louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00041223: IH636 Grape Seed Extract in Treating Hardening of Breast Tissue in Women Who Have Undergone Radiation Therapy for Early Breast Cancer
Official title: Double-Blind, Placebo-Controlled, Randomized Phase II Trial of IH636 Grape Seed Proanthocyanidin Extract (GSPE) in Patients With Adverse Effects of High Dose Breast Radiotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Radiation Fibrosis
Keywords: radiation fibrosis
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

Brief summary: RATIONALE: IH636 grape seed extract may lessen hardening of breast tissue caused by radiation therapy and may help patients live more comfortably.

PURPOSE: Randomized phase II trial to study the effectiveness of IH636 grape seed extract in treating hardening of breast tissue in women who have undergone radiation therapy for early breast cancer.

Detailed description: OBJECTIVES:

* Determine the efficacy of IH636 grape seed proanthocyanidin extract for the treatment of radiation-induced fibrosis after high-dose radiotherapy in women with a history of early breast cancer.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to time since prior radiotherapy. Patients are randomized to 1 of 2 arms.

* Arm I: Patients receive oral IH636 grape seed proanthocyanidin extract three times daily for 6 months.
* Arm II: Patients receive an oral placebo three times daily for 6 months. Patients are followed at 6 months.

PROJECTED ACCRUAL: A total of 72 patients (48 for arm I and 24 for arm II) will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* History of early breast cancer

  * T1-T3, N0-N1, M0
* No evidence of cancer recurrence
* Palpable breast induration due to prior radiotherapy
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Sex:

* Female

Menopausal status:

* Not specified

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics
* At least 2 years since prior radiotherapy

Surgery:

* Not specified

Other:

* At least 3 months since prior dietary supplementation containing IH636 grape seed proanthocyanidin extract over 50 mg per day

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
state: England
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: John R. Yarnold, MD, FRCR
role: STUDY_CHAIR
References:
Clinical trial NCT03273023: PROMUS PREMIER™ China Post-Approval Study
Official title: Post-Approval Study of the PROMUS PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2017-09-06
Enrollment: 2059
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects who are candidates for coronary artery stenting, signed the informed consent form and eligible to receive a Promus PREMIERTM Stent System will be evaluated for enrollment in this study.

Brief summary: To compile real-world clinical outcome data for the Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System (Promus PREMIERTM Stent System) in routine clinical practice in China.

Detailed description: Each site will be allowed to enroll up to a maximum of 300 subjects. The scheduled follow up will occur at 30 days, 6 months, 12 months and then annually through 5 years post stent implant, for all enrolled subjects. Follow-up will be conducted via telephone contact or clinic visit

Eligibility criteria: Inclusion Criteria:

* Subject must be at least 18 years of age
* Subject understands and provides written informed consent
* Subject who is clinically indicated and will have an attempt of at least one Promus PREMIERTM Stent OR Subject who is clinically indicated and was implanted with at least one Promus PREMIERTM Stent
* Subject is willing to comply with all protocol-required follow-up evaluation

Exclusion Criteria:

* Exclusion criteria are not required in the PE PREMIERTM China Post-Approval Study which is an "all comers" study.

Primary outcomes:
measure: 12-month Primary Endpoint: Major Adverse Cardiac Event (MACE) rate, defined as cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)
timeFrame: 12-month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
Study officials:
affiliation: The Second Affiliated Hospital of Harbin Medical University
name: Bo Yu, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00663923: Comparison of Cross-cylinder and Conventional Photorefractive Keratectomy(PRK) in Correcting Medium-high Astigmatism
Official title: Comparison of Cross-cylinder and Conventional PRK for Laser Correction of Astigmatism: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Astigmatism
Keywords: Excimer Laser
photorefractive keratectomy
astigmatism
Lead sponsor: Tabriz University
Sponsor class: OTHER
First posted: 2008-04-22
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether cross-cylinder approach is more effective than routine method in laser correction of astigmatism.

Detailed description: Both eyes of 50 patients(100 eyes) with medium-high compound myopic astigmatism and inclusion criteria,will be treated by photorefractive keratectomy (PRK) using excimer laser.It breaks chemical bonds within corneal stroma.It's wavelength is 193 nm that is in the ultraviolets range with high energy and very low tissue penetrance. The right or left eye of every patient would be allocated randomly to one of the study groups using RandList 1.1. In spite of recent advances in excimer laser machines and surgical techniques,correction of astigmatism is not more successful compared to myopia. In this study we will compare two methods of laser correction of astigmatism regarding to visual acuity,residual error and aberrations.

Eligibility criteria: Inclusion Criteria:

* \>20 years of age
* refractive stability for at least one year
* regular and symmetric astigmatism of \>1.5 diopters

Exclusion Criteria:

* corneal thickness\<470 microns
* keratoconus or suspected keratoconus
* active ocular disease and systemic collagen disease

Primary outcomes:
measure: Correction of Astigmatism
timeFrame: six months after surgery
Secondary outcomes:
measure: Higher Order Aberrations
timeFrame: six months postoperative
measure: Corrected Distance Visual Acuity(CDVA)
timeFrame: six months
measure: Uncorrected Distance Visual Acuity (UCDVA)
timeFrame: six months
measure: Surgically Induced Astigmatism
timeFrame: six months after surgery
Other outcomes:
Locations:
city: Tabriz
country: Iran, Islamic Republic of
facility: Nikookari eye hospital
state: East Azarbaijan
Study officials:
affiliation: Ophthalmology Department, Tabriz University of medical Sciences
name: Mohammad R Sedghipoor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01633723: Phase I Clinical Trial of DA-6886 in Healthy Male Subjects
Official title: A Phase I, Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose Escalation Clinical Trial With Open-labelled Food Effect Study of Single Dose to Investigate the Safety, Tolerability and Pharmacokinetics of DA-6886 After Oral Administration in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Irritable Bowel Syndrome
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-07-04
Enrollment: 105
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: DA-6886_IBS_I is a phase I, dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose escalation clinical trial with open-labelled food effect study of single dose to investigate the safety, tolerability and pharmacokinetics of DA-6886 after oral administration in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* 20 \~ 45 years old
* 27kg/m2 ≥ BMI ≥ 20kg/m2
* Healthy Male
* Informed consent

Exclusion Criteria:

* Clinically significant medical history
* smokers
* Clinically significant hypersensitivity of Drugs
* Clinically significant cutaneous disorder
* QTcB \> 450msec
* have a history of drug abuse or show positive for drug abuse or cotinine at urine screening

Primary outcomes:
measure: Assessment of safety
timeFrame: up to 7 days (single dose study, single dose study for food effect), 15 days (multiple dose study)
Secondary outcomes:
measure: Pharmacokinetics and Pharmacodynamics
timeFrame: up to 48 hours after last dosing of DA-6886
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: ASAN medical center
state: Songpa-gu
Study officials:
References:
Clinical trial NCT04069923: OsteoCrete in Filling Bone Voids in Participants With Bone Voids or Defects
Official title: Use of Magnesium Oxide Biomaterial as a Bone Void Filler for Bone Voids or Defects Not Intrinsic to the Stability of Bony Structure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Status Unknown
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 5
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: This trial studies the side effects of OsteoCrete in filling bone voids in participants with bone voids or defects. OsteoCrete may eliminate the need for further surgery and the removal of healthy bone.

Detailed description: PRIMARY OBJECTIVES:

I. To assess the safety of the device, which for the purpose of this study is defined as the compound injected into bone.

SECONDARY OBJECTIVES:

I. To determine the rate of absorption and bone ingrowth.

OUTLINE:

Participants receive OsteoCrete intraoperatively to fill voids that occur in bones during surgery or to augment screw fixation.

After completion of study treatment, participants are followed for up to 1 year.

Eligibility criteria: Inclusion Criteria:

* Documentation of a diagnosis as evidenced by one or more clinical features consistent with one or more of the following criteria:

  * Bone void created during surgery.
  * Lucency noted on x-ray preoperatively.
* Written informed consent (and assent when applicable) obtained from subject or subject?s legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
* Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
* Creatinine greater than 1.3.
* Presence of active bone infection.

Primary outcomes:
measure: Participants reaching one year post-op and completing all study visits
timeFrame: Up to 1 year
Secondary outcomes:
measure: Amount of reabsorption and bone ingrowth
timeFrame: Up to 1 year
measure: Incidence of adverse events rates
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Francis Hornicek
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02907723: Feasibility of Continuous Sleep Recording in Patients Undergoing Deep Brain Stimulation for Parkinson's Disease
Official title: Assessment of a Wrist Device Recording Sleep Parameters, Before and After Deep Brain Stimulation for Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
Collaborators: name: Teva Pharmaceutical Industries, Ltd.
First posted: 2016-09-20
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This pilot study aims to assess a new device designed for an objective measure of sleep parameters. The purpose of the device is to assess, in a more simple and precise way, the impact of deep brain stimulation on patient's sleep.


Eligibility criteria: Inclusion Criteria:

* patient \> 18 years old
* with Parkinson disease
* scheduled for implantation of electrodes for deep brain stimulation

Exclusion criteria:

* pregnant or breast feeding patient
* refusal to participate in the study
* patient under legal protection
* no health insurance coverage

Primary outcomes:
measure: mean sleep duration per night
timeFrame: 15 days
measure: mean sleep onset latency
timeFrame: 15 days
measure: mean number of awakenings per night
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fondation OPH A de Rothschild
name: Jean-Philippe BRANDEL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00602823: Genomic Study for the Prediction of Efficacy and Adverse Effects of CD11a Monoclonal Antibodies(Raptiva)
Official title: Ex Vivo Monocyte and Lymphocyte Stimulation Tests and Genomic Study for the Prediction of Efficacy and Adverse Effects of CD11a Monoclonal Antibodies(Raptiva)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-01-28
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The pathogenesis of psoriasis has evolved from epidermal hyperproliferation to immune dysregulation in recent years. A Th1 cytokine profile is universally found is psoriasis. Biologics targeting the immune system have become the focus of study. Raptiva (Efalizumab) is one of biologics indicated for the treatment of psoriasis, and is the first biologic approved for use in psoriasis in the EU (EMEA). In USA, it is the second biologic drug (after Amevive) for psoriasis. Raptiva is a humanized chimeric antibody of CD11a (LFA-1), which blocks the interaction of CD11and ICAM-1, thus preventing lymphocyte trafficking. It is used for moderate to severe chronic plaque type psoraisis. The first clinical trial of Raptiva in Asians iscurrently done in the department of Dermatology, National Taiwan University Hospital and the incidence of psoriatic arthritis (either de novo or aggravation of preexisting psoriatic arthritis) is significantly higher than previously reported in Western countries（30％ versus 7%，and personal communication with doctors in Hong-Kong and Singapore also reveals a similar safety profile. It seems likely that a racial difference is present. Monocytes play a central role in the pathogenesis of psoriatic arthritis. It is thus intriguing to study the pathogenesis of Raptiva-induced aggravation of psoriatic arthritis by comparing the difference of monocyes response in the presence of Raptiva between patients with and without Raptiva-induced psoriatic arthritis. In further study, the CD11a genomic polymorphism will also be investigated. The suudy can provide us with important information on how a novel monoclonal antibody like Raptiva can have both therapeutic and detrimental actions on psoriasis. The short term benefit of the study will be in pharmacogenomics and pharmacoeconomics, finding the best candidates for the expensive drug. The long term goal will be the clarification of the pathogenesis of psoriasis and psoriatic arthritis.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of psoriasis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: TSEN-FANG Tsai
name: TSEN-FANG Tsai, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05233423: Pressurized Cold Application for Patients Total Knee Prosthesis Surgery
Official title: The Effect of Pressurized Cold Application on Pain Level in Patients Wıth Total Knee Prosthesis Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Prosthesis
Cryotherapy
Pain
Patient Satisfaction
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 52
Sex: ALL
Minimum age (years): 46
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a parallel group randomized controlled study
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was conducted to examine the effects of pressurized cold applicatıon for patients total knee prosthesis surgery.

Detailed description: The study was conducted as a randomized controlled experimental study in order to determine the effect of pressurized cold application applied after total knee replacement surgery on the level of pain and satisfaction.This study was conducted in 52 patients who applied to Pamukkale University Hospitals Orthopedics and Traumatology Clinic between July 2019 and February 2020, who met the inclusion criteria and accepted to participate in the study. The patients were divided into 26 in the control group (cold gel) and 26 in the study group (compressed cold therapy bandage) using a simple randomization method. The patients in the control group received 9 cold applications, in the form of 20 minutes of application and 40 minutes of rest after surgery. The patients in the study group were applied 9 cold applications with 30 mmHg pressure for 20 minutes and 40 minutes of rest.

Eligibility criteria: Inclusion Criteria:

* 18 Years and older
* TDP surgery is planned to be performed by the same physician according to the rapid recovery protocol
* volunteer to participate in research
* had no problems in communicating cognitively, emotionally and verbally were included.

Exclusion Criteria:

* have a cold allergy
* have peripheral vascular disease
* diagnosed with Raynaud's disease
* have cognitive, affective and verbal communication problems

Primary outcomes:
measure: The change in pain level of total knee prothesis patients at 9 cold applicatiıon with Visual Analog Scale.
timeFrame: According to the fast track protocol, a total of 9 cold applications were applied to the patients who stayed in the service for an average of 1 day after the operation, except during sleep and physical therapy times.
Secondary outcomes:
measure: The level of satisfaction of patients with the type of cold application applied
timeFrame: ,The patient was asked once before discharge (about 1 day after surgery), the level of satisfaction with the type of cold application.
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
References:
Clinical trial NCT03275623: Management of Sub-Clinical Bacteriuria in Pregnancy
Official title: Management of Sub-Clinical Bacteriuria in Pregnancy: A Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cystitis
Cystitis;Puerperium
Pyelonephritis
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2017-09-07
Enrollment: 60
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 the study is to determine if treatment of pregnant women with urine cultures with a low level of bacteria (less than 100,000 colony forming units (CFU)) may decrease adverse pregnancy outcomes.


Eligibility criteria: Inclusion Criteria:

* Pregnant women who seek prenatal care within the University of Texas Health System with UT Physicians.
* Urine culture of less than 100,000 CFU

Exclusion Criteria:

* Less than 18 years of age
* Risk factors to complicated UTI (including but not limited to: diverticula, urolithiasis, renal cysts, indwelling catheter, intermittent catheterization, stent placements, nephrostomy tubes, neurogenic bladder, cystocele, vesicoureteral reflux, ileal conduit)
* Use of immunosuppressant drugs
* Abnormalities of the urinary tract (including but not limited to: known ureteric or urethral strictures, tumors of the urinary tract, pelvicalyceal obstruction, congenital anomalies, history of urological procedures)
* History of renal disease including renal failure and transplants
* Urine culture \> 100,000 CFU of any organism

Primary outcomes:
measure: Number of Participants Who Have Cystitis
timeFrame: about 10 months
measure: Number of Participants Who Have Pyelonephritis
timeFrame: about 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Akwugo A Eziefule, MD
role: PRINCIPAL_INVESTIGATOR
References: