louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00652002: Efficacy of Symbicort Versus Its Monocomponents - SPRUCE 160/4.5
Official title: A 12 Week, Randomized, Double-blind, Double-dummy, Placebo-controlled Trial of Symbicort TM (160/4.5mcg) Versus Its Mono-products (Budesonide and Formoterol) in Adolescents (at Least 12 Years of Age) and Adults With Asthma - SPRUCE 160/4.5
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Symbicort
budesonide/formoterol
budesonide
formoterol
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-04-03
Enrollment: 450
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare Symbicort with budesonide alone and with formoterol alone in the treatment of asthma in adolescents and adults


Eligibility criteria: Inclusion Criteria:

* At least 12 years of age
* Diagnosis of asthma
* Baseline lung function test results as determined by protocol and required and received treatment with inhaled corticosteroids and/or lung treatments specified in protocol within the timeframe and doses specified in the protocol

Exclusion Criteria:

* Has required treatment with non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
* Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator

Primary outcomes:
measure: 12 hour serial FEV1 measurements and withdrawals due to asthma exacerbation
timeFrame: FEV1: before start of tretment and at 2 and 12 weeks after start of treatment. Withdrawals: throughout the treatment period
Secondary outcomes:
measure: Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments
timeFrame: Throughout the treatment period
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Catherine Bonuccelli
role: STUDY_DIRECTOR
References:
citation: Tashkin DP, Moore GE, Trudo F, DePietro M, Chipps BE. Assessment of Consistency of Fixed Airflow Obstruction Status during Budesonide/Formoterol Treatment and Its Effects on Treatment Outcomes in Patients with Asthma. J Allergy Clin Immunol Pract. 2016 Jul-Aug;4(4):705-12. doi: 10.1016/j.jaip.2016.02.014. Epub 2016 Mar 30.
citation: Tashkin DP, Chipps BE, Trudo F, Zangrilli JG. Fixed airflow obstruction in asthma: a descriptive study of patient profiles and effect on treatment responses. J Asthma. 2014 Aug;51(6):603-9. doi: 10.3109/02770903.2014.895012. Epub 2014 Mar 19.
citation: Murphy KR, Uryniak T, Martin UJ, Zangrilli J. The effect of budesonide/formoterol pressurized metered-dose inhaler on predefined criteria for worsening asthma in four different patient populations with asthma. Drugs R D. 2012 Mar 1;12(1):9-14. doi: 10.2165/11630600-000000000-00000.
Clinical trial NCT01402102: A Human Trial to Evaluate the Efficacy and Safety of Aged Garlic Powder on Improvement of Blood Lipids in Subjects With Hyperlipidemia
Official title: Efficacy and Safety of Aged Garlic Powder on Lipids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hyperlipidemia
Keywords: Aged garlic
Hyperlipidemic
LDL
HDL
Triglyceride
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2011-07-26
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: We performed a double-blind parallel study in a group of mildly hypercholesterolemic subjects who were given aged garlic powder over a period of 12 weeks. We measured serum lipids, including total cholesterol, low-density-lipoprotein (LDL) and high-density-lipoprotein (HDL) cholesterol, and triglycerides, and monitored their blood pressure.

Detailed description: An increased serum cholesterol level is an important risk factor for the development of cardiovascular and cerebrovascular disease. Reduction of these and other risk factors through dietary modification, behavioral changes, and medicinal intervention has already substantially decreased the incidence and mortality from cardiovascular and cerebrovascular disease. Supplementation of the diet with certain biofactors may further reduce such risk factors. Aged garlic belongs to a group of dietary supplements that may lessen the incidence of cardiovascular and cerebrovascular disease by reducing lipids levels and decreasing platelet responsiveness to activating agents.

Eligibility criteria: Inclusion Criteria:

* Mild hypercholesterolemic subjects aged from 20 to 80 years
* had no received lipid-lowering drugs for at least 3 months prior to the recruitment

Exclusion Criteria:

* self-reported pregnancy,lactation
* prevalent heart disease,cancer,renal disorder, or diabetes mellitus, and use of lipid or antihypertensive medications

Primary outcomes:
measure: Changes in LDL-cholesterol(Low Density Lipoprotein - Cholesterol)
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in HDL-Cholesterol(High Density Lipoprotein - Cholesterol)
timeFrame: 12 weeks
measure: Changes in Triglycerides
timeFrame: 12 weeks
measure: Changes in Total Cholesterol
timeFrame: 12 weeks
measure: Changes in Apo-A1(Apolipoprotein A1)
timeFrame: 12 weeks
measure: Changes in Apo-B(Apolipoprotein B)
timeFrame: 12 weeks
measure: Changes in FFA(Free Fatty Acid)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
affiliation: Chonbuk National University Hospital
name: Dal-Sik Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00947102: Influence of Gemcitabine Treatment on Immunological and Serological Profile in Patients With Pancreatic Cancer
Official title: Observational Study - Influence of Gemcitabine Treatment on Immunological and Serological Profile in Patients With Pancreatic Tubular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Tubular Adenocarcinoma
Keywords: pancreatic tubular adenocarcinoma
gemcitabine
gene expression
immunological status
serological status
pancreatic tubular adenocarcinoma adjuvant setting
Lead sponsor: Blood Transfusion Centre of Slovenia
Sponsor class: OTHER_GOV
Collaborators: name: University Medical Centre Ljubljana
First posted: 2009-07-27
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after resection of pancreatic tubular adenocarcinoma

Brief summary: Observational study of influence of gemcitabine treatment on serological and immunological status and gene expression profile in patients with pancreatic tubular carcinoma after tumor resection.


Eligibility criteria: Inclusion Criteria:

* ECOG performance status 0-2 at the time of inclusion
* Following R0 or R1 pancreatic tubular adenocarcinoma resection

Exclusion Criteria:

* Pregnancy
* Serious comorbidity

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana; Department for Gastroenterology
Study officials:
References:
Clinical trial NCT06104202: Early Maladaptive Schemas in French Health Care Professionals With Burn Out
Official title: Early Maladaptive Patterns as Markers of Vulnerability and Targets for Therapeutic Intervention in Burned-out Healthcare Professionals
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Burn Out
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2023-10-27
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be made up of care professionals in a state of burn out, care professionals without a state of burn out, and care non-professionals in a state of burn out.

Brief summary: The purpose of this study is to compare the profiles and domains of maladaptive early schemas in care professionals with burnout symptoms with care professionals without burnout symptoms and with care non-professionals with burnout symptoms.

Detailed description: This is an ambispective, non-interventional, comparative, multicentre study in France.

Participants who are care professionals without burn out and care non-professionals with burn out will be matched in age (± 2 years) and gender to participants who are care professionals with burn out.

The study population will be made up of care professionals in a state of burn out, care professionals without a state of burn out, and care non-professionals in a state of burn out.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years ;
* State of burnout (at least one of the 3 dimensions of the Maslach Burnout Inventory) for care professionals and non-professionals in a state of burnout and absence of a state of burnout for the group of care professionals without a state of burnout;
* Membership of a social security scheme;
* Patient having been informed and having given his/her oral non-opposition.

Exclusion Criteria:

* Characterised psychiatric pathology pre-existing the burn out state for the burn out groups and characterised psychiatric pathology for the no burn out group;
* Participation in another clinical trial, or in a period of exclusion from another clinical trial;
* Participant under guardianship, curatorship or deprived of liberty.

Primary outcomes:
measure: Young Schema Questionnaire Short form
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Écully
country: France
facility: Clinique Mon Repos
Study officials:
References:
Clinical trial NCT06101602: Immediate Effect of Dynamic Stretching With and Without Floss Band on Flexibility of Hamstrings in Futsal Players
Official title: Immediate Effect of Dynamic Stretching With and Without Floss Band on Flexibility of Hamstrings in Futsal Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Physical Therapy
Keywords: Dynamic Stretching
Flexibility
Flossing
Hamstring Muscles
Soccer
Sports Injuries
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 54
Sex: ALL
Minimum age (years): 17
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Concurrent Parallel Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: To compare the immediate effect of dynamic stretching with and without floss band on the hamstring flexibility in futsal players.

Detailed description: Futsal is a soccer-like indoor sport that has been gaining popularity worldwide.To increase the flexibility and ROM of involved muscle group a new method has been introduced named Flossing of tissue by using a floss band.

This research study will be helpful to enable therapists to broaden their treatment plans or choose better treatment tools for improving hamstrings flexibility in futsal players. Thus, this study has been designed with the purpose to examine the effect of dynamic stretching with and without floss band on the flexibility of the hamstring.

Eligibility criteria: Inclusion Criteria:

* National level futsal players.
* Active for past 3 months.

Exclusion Criteria:

* Players with any systemic disease/disorder.
* Players with any recent ligamentous or musculoskeletal injury that isn't healed yet.

Primary outcomes:
measure: Straight Leg Raise (SLR) Test
timeFrame: Baseline and immediately after the intervention
measure: Active Knee Extension (AKE) Test
timeFrame: Baseline and immediately after the intervention
measure: Sit and Reach Test
timeFrame: Baseline and immediately after the intervention
Secondary outcomes:
measure: Serum Creatine Kinase (CK) Levels
timeFrame: Baseline and after 24 hours of the intervention
measure: Serum Lactate Dehydrogenase (LDH) levels
timeFrame: Baseline and after 24 hours of the intervention
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Riphah International University (RIU)
state: Islamabad Capital Territory
Study officials:
affiliation: Riphah International University, Islamabad.
name: Noman Sadiq, MS-SPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04724590: OPHTHALMOLOGIC EVALUATION OF RADIATION-RELATED OPTIC NEUROPATHY FOLLOWING IMAGE GUIDED INTENSITY-MODULATED RADIATION THERAPY (IMRT) FOR NASOPHARYNGEAL CARCİNOMA
Official title: OPHTHALMOLOGIC EVALUATION OF RADIATION-RELATED OPTIC NEUROPATHY FOLLOWING IMAGE GUIDED INTENSITY-MODULATED RADIATION THERAPY (IMRT) FOR NASOPHARYNGEAL CARCİNOMA (ORONIN)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: The Aim of Our Study is to Prospectively Evaluate the Optic Neuropathy in Nasopharynx Cancer Patients
Keywords: RADIATION-RELATED OPTIC NEUROPATHY,NASOPHARYNGEAL CARCİNOMA, RADIOTHERAPY
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Prospective study
Primary purpose: OTHER

Brief summary: Primary treatment in nasopharynx cancers is radiotherapy (RT) or chemoradiotherapy (CRT) depending on the stage of the tumor. According to the guidelines, the dose of radiotherapy for primary tumors varies between 66-70 Gy. In consideration of modern radiotherapy techniques like IMRT with systemic chemotherapy for nasopharyngeal cancer, loco-regional control has been perfect. However, the rate of late complications from treatment, many of which are irreversible, is still high. Radiation-related optic neuropathy is the late complication that optic nerves might be affected during the radiotherapy due to the close location of the nasopharynx. Incidence of this is 8.7-9% in head and neck cancer and is observed between 2-9 years after RT. Painless, irreversible, and progressive vision loss usually occurs, and the pallor of optic disc margins, retinal vein dilatation, bleeding, and neovascularization are in the ophthalmic examination. The risk of optic neuropathy increases when the tumor is in close contact with optic nerves, radiation dose, concurrent chemotherapy used, history of diabetes or hypertension.

The aim of our study is to prospectively evaluate optic neuropathy in nasopharynx cancer patients treated in our clinic.


Eligibility criteria: Inclusion Criteria:

Patient with nasopharyngeal carcinoma that histopathologically confirmed Age \>18 Radiotherapy or chemoradiotherapy applied to the patient in our clinic No recurrence or metastasis during follow-up Optic evaluation Evaluation with MRI or CT during follow-up

Exclusion Criteria:

Cranial RT No histopathological verification Age\< 18 There were locoregional recurrence or metastasis

Primary outcomes:
measure: OPHTHALMOLOGIC EVALUATION OF RADIATION-RELATED OPTIC NEUROPATHY FOLLOWING IMAGE GUIDED INTENSITY-MODULATED RADIATION THERAPY (IMRT) FOR NASOPHARYNGEAL CARCİNOMA (ORONIN) RADIATION-RELATED OPTIC NEUROPATHY
timeFrame: 2-9 years
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Meltem Dağdelen
Study officials:
References:
Clinical trial NCT02483390: Use of Online Communications to Support Patients and Their Families in the Hospice Unit
Official title: Use of Online Communications to Support Patients and Their Families in the Hospice Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Palliative Care
Keywords: palliative care
e-health
e-therapy
psychosocial services
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2015-06-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The increasing awareness of the importance of palliative care has led, in Israel, to the 2005 Law for the Rights of Persons with Terminal Illness. Still, problems of accessibility to palliative care remain unresolved. The use of e-health services is likely to expand the ability of the medical, psychosocial and nursing staff to reach patients who are either living in the periphery, are unable to make clinic visits or whose family members are housebound in order to be caregivers. This exploratory research is designed to explore the issues, barriers and advantages of e-health care through the perspective of the palliative care staff members, the patients themselves and their caregiving family members.

Detailed description: This study is designed to test the applicability and suitability of e-health services (e.g. by use of SKYPE) to the psychosocial needs of patients and their families who are getting services through home hospice care. In addition, the attitudes of the hospice staff will be investigated to the use of e-health methods. The study will clarify selection criteria, referral pathways and barriers and/or supporting elements that will allow e-health services to be provided in a highly professional fashion. Up to 20 dyads of a patient and their primary caregiver will be recruited from those who are receiving services from the home hospice unit of the Kupat Holim Clalit (General Sick Fund) in the South of Israel.

Eligibility criteria: Inclusion Criteria:

* Patient currently receiving care from the home hospice unit,
* over the age of 18,
* able to give informed consent,
* with a computer that can use SKYPE or a smartphone,
* speaking a language of the psychosocial staff person (Hebrew, English, Russian, Arabic).

Exclusion Criteria:

* Brain tumors,
* dementia,
* speech disturbance,
* refusal to participate,
* language other than the four spoken by psychosocial staff members,
* inability to use technology or lack of computer in the home.

Primary outcomes:
measure: SWAT - The social work assessment tool
timeFrame: One year
Secondary outcomes:
measure: EIS (Emotional Intimacy Scale)
timeFrame: 6 month
measure: SLDS (Satisfaction with cancer scale)
timeFrame: 6 month
measure: the will to live question
timeFrame: 6 month
measure: ZBI (Zarit burden scale),
timeFrame: 6 month
measure: attitudes toward use of e-therapy questionnaire.
timeFrame: 6 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06119490: Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis
Official title: Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis: Two-arm, Open, Single-center Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Toxic Epidermal Necrolysis
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of methylprednisolone combined with the JAK inhibitor abxitinib and tofacitinib in the treatment of toxic epidermal necrolysis


Eligibility criteria: Inclusion Criteria:

1. Age 18 and above.
2. Diagnosed with SJS/TEN according to the Registry of Severe Cutaneous Adverse Reactions (RegiSCAR) criteria.
3. Liver and kidney function is within acceptable ranges.
4. Blood parameters, including complete blood count, coagulation function, and platelet count, are within acceptable ranges.
5. Patients must sign an informed consent form, understanding the risks and potential benefits of the treatment.
6. Patients need to be capable of participating in follow-up visits and treatment plans.

Exclusion Criteria:

1. History of allergy to JAK inhibitors.
2. Pregnant or breastfeeding women.
3. Severe infectious conditions.
4. History of central nervous system demyelinating diseases.
5. History of lymphoproliferative diseases.
6. Active and latent tuberculosis.
7. HIV carriers with a CD4+ T cell count lower than (\<200/mL).
8. Active HBV/HCV infection.
9. Coagulation disorders or a tendency for thrombosis.
10. Significant abnormalities in blood routine indicators.
11. Liver or kidney dysfunction.

Primary outcomes:
measure: Time to Reepithelization
timeFrame: up to 8 week
Secondary outcomes:
measure: Adverse events
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Dermatology, the First Affiliated Hospital of Fujian Medical University.
state: Fujian
Study officials:
References: