louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03804307: Short Course Radiation Therapy in Palliative Treatment of Thoracic Cancer
Official title: SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Thoracic Cancer: an Interventional, Randomized, Multicentric Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thoracic Cancer
Radiotherapy
Palliative Care
Keywords: Short Course Radiotherapy
Symptomatic thoracic lesions
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 72
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: Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic thoracic malignant lesions

Detailed description: Standard treatment for thoracic lesions (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (2000 cGy in 4 fractions of 500 cGy twice a day) to demonstrate non-inferiority of this scheme

Eligibility criteria: Inclusion Criteria:

* symptomatic thoracic malignant lesions (primary solid tumors or metastases from solid tumor)
* age\> 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3
* no changes in supportive care in the week before radiotherapy

Exclusion Criteria:

* pregnancy
* previous irradiation of the same region

Primary outcomes:
measure: Efficacy of palliation using the short course scheme compared with the standard scheme: Likert scale
timeFrame: 3 months
Secondary outcomes:
measure: acute toxicity in the two treatment groups
timeFrame: 3 months
measure: late toxicity in the two treatment groups
timeFrame: 12 months
measure: Quality of Life (QoL) assessment in the two groups: EORTC questionnaire C15-PAL
timeFrame: 12 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital
state: BO
Study officials:
affiliation: Radiation Oncology Center, Dept of Experimental, Diagnostic and Speciality Medicine-DIMES, Unviersity of Bologna, S.Orsola-Malpighi Hospital
name: Alessio G Morganti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02066207: CKD-337 Drug Interaction Study
Official title: Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Pharmacokinetic Interaction Between Fenofibrate and Atorvastatin in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidemia (Fredrickson Type Ⅱa)
Dyslipidemia (Fredrickson Type Ⅱb)
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2014-02-19
Enrollment: 30
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate a pharmacokinetic drug interaction between atorvastatin and fenofibrate in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* A healthy male volunteer between 19 and 55 years old.
* BMI between 18.5 and 27.
* Able to participate in the entire trial
* Signed the informed consent form prior to study participation.

Exclusion Criteria:

* Clinically significant digestive system, cardiovascular system, respiratory system, endocrine system, hepatic system, renal system
* sit SBP \< 100mmHg or sit SBP ≥ 150mmHg or sit DBP \< 70mmHg or sit DBP ≥ 100mmHg
* Have acute infection history within 14 days
* Have a allergic disease of need to treat
* Have hypersensitivity reactions history for IP or any specific drugs.
* AST, ALT or Total bilirubin \> UNL \* 1.5
* Estimated GFR \< 60 ml/min
* Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* A heavy smoker (cigarette \> 10 cigarettes per day)
* A heavy alcohol consumer (alcohol \> 140g/week)
* A heavy grapefruit consumer (more than 1cup per a day)
* Have a history of drug abuse or showed a positive for urine drug test.
* Administrated IP within 60 days prior to screening
* Rhabdomyolysis include of having a history or family history of genetic muscle diseases
* Positive for HIV antibody, HBsAg, HCV antibody test
* Previously donate whole blood within 60 days or component blood within 30 days
* Subject takes ethical drug or herbal medicine within 30 days
* Clinically significant laboratory test result
* An impossible one who participates in clinical trial by investigator's decision including other reason

Primary outcomes:
measure: AUCt, Cmax,ss of fenofibric acid and atorvastatin
timeFrame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 h
Secondary outcomes:
measure: Tmax,ss, Cmin,ss, t1/2, CL/Fss, Vd/Fss, %swing, Cav, %fluctuation
timeFrame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48 h
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Wooseong Huh, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04688307: Cigarette Smoking in Non-alcoholic Steatohepatitis
Official title: The Effect of Cigarette Smoking Reduction on Liver Function Tests and Metabolic Profile in Subjects With Non-alcoholic Steatohepatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: Steatohepatitis
Smoking
Aminotransferase
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This non-randomized clinical trial was performed to clarify the effect of cigarette smoking reduction on liver function and some anthropocentric indices in smoker patients with non-alcoholic steatohepatitis.

Detailed description: After excluding other causes of high aminotransferase level, participants with persistent elevated serum aminotransferase levels and evidence of fatty liver in ultrasonography were presumed to have non-alcoholic steatohepatitis. Those with NAFLD liver fat score greater than (-0.64) were enrolled. They were assigned to lifestyle modification alone or lifestyle modification plus smoking reduction groups.

Liver fat content, fasting serum glucose, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride, cholesterol, high and low-density lipoprotein, homeostasis model assessment-insulin resistance(HOMA-IR), and anthropometric measurements (body mass index and waist circumference) were checked at baseline and six months later.

Eligibility criteria: Inclusion Criteria:

Smokers with persistent elevated aminotransferase levels with the evidence of fatty liver in ultrasonography, who were referred to a gastroenterology clinic.

Exclusion Criteria:

* alcohol use (more than 20 gram per day in men and 10 gram per day in women per day),
* heart disease (ischemic or congestive),
* hepatic disease (viral hepatitis, autoimmune hepatitis, wilson disease, hemochromatosis, liver mass lesion),
* renal disease (serum creatinine concentration of \> 1.5 mg/dl),
* any severe systemic co-morbidities, neoplasm,
* using any hepatotoxic medication during the past 3 months,
* pregnant or lactating women.

Primary outcomes:
measure: Liver fat content percent change from baseline to 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Serum alanine aminotransferase level changes form baseline to 6 months
timeFrame: 6 months
Other outcomes:
measure: Serum aspartate aminotransferase level changes form baseline to 6 months
timeFrame: 6 months
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Gastroenterology clinic, Sina hospital.
city: Tehran
country: Iran, Islamic Republic of
facility: Sina Hospital, TUMS
Study officials:
affiliation: TUMS
name: Raika Jamali, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03786588: Patients With Chronic Pelvic Pain With Vaginal Microbiota
Official title: Chronic Pelvic Pain With Vaginal Microbiota in Gestational Women Without HPV Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Pain
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 1
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Gestational participants without HPV infection

Brief summary: Vaginal microorganisms play an important role in the occurrence and development of many diseases, such as persistent infection of high-risk human papillomavirus (HR-HPV) causing cervical intraepithelial neoplasia and cervical cancer, and the role of microorganisms in chronic prostatitis.


Eligibility criteria: Inclusion Criteria:

* Those are aged 20 to 45 years old, have vaginal intercourse more than 3 years, and aren't in menstrual, pregnancy or puerperium period.

Exclusion Criteria:

* Those are aged more than 45 years old without HPV infection in the last one year, having no vaginal intercourse, and those can't cooperate the examiner. Women who are HIV or hepatitis B/C positive, have autoimmune disorders and systemic disease (like diabetes mellitus, hormone treatment diseases, severe liver and kidney dysfunction), or have severe mental illness and malignant tumors are also excluded. At the same time, all the participants should meet the following requirements: no vagina douching within last 2 days, no vaginal intercourse within last 3 days, no systemic application of antifungal agents or antibiotics or pessaries within last 14 days of sampling.

Primary outcomes:
measure: Vaginal microbiota difference
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT06741488: Fibromyalgia, Exercise Adherence and Barriers
Official title: Adherence of Women With Fibromyalgia to Home Exercise Programme and Perceived Barriers to Exercise
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Fibromyalgia
Lead sponsor: Konya Beyhekim Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-12-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: physical medicine and rehabilitation outpatient clinic

Brief summary: We aimed to investigate adherence to exercise and perceived barriers to exercise in patients with fibromyalgia who were advised to exercise.


Eligibility criteria: Inclusion Criteria:

* Being diagnosed with fibromyalgia according to ACR 2016 criteria
* Female
* To be informed about the benefits of exercise, the importance of exercise compliance and to be shown the exercise program in practice and to be given a printed form

Exclusion Criteria:

* Having a systemic or mental disease that may prevent exercise

Primary outcomes:
measure: exercise adherence
timeFrame: one month after the exercise is recommended
measure: perceived barriers to exercise
timeFrame: one month after the exercise is recommended
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03975088: Sub-macular Injection of Ranibizumab as a New Surgical Treatment for Refractory Diabetic Macular Edema
Official title: Sub-macular Injection of Ranibizumab as a New Surgical Treatment for Refractory Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Macular Edema
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The best treatment strategy for refractory DME is not known, options include switching between anti-VEGF agents, corticosteroids, and vitrectomy. In this study, authors describe a new surgical technique for the treatment of refractory non tractional DME. The technique consists of vitrectomy with ILM peeling with subretinal injection of Ranibizumab.

Detailed description: Purpose: In this study, authors describe a new surgical technique for the treatment of refractory DME. The technique consists of vitrectomy with ILM peeling with subretinal injection of Ranibizumab.

Methods: This is a prospective interventional non-comparative study including patients with refractory DME. Included patients were subjected to the new surgical technique of pars plana vitrectomy with sub-retinal injection of Ranibizumab.

Eligibility criteria: Inclusion Criteria:

* refractory diffuse non tractional DME.
* Central retinal thickness (CRT) should exceed 350 µm despite undergoing multiple anti-VEGF therapy.
* Decimal best corrected visual acuity (BCVA) must be ≥0.01 and ≤0.5.

Exclusion Criteria:

* Previous vitrectomy, recent cataract surgery less than 6 months,
* evident RPE atrophy, proliferative diabetic retinopathy, massive foveal hard exudation, foveal traction on OCT,
* glaucoma and one eyed patients.

Primary outcomes:
measure: The primary endpoint for this study was the change in CMT at the final visit.
timeFrame: at the 6 month follow up visit
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: El-Baha SM, Abdel Hadi AM, Abouhussein MA. Submacular Injection of Ranibizumab as a New Surgical Treatment for Refractory Diabetic Macular Edema. J Ophthalmol. 2019 Oct 21;2019:6274209. doi: 10.1155/2019/6274209. eCollection 2019.
Clinical trial NCT02396888: Effects of Local Insulin on Wound Angiogenesis
Official title: Effects of Local Insulin on Angiogenesis in Acute Wounds in Non-diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Angiogenesis
Keywords: Blood vessel
Fibroplasia
Wound healing
Insulin
Lead sponsor: Hospital Central "Dr. Ignacio Morones Prieto"
Sponsor class: OTHER
Collaborators: name: Universidad Autonoma de San Luis Potosí
First posted: 2015-03-24
Enrollment: 20
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: Randomized, split plot, double-blind, placebo controlled trial. Half of the wounds surface was applied daily with insulin and the other half with saline solution as placebo. Biopsy specimens of the two sides were obtained on days 0 and 14. Number of blood vessels will be evaluated as main outcome.

Detailed description: Randomized, split plot, double-blind, placebo controlled trial. Non-diabetic patients with full-thickness wounds will be treated in the following manner: in half of the surface insulin will be applied in a daily basis, on the other half, saline solution will be used as placebo. Biopsy specimens of both sides will be obtained on days 0 and 14. Number of blood vessels will be evaluated as main outcome.

Eligibility criteria: Inclusion Criteria:

* Nondiabetic patients with full-thickness acute wounds

Exclusion Criteria:

* Diabetic patients

Primary outcomes:
measure: Number of blood vessels
timeFrame: 14 days
Secondary outcomes:
measure: Hypoglycaemia
timeFrame: 14 days
Other outcomes:
Locations:
city: San Luis Potosí
country: Mexico
facility: Hospital Central Dr. Ignacio Morones Prieto
Study officials:
affiliation: Hospital Central "Dr. Ignacio Morones Prieto"
name: Jorge Aguilar-García, MD
role: STUDY_CHAIR
References:
citation: Martinez-Jimenez MA, Aguilar-Garcia J, Valdes-Rodriguez R, Metlich-Medlich MA, Dietsch LJP, Gaitan-Gaona FI, Kolosovas-Machuca ES, Gonzalez FJ, Sanchez-Aguilar JM. Local use of insulin in wounds of diabetic patients: higher temperature, fibrosis, and angiogenesis. Plast Reconstr Surg. 2013 Dec;132(6):1015e-1019e. doi: 10.1097/PRS.0b013e3182a806f0.
Clinical trial NCT01692288: Evaluation of the Effectiveness of a Home Visiting Program for New Parents in New Mexico
Official title: Evaluation of the Effectiveness of the First Born® Program for New Parents in Santa Fe County, New Mexico
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Health Risk Factors
Lead sponsor: RAND
Sponsor class: OTHER
First posted: 2012-09-25
Enrollment: 278
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if children and mothers who participate in the First Born® Program (FBP) experience better outcomes than they would have in the absence of the program. The evaluation employs a randomized trial design to assess the effectiveness of the FBP in the Santa Fe County, NM, site. FBP is a home visitation program that uses clinically trained professionals to provide first-time parents with information, training, and access to resources designed to promote early childhood development. Services are free and may begin at any time during pregnancy or up to two months after the baby's birth and may continue until the child is three years old. In addition, a nurse postpartum home visit is offered to the parents of all participating newborns. The FBP model builds on other home visiting and prevention programs that have been shown to improve long-term outcomes of children and their families.


Eligibility criteria: Inclusion Criteria:

* First-time parent
* Mother is currently pregnant or child is less than two months old
* Lives within Santa Fe County, New Mexico
* Parent accepts referral to First Born Program

Exclusion Criteria:

* Child is not first born
* First-born child is two months or older
* Parent resides outside Santa Fe County
* Parent has not been referred to First Born Program

Primary outcomes:
measure: Number of participants with child health or development risk factors
timeFrame: First year of life
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Fe
country: United States
facility: United Way of Santa Fe County First Born® Program
state: New Mexico
Study officials:
affiliation: RAND
name: Rebecca Kilburn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kilburn MR, Cannon JS. Home Visiting Start-Up: Lessons Learned From Program Replication in New Mexico. J Prim Prev. 2015 Aug;36(4):275-9. doi: 10.1007/s10935-015-0392-5.
citation: Kilburn, M.R. Lessons from the randomized trial evaluation of a new parent program: when the evaluators see the glass as half full, and the community sees the glass as half empty. J Exp Criminol (2012) 8: 255. doi:10.1007/s11292-012-9152-1
citation: Kilburn MR, Cannon JS. Home Visiting and Use of Infant Health Care: A Randomized Clinical Trial. Pediatrics. 2017 Jan;139(1):e20161274. doi: 10.1542/peds.2016-1274. Epub 2016 Dec 15.
Clinical trial NCT00675688: Study Evaluating Safety and Efficacy of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women
Official title: A Double-Blind, Randomized, Placebo- and Active-Controlled Safety and Efficacy Study of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endometrial Hyperplasia
Osteoporosis
Keywords: Menopause
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-05-12
Enrollment: 3544
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective for the prevention of endometrial hyperplasia and for the prevention of osteoporosis in postmenopausal women.


Eligibility criteria: Inclusion Criteria:

* Generally healthy, postmenopausal women aged 40 - 75 years inclusive
* Intact uterus
* Last natural menstrual cycle (without exogenous hormone therapy) completed at least 12 consecutive months before screening

Exclusion Criteria:

* A history or active presence of thrombophlebitis, thrombosis or thromboembolic disorders
* A history or active presence of cerebrovascular accident, stroke, or transient ischemic attack
* A history or active presence of malignancy, or treatment for malignancy, within the previous 10 years

Additional criteria applies.

Primary outcomes:
measure: To evaluate the effects of Bazedoxifene/Conjugate Estrogens (CE) combinations on the incidence of endometrial hyperplasia in postmenopausal women.
timeFrame: one year
Secondary outcomes:
measure: To evaluate the efficacy of Bazedoxifene/CE combinations in preventing osteoporosis. To evaluate the effects of Bazedoxifene/CE combinations on vaginal atrophy, metabolic parameters, uterine bleeding, vasomotor symptoms and quality of life indices.
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Archer DF, Freeman EW, Komm BS, Ryan KA, Yu CR, Mirkin S, Pinkerton JV. Pooled Analysis of the Effects of Conjugated Estrogens/Bazedoxifene on Vasomotor Symptoms in the Selective Estrogens, Menopause, and Response to Therapy Trials. J Womens Health (Larchmt). 2016 Nov;25(11):1102-1111. doi: 10.1089/jwh.2015.5558. Epub 2016 Sep 27.
citation: Lobo RA, Pinkerton JV, Gass MLS, Dorin MH, Ronkin S, Pickar JH, Constantine G. Evaluation of bazedoxifene/conjugated estrogens for the treatment of menopausal symptoms and effects on metabolic parameters and overall safety profile. Fertil Steril. 2009 Sep;92(3):1025-1038. doi: 10.1016/j.fertnstert.2009.03.113. Epub 2009 Jul 26.