louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00636259: Casodex 150-mg Compassionate Use Trial for Subjects With Prostate Cancer
Official title: A Compassionate Use Trial With Bicalutamide (Casodex) 150-mg for Subjects With Prostate Cancer
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Adenocarcinoma of the Prostate
Keywords: Prostate cancer
Casodex
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-14
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This study provides compassionate use of bicalutamide (Casodex) at a 150-mg dose for subjects with prostate cancer prior to it becoming commercially available. The patient will receive bicalutamide 150-mg as long as the physician feels that the subject is benefiting from this therapy and safety information is provided regularly to AstraZeneca. Treatment will be discontinued after bicalutamide 150-mg becomes commercially available.


Eligibility criteria: Inclusion Criteria:

* Patients with adenocarcinoma of the prostate
* Subjects with locally advanced, and/or metastatic prostate cancer for whom surgical castration or other medical interventions are not considered appropriate or acceptable

Exclusion Criteria:

* Any known history of abnormal liver function tests
* Any severe concomitant condition that would make it undesirable, in the clinician's opinion, for the subject to participate in the trial.
* Known hypersensitivity to bicalutamide or any of the components found in bicalutamide

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04164459: Evaluating the Efficacy and Safety of Xalost S in Glaucoma Patients.
Official title: A Multi-center, Randomized, Blinded Evaluator, Active Control, Parallel, Phase IV Study to Evaluate the Efficacy and Safety of Xalost S in Glaucoma Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Glaucoma
Lead sponsor: Taejoon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-11-15
Enrollment: 144
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In patients with Glaucoma, Xalost S or Xalatan or Taflotan-S are administered for 12 weeks. After 12 weeks, among them, Xalatan administration group are switched to Xalost S or Taflotan-S. Extension study period is 8 weeks.

To compare effect (ocular surface damage) and safety of preservative-free Latanoprost/Tafluprost to Benzalkonium chloride-preserved Latanoprost in primary open angle glaucoma or normal tension glaucoma.


Eligibility criteria: Inclusion Criteria:

* Male or female diagnosed with glaucoma, age 19 or over
* Written informed consent to participate in the trial

Exclusion Criteria:

* Patients who have received or have plans lacrimal puntual occulsion
* Use of contact lenses
* Any other Glaucoma except primary open angle glaucoma/normal tension glaucoma (ex) Closed anterior chamber angle/ angle-closure Glaucoma)
* Any condition limiting patient's ability to participate in the trial

Primary outcomes:
measure: Corneal Staining Score at week 12
timeFrame: week 12
Secondary outcomes:
measure: Change from baseline in Hyperemia Score at week 4, 8, 12
timeFrame: baseline and week 4, 8, 12
measure: Change from baseline in Intraocular Pressure at week 4, 8, 12
timeFrame: baseline and week 4, 8, 12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Taejoon Pharmaceutical Co., Ltd.
Study officials:
References:
Clinical trial NCT00282659: The Use of Magnesium to Improve Blood Pressure, Cholesterol, and Glucose Control
Official title: The Use of Magnesium to Improve Hemodynamics, Cholesterol, and Glucose Control: A Substudy of AdMag
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Hypertension
Dyslipidemia
Diabetes
Keywords: Hemodynamics
Hypertension
Dyslipidemia
Diabetes
Implantable Cardioverter Defibrillator
Blood Pressure
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2006-01-27
Enrollment: 240
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 determine if magnesium can improve blood pressure, cholesterol, and blood sugar control in patients with implantable cardioverter defibrillators (ICDs).

Detailed description: Magnesium is the second most abundant intracellular cation and plays a vital role in many physiologic processes. It has been determined that patients with cardiovascular disease have intracellular magnesium (Mgi) deficiencies. Among the ICD registries in Europe and the United States 64% and 77% of patients also carry the diagnosis of CAD, respectively. Patients with CAD have risk factors that lead to the development and or propagation of atherosclerosis. Paramount among these risk factors are hypertension, dyslipidemia, and diabetes.

Comparison: Magnesium compared to placebo in patients with ICDs to evaluate the effect they have on cholesterol, blood pressure, and blood glucose.

Eligibility criteria: Inclusion Criteria:

* Newly implanted ICD or recent ICD shock (within 6 months)

Exclusion Criteria:

* Inability to swallow
* A non-cardiac disease with a survival prognosis of less than 12 months
* Hypermagnesemia
* Creatinine clearance less than 30mL/min
* Lactic acidosis or systemic acidosis syndrome
* Previous intolerance to magnesium L-lactate

Primary outcomes:
measure: Blood pressure, cardiac output, systemic vascular resistance, thoracic fluid content, total cholesterol, low density lipoprotein, high density lipoprotein, triglycerides, and blood glucose
timeFrame: at baseline, 3, and 6 months of follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
affiliation: University of Connecticut School of Pharmacy, Hartford Hospital Division of Drug Information
name: Charles M White, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00577759: Community and Clinician Partnership for Prevention
Official title: Community and Clinician Partnership for Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Dietary Habits
Tobacco Use Cessation
Keywords: Quality assurance, health care
primary health care
community health services
referral and consultation
exercise
diet
tobacco
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2007-12-20
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the impact of strategies to develop and foster the relationship between primary care practices and community resources to address specific unhealthy behaviors (tobacco use, poor nutrition, and lack of physical activity).

Detailed description: Tobacco use, poor diet, and lack of physical activity are associated with the leading causes of significant morbidity and mortality, including coronary heart disease, hypertension, cancer, stroke, diabetes, and respiratory dysfunction. One solution to decreasing unhealthy behaviors would be to better integrate primary care providers with community resources, including community and public health organizations that already have the capacity and expertise to deliver effective interventions. This project is a randomized trial to evaluate different practice-level interventions to link practices to community resources to decrease unhealthy behaviors.

Eligibility criteria: Inclusion Criteria:

* Internal medicine and family practices in Durham and Orange counties, North Carolina

Exclusion Criteria:

* None

Primary outcomes:
measure: The number of referrals from the practices to the community resources
timeFrame: 6 months
Secondary outcomes:
measure: Number of referrals received by each resource
timeFrame: 6 months
measure: The proportion of patients with unhealthy behaviors who were referred from the practices to community resources
timeFrame: 6 months
measure: Practice attitudes and practice regarding referral to community resources
timeFrame: 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Clinical Research Institute
state: North Carolina
Study officials:
affiliation: Duke University
name: Alex R Kemper, MD, MPH, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00180336: Safety and Efficacy Study of RENEWAL 4 AVT
Official title: CONTAK RENEWAL 4 AVT Field Following
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Heart Failure
Tachycardia
Atrial Fibrillation
Atrial Flutter
Ventricular Fibrillation
Keywords: Heart Failure
Tachycardia
Atrial Fibrillation
Atrial Flutter
Ventricular Fibrillation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 170
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: The purpose of this study is to assess the safety and effectiveness of the CONTAK RENEWAL 4 AVT device.

Detailed description: This is a prospective, two-arm, non-randomized, multi-center European field following, designed to demonstrate the safety and effectiveness of the CONTAK RENEWAL 4 AVT device in humans.

Eligibility criteria: Inclusion Criteria:

* Indications for the device
* Availability for follow-up at an approved Field Following center, at the protocol defined intervals
* Willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation
* Prescribed to stable optimal pharmacologic therapy for HF
* Age 18 or above, or of legal age to give informed consent specific to national law
* Able to provide documented evidence of one or more episodes of AF/AT within 12 months of implantation NOTE: Guidant recommends anticoagulation therapy per physician discretion.

Exclusion Criteria:

* Right bundle branch block morphology
* Life expectancy of less than six months due to other medical conditions
* Expectation of a heart transplant during the period of the study
* Patients with or who are likely to receive a mechanical tricuspid valve during the course of the study
* Have a preexisting unipolar pacemaker that will not be explanted/abandoned
* Have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) within 180 days prior to enrollment
* Have a known hypersensitivity to dexamethasone acetate
* Enrolled in any other study, including drug investigation
* Women that are pregnant or planning to become pregnant
* A Cerebral Vascular Event/ Transient Ischemic Attack within 12 months of implantation
* During the four weeks prior to implantation, a patient experiences an episode of AF \>= 48 hours in duration and was not anticoagulated for at an adequate therapeutic level (INR \>= 2.0) for the 4 weeks prior to enrollment

Primary outcomes:
measure: System Complication-Free Rate at 6 months
measure: Effectiveness of LV Only/LV Offset at 6 months
Secondary outcomes:
measure: LVESD at 6 months
measure: Six-minute walk at 6 months
measure: NYHA at 6 months
measure: QOL at 6 months
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhof Klinik
Study officials:
affiliation: Kerckhoff Klinik Bad Nauheim (Germany)
name: Johannes Sperzel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06073249: Comparison of the Efficacy of Different Nerve Stimulation Methods in Individuals With Chronic Consipation
Official title: Comparison of the Efficacy of Different Nerve Stimulation Methods in Individuals With Chronic Consipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Keywords: Constipation
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Consipation is the most common digestive complaint in the general population. The normal frequency of defecation ranges from a minimum of three times a week to a maximum of two times a day.

Detailed description: Constipation is one of the most common health problems in the geriatric population, negatively affecting the physical and emotional status of individuals. Constipation can be classified into three main groups: normal transit time constipation, slow transit time constipation and dyssynergic defecation disorders .

Treatment in chronic constipation should be directed towards the underlying cause. In the treatment of chronic constipation, lifestyle modifications and physiotherapy are the first, pharmacologic treatment is the second, and surgical treatment is the third. Physiotherapy modalities such as defecation training, classical massage, electrical stimulation, anorectal biofeedback and exercise training can be used in the treatment of chronic constipation.

Eligibility criteria: Inclusion Criteria:

* 18-65 ages Female
* Rome III diagnostic criteria

Exclusion Criteria:

* Severe heart or kidney diseaseprevious gastrointestinal, spinal or pelvic surgery other than cholecystectomy, hysterectomy or appendectomy neurological diseases such as multiple sclerosis, stroke, Parkinson's disease or spinal injury,
* Impaired awareness (mini-mental score \< 15),
* Legal blindness, pregnancy,
* Rectal prolapse
* Anal fissure and altered constipation and diarrhea pattern.

Primary outcomes:
measure: Bristol Stool Scale (BGS)
timeFrame: 4 weeks
measure: Pelvic Pain Impact Questionnaire
timeFrame: 4 weeks
measure: Constipation Severity Scale
timeFrame: 4 weeks
measure: Superficial Electromyography Biofeedback
timeFrame: 4 weeks
measure: Autonomic nervous system device
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: HAZAL genç
state: None Selected
Study officials:
References:
Clinical trial NCT00001549: Diagnosis and Natural History Study of Patients With Neurological Conditions
Official title: Diagnosis and Natural History Protocol for Patients With Neurological Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Dementia
Movement Disorder
Multiple System Atrophy
Parkinson's Disease
Keywords: Movement Disorders
Parkinson's
Alzheimer's
Screening
Diagnostic Puzzles
Alzheimer Disease
Progressive Supranuclear Palsy
PSP
Restless Leg Syndrome
RLS
Parkinsonism
PD
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to improve understanding of neurological conditions. Patients participating in this study will continue receiving medical care, routine laboratory tests, and diagnostics tests (X-rays, CT-scans, and nuclear imaging), from their primary care physician. Doctors at the NIH plan to follow these patients and offer advice and assistance to their primary care physicians.

Detailed description: The objective of this protocol is to provide diagnosis and follow Experimental Therapeutics Branch (ETB) patients not currently entered on another research protocol. No investigational treatments will be administered on this protocol, and the NIH physicians will be playing largely a consultative role to the patient's primary physician.

Eligibility criteria: INCLUSION CRITERIA:

Patients may be included on this protocol if they have an identifiable neurological disorder or represent a diagnostic puzzle. These disorders would include patients with Parkinson's disease, Alzheimer's disease, multiple system atrophy, progressive supranuclear palsy, restless legs syndrome, other cognitive and movement disorders, and diagnostic puzzles.

Patients 18-90 years of age, inclusive, are eligible.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute of Neurological Disorders and Stroke (NINDS)
state: Maryland
Study officials:
References:
Clinical trial NCT03214549: Comparison in Marginal Adaptation Between Conventional and Gull Wing Preparation in Laminates Veneers
Official title: Marginal Adaptation of E.Max Laminate Veneers Prepared With Modified Gull Wing Preparation and Conventional Preparation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Teeth Sensitivity
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate tooth sensitivity and marginal adaptation of porcelain laminates veneers prepared with modified gull wing preparation and conventional preparation.

Detailed description: Visit 1: Preoperative records, face-to-face adherence reminder session, clinical, radio-graphic examination and primary impression for diagnostic cast construction.

Visit 2: Teeth preparation, secondary impression,temporary restoration and teeth sensitivity evaluation using United States Public Health Service criteria.

Visit 3: Placement and permanent cementation of the final restoration

Visit 4: marginal adaptation measurement by electron microscope using impression replica.

Eligibility criteria: Inclusion Criteria:

* From 18-40 years old, be able to read and sign the informed consent document.
* Be physically and psychologically able to tolerate conventional restorative Procedures.
* Have no active periodontal or pulpal diseases, have teeth with good restorations.
* Patients with teeth problems indicated for laminate veneer (e.g:discoloration, fracture not involve more than 50% enamel loss, mild malposition.
* Be willing to return for follow-up examinations and evaluation.

Exclusion Criteria:

* Patients in the growth stage with partially erupted teeth.
* Patient with fractured teeth of more than 50% enamel loss.
* Patients with poor oral hygiene and motivation.
* Pregnant women.
* Patient with post and core endodontically treated teeth.
* Psychiatric problems or unrealistic expectations.
* Lack of opposite occluding dentition in the area intended for restoration

Primary outcomes:
measure: measuring marginal adaptation of laminates veneers using stero-microscope
timeFrame: immediately before laminates delivery up to 4 week sfter tooth preparation
Secondary outcomes:
measure: measuring tooth sensitivity after tooth preparation for laminates veneers
timeFrame: one week after tooth preparation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06095349: Effect of Sulfur Thermal Water on Circulating H2S Levels and Markers of Bone Metabolism in Osteopenic Subjects.
Official title: Effect of Sulfur Thermal Water on Circulating H2S Levels and Markers of Bone Metabolism in Osteopenic Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hydrogen Sulfide
Osteoporosis
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 50
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of the study is to investigate whether inhalation treatment with high-sulfide waters from some spas (referred to as "thermal waters"), performed for 12 consecutive days, is able to change circulating H2S levels and alter bone metabolism. Identifying a clear correlation between circulating levels of H2S and sulfur water administration, as well as a potential anabolic effect on bone, would set the stage for new studies that could have important clinical implications for promoting health and preventing osteoporosis


Eligibility criteria: Inclusion Criteria:

* post-menopausal women with a diagnosis of osteopenia

Exclusion Criteria:

* concurrent muscoloskeletal conditions or chronic pharmacological treatment interfering with bone metabolism

Primary outcomes:
measure: Measurement of biomarkers of bone turnover, marker #1
timeFrame: 15 days
measure: Measurement of biomarkers of bone turnover, marker #2
timeFrame: 15 days
measure: Measurement of biomarkers of bone turnover, marker #3
timeFrame: 15 days
Secondary outcomes:
measure: Measurement of serum H2S levels
timeFrame: 15 days
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
Clinical trial NCT06952049: Does Psychoeducation Improve the Pain Relief Derived From a Brief Intervention
Official title: Does Psychoeducation Improve the Pain Relief Derived From a Brief Mindfulness-Based Intervention Delivered in a Clinic Waiting Room
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Acute Pain
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 200
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: This project is a single-site, five-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room psychoeducation about mindfulness impacts the degree of pain relief they experience during a mindfulness-based intervention.


Eligibility criteria: Inclusion Criteria:

* Receiving pain treatment at Tallahassee Orthopedic Center
* Understanding English instructions fluently
* Being 18 years of age or older

Exclusion Criteria:

* Unable to consent because of physical or mental incapacity.

Primary outcomes:
measure: Change in Pain Unpleasantness Numeric Rating Scale
timeFrame: Immediately before to after 3-minute audio recording
Secondary outcomes:
measure: Change in Pain Intensity Numeric Rating Scale
timeFrame: Immediately before to after 3-minute audio recording
measure: Change in Anxiety Numeric Rating Scale
timeFrame: Immediately before to after 3-minute audio recording
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Tallahassee Orthopedic Clinic (TOC)
state: Florida
Study officials:
References: