louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06523114: Transcatheter Arterial Embolization for Elbow and Foot Plantar Pain
Official title: Transcatheter Arterial Embolization for Relief of Chronic Musculoskeletal Elbow and Foot Plantar Pain Refractory to Conservative Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Elbow Tendinitis
Elbow Tendinopathy
Epicondylitis of the Elbow
Epicondylitis, Lateral
Plantar Fascitis
Embolization
Lead sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Sponsor class: OTHER
Collaborators: name: Dongkook Pharmaceutical Co., Ltd.
First posted: 2024-07-26
Enrollment: 13
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective single arm study in which patients with moderate to severe chronic elbow or foot plantar pain, in the setting of lateral epicondylitis or plantar fascitis refractory to conservative treatment, will be enrolled.

The primary aim of this study is to estimate the effectiveness and safety of transcatheter arterial embolization (TAE) for changes in elbow or plantar pain with 6 and 12-month follow-up.

Detailed description: This is a prospective single arm, single center study at Chung-Ang University Hospital. Patients with moderate to severe elbow or foot pain, and pain refractory to at least 6 months of physician directed conservative therapy (oral analgesic, physical therapy or local injection treatment) will be eligible for enrollment.

Transcatheter arterial embolization (TAE) is performed after receiving informed consent, and imipenem is used as an embolic material to embolize the target lesion. After the procedure, evaluate the VAS score and limitation of range of motion (LOM) of the joint area.

Follow-up at 1, 3, 6 and 12 months after embolization, and changes of VAS score and LOM are checked.

Eligibility criteria: Inclusion Criteria:

* Patients who voluntarily signed a written consent form after receiving an explanation of the purpose, method, and effects of this clinical trial
* Patients who have had pain in the relevant area for more than 6 months and have a history of receiving physical therapy, analgesic anti-inflammatory medication, or local injection treatment
* Patients in whom hypervascularization was confirmed in the relevant area through imaging results (US, CT, MRI) evaluating the cause of pain.

Exclusion Criteria:

* Patients are pregnant or breastfeeding
* Local infection in the painful area
* Patients have a bleeding disease

Primary outcomes:
measure: Visual Analog Scale Pain (VAS) Score
timeFrame: 1,3,6,12 month
Secondary outcomes:
measure: Adverse Events
timeFrame: 1,3,6,12 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
affiliation: Associate Professor
name: Woosun Choi, MD. Ph D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00040014: Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women
Official title: Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women With Advanced Breast Cancer Having Progressed on Tamoxifen.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2002-06-20
Enrollment: 100
Sex: FEMALE
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 find out if the two different formulations of exemestane (Aromasin), oral and injectable, are equivalent in terms of pharmacodynamics and pharmacokinetics, i.e., if ultimately both formulations have the same efficacy in postmenopausal women with metastatic breast cancer who have failed previous antiestrogens therapy and are equally safe.


Eligibility criteria: Inclusion Criteria:

* other diagnosed with breast cancer
* estrogen receptor positivity
* Postmenopausal status
* advanced disease
* progression to previous tamoxifen therapy

Exclusion Criteria:

* more than 1 chemotherapy and / or more than 1 hormonotherapy for advanced disease
* previous hormonotherapy other than Tamoxifen

Primary outcomes:
measure: To determine the pharmacodynamic equivalence at steady state of the IM formulation of exemestane with the oral formulation in terms of plasma estrone sulphate inhibitory effect in postmenopausal women with advanced breast cancer.
Secondary outcomes:
measure: to characterize the pharmacodynamic profile of the two formulations in terms of estrogens, androgens, and sec hormone binding globulin
measure: to characterize the pharmacokinetics of exemestane and 17 hydroexemestane after administration of the two formulations
measure: to evaluate the relationships between pharmacokinetics and pharmacodynamics after intramuscular and oral administration of exemestane
measure: to evaluate the efficacy (as tumor response)
measure: to evaluate the incidence and severity of systemic toxicities and of the local tolerability of the injectable formulation
measure: to evaluate the effect on serum bone turnover markers
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05622214: The Efficacy and Tolerability of 12-weeks Treatment With Almond and Buckwheat Based Formula in Pediatric Patients With Active EoE
Official title: An Open Label, Pilot Study Assessing the Efficacy and Tolerability of 12-weeks Treatment With Almond and Buckwheat Based Formula in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eosinophilic Esophagitis
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Else Nutrition GH Ltd
First posted: 2022-11-18
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Eosinophilic esophagitis (EoE) is a chronic, relapsing, immune-mediated esophageal disease. Clinical manifestations in infants and toddlers generally include vomiting, food refusal, choking with meals and, less commonly, failure to thrive. The management of the disease includes dietary and pharmaceutical interventions, and the goal of the treatment should ideally be both the resolution of symptoms and the normalization of the macroscopic and microscopic abnormalities. Milk is the most common food trigger identified, followed by wheat, soy, and eggs. The aim of the study is to examine the tolerability of a new plant based formula made of minimally processed almond and buckwheat and enriched with vitamins and minerals.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients with active EoE (naïve and experienced)
* Ages 1-18 years

Exclusion Criteria:

* Change in dosing of Proton pump inhibitors (PPI) medication
* Local steroid treatment \< 1 month
* Refusal to comply with study protocol
* Known allergy to almonds and buckwheat
* Use of dairy during the study

Primary outcomes:
measure: Improvement in Pediatric Eosinophilic Esophagitis Symptom Severity Module (PEESS), endoscopic and histological scoring
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Campus
name: Ron Shaoul, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00957814: Nutritional Orientations and Adherence, Nutritional Status, Clinical and Life Quality Parameters of Heart Failure (HF) Patients
Official title: Impact of Nutritional Orientations on Adherence to Diet and Relation to Nutritional, Clinical and Life Quality Parameters of Heart Failure Outpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition
Heart Failure
Keywords: nutritional education
diet adherence
nutritional knowledge
life quality
nutritional status
impact of nutritional orientations by a systematic education program applied to outpatients with HF, in comparison to patients in a conventional treatment.
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
First posted: 2009-08-12
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The nutritional systematic orientations in outpatients with heart failure throughout 1 year in comparison to conventional treatment is estimated to lead to higher nutritional treatment adherence and improved nutritional status, clinical and life quality parameters.

Detailed description: To evaluate the impact of systematic nutritional orientation on adherence to diet and relation to clinical, life quality and nutritional knowledge parameters in heart failure outpatients.

* To evaluate the impact of systematic nutritional orientation on nutritional status;
* To evaluate the impact of nutritional systematic orientation on dietary patterns
* To evaluate the impact of systematic nutritional orientation on clinical and biochemical parameters
* To evaluate the impact of nutritional systematic orientation on life quality
* To evaluate the impact of nutritional systematic orientation on nutritional knowledge

Eligibility criteria: Inclusion Criteria:

* \>= 18 years old
* Outpatients from the HF Ambulatory (HCPA)
* Functional class I and II (NYHA)

Exclusion Criteria:

* Outpatient who had received any orientation from a nutritionist in the last 6 months
* Outpatients which has not received nursing orientation in the ambulatory,
* Patients from other NYHA class
* Non alphabetized

Primary outcomes:
measure: Diet adherence
timeFrame: 1 year
Secondary outcomes:
measure: Knowledge about nutrition, nutritional status, biochemical parameters and life quality
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01091714: Is Omega-3 Fatty Acid Red Blood Cell (RBC) Saturation Product Dependent?
Official title: Is Omega-3 Fatty Acid RBC Saturation Product Dependent?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardioprotective Levels
Lead sponsor: Bucci Laser Vision Institute
Sponsor class: OTHER
First posted: 2010-03-24
Enrollment: 60
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: To demonstrate that RBC saturation of the Omega-3 fatty acids reaching cardioprotective levels as proven with the HS-Omega-3 Index test will be achieved most efficiently depending on a specific product utilized within this study.

Detailed description: To demonstrate that RBC saturation of the Omega-3 fatty acids reaching cardioprotective levels as proven with the HS-Omega-3 Index test will be achieved most efficiently depending on a specific product utilized within this study. The HS-Omega-3 Index is a new test that measures blood levels of the cardioprotective omega-3 fatty acids, EPA and DHA. RBS saturation is being measured to identify how much Omega 3 is in the blood.

Eligibility criteria: Inclusion Criteria:

* Willing and able to give written informed consent.
* Subject motivation and willingness to cooperate with the investigator by following the required medication regimen.
* Subject willingness and ability to return for all visits during the study.
* Must be willing to discontinue all use of Omega-3 supplementation 2 weeks prior to study participation.

Exclusion Criteria:

* Concurrent involvement in any other clinical trial involving an investigational drug or device.
* Compromised cognitive ability which may be expected to interfere with study compliance.
* Uncontrolled or poorly controlled systemic disease ot the presence of any significant illness that could, in the judgment of the investigator, jeopardize subject safety or interfere with the interpretation of the results of the study.
* Subjects must not eat more that 1 non-fried fish meal per week.
* Subjects must not have undergone any bariatric surgery or have a malabsorption disorder.

Primary outcomes:
measure: RBC saturation of Omega-3 fatty acids reaching cardioprotective levels as proven with HS-Omega_3 Index test.
timeFrame: one month
Secondary outcomes:
measure: RBC saturation of Omega-3 fatty acids reaching cardioprotective levels as proven with HS-Omega_3 Index test.
timeFrame: 3 months
Other outcomes:
Locations:
city: Wilkes-Barre
country: United States
facility: Bucci Laser Vision Institute
state: Pennsylvania
Study officials:
affiliation: Bucci Laser Vision Institute
name: Frank A Bucci, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03416114: RegistRare: a Retro-prospective Registry of Rare Primary Headaches in Italian Tertiary Headache Centres
Official title: RegistRare: a Retro-prospective Registry of Rare Primary Headaches in Italian Tertiary
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Headache Disorders
Keywords: rare headaches
epidemiology
Lead sponsor: University of Florence
Sponsor class: OTHER
Collaborators: name: University of Modena and Reggio Emilia
name: University of Roma La Sapienza
name: University of Naples
name: University of Trieste
name: Maggiore Bellaria Hospital, Bologna
name: University of L'Aquila
First posted: 2018-01-30
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective data collection:

Patients referred to Italian Tertiary Headache Centres in a 3-year (May 1, 2014 to April 30, 2017) period

Prospective data collection:

Patients referred to Italian Tertiary Headache Centres after April 30, 2017

Brief summary: Retro-prospective survey on specific and overall prevalence and incidence of rare primary headaches (Part One, Chapter 3 and Chapter 4, ICHD-3 beta) in patients referred to Italian Tertiary Headache Centres in a 3-year (May 1, 2014-April 30, 2017 - retrospective data) and annually (from May 1, 2017 - prospective data).

Detailed description: We planned to collect data from May 1, 2014 and afterwards, by means of both retrospective and prospective approaches.

All patients who have received or will receive a diagnosis of rare primary headache will be asked to participate and, to this aim, to give their informed consent. Each participating Centre should have received the approval of the competent Ethics Committee before commencing any study procedures.

The registry will contain anagraphic information and data about diagnosis, treatment, comorbidity, and clinical features of the headache. Patients' data will be coded through the Italian Health System unique identifier, in order to avoid duplications of patients referring to more than one Centre and also to monitor multiple referrals.

A web-based open source platform (SurveyMonkey.org) will be used to collect data.

Eligibility criteria: Inclusion Criteria:

* diagnosis of rare primary headaches (Part One, Chapter 3 and Chapter 4, ICHD-3 beta)
* signed informed consent

Exclusion Criteria:

* none

Primary outcomes:
measure: Incidence and prevalence in Tertiary headache Centres
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Careggi University Hospital
Study officials:
affiliation: Careggi University Hospital
name: Silvia Benemei, MD
role: STUDY_CHAIR
References:
citation: Lupi C, Evangelista L, Favoni V, Granato A, Negro A, Pellesi L, Ornello R, Russo A, Cevoli S, Guerzoni S, Benemei S. Rare primary headaches in Italian tertiary Headache Centres: Three year nationwide retrospective data from the RegistRare Network. Cephalalgia. 2018 Jul;38(8):1429-1441. doi: 10.1177/0333102418768824. Epub 2018 May 12.
Clinical trial NCT04410614: Dimensional Changes of Free Epithelial Graft at Teeth and Implant Sites
Official title: Dimensional Changes of Free Epithelial Graft at Teeth and Implant Sites: A Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratinized Mucosa
Lead sponsor: Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Teeth and implants receiving free epithelial grafts harvested from the palate
Primary purpose: TREATMENT

Brief summary: For the management of peridontal and peri-implant conditions, free epithelial grafts have been proposed to provide a sufficient band of keratinized mucosa with the goal of enhancing confort during brushing and reducing the level of inflammation. Nevertheless, these are subjected to dimensional changes that may jeopardise the final outcome of providing sufficient keratinized mucosa to teeth and implants. Hence, this prospective study will aim at shedding light on the dimensional changes and the variables affecting these changes.


Eligibility criteria: Inclusion Criteria:

* Patients in need of keratinized mucosa to improve the periodontal and peri-implant condition
* With no uncontrolled disease
* Non-smokers

Exclusion Criteria:

* Patients with uncontrolled diseases and conditions
* Smokers
* Patients with sufficient keratinized mucosa

Primary outcomes:
measure: Change in keratinized mucosa
timeFrame: 3 weeks, 3 months, 6 months follow-up
Secondary outcomes:
measure: Factor 1 affecting the dimensional changes
timeFrame: 3 weeks, 3 months, 6 months
measure: Factor 2 affecting the dimensional changes
timeFrame: 3 weeks, 3 months, 6 months
measure: Factor 3 affecting the dimensional changes
timeFrame: 3 weeks, 3 months, 6 months
Other outcomes:
Locations:
city: Badajoz
country: Spain
facility: Centro de Implantologia Cirugia Oral y Maxilofacial
Study officials:
References:
citation: Monje A, Blasi G. Significance of keratinized mucosa/gingiva on peri-implant and adjacent periodontal conditions in erratic maintenance compliers. J Periodontol. 2019 May;90(5):445-453. doi: 10.1002/JPER.18-0471. Epub 2018 Dec 7.
citation: Monje A, Blasi G, Amerio E, Sanz-Martin I, Nart J. Dimensional changes in free epithelialized gingival/mucosal grafts at tooth and implant sites: A prospective cohort study. J Periodontol. 2022 Jul;93(7):1014-1023. doi: 10.1002/JPER.21-0521. Epub 2022 Jan 25.
Clinical trial NCT02940314: Safety and Pharmacokinetic Characteristics After Administration of HIP1503 and HGP1103 in Healthy Male Volunteers
Official title: A Randomized, Open-label, Single Dose, 2-way Crossover Study to Compare the Safety and Pharmacokinetic Characteristics After Administration of HIP1503 and HGP1103 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overactive Bladder
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2016-10-20
Enrollment: 36
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and pharmacokinetic characteristics after administration of HIP1503 and HGP1103 in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

1. Healthy male volunteers, age 19 to 45 years.
2. The result of Body Mass Index(BMI) 17.5 kg/m2\~ 30.5 kg/m2, body weight over 55kg.
3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing.

Exclusion Criteria:

1. Presence of medical history or a concurrent disease, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
2. Medical history of Gastrointestinal Diseases that effects drug absorption (esophageal disease, chronic disease) or surgery( except appendectomy , herniolaparotomy)
3. sit SBP \> 140 mmHg, sit DBP \> 90 mmHg
4. Alcohol or Drug abuse within 1 year

Primary outcomes:
measure: AUClast
timeFrame: 0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14)
measure: Solifenacin Cmax
timeFrame: 0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14)
Secondary outcomes:
measure: Solifenacin AUCinf
timeFrame: 0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14)
measure: Solifenacin Tmax
timeFrame: 0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14)
measure: Solifenacin t1/2
timeFrame: 0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00346814: Antiangiogenic Therapy With Bevacizumab in Retinopathy of Prematurity. Structural Outcome
Official title: Antiangiogenic Therapy With Bevacizumab in Retinopathy of Prematurity. Structural Outcome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Retinopathy of Prematurity
Keywords: Retinopathy of prematurity
antiangiogenic therapy
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2006-06-30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purpose:Retinopathy of prematurity (ROP) continues tobe a major cause of blindness in children. Although ablation of the retina with laser or cryotherapy reduces the incidence of blindness by suppressing the neovascular phase of ROP the visual outcomes after treatment are often poor. Vascular endothelial growth factor(VEGF) has an important role in the pathogenesis of ROP and inhibition of VEGF expression in the neovascular phase might prevent destructive neovascularization in ROP. The aim of this study is to determine the safety and efficacy of intravitreal bevacizumab in the treatment of retinopathy of prematurity


Eligibility criteria: Inclusion Criteria:

* Retinopathy of prematurity stages III, IV and V in which we can not treat with laser o cryotherAPY

Exclusion Criteria:

* PATIENTS THAT COULD BE TREATED WITH CRYOTHERAPY OR LASER

Primary outcomes:
measure: Clinical appearance
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Asociación para Evitar la Ceguera en México Hospital "Luis Sanchez Bulnes"
state: Mexico DF
Study officials:
affiliation: Asociación para Evitar la Ceguera en México
name: Maria Martínez-Castellanos, MD
role: PRINCIPAL_INVESTIGATOR
References: