louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00669552: Intracardiac T-wave Alternans and Ischemia
Official title: Intracardiac T-wave Alternans and Ischemia During Percutaneous Coronary Interventions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemia
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2008-04-30
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary artery disease (CAD) undergoing PCI that also have an appropriate Medtronic implantable defibrillator.

Brief summary: T-wave alternans is a test that looks at microvolt changes in the T-wave on a beat to beat basis. The presence or absence of such changes has been shown to predict or exclude future arrhythmic events. The mechanism of T-wave alternans is unclear, but may relate to calcium metabolism in the heart, and may be affected by conditions such as ischemia or heart failure.

The purpose of this study is to determine whether T-wave alternans, as measured through the lead of an implantable defibrillator, is produced by acute ischemia induced by occlusion during percutaneous coronary interventions.


Eligibility criteria: Inclusion Criteria:

* patient with CAD undergoing PCI with appropriate Medtronic implantable defibrillator.

Exclusion Criteria:

* non-elective procedure
* non-qualifying defibrillator type.

Primary outcomes:
measure: Number of Subjects With Positive T Wave Studies During a Coronary Intervention
timeFrame: During the coronary intervention, upto 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Jose M Dizon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05964452: Efficacy of Methimazole Dosing Algorithm
Official title: The Efficacy of Cook County Health's Methimazole Dosing Algorithm in the Setting of Ne Onset Graves' Hyperthyroidism
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Graves Disease
Lead sponsor: Cook County Health
Sponsor class: OTHER_GOV
First posted: 2023-07-28
Enrollment: 11
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: Adults with new onset Graves' disease.

Brief summary: To prospectively study the efficacy and safety of the Cook County Health (CCH) methimazole (MMI) dosing algorithm in the setting of new onset Graves' disease.

Detailed description: To conduct a prospective observational study in 60 patients with newly diagnosed Graves' disease who are either methimazole naive or who have been initiated on MMI within previous 4-6 weeks per CCH algorithm and assess for efficacy and safety of MMI dosing administered. Study group size is based on 90% power and projected efficacy of 70% patients reaching target.

Eligibility criteria: Inclusion Criteria:

* Non-pregnant adults (\>18 years of age) with new diagnosis of Graves' Disease (elevated free T4, Free T3, low or suppressed TSH, positive TSI and or thyroid eye disease) and
* either drug naïve or who have been initiated on MMI within previous 4-6 weeks per CCH algorithm.

Exclusion Criteria:

* Pregnant patients
* hyperthyroidism due to other causes, example - Toxic Multinodular Goiter, Iodine induced thyrotoxicosis, etc.
* Graves patients who present with atrial fibrillation, CHF or other end organ damage

Primary outcomes:
measure: Achievement of euthyroid state
timeFrame: 17 weeks
Secondary outcomes:
measure: Factors influencing achievement of euthyroid state
timeFrame: 17 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Cook County Health
state: Illinois
Study officials:
affiliation: Cook County Health
name: Dan Mihailescu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01216852: Bioequivalency Study of Losartan Potassium 100 mg Tablet Under Fasted Conditions
Official title: A Single Dose, 2-Period, 2-Treatment Bioequivalency Study of Losartan Potassium Tablets 100 mg Under Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2010-10-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Losartan Potassium 100 tablet under fasted conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to losartan potassium or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Bio-Kinetic Clinical Applications, Inc.
state: Missouri
Study officials:
affiliation: Bio-Kinetic Clinical Applications, Inc.
name: Dennis N. Morrison, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02011152: Spinal Anesthesia Magnesium Infusion
Official title: The Effect of Intravenous Magnesium Sulfate Infusion on Sensory Spinal Block and Postoperative Pain Score in Abdominal Hysterectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Operation
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2013-12-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 18 and 65 female patients undergoing abdominal hysterectomy

Brief summary: The aim of this study was to investigate the effect of i.v. infusion of magnesium sulphate during spinal anesthesia on duration of spinal block and postoperative pain.


Eligibility criteria: Inclusion Criteria:

* ASA physical status I and II, aged between 18 and 65 female patients undergoing abdominal hysterectomy

Exclusion Criteria:

* severe cardiovascular, renal and hepatic dysfunction, neuromuscular diseases, using calcium channel blockers, and inappropriate for spinal anesthesia.

Primary outcomes:
measure: pain scores
timeFrame: 6 mo
Secondary outcomes:
measure: sensory block
timeFrame: 6 mo
Other outcomes:
measure: motor block
timeFrame: 6mo
Locations:
Study officials:
affiliation: KTU
name: Fatih Kahraman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02005952: Effectiveness of Two Methods for Quality Control in Primary Care Spirometry
Official title: Effectiveness of Two Methods for Quality Control in Primary Care Spirometry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spirometry
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 3000
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring spirometry performing a diagnostic or tracking control for respiratory disease

Brief summary: Still not well resolved access, execution and interpretation of spirometry in primary care medicine. This seriously affects the quality of care of chronic respiratory diseases.

OBJECTIVE: To compare the effectiveness of two methods for quality control in performing spirometry in primary care teams (EAP) participating in the "Healthcare Process Chronic Obstructive Pulmonary Disease (COPD )" (multidisciplinary program between primary care medicine and hospital for improved care COPD).

METHODS: Randomized controlled trial of clusters of EAP participants ( n = 17 ). The quality control of spirometry in each EAP randomize into three branches:

1. Supervision from the pulmonary function laboratory of the Hospital ; computer.
2. Program incorporated into automated spirometer.
3. Spirometric usual practice (control group without any support on the quality ). Spirometry EAP participants include year follow-up study . All sites use the same model spirometer and have received the same previous training . In a 2nd phase results implementing the most effective method shown in the 1st phase was studied.

EXPECTED RESULTS : The method for quality control more effective to obtain and maintain the quality spirometry.

POTENTIAL IMPACT EXPECTED : performing spirometry quality in the EAP , improve early detection (secondary prevention ) , the diagnosis of the severity and developmental control of COPD.


Eligibility criteria: Inclusion Criteria:

* All patients seen in the participating primary care, requiring spirometry for both the diagnosis and control of any disease will be included.

Exclusion Criteria:

* Patients under 15 years

Primary outcomes:
measure: Effectiveness of two methods for quality control in primary care spirometry
timeFrame: Basal
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Jordi Giner, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06623552: Relationship Between Cervical Pain and Temporomandibular Dysfunction Craniovertebral Angle, Jaw Functional Limitation and Cervical Mobility
Official title: Relationship Between Cervical Pain and Temporomandibular Dysfunction Craniovertebral Angle, Jaw Functional Limitation and Cervical Mobility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temporomandibular Disorder
Lead sponsor: Yeditepe University
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 129
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All individuals in the study were included on a voluntary basis.All participants were informed about the study before the evaluations and the consent form was signed (Appendix- ).All necessary evaluations for the study were carried out on the same day.During the study, both the participants in the study group and the participants in the control group completed the evaluation completely.No health problems were observed in any participant during and after the evaluations.

Brief summary: The aim of this study is to examine temporomandibular dysfunctions, jaw functional limitation, cervical mobility and craniovertebral angles and possible relations between individuals with cervical pain and individuals without cervical pain and to compare the this four variables between the two groups.

Detailed description: This study was conducted with 129 individuals (mean age 34.08:years, M/F=52/77) to determine the possible relationships between Cervical Pain and Temporomandibular Dysfunction, Craniovertebral Angle, Jaw Functional Limitation and Cervical Mobility. Pati,ents were assessed with Neck Pain and Disability Questionnaire , Fonseka Anamnestic Index , goniometric measurements, ,Cervical Mobility Measurement. JFSL-20 questionnaire and Craniovertebral Angle measurement was made by photographic method.

Eligibility criteria: Inclusion Criteria:

Neck pain disability score below 15 Not having painting problem for TME Being in the age range of 18-50 Volunteering to participate in the study

Exclusion Criteria:

* he presence of any orthopedic and / or neurological problem that may prevent evaluations.

Being diagnosed with any psychiatric disorder Situations that will prevent evaluation or communication

* Illiterate individuals
* Head, neck and maxillofacial surgery operation history
* Conditions in systemic pathological conditions such as malignant condition, fracture and rheumatoid arthritis

Primary outcomes:
measure: Neck Pain and Disability Scale (NPDS):
timeFrame: one day
Secondary outcomes:
measure: Fonseca Anamnestic Index (FAI):
timeFrame: one day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yeditepe University
Study officials:
References:
Clinical trial NCT00828152: Internet-delivered Cognitive Behavioral Therapy (CBT) for Health Anxiety
Official title: Internet-delivered Cognitive Behavioural Therapy for Health Anxiety - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypochondriasis
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2009-01-23
Enrollment: 80
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: Hypochondriasis (health anxiety) is common, has many negative consequences for the afflicted individual and is associated with high societal costs. Cognitive Behavioural Therapy (CBT) has proven to be effective when administered in live-sessions. The aim of this study is to investigate whether CBT remains effective when administered via a self-help programme on the Internet.


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of hypochondriasis
* At least 18 years old
* Able to read and write in swedish
* Computer access

Exclusion Criteria:

* Drug abuse
* Concurrent severe depression
* No serious somatic illness
* Previous treatment with CBT for hypochondriasis

Primary outcomes:
measure: Health Anxiety Inventory
timeFrame: 3 days before treatment start
measure: Health Anxiety Inventory
timeFrame: 12 weeks after pre asessment
measure: Health Anxiety Inventory
timeFrame: 6 months after post assessment
measure: Health Anxiety Inventory
timeFrame: 12 months after post assessment
Secondary outcomes:
measure: IAS
timeFrame: Immediately pre and post treatment,and 6 and 12 month follow up
measure: BAI
timeFrame: Immediately pre and post treatment, and 6 and 12 month follow-up
measure: MADRS-S
timeFrame: Immediately pre and post treatment, and 6 and 12 month follow-up
measure: QOLI
timeFrame: Immediately pre and post treatment, and 6 and 12 month follow-up
measure: WI
timeFrame: Immediately pre and post treatment, and 6 and 12 month follow-up
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Psykiatri Sydväst
Study officials:
References:
citation: Hedman E, Andersson G, Lindefors N, Gustavsson P, Lekander M, Ruck C, Andersson E, Ljotsson B. Personality change following internet-based cognitive behavior therapy for severe health anxiety. PLoS One. 2014 Dec 1;9(12):e113871. doi: 10.1371/journal.pone.0113871. eCollection 2014.
citation: Hedman E, Andersson E, Lindefors N, Andersson G, Ruck C, Ljotsson B. Cost-effectiveness and long-term effectiveness of internet-based cognitive behaviour therapy for severe health anxiety. Psychol Med. 2013 Feb;43(2):363-74. doi: 10.1017/S0033291712001079. Epub 2012 May 21.
citation: Hedman E, Andersson G, Andersson E, Ljotsson B, Ruck C, Asmundson GJ, Lindefors N. Internet-based cognitive-behavioural therapy for severe health anxiety: randomised controlled trial. Br J Psychiatry. 2011 Mar;198(3):230-6. doi: 10.1192/bjp.bp.110.086843.
Clinical trial NCT00981552: Dosimetric Planning Study Comparing Intensity Modulated Radiotherapy (IMRT) and 4-field Radiotherapy for Definitive Treatment of Cancer of the Cervix
Official title: Dosimetric Planning Study Comparing IMRT and 4-field Radiotherapy for Definitive Treatment of Cancer of the Cervix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cervix Cancer
Keywords: Cervix Cancer
IMRT
Organ Motion
Target Definition
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2009-09-22
Enrollment: 55
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A theoretical planning study to compare the normal tissue irradiation when using intensity modulated radiotherapy (IMRT) as opposed to standard radiotherapy for the definitive treatment of cervical cancer.

Detailed description: Radiotherapy in combination with chemotherapy is the standard treatment of locally advanced cervix cancer, however with traditional techniques large volumes of bowel and bladder are irradiated causing short-term and long-term genito-urinary and gastro-intestinal side effects. IMRT has the potential to conform precisely to the target and spare normal tissues and reduce side effects. However because there are large dose gradients there is the potential to miss the target due to organ motion. Recent studies have documented organ motion and will be used to define the target. Approximately 60 planning scans, previously used to treat patients with cervix cancer, will be used to replan using an IMRT technique and differences in doses to tumour and normal tissues compared.

Eligibility criteria: Inclusion Criteria:

* last 60 patients treated definitively for cervical cancer at Sunnybrook Odette Cancer Centre

Exclusion Criteria:

* no imaging and no anatomical description of disease

Primary outcomes:
measure: Reduction in dose to organs at risk
timeFrame: 6 months
Secondary outcomes:
measure: Target Coverage
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Gillian Thomas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01324752: A Drug-Drug Interaction Study of Losartan and PA21
Official title: A Single-centre, Open-label, Three-period Study of the Pharmacokinetic Effect of PA21 on Losartan Potassium in Healthy Male and Female Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Interaction Potentiation
Keywords: Drug-drug interaction
Pharmacokinetics
PA21
Lead sponsor: Vifor Pharma
Sponsor class: INDUSTRY
First posted: 2011-03-29
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine if Losartan potassium is affected by PA21.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Written informed consent

Exclusion Criteria:

* No significant medical conditions
* Pregnancy

Primary outcomes:
measure: Effect of PA21 on Losartan potassium
timeFrame: PK assessment on Day 0, 11, 22
Secondary outcomes:
measure: Effect of PA21 on the active metabolite of Losartan potassium
timeFrame: PK assessment on Day 0, 11, 22
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: ACRI- Phase 1
state: California
Study officials:
affiliation: ACRI - Phase 1 (Advanced Clinical Research Institute)
name: Peter J Winkle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00913952: To Demonstrate the Relative Bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed and Fasted Conditions
Official title: Comparative, Randomized, 3-way Crossover Bioavailability Study of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules In Health Adult Males Under Fed and Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Keywords: Antidepressant
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride capsules under fed and fasted conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 53 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Phoenix International Life Science Inc.
name: Richard Lalonde, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00409552: Human Factors Analysis in VR for Burn Treatment
Official title: Phase 1 and 2 Study of Human Factors Analysis in VR for Burn Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pain
Chronic Pain
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2006-12-11
Enrollment: 10
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: SUPPORTIVE_CARE

Brief summary: A number of studies have shown that virtual reality (VR) can be used to distract patients from pain and anxiety during painful medical procedures for which medication provides inadequate relief. An inexpensive, commercially available VE could have significant impact in reducing perceived pain involved in a variety of medical procedures. The Virtual Reality Medical Center (VRMC) developed an engaging virtual world that proved to be effective in reducing reported pain ratings of participants experiencing several different forms of painful stimuli. The virtual world called Icy Cool World was found to successfully distract patients from painful stimuli and reduce patients' perceived levels of pain. Phase II looks to expand on these findings and examine the effectiveness as a pain distraction technique for a variety of acute and chronic pain etiologies. The main objective of the clinical investigation will be to expand on the findings from earlier studies and obtain a more comprehensive analysis regarding the clinical versatility of VR pain distraction.


Eligibility criteria: Inclusion Criteria:

* Age 18-65, male or female, any ethnicity as long as candidates can understand and read English adequately.

Exclusion Criteria:

* We will exclude participants who meet DSM-IV-TR criteria for alcohol or other substance abuse in the past year, or are currently using any recreational drugs, or taking more than 20 alcoholic drinks a week. In addition, the Beck Depression Inventory II (BDI-II) score must be less than 16, with no suicidal ideation.

Primary outcomes:
measure: Pain rating reduction
timeFrame: Following each trial
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: VRMC
name: Mark D Wiederhold, MD, PhD, FACP
role: PRINCIPAL_INVESTIGATOR
References: