Randomized study design focusing on radiolucent lines on standard x-ray.


Eligibility criteria: Inclusion Criteria:

* primary THA

Exclusion Criteria:

* fractured hips

Primary outcomes:
measure: The investigators will measure radiolucent lines on X-ray.
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06565533: Exploring the Synergistic Effects of Virtual Reality and Retrogressive Imagery on Basketball Free Throw Performance and Self-efficacy Among University Students: A Randomized Controlled Trial
Official title: A Randomized Controlled Trial Was Conducted With Participants Divided Into Three Groups: RETI, VR, and a Control Group. The RETI Group Visualized Successful FT Scenarios, the VR Group Practiced FTs in a Simulated Game Environment, and the Control Group Continued Regular Practice. Measurements Were Taken Before and After the Interventions Using Standard FT Performance Tests and the FTSE Questionnaire. Statistical Analyses, Including Mixed Factorial ANOVA, Were Performed to Evaluate the Effectiveness of the Interventions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: RETI
VR
FTSE
Keywords: RETI
VR
FTSE
university students
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 45
Sex: ALL
Minimum age (years): 17
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The 45 students were randomly selected from South China Normal University. Of these selected students, 15 were randomly assigned to Intervention Group 1 (RETI), 15 to Intervention Group 2 (VR), and the remaining 15 to the control group.
Primary purpose: TREATMENT

Brief summary: This research contributes to the growing body of evidence supporting the use of mental training techniques in sports. By demonstrating the effectiveness of RETI and VR in improving FT performance and FTSE, this study provides valuable insights for coaches, athletes, and sports psychologists.


Eligibility criteria: Inclusion Criteria:

participants to be university students aged 17 to 23 years, with the ability to read and communicate in Mandarin.

Exclusion Criteria:

students with visual, auditory, or other motor impairments

Primary outcomes:
measure: Free Throw (FT) Shooting Performance
timeFrame: week 8
measure: Free throw shooting self-efficacy (FTSE)
timeFrame: week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Kota Bharu
country: Malaysia
facility: Universiti Sains Malaysia
state: Kelantan
Study officials:
References:
Clinical trial NCT01166633: Efficacy and Safety Study of Pitavastatin Versus Atorvastatin to Treat Hypercholesterolemia
Official title: A Randomized , Open Label, Dose Titration Study to Evaluate the Effect of Pitavastatin Versus Atorvastatin in Patients With Hypercholesterolemia and Mild to Moderate Hepatic Damage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Keywords: Hydroxymethylglutaryl-CoA Reductase Inhibitors
hyperlipidemia
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2010-07-21
Enrollment: 200
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Statin is an effective drug to treat hyperlipidemia (hypercholesterolemia), and it rarely leads to hepatic damage to the patients with hepatic disorder. For these patients, intensive monitoring is required.


Eligibility criteria: Inclusion Criteria:

* Patients aged between 25 and 75
* Patients who signed informed consent forms of their own volition;
* Patients who had taken statins for 2 months and longer or whose fasting LDL-C levels, were 130mg/dL and over (Friedewald's formula);
* Patients whose ALT levels were 1.25 to 2.5 times higher than the upper limit of normal

Exclusion Criteria:

* Patients with uncompensated liver cirrhosis.
* Patients whose total bilirubin levels were over 2 times higher than the upper limit of normal.
* Patients who had taken antiviral drugs for viral hepatitis.
* Patients who experienced cerebrovascular diseases or myocardial infarction within 3 months before screening visit or patients with heart failure (NYHA class IV).
* Patients whose triglyceride(TG) levels were 400mg/dL or higher.
* Patients with uncontrolled hypertension (DBP≧100mmHg)
* Patients under suspicion of renal dysfunction (serum creatinine≧2.0mg/dL)
* Patients whose CK levels were over 2.5 times higher than the upper limit of normal.
* Patients with uncontrolled hypothyroidism although drug treatment (TSH≧ULN×1.5)
* Female patients who were nursing or being pregnant or were planning on becoming pregnant.
* Patients judged to be unsuitable by investigators.

Primary outcomes:
measure: Proportion of the subjects whose ALT levels were over CTCAE grade II after treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: 1.Changes in ALT after treatment
timeFrame: 12 weeks
measure: 2.Changes in AST after treatment
timeFrame: 12 weeks
measure: 3.Changes in LDL-C, TC, TG and HDL-C after treatment
timeFrame: 12 weeks
measure: 4.Changes in fat in liver after treatment
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Kangdong Sacred Heart Hospital
name: Kyoo-Rok Han
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01673633: Sacroiliitis in Systemic Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Sclerosis
Sacroiliitis
Inflammatory Back Pain
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2012-08-28
Enrollment: 175
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive systemic sclerosis and rheumatoid arthritis patients and healthy volunteers

Brief summary: One of the major problems of systemic sclerosis (SSc) patients is suggested to be articular involvement. Mostly involved joints in SSc were reported as wrist, carpometacarpal-interphalangeal, foot, knee, hip and shoulder however there have been little knowledge on sacroiliac joint. Here the investigators plan a study on the involvement of this joint in SSc.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed as systemic sclerosis and rheumatoid arthritis and healthy volunteers

Exclusion Criteria:

* Not giving informed consent

Primary outcomes:
measure: The frequency of sacroiliitis in systemic sclerosis
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: