louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00668200: Impact on Reducing the Incidence of Low Serum Calcium by Providing Educational Materials on the Need to Take Daily Supplemental Calcium and Vitamin D to Patients With Paget's Disease Treated With Reclast®
Official title: Post US Approval Voluntary Registry Study to Determine Incidence of Hypocalcemia Post Reclast® Treatment in Patients With Paget's Disease After Institution of Educational Strategies to Improve Adherence to Calcium and Vitamin D Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Paget's Disease of the Bone
Hypocalcemia
Keywords: Paget's
hypocalcemia
zoledronic acid
serum calcium
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-04-29
Enrollment: 81
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the impact of investigator and patient education and educational materials to foster calcium and vitamin D supplementation to mitigate the potential for hypocalcemia post Reclast® administration in patients with Paget's disease of bone.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* As per currently approved Reclast® Package Insert:

Exclusion Criteria:

- As per currently approved Reclast® Package Insert:

Primary outcomes:
measure: Percentage of Patients With Serum Calcium <2.07 mmol/L at 9-11 Days After Receiving Zoledronic Acid.
timeFrame: at Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)
Secondary outcomes:
measure: Change From Baseline in Serum Calcium (mmol/L) - Safety Population
timeFrame: Baseline, Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)
measure: Percentage of Newly Occurring Post-baseline Hypocalcemia Symptoms Based on Hypocalcemia Questionnaire at End of Study Visit 2 or Visit 3 (Safety Population)
timeFrame: End of study: Visit 2 (days 9 - 11 post-infusion) or visit 3 (day 30)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Tucson
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Gainesville
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Detroit
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Syracuse
country: United States
facility: Novartis Investigative Site
state: New York
city: Providence
country: United States
facility: Novartis Investigative Site
state: Rhode Island
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Waco
country: United States
facility: Novartis Investigative Site
state: Texas
city: Madison
country: United States
facility: Novartis Investigative Site
state: Wisconsin
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06427200: Efficacy and Safety of Lactoferrin in Heart Failure Patients
Official title: Efficacy and Safety of Lactoferrin in Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Heart Failure With Reduced Ejection Fraction
Keywords: Lactoferrin
oral iron
reduced ejection fraction
iron deficiency
heart failure
clinical trial
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to determine the efficacy and safety of lactoferrin versus oral iron versus lactoferrin plus oral iron as an add on therapy in reduced ejection fraction heart failure patients with iron deficiency.

•Patients will be randomly distributed into the three groups

* All patients will be subjected to baseline data assessment
* Follow up after 12 weeks


Eligibility criteria: Inclusion Criteria:

1. Age: 18-65 years old.
2. Chronic heart failure (\> 6 months duration) with reduced ejection fraction defined as LVEF ≤ 40%.
3. NYHA-class II or III or IV with stable symptoms for at least the past 3 months.
4. Stabilized on beta blockers, renin-angiotensin system inhibitor (ACEI/ARB) or angiotensin receptor-neprilysin inhibitors (ARNIs), mineralocorticoid receptor antagonists (MRAs) and sodium-glucose co-transporter 2 Inhibitors (SGLT2i) and diuretics as needed.
5. No dose changes of heart failure drugs during the last 2 weeks (exception: diuretics)
6. No introduction of a new heart failure drug class during the last 4 weeks.
7. Iron deficiency: serum ferritin level of 15 to 100 ng/mL or a serum ferritin level of 101 to 299 ng/mL with transferrin saturation of less than 20%.

Exclusion Criteria:

* 1. Arrythmia including atrial fibrillation (AF) with poorly controlled ventricular rate at rest (\> 100 beats/min).

  2. Recent cardiac related hospitalizations in the past 3 months. 3. Known active infection. 4. Associated chronic medical disorder (chronic kidney disease (creatinine clearance \< 60 ml/min), liver disease (ALT or AST \> 3× upper limit of normal), peptic ulcer or chronic blood loss).

  5. Associated bleeding disorder. 6. Previous iron supplement in past 3 months. 7. Anemia requiring blood transfusion (haemoglobin (Hb) \< 7 g/dL). 8. Folic acid or vitamin B12 deficiency. 9. Hypersensitivity to lactoferrin or iron. 10. Haemoglobinopathies (G6PD, thalassemia's, sickle cell disease). 11. Pregnancy and lactation.

Primary outcomes:
measure: Change in health-related quality of life (HR-QoL)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00037700: Evaluation of the Efficacy of Combination Treatment With Anakinra and Pegsunercept in Improving Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Swedish Orphan Biovitrum
Sponsor class: INDUSTRY
First posted: 2002-05-21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of anakinra (IL-1 ra) and pegsunercept (PEG sTNF-RI) when they are used together in improving the signs and symptoms of rheumatoid arthritis. The study will also evaluate the safety of the combination treatment and its effect on slowing down bone and joint destruction due to rheumatoid arthritis. The results will be compared to the effect when only 1 single medication (anakinra or pegsunercept) is used.


Eligibility criteria: * diagnosed with rheumatoid arthritis for at least 6 months
* must be taking methotrexate \* must not take DMARDS other than methotrexate during the study
* must not have had previous treatment with and protein-based TNF-alpha inhibitor (eg. etanercept, infliximab, PEG sTNF-RI, or D2E7)
* must not have had previous treatment with anakinra
* subjects must meet tender and swollen joint requirements at screening, have morning stiffness, and/or have elevated acute phase reactants

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01589900: Identification the Expression of Sox2 in Colorectal Cancer Tissues
Official title: The Role of Sox2 in Tumor Genesis and Migration in Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: colorectal cancer
invasion
metastasis
IHC
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2012-05-02
Enrollment: 136
Sex: ALL
Minimum age (years): 24
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All rchived 136 tissues were obtained and pathologically confirmed from patients who underwent surgical resections between 2005 and 2006 at the Cancer Center of Sun Yat-sen University (Guangzhou, Guangdong, P. R. China)). The patients from whom the samples were derived underwent curative resection between 2005 and 2006. Tumor differentiation was characterized according to WHO classification, while the surgical pathologic stage was analyzed according to the TNM classification system of the International Union against Cancer. All samples were anonymously coded in accordance with local ethical guidelines.

Brief summary: Sox2 has been studied in several types of human solid tumors. The investigators found that Sox2 had higher expression level in colorectal cancer and metastatic tissues than normal tissues. So the investigators assumed that whether Sox2 plays an important role in the progression and migration of colon cancer.

Detailed description: In our study, we examined Sox2 expression in archived human colon cancer tissues and found that its Sox2 expression correlates with reduced patient survival, increased tumor grade and metastasis probability.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of colorectal cancer

Exclusion Criteria:

* Clinical diagnosis characteristics not exactly described in the patients information

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Laboratory of Cancer and Stem Cell Biology School of Life Sciences Sun Yat-sen University
name: Yan Zhang, M.D.Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00978900: Effects of Artificial Sweetener on Gastrointestinal (GI) Peptide Secretion
Official title: Carbohydrates and Non Caloric Sweeteners: Differential Effects on Appetite and Secretion of Gastrointestinal Satiety Peptide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: satiety peptides
GLP-1
PYY
ghrelin
appetite profile
Sweetening Agents
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2009-09-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine the influence of artificial sweeteners (aspartame, acesulfame K, sucralose) and carbohydrate sugars (glucose, fructose) on the release of gastrointestinal satiety hormones in humans.

Detailed description: Artificial Sweeteners significantly lower energy density of foods and beverages. They are used by diabetics as sugar substitutes as well as by consumers as aids for dietary control. Despite numerous studies which show mainly no influence of artificial sweeteners on glucose metabolism and food intake, discrepancies consist about the real effects of artificial sweeteners. Studies by Blundell and Hill in 1986 have however shown that the consumption of artificial sweeteners resulted in an increase of appetite ratings; the efficiency of AS has therefore been questioned. With respect to the world wide increase in the prevalence in obesity, it seems important to clarify whether artificial sweeteners can help regulate body weight or not. This study will explore the effect of artificial sweeteners on the release of the gastrointestinal satiety hormones PYY, GLP-1, GIP and ghrelin.

Eligibility criteria: Inclusion Criteria:

* Healthy subject with a body-mass index of 19.0-24.5
* Normal eating habits
* Age 18-40 years
* Stable body weight for at least three months

Exclusion Criteria:

* Smoking
* Substance abuse
* Regular intake of medications (except for oral contraceptives)
* Medical or psychiatric illness
* history of gastrointestinal disorders
* food allergies

Primary outcomes:
measure: Gastrointestinal peptide secretion
timeFrame: 2 hour blood sampling
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Research Center, University Hospital Basel
name: Christoph Beglinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05769400: Awareness of Osteoporosis in Patients With Hepatitis C Infection
Official title: Awareness of Osteoporosis in Patients With Hepatitis C Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C
Osteoporosis
Osteoporosis Risk
Lead sponsor: Uskudar State Hospital
Sponsor class: OTHER_GOV
First posted: 2023-03-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 to 90 years with hepatitis c virus infection who gave consent to participate in the study.

Brief summary: Osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. Patients with hepatitis c virus infection are at increased risk for developing osteoporosis. Identifying whether patients with hepatitis c virus infection have information and awareness about this disease is crucial. This study is aimed to investigate awareness and knowledge of osteoporosis in patients with hepatitis c virus infection.

Detailed description: Osteoporosis is a common disease of bone loss. The reduced bone strength predisposes an increased risk for fractures in older individuals. It can affect people from different ethnicity. Many factors increase the risk of osteoporosis, including age, postmenopausal state, glucocorticoid use, low body weight, calcium, vitamin D, immobility, and chronic inflammation. Patients with hepatitis c virus infection are at high risk of developing osteoporosis due to chronic inflammation and their medications. Patients' knowledge and awareness about osteoporosis are essential for early detection, implementation of lifestyle changes, and treatment compliance. This study aimed to investigate osteoporosis awareness and knowledge about osteoporosis in patients with hepatitis c virus infection.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of hepatitis b virus infection
* Must be between the ages of 18 and 90
* Must give consent to participate in the study

Exclusion Criteria:

• Not giving consent

Primary outcomes:
measure: Revised Osteoporosis Knowledge Test
timeFrame: 1 day
Secondary outcomes:
measure: Osteoporosis Self-Efficacy Scale
timeFrame: 1 day
measure: Osteoporosis Health Belief Scale
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Uskudar State Hospital
name: Mustafa H Temel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04457700: CT-based Radiomics of ALN pCR (ypN0) in Breast Cancer Undergoing NAC
Official title: Computed Tomography-based Radiomics of Axillary Lymph Node Pathological Complete Remission (ypN0) in Breast Cancer Undergoing Neoadjuvant Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Triple-negative Breast Cancer
HER2-positive Breast Cancer
Keywords: Breast cancer
Neoadjuvant chemotherapy
Lymph node
Radiomic
Pathologic complete remission
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 218
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Triple-negative or HER2-positve invasive breast cancer with axillary lymph node metastasis: stage T1-3N1-2M0.

Brief summary: This is a prospective, single-center, non-randomized, non-controlled observational study.

Detailed description: Almost 55-62% of patients with triple-negative or human epidermal growth factor receptor 2 (HER2) positive, node-positive breast cancer achieve an axillary pathologic complete remission (pCR) after neoadjuvant chemotherapy (NAC). To avoid surgery post-NAC, it is paramount to accurately identify patients who achieve pCR in axillary lymph node (ALN). We found that patients with normal-appearing lymph nodes on computed tomography (CT) based radiomics of the axilla after chemotherapy had a lower risk of developing residual nodal disease. However, the features of CT-based radiomics for pCR ALN following NAC has not been established yet. This study aimed to assess the performance of CT-based radiomics in evaluating the response and predicting pCR of metastatic lymph nodes after NAC in breast cancer patients.

Eligibility criteria: Inclusion Criteria:

* Triple-negative or HER2-positve invasive breast cancer with axillary lymph node metastasis by confirmed by fine needle aspiration or core needle biopsy.
* Underwent computed tomography for assessment of axillary lymph node status before and after neoadjuvant chemotherapy.
* Attend the study voluntarily, sign the informed consent.

Exclusion Criteria:

* Contradiction for adjuvant chemotherapy.
* Contradiction for proceeding surgery.

Primary outcomes:
measure: The features of CT-based radiomics for axillary lymph node achieved pCR after neoadjuvant chemotherapy
timeFrame: within 8 weeks after obtaining the post-surgery pathological results
Secondary outcomes:
measure: Receiver operating characteristic (ROC) curve analysis
timeFrame: within 8 weeks after obtaining the post-surgery pathological results
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
affiliation: Breast center at Peking University Cancer Hospital
name: Lize Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00748800: An Affect Management Intervention for Juvenile Offenders
Official title: An Affect Management Intervention for Juvenile Offenders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: HIV prevention
HIV seronegativity
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2008-09-09
Enrollment: 95
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Adolescents are at risk for HIV because of sexual and drug behavior initiated during this developmental period. Adolescents in the juvenile justice system are at increased risk for HIV due to higher rates of substance use and psychopathology than their non-offending peers. Juvenile justice youth may therefore also be less likely to benefit from frequently used skills based interventions. It appears that emotional lability, frequently found in this population, disrupts skills learned. This project will implement and evaluate an affect management HIV prevention intervention for adolescents in a juvenile drug court program. Affect management and general health promotion interventions will be compared to determine which intervention best reduces risk behavior among adolescents in the drug court.


Eligibility criteria: Inclusion Criteria:

* Adolescents enrolled in the juvenile drug court program

Exclusion Criteria:

* Adolescent is HIV positive
* Adolescent is pregnant
* Adolescent is developmentally delayed
* Adolescent has history of sexual crime

Primary outcomes:
measure: Adolescent-reported sexual activity and condom use
timeFrame: 3 month post-intervention
Secondary outcomes:
measure: Adolescent substance use (self-report and urine toxicology screen results)
timeFrame: 3 months post-intervention
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Larry K Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04599400: Online Information on Myofascial Pain Syndrome
Official title: Quality and Readability of Online Information on Myofascial Pain Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myofascial Pain Syndrome, Diffuse
Keywords: muscle
pain
online information
Lead sponsor: Kars State Hospital
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 151
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Not appropriate

Brief summary: The investigators aim in this study is to evaluate myofascial pain syndrome (MPS) related websites in terms of the quality and the readability of the information. Also, to identify the typologies of websites that provide high-quality information about MPS.

Detailed description: Introduction The reliability of information on the internet, which people use as an easy and practical solution about diseases, is very important for public health. The ivestigatior aim in this study to evaluate the quality and readability of websites related to myofascial pain syndrome.

Methods On April 4, 2020, web sites were searched on the Google search engine by using the term "myofascial pain syndrome". The typologies, quality and readability parameters of the sites were analyzed. Websites were divided into eight categories according to typology. In order to evaluate the quality, it is checked whether there is JAMA scoring system and HONcode certificate. Flesch-Kincaid grade and the Simple Measure of Gobbledygook was used to evaluate readability.

Eligibility criteria: Inclusion Criteria:

• The URL of the first 200 sites

Exclusion Criteria:

* The sites in languages other than English
* The sites with video and audio recording but without reading text
* The sites with access problems or requesting registration
* Subscription and the sites that do not provide information about myofascial pain syndrome

Primary outcomes:
measure: % of websites
timeFrame: One day
measure: Readability Scores
timeFrame: One day
measure: Readability Scores
timeFrame: One day
measure: Quality Scores
timeFrame: One day
measure: Reliability sertification
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Biruni University Faculty of Medicine
Study officials:
affiliation: Biruni University Faculty of Medicine
name: Fatih Bagcier
role: PRINCIPAL_INVESTIGATOR
References: