louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03438591: The Effect of "Cerclage Pacing" for the Heart Failure Patients Who Need Cardiac Resynchronization Therapy (CRT)
Official title: The Effect of "Cerclage Pacing" for the Heart Failure Patients Who Need Cardiac Resynchronization Therapy (CRT): Early Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
LBBB Complete
Keywords: cerclage pacing
cerclage-CRT
wide QRS
Lead sponsor: Tau-MEDICAL Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-02-19
Enrollment: 2
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: patients who meet the criteria of current CRT treatment
Primary purpose: TREATMENT

Brief summary: trans-coronary sinus intraseptal pacing (cerclage pacing)

Detailed description: This study is aimed at looking at the effect of "Cerclage pacing" for the heart failure patients who need cardiac resynchronization therapy (CRT). The study hypothesis is that parahisian pacing by 'cerclage pacing' may have a similar benefit as is seen with permanent Hisian pacing

Eligibility criteria: Inclusion Criteria:

* who need cardiac resynchronization therapy (CRT) or CRT-non responder
* Left bundle branch block \[LBBB\]) \> 120ms of QRS width
* Ejection fraction (EF) \< 35%
* NYHA class III-IV in spite of optimal medical Tx

Exclusion Criteria:

* Unsuitable coronary vein anatomy on cardiac CT
* Subjects with prosthetic mechanical tricuspid valve
* Active infection
* Life expectancy less than 6 months

Primary outcomes:
measure: rate of procedural success
timeFrame: immediate postprocedure
Secondary outcomes:
measure: Change in subjects' symptoms referred to NYHA Classification System
timeFrame: 12 months
measure: Change in subjects' improvement of parameters by Echocardiography
timeFrame: 12 months
measure: Change of Six minute walk Distance
timeFrame: 12 months
measure: interrogation index of pacemaker lead
timeFrame: 12 months
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangnamdo
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: June-Hong Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim JH, Hwang KW, Chon MK, Nam GB. Trans-coronary sinus intraseptal para-Hisian pacing: Cerclage pacing. Heart Rhythm. 2016 Apr;13(4):992-6. doi: 10.1016/j.hrthm.2015.12.002. Epub 2015 Dec 3. No abstract available.
Clinical trial NCT00707291: Characterization of the Edge of Soft Contact Lens and Its Interaction With Ocular Surface
Official title: Characterization of the Edge of Soft Contact Lens and Its Interaction With Ocular Surface
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: contact lens
normal
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson Vision Care, Inc.
First posted: 2008-06-30
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: normal healthy subjects

Brief summary: The goal of this study is to look at contact lens on the eye and its interaction with the eye during wearing.

Detailed description: The goal of this study is to characterize the edge of contact lenses and its interaction with ocular surface.

Eligibility criteria: Inclusion Criteria:

* self reported normal subjects

Exclusion Criteria:

* any ocular diseases/conditions
* will not wear contact lenses

Primary outcomes:
measure: difference characteristics with different contact lenses and different interactions with the eye
timeFrame: 10 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Bascom Palmer Eye Insititute
state: Florida
Study officials:
affiliation: University of Miami
name: Jianhua Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05595291: Walking Characteristics of Patients With Amputation
Official title: Walking Characteristics of Patients With Amputation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amputation
Keywords: amputation
walking
satisfaction
pain
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One hundred patients with lower extremity amputation will be participated in this cross-sectional study.

Brief summary: The main purpose of the study is to reveal the early and late changes in the walking characteristics of patients with lower extremity amputation. Secondly, it is planned to reveal the factors affecting the walking characteristics of patients with amputation and to compare individuals with different levels of amputation in terms of clinical outcome measures.

Detailed description: It is important to investigate the long-term changes in walking characteristics of patients with amputation and the factors affecting walking characteristics in these patients regarding prosthesis rehabilitation.

The main purpose of the study is to reveal the early and late changes in the walking characteristics of patients with lower extremity amputation. Secondly, it is planned to reveal the factors affecting the walking characteristics of patients with amputation and to compare individuals with different levels of amputation in terms of clinical outcome measures.

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 65
* Presence of lower extremity amputation

Exclusion Criteria:

* Conditions that prevent the use of prosthesis (wound, pain, etc.)
* Having a history of rheumatic disease
* Having cardiac pathology
* Having pulmonary pathology
* Having a situation that prevents communication
* Not giving written consent

Primary outcomes:
measure: 2-minute walking test
timeFrame: through study completion, an average of one month
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: through study completion, an average of one month
measure: Locomotor capacity index
timeFrame: through study completion, an average of one month
Other outcomes:
Locations:
Study officials:
affiliation: Associate Professor
name: Yasin Demir
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01651091: Effects of Meditation Awareness Training on Psychosocial Functioning in Prison Participants
Official title: Effects of Meditation Awareness Training on Psychosocial Functioning in Prison Participants: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychosocial Functioning
Lead sponsor: Nottingham Trent University
Sponsor class: OTHER
Collaborators: name: Awake to Wisdom Foundation
name: Serco Group Plc
First posted: 2012-07-26
Enrollment: 102
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to investigate the effects of an eight-week long group-based secular intervention known as Meditation Awareness Training (MAT) on psychosocial functioning in prison participants.

Detailed description: In Western practitioner settings, Buddhist principles are increasingly being used in the treatment of a wide range of mental health issues. However, there is a dearth of high quality research examining the effects of Buddhist-derived interventions (BDIs) on mental health in forensic settings. The purpose of this study is to assess the salutary effects and acceptability of a secularised group-based eight-week BDI known as Meditation Awareness Training (MAT) against relevant predictors of adaptive psychosocial functioning and mental health in violent offenders. A randomized controlled trial (RCT) design will be employed structured with reference to CONSORT (Consolidated Standards of Reporting Trials) 2010 guidelines. English speaking adult males (aged 18-65 years) serving indeterminate prison sentences for offences of instrumental violence at a category B prison will be invited to receive MAT on a voluntary basis. Computer-generated numbers will be used to randomly allocate prison participants (n=102 - based on statistical power calculations) to either an intervention or 'treatment as usual' (TAU) control condition. Measures will be taken pre- and post-intervention and at three-month follow-up to assess maintenance effects.

Eligibility criteria: Inclusion Criteria:

* Adult male (aged 18 to 65)
* English speaking
* Intact cognition(mini-mental status exam ≥23)
* Incarceration for an act of instrumental violence
* Evidence of self-harming and/or suicidal ideations and/or substance-use during the 12 months prior to the study.

Exclusion Criteria:

* current participation in a program of structured psychotherapy or counselling
* any prior formal meditation training
* psychopharmacology commenced or dosage changed one-month prior to intervention (stable medication permitted)

Primary outcomes:
measure: Risk of Reoffending
Secondary outcomes:
measure: Anger levels
measure: Self-esteem
measure: Substance-use locus of control
measure: Self-harming
measure: Affective mood states
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham Trent University
Study officials:
References:
Clinical trial NCT00273091: MODULA Modul 5 BEAT-HF
Official title: MODULA-Study: Modul 5 / BEAT HF: Detektion and Registration of Atrial Tachyarrhythmias at Patients With Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: Guidant Corporation
First posted: 2006-01-09
Enrollment: 100
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: Elegible patients comprise the investiagators standard CRT-D population.

Brief summary: Detektion and Registration of Atrial Tachyarrhythmias at Patients with Heart Failure; What proportion of patients with CRT-therapy are affected at least temporarily by Atrial Arrhythmia?

Detailed description: How many patients with CRT-therapy are affected at least temporarily by Atrial Arrhythmia in terms of rate, characteristics and severity of atrial rhythm disturbances at patients with CRT-therapy within 12 months after implantation of a CRT-device.

Eligibility criteria: Inclusion Criteria:

* patient under CRT-D or CRT-P therapy

Exclusion Criteria:

* patients with permanent Atrial Fibrillation

Primary outcomes:
measure: Occurrence of atrial tachycardia in CRT patients
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Berka
country: Germany
facility: Herzzentrum / Klinik für Kardiologie / Robert-Koch-Allee 9
Study officials:
affiliation: Herzzentrum / Klinik für Kardiologie / Robert-Koch-Allee 9 / 99437 Bad Berka / Germany
name: Burkhard J. Hügl, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03989791: The Clinical Effect of Normal Diet and Absolute Diet on Post-polypectomy Patients: an Open-label, Randomized Controlled Trial
Official title: The Clinical Effect of Normal Diet and Absolute Diet on Post-polypectomy Patients: an Open-label, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polyp Colorectal
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: There is no evidence to prove the impact of post-procedural diet on post-polypectomy bleeding (PPB) or delayed perforation. No relevant study has been conducted and it is yet to be determined if absolute diet is necessary for post-polypectomy patients, and the comparison between normal diet and absolute diet also remains unclear. Therefore, we carried out this randomized controlled study to evaluate and compare tthe clinical effect of different diets on post-polypectomy patients.


Eligibility criteria: Inclusion Criteria:

1. 18-75 patient with initial diagnosis of colorectal polyp by colonoscopy;
2. The maximum size of polyp is more than 20mm;
3. The patients underwent single ESD procedure for the polyp and agreed to participate this trial.

Exclusion Criteria:

1. Uncontrollable hypertension or diabetes；
2. Severe comorbidities such as cancer and organ failure etc；
3. Patients who were pregnant;
4. Patients had anticoagulants during perioperative period;
5. Patients with poor compliance. -

Primary outcomes:
measure: postoperative adverse event rate
timeFrame: 14-day after polypectomy
Secondary outcomes:
measure: length of stay
timeFrame: 14-day after polypectomy
measure: hospitalization cost
timeFrame: 14-day after polypectomy
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06626191: Comparison of the Postoperative Analgesic Efficacy of SPSIPB and ISBPB
Official title: Comparison of the Postoperative Analgesic Efficacy of Serratus Posterior Superior Intercostal Plane Block and Interscalene Brachial Plexus Block in Shoulder Arthroscopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Arthroscopy
Peripheral Nerve Block
Pain Management
Keywords: Shoulder Arthroscopy
Interscalene Brachial Plexus Block
Serratus Posterior Superior Intercostal Plane Block
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-03
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Shoulder arthroscopy is one of the common surgical procedures performed today. After shoulder surgery, providing adequate analgesia is necessary for both the comfort of the patient and the ability to perform the necessary post-operative rehabilitation exercises early and regularly.

Nerve blocks reduces opioid consumption in the postoperative period by providing better pain control and therefore has advantages such as fewer side effects and less risk of pulmonary and cardiac complications.

In this study; it was aimed to compare the analgesic effectiveness of interscalene brachial plexus block and serratus posterior superior intercostal plane block, with each other and with the control group in the postoperative period in patients who underwent shoulder arthroscopy.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18-80 years
* American Society of Anesthesiologists (ASA) score I-II-III
* Body Mass Index (BMI) between 18-30 kg/m2

Exclusion Criteria:

* Patients under 18 and over 80 years of age
* ASA score IV and above
* Patients with a history of bleeding diathesis
* BMI below 18 or above 30 kg/m2

Primary outcomes:
measure: Pain Scores
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Intraoperative remifentanil consumption Intraoperative opioid consumption
timeFrame: Intraoperative period
measure: Postoperative Tramadol Consumption
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Altındağ
country: Turkey
facility: Ankara Etlik City Hospital
state: Ankara
Study officials:
References:
Clinical trial NCT04462991: COMPARISON OF CORNEAL MEASUREMENTS IN NORMAL AND KERATOCONUS EYES USING ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY AND PENTACAM HR TOPOGRAPHER
Official title: COMPARISON OF CORNEAL MEASUREMENTS IN NORMAL AND KERATOCONUS EYES USING ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY AND PENTACAM HR TOPOGRAPHER
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Reliability of Corneal Topographic Measurements of Keratoconus Eyes
Lead sponsor: Fayoum University
Sponsor class: OTHER
Collaborators: name: Sara Tawfik
First posted: 2020-07-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: keratoconus patients

Brief summary: The purpose of current study is to provide a comprehensive comparison of the reliability of corneal topographic measurements between Optovue AS- OCT and a combined Scheimpflug imaging using Wavelight Oculyzer Pentacam HR in normal and keratoconus eyes.


Eligibility criteria: Inclusion Criteria:

* topography characteristic of keratoconus (skewed asymmetric bow-tie, inferior steep spot, etc.) and at least one clinical sign e.g., slit lamp findings of Munson's sign, Vogt's striae, Fleischer's ring, apical thinning, Rizutti's sign, etc.

Exclusion Criteria:

* are advanced complications of keratoconus such as corneal scars or hydrops.

Primary outcomes:
measure: Corneal measurments in KC CORNEAL MEASUREMENTS IN NORMAL AND KERATOCONUS EYES USING ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY AND PENTACAM HR TOPOGRAPHER
timeFrame: we will recruit patients who meer the inclusion criteria during the study period januray-August 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum University
Study officials:
References:
Clinical trial NCT00094991: Mechanism of Action and Efficacy of Muraglitazar in Type 2 Diabetes
Official title: Mechanism of Action and Efficacy of Muraglitazar (BMS298585) in the Treatment of Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2004-11-01
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 learn more about how muraglitazar lowers blood sugar in people with type 2 diabetes. The safety of this treatment will also be studied.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes;
* Serum triglyceride concentration \< or = 600 mg/dL;
* Body mass index \< or = 37 kg/m2

Exclusion Criteria:

* Type 1 diabetes;
* History of myocardial infarction (MI), coronary angioplasty, bypass graft(s), valvular disease, unstable angina pectoris, transient ischemic attack (TIA), or cerebrovascular accident (CVA) within 6 months;
* Congestive heart failure (NYHA Class III and IV);
* Uncontrolled hypertension;
* Women of Child Bearing Potential
* History of renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease, or endocrine disease

Primary outcomes:
measure: The change from baseline in insulin medicated glucose disposal after 16 weeks of treatment with Muraglitazar
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Local Institution
state: Texas
city: Pisa
country: Italy
facility: Local Institution
Study officials:
References:
Clinical trial NCT01459991: The Mediterranean Diet and Lactation Study: A Diet Study in Lactating Women
Official title: The Mediterranean Diet and Lactation Study: A Diet Study in Lactating Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Feeding
Keywords: walnut
mediterranean
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: California Walnut Commission
First posted: 2011-10-26
Enrollment: 138
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Purpose: During lactation, several physiological modifications occur including cellular differentiation and proliferation, as well as elevation in inflammation. The role of the Mediterranean (MED) diet rich in walnuts has been shown to favorably modify fatty acid profiles and to reduce inflammation. The study goal is to evaluate the anti-inflammatory effects of the MED diet rich in walnuts during lactation, a time of increased inflammatory response.

Procedures: A randomized, controlled dietary intervention trial among lactating women comparing the effects of a Mediterranean-style diet with walnuts to the USDA's MyPyramid Diet for Moms was commenced to determine the effects of the diet on fatty acid profiles and biomarkers of inflammation in breast milk and material serum/plasma. Secondary outcomes of interest include effects of maternal diet assignment on maternal body weight and body composition as well as infants' growth and health during the study trial period.

Population: The study population includes healthy women between the ages of 18-40 years who are within 6 months post-partum and plan to breastfeed a minimum of 3 times per day for 6 months following study entry. There have been a total of 138 participants enrolled in the study. All 138 participants are women; 34 identified themselves as Hispanic, and 104 said they were not Hispanic.


Eligibility criteria: Inclusion Criteria:

* plan to breastfeed 3 times daily for 6 months
* no nut allergies
* no history of cancer, renal disease, liver disease, or diabetes
* no smoking

Exclusion Criteria:

Primary outcomes:
measure: Estrogen associated hormones
timeFrame: baseline, 2 month, 4 month, 6 month, 12 month
measure: inflammatory and oxidative stress biomarkers
timeFrame: baseline, 2, 4, 6, and 12 months
measure: body measurements
timeFrame: baseline, 2, 4, 6, and 12 months
measure: diet adherence
timeFrame: Baseline, 2, 4, 6, and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Nutrition Research Clinic
state: Arizona
Study officials:
References: