louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01144754: Observational Study of Diffuse Large B Cell Primary Breast Lymphomas Treated With RCHOP +/- XRT
Official title: A Prospective Observational Study of Newly Diagnosed Diffuse Large B Cell Primary Breast Lymphomas Treated With RCHOP With or Without Radiotherapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lymphoma
Non-Hodgkin's Lymphoma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-06-16
Enrollment: 1
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Previously untreated patients with DLBCL of the breast.

Brief summary: This is a multi-center observational study to assess addition of Rituximab in the treatment of previously untreated patients with Diffuse Large B-Cell Lymphomas(DLBCL) over an enrollment period of 60 months. Patients in this study are enrolling for the collection of their data on observations made during normal clinical practice.


Eligibility criteria: Inclusion Criteria:

* Previously untreated patients with DLBCL of the breast.
* Patients must have CD20 positive tumors.
* Stage IE or IIE.
* Must have at least one objective measurable or evaluable disease. Baseline measurements and evaluations must be obtained within 4 weeks of registration to the study.
* Patients must not have historical or radiographic evidence of CNS metastasis including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement.
* Patients must have an ECOG performance status 0-2.
* Patients must have adequate organ function as evidenced by the following laboratory studies (within 2 weeks prior to registration):

  * Creatinine Clearance \>= 50 ml/min
  * Total bilirubin \<= 2.0 mg/dl and AST \<= 2 x upper limit of normal. If documented hepatic involvement with lymphoma, total bilirubin can be \<= 3 x \*ULN, and AST \<= 5 x ULN.
  * Absolute neutrophil count \>= 1500/mm3 and platelet count \>= 100,000/mm3. If documented bone marrow involvement with lymphoma, absolute neutrophil count \>= 500/mm\^3 and platelet count \>= 50,000/mm\^3.
* Patients must be age \>= 18 years.
* Women must not be pregnant or breast feeding due to potential harmful effects to the fetus/baby. Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception.
* Patients must not have an active infection requiring parental antibiotics.
* Patients with known HIV infection are excluded.
* Patients must have a normal left ventricular ejection fraction to be eligible.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Kristen N. Ganjoo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04685954: Clinical Comparison of Bulk-fill and Incremental Composite
Official title: Clinical Comparison of Bulk-fill and Incremental Composite Resin Restorations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Disease
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical performance of a 5-mm bulk-fill and an incremental resin composite in class II restorations will be evaluated and compared. After recruiting participants with at least 2 approximal caries lesions, all restorations will be placed by a single clinician. All caries lesions will be removed before restoring. Cavities will be divided into two groups: a 5 mm bulk-fill composite resin \[Filtek™ Bulk Fill Posterior, 3M ESPE, St. Paul MN, USA (FB)\] and an incremental posterior composite resin \[Filtek Ultimate Universal, 3M ESPE, St. Paul MN, USA (FU)\] All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using modified United States Public Health Service (USPHS) criteria after a week (baseline) 6, 12, 24, 36 and 48 months. Descriptive statistics will be performed using chi-square tests.


Eligibility criteria: Inclusion Criteria:

* age range will be 18 to 65
* patients should have at least 2 approximal caries lesions require restoration
* healthy periodontal status
* a good likelihood of recall availability

Exclusion Criteria:

* poor gingival health
* adverse medical history
* potential behavioral problems

Primary outcomes:
measure: Clinical performances of different restorative systems according to USPHS criteria
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT05285254: The Impact of the Certified Child Life Specialist on Children's Pain During Immunizations
Official title: The Impact of the Certified Child Life Specialist in the Pediatric Primary Care Clinic on Children's Pain During Routine Immunizations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 126
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to provide the first systematic evidence that Certified Child Life Specialists reduce pain during vaccine administration and improve caregiver visit satisfaction in the pediatric primary care setting.


Eligibility criteria: Inclusion Criteria:

* Children 4-12 years of age presenting to MCHS Red Wing for a well child examination and vaccine administration.
* Parents or caregivers of any age presenting to well child examination with child.
* Legal guardians of all participants must provide verbal consent.
* Patients must provide verbal assent for participation.Verbal assent will be waived for children younger than 6 years.

Exclusion Criteria:

* Children with autism or other severe developmental disabilities.
* Children must be able to communicate pain before and after vaccine administration using the FPS-R.

Primary outcomes:
measure: Patient-reported pain
timeFrame: Post vaccine administration, approximately 1 hour
measure: Observed Negative Emotional Responses
timeFrame: Post vaccine administration, approximately 1 hour
Secondary outcomes:
measure: Caregiver visit satisfaction
timeFrame: Post vaccine administration, approximately 1 hour
Other outcomes:
Locations:
city: Red Wing
country: United States
facility: Mayo Clinic Health System - Red Wing
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Seth Gregory, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07018154: Gender Differences in Musculoskeletal Assessment Methods in Patients With Chronic Mechanical Low Back Pain
Official title: Gender Differences in Musculoskeletal Assessment Methods in Patients With Chronic Mechanical Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gender Differences
Musculoskeletal Assessment
Chronic
Low Back Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The current study is an observational test-retest study designed to investigate the effect of gender on core strength, balance, spinal mobility, and hamstring flexibility in patients with chronic nonspecific low back pain (NS-LBP).

Brief summary: This study is an observational test-retest study designed to investigate the effect of gender on core strength, balance, spinal mobility, and hamstring flexibility in patients with chronic non-specific low back pain (NS-LBP).

Detailed description: Low back pain (LBP) is the primary contributor to years of disability. Individual features (age, physical fitness), psychosocial factors (stress, anxiety, and depression), and occupational factors (hard physical work, bending and twisting motions, and vibration) have all been linked to the development of LBP, which is thought to have a complex etiology.

Eligibility criteria: Inclusion Criteria:

* Both sexes will be involved.
* Patients suffer from chronic NS-LBP for more than 3 months.
* Patients' age ranges from 18 to 40 years, and body mass index ranges from 18 to 25 kg/m2.
* Patients with sufficient cognitive abilities that enable them to understand and follow instructions.

Exclusion Criteria:

* History of spinal trauma or fractures.
* Osteoporotic patients.
* Patients using analgesics during the last 3 months.
* Pregnant or lactating females.
* Neurological musculoskeletal diseases that affect the lower back (eg, spondylosis, spondylolisthesis, disc injuries).
* Previous spinal surgery.
* Posture deformities.
* Cauda equina symptoms related to the spine, including changes in bowel and bladder control.
* Signs of severe pathology (eg, malignancy, inflammatory disorders).
* Patients with severe psychiatric disorders.

Primary outcomes:
measure: Core strength
timeFrame: 6 months post-procedure
Secondary outcomes:
measure: Balance control
timeFrame: 6 months post-procedure
measure: Spinal mobility
timeFrame: 6 months post-procedure
measure: Hamstring flexibility
timeFrame: 6 months post-procedure
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University (Physical therapy)
Study officials:
References:
Clinical trial NCT01610154: Contribution of Pancreatic αcells Function to Blood Glucose Regulation in Chinese Type 2 Diabetics- the Effect of Sitagliptin on Glucagon Secretion, Insulin Secretion and Insulin Resistance in Chinese Type 2 Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Insulin Secretion
Insulin Resistance
Keywords: glucagon
dipeptidyl peptidase-4 inhibitor
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2012-06-01
Enrollment: 85
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 1. The purpose of this study is to determine whether Sitagliptin therapy suppress glucagon release and improve glucose control in Chinese type 2 diabetic.
2. There are different effects of Sitagliptin therapy on blood glucose regulation, pancreatic alpha \& beta cell function are different in lean (BMI\<25) and overweight (BMI\>25) Chinese type 2 diabetics.
3. The purpose of this study is to determine whether glucagon release may contribute over 30% to the hyperglycemia in Chinese type 2 diabetics.


Eligibility criteria: Inclusion Criteria:

1. Age: 25\~60 years
2. Duration of disease \< 3 years,no drug treatment for diabetes
3. Newly diagnosed type 2 diabetic patients (fasting plasma glucose \> 7.0mmol/L or/and 2h postprandial blood glucose\>11.1mmol/L WHO 1999)
4. Fasting plasma glucose \< 10 mmol/L

Exclusion Criteria:

1. Type 1 diabetes
2. DKA, infection and other stress status
3. Autoimmune disease
4. Hepatic and renal diseases

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose (FPG)
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in Postprandial Plasma Glucose (PPG)
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in Insulin Sensitivity
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in Insulin Sensitivity in Patients With Different BMI
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in Pancreatic β Cell Function
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in Pancreatic β Cell Function in Patients With Different BMI
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in Pancreatic α Cell Function
timeFrame: Baseline to 12 weeks
measure: Change From Baseline in Pancreatic α Cell Function in Patients With Different BMI
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
Study officials:
References:
Clinical trial NCT03007654: Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®)
Official title: Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) for Intraperitoneal Adhesion in Patient With Gynecological Surgery, a Multicenter Single-blinded, Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gynecologic Disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 192
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the efficacy and safety of Mediclore®, as an antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan.


Eligibility criteria: Inclusion Criteria:

* Patients with Gynecological disease (benign disease)
* Patients who Written informed consent
* Patients without clinically significant lab

Exclusion Criteria:

* having enrolled another clinical trials within 1 month
* Immunosuppression or autoimmune disease
* Anticoagulant, general steroids within a week from surgery
* Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)
* Patients with previous history of surgery at the same operate site

Primary outcomes:
measure: adhesion rate
timeFrame: 4 weeks after surgery
Secondary outcomes:
measure: Incidence of adhesion symptoms
timeFrame: 4 weeks after surgery
measure: adverse event
timeFrame: 4 weeks after surgery
Other outcomes:
Locations:
city: Seoul City
country: Korea, Republic of
facility: Seoutl National University Hospital
Study officials:
References:
Clinical trial NCT05397054: Intervention for Monitoring of Salt Intake in Hypertensive Patients
Official title: Community-based Intervention for Monitoring of Salt Intake in Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Salt; Excess
Keywords: hypertension
salt
salt reduction
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: World Health Organization
name: Thai health promotion foundation.
First posted: 2022-05-31
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sodium is an essential nutrient for humans, but excessive sodium consumption is causally associated with high blood pressure and increase risk of cardiovascular diseases. Dietary sodium consumption of greater than the recommended daily amount of 5 grams of salt or 2,000 mg of sodium is a major risk factor for CVD-related mortality. From recent national survey, Thai people had consumed more than 9.1 g of salt per day, which was nearly two times above WHO reference level. Dietary salt reduction was unsuccessful because of lacking awareness, and the higher threshold to detect salt taste in chronic high salt ingestion. To create awareness in the community, we should be educated, managed the environmental for salt reduction, and used salt meter to detect sodium content in daily food. This study aimed to compare the efficacy of intervention; education, reformulation, environmental change and used salt meter compared with standard treatment alone in terms of salt intake reduction and blood pressure.

Detailed description: A randomized-controlled trial was conducted in adult 18-70 years old with hypertensive patients (SBP\>130 mmHg) in Uthaithani. Participants were randomized to intervention groups (education, reformulation, environmental change and used salt meter) and control group (standard education and treatment). Trial was followed up for 12 weeks. The primary objective was change in 24-hour urinary sodium excretion between groups and secondary objectives was change in systolic and diastolic blood pressure.

Eligibility criteria: Inclusion Criteria:

* Adults 18-70 years of age with hypertension
* Systolic blood pressure \> 130 mmHg
* Provided informed consent to participate in the study

Exclusion Criteria:

* Participants with end stage kidney disease
* History of adjust antihypertensive agents or diuretic within 2 weeks before enrollment
* Pregnant or breastfeeding women
* Adjustment of any antihypertensive agents during study period
* Participants with salt supplement

Primary outcomes:
measure: 24-hour urine sodium excretion
timeFrame: 12 weeks
Secondary outcomes:
measure: blood pressure
timeFrame: 4, 8 12 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Study officials:
References:
Clinical trial NCT00767754: Changes of Cerebral Glucose Metabolism After 12 Weeks of Paroxetine Treatment in Panic Disorder
Official title: Phase 4 Study of Panic Disorder That Expresses to Change of Cerebral Glucose Metabolism After 12 Week of Paroxetine Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Panic Disorder
Keywords: panic disorder
paroxetine
PET
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2008-10-07
Enrollment: 37
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Panic disorder is one of the most prevalent and disabling psychiatric disorders. Brain regions such as amygdala, hippocampus, periaqueductal gray (PAG), locus coeruleus, parahippocampal gyrus, frontal cortex, and thalamus has been reported to be related with the pathophysiology and treatment outcome in panic disorder. Paroxetine has been used as primary agent for treatment of panic disorder but there is little information on how paroxetine affects the brain function in patients with panic disorder.

The specific aim of this study is to examine the differences in brain activity between responders and nonresponders and to determine the predictor of paroxetine treatment in patients with panic disorder in terms of brain activity.


Eligibility criteria: Inclusion Criteria:

* panic disorder 20-60 years

Exclusion Criteria:

* history of major psychosis (schizophrenia or bipolar disorder), social phobia, obsessive-compulsive disorder, and generalized anxiety disorder, and posttraumatic stress disorder, alcohol abuse and dependence, current regular use of benzodiazepines
* less than 17 on the HAM-D

Primary outcomes:
measure: 18FDG PET, PDSS & HAM-A
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Bum-Hee Yu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01259154: Combined RF Surgery of the Tongue Base and Uvulopalatopharyngoplasty (UPPP) for Obstructive Sleep Apnea
Official title: Combined Bipolar Radiofrequency Surgery of the Tongue Base and Uvulopalatopharyngoplasty for Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea Syndrome
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2010-12-14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with obstructive sleep apnea not treated by CPAP

Brief summary: Introduction: The aim of the study was to investigate the effectiveness of combined bipolar radiofrequency surgery of the tongue base (RFBT) and uvulopalatopharyngoplasty (UPPP) in a single session for obstructive sleep apnea (OSA) and to determine whether this combination is safe and well tolerated.


Eligibility criteria: Inclusion Criteria: obstructive sleep apnea not treated by CPAP

Exclusion Criteria: a history of previous surgery for OSA and only one level of airway obstruction

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Faculty Hospital Motol
Study officials:
References:
Clinical trial NCT05172154: GlowTest COVID-19 Antigen Home Test Kit Usability Study
Official title: GlowTest COVID-19 Antigen Home Test Kit Usability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: Arion Bio
Sponsor class: INDUSTRY
Collaborators: name: CSSi Life Sciences
First posted: 2021-12-29
Enrollment: 35
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A minimum of 30 completed subjects with a minimum of 15 subjects testing themselves and a minimum of 15 subjects testing another person (child).

Brief summary: The purpose of this study is to evaluate the usability of the GlowTest COVID-19 Antigen Home Test in Home Use.

Detailed description: The Arion Bio GlowTest COVID-19 Antigen Home Test is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens from individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection. The test is intended for non-prescription home use with self collected direct anterior nares swab samples from individuals ages 14 years and older or adult collected anterior nares swab samples from individuals aged 2 to 13.

Eligibility criteria: Inclusion Criteria:

1. An Institutional Review Board (IRB) approved informed consent/assent is signed and dated prior to any study-related activities.
2. Male and female Subjects 2 years of age and older.
3. Subject is willing to provide a self-collected nasal swab sample. (If under the age of 14, the sample will be collected by an adult.)
4. Subject agrees to complete all aspects of the study.

Exclusion Criteria:

1. Subject has a visual impairment that cannot be restored with glasses or contact lenses.
2. Subject has prior medical or laboratory training.
3. Subject uses home diagnostics, e.g., glucose meters, HIV tests.
4. Subject has prior experience with home COVID test kits

Primary outcomes:
measure: Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation.
timeFrame: 90 minutes
measure: Assess the usability of the kit for home use based upon participant evaluation
timeFrame: 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Elkridge
country: United States
facility: Centennial Medical
state: Maryland
Study officials:
affiliation: Centennial Medical Group
name: Steven Geller, MD
role: PRINCIPAL_INVESTIGATOR
References: