louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04491864: DWIBS-MRI: An Adjunct to the Traditional Diagnostic Breast Imaging Evaluation
Official title: DWIBS-MRI: An Adjunct to the Traditional Diagnostic Breast Imaging Evaluation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 200
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Genetically female patients age 30 and greater with suspicious BIRADS 4 or BIRADS 5 masses and/or asymmetries on standard 2D/3D mammogram and ultrasound imaging

Brief summary: 1.1. Primary Objectives

* To determine if MRI DWIBS can accurately identify suspicious lesions previously categorized on mammography and sonography as potentially malignant.
* We will also validate whether DWIBS-MRI ADC values can be used to accurately differentiate benign from malignant lesions. Additionally, because it is not known whether tumor type or growth rate (Ki67 values) will affect our results, we will include these parameters in our analysis.
* Once we validate the use of DWIBS-MRI ADC values to determine malignancy, can we establish an ADC threshold value to decrease the number of false positive biopsies that are performed while still maintaining a zero false negative rate?
* This study will also assess the correlation between ADC values and the Ki-67 proliferative index of malignant lesions.


Eligibility criteria: Inclusion Criteria:

* A patient will be eligible for inclusion in this study if she meets all of the following criteria:

  1. \>30 years of age
  2. Genetic Female
  3. Suspected diagnosis of BIRADS 4 or BIRADS 5 masses and/or asymmetries greater than 1 centimeter based on standard 2D/3D mammogram and ultrasound imaging.

Exclusion Criteria:

* A patient is ineligible for inclusion in this study if she meets any of the following criteria:

  1. Prior biopsy of suspicious lesion
  2. Breast implants
  3. Prior history of breast cancer
  4. Patient has a pacemaker
  5. Contraindications to use of MRI imaging (metal implants, etc.)
  6. Woman pregnant or lactating
  7. Calcifications as only findings present for a suspicious lesion

Primary outcomes:
measure: MRI DWIBS Accuracy
timeFrame: 1 month
measure: Validate DWIBS-MRI
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Scott & White Research Insitute
state: Texas
Study officials:
References:
Clinical trial NCT02441764: Halaven Post-Marketing Surveillance (PMS)
Official title: Post-Marketing Surveillance of Halaven Injection in Korean Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Halaven
Eribulin Mesylate
locally advanced or metastatic breast cancer
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-12
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who are prescribed with Halaven per approved prescribing information of Halaven will be enrolled in the study.

Brief summary: This is a PMS to observe the safety profile of Halaven in normal clinical practice setting.


Eligibility criteria: Participants who are prescribed with Halaven per approved prescribing information of Halaven will be enrolled in the study. This study will be conducted as complete surveillance method; participants who meet the inclusion/exclusion criteria and administrate Halaven for the first time after conclusion of agreement will be enrolled after consent.

Inclusion Criteria:

Participants who meet all of the following criteria will be eligible for inclusion in the study:

1. Participants with following indication: Participants with locally advanced or metastatic breast cancer who have previously received at least two chemotherapeutic regimens which should have included an anthracycline and a taxane.
2. Participants who have verbal or written consent for use of personal and medical information.

Investigators will refer to indications regarding inclusion criteria.

Exclusion Criteria:

1. Hypersensitivity to the active substance or to any of the excipients
2. Breast feeding
3. Pregnancy

Investigators will refer to indications and contraindications regarding exclusion criteria.

Primary outcomes:
measure: Safety of Halaven as a measure of number of participants with adverse events/serious adverse events/adverse drug reactions
timeFrame: Up to 1 year
Secondary outcomes:
measure: Tumor response to Halaven treatment
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
city: Chuncheongnam-do
country: Korea, Republic of
city: Chungcheongbuk-do
country: Korea, Republic of
city: Chungcheongnam-do
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: Gyeonggi-do
country: Korea, Republic of
city: Gyeongsanbuk-do
country: Korea, Republic of
city: Gyeongsannam-do
country: Korea, Republic of
city: Jeollabuk-do
country: Korea, Republic of
city: Jeollanam-do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
Study officials:
References:
Clinical trial NCT04133064: Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study
Official title: Pivot Breath Sensor Study to Evaluate the Effect of the Pivot Breath Sensor on a User's Attitudes Towards Quitting Smoking and Smoking Behavior.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Reduction
Smoking Behaviors
Smoking, Tobacco
Smoking Cessation
Lead sponsor: Pivot Health Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-21
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Prospective open label, single center study enrolling up to 220 participants to evaluate the effect of the Pivot Breath Sensor on a user's attitudes towards quitting smoking and smoking behavior.

Detailed description: Study to collect the following data during and after use of a personal carbon monoxide breath sensor (Pivot Breath Sensor):

* Change in attitudes towards quitting smoking
* Change in smoking behavior
* Participant feedback

Eligibility criteria: Inclusion Criteria:

* 18-80 years of age
* Current daily cigarette smokers (at least 10 cigarettes per day)
* Resident of the United States
* Able to read and comprehend English
* Owns and uses a smartphone compatible with the study app (iPhone 5 and above with operating system iOS 11 and above, or, Android 5.0 and above with operating system Android 5.0 and above)
* Willing to sign the Informed Consent Form

Exclusion Criteria:

* Pregnancy
* Participation in a previous study sponsored by Carrot Inc

Primary outcomes:
measure: Number of Participants With Different Stages of Change in Desire to Quit Smoking
timeFrame: 3 months (12 weeks) compared to baseline
measure: Success to Quit (STQ)
timeFrame: 3 months (12 weeks)
measure: Difficulty to Quit (DTQ)
timeFrame: 3 months (12 weeks)
measure: Average Quit Attempts Made Since Using the Pivot Breath Sensor
timeFrame: 3 months (12 weeks)
measure: Change in Cigarettes Per Day (CPD) From Baseline
timeFrame: 3 months (12 weeks)
measure: Point Prevalence Abstinence (PPA)
timeFrame: 3 months (12 weeks)
Secondary outcomes:
measure: Feedback on Breath Sensor Setup, Experience and Use
timeFrame: 1 week
measure: Feedback on Impact on Motivation to Quit Smoking
timeFrame: 1 week
measure: Feedback on Impact on Number of Cigarettes Smoked Per Day
timeFrame: 1 week
measure: Feedback on Commercialization
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Carrot Inc.
state: California
Study officials:
affiliation: Pivot Health Technologies Inc.
name: Jen Marler
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marler JD, Fujii CA, Wong KS, Galanko JA, Balbierz DJ, Utley DS. Assessment of a Personal Interactive Carbon Monoxide Breath Sensor in People Who Smoke Cigarettes: Single-Arm Cohort Study. J Med Internet Res. 2020 Oct 2;22(10):e22811. doi: 10.2196/22811.
Clinical trial NCT06421064: Clinical Profile and Outcome of Perforated PUD
Official title: Clinical Profile and Surgical Treatment Outcome of Perforated Peptic Ulcer Disease in Public Hospitals of Eastern Ethiopia: a Prospective Multicenter Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diseases or Conditions
Lead sponsor: Haramaya Unversity
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All surgical emergency admissions.

Brief summary: Perforated peptic ulcer disease (PPUD) is series illness that need emergency intervention. Its overall clinical profile and treatment outcome was also not well studied in developing countries. Therefore the study was aimed to see the outcome of surgical intervention and associated factors.

The study was a retrospective observational study conducted using the medical records of patients operated on for perforated peptic ulcer disease at a multicenter, in eastern Ethiopia.

Detailed description: This study was designed to investigate the clinical characteristics and treatment outcomes among adult patients presented to the study areas. Three teaching Hospitals and one Regional Hospital were chosen and data collection was effected for two years. One hundred seventy patients participated in this observational study.

Eligibility criteria: Inclusion Criteria:

* All adults with a diagnosis of perforated PUD managed at HU until discharged

Exclusion Criteria:

* Patients who were referred to other institutions before official discharge, Incomplete Medical record

Primary outcomes:
measure: Survival outcome of perforated PUD
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Harar
country: Ethiopia
facility: Haramaya University
Study officials:
References:
Clinical trial NCT03953664: The Effects of Three Different Modalities of Exercise in Patients With Schizophrenia
Official title: The Effects of Three Different Modalities of Exercise Training (Aerobic, Strength, Aerobic-strength) on Psychological and Physiological Correlates in Schizophrenia: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 84
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: Exercise has been shown to improve health in patients with schizophrenia. However, it remains unclear which modality of exercise reports better benefits.

Aim: To compare the effects of different modalities of exercise training on psychological and physiological variables in schizophrenia.

Detailed description: Exercise has been shown to improve psychological, physiological, and biological correlates in patients with schizophrenia. However, it remains unclear which modality of exercise reports better health benefits.

Aim: To compare the effects of three different modalities of exercise (aerobic, strength, aerobic-strength) on psychological and physiological variables in patients with schizophrenia.

Design: Randomized clinical trial

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Schizophrenia
* Age between 18-65 years

Exclusion Criteria:

* Patients with other mental diseases
* Patients with mental disabilities
* Patients who present motor or behavioral pathologies that prevent the realization of the exercise training.

Primary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: 16 weeks
Secondary outcomes:
measure: World Health Organization Quality of Life-Short version (WHOQOL-BREF)
timeFrame: 16 weeks
measure: Body Mass Index (BMI)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Moncada
country: Spain
facility: Universidad CEU Cardenal Herrera
state: Valencia
Study officials:
affiliation: Cardenal Herrera University
name: JF Lisón, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03862664: Respiratory Complications Among Living Liver-donors
Official title: Respiratory Complications Among Living Liver-donors: a Single Center Observational Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Complication of Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 124
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Donors who underwent hepatic lobectomy for liver transplantation

Brief summary: Recently, there are increasing reports about pulmonary complications within living liver donors postoperatively. In this retrospective study, the investigators will highlight the risk factors and incidence of pulmonary complication among living liver-donors in our center.


Eligibility criteria: Inclusion Criteria:

* Excellent general physical and mental condition,
* Free of chronic disease or
* Previous major abdominal surgery,
* Body mass index (BMI) \<28,
* ABO blood group identical to recipients and
* Negative for hepatitis B, C and human immunodeficiency viruses (HIV).

Exclusion Criteria:

* ASA physical status\> II,
* BMI\>28,
* Psychiatric or mental retardation,
* pregnant and nursing women or
* Patients with significant laboratory abnormalities

Primary outcomes:
measure: The number of participants with postoperative respiratory complications
timeFrame: an average period of 3 year
Secondary outcomes:
measure: The average of ICU stay among patients
timeFrame: an average period of 3 year
measure: The average of hospital stay among patients
timeFrame: an average period of 3 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hospitals
Study officials:
References:
Clinical trial NCT05982964: Impact of Scapula Position on Functionality and Balance in People With Chronic Low Back Pain
Official title: Impact of Scapula Position on Functionality and Balance in People With Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Back Pain
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our study was carried out on healthy and non-specific low back pain individuals who came to Bahçeşehir University.

Brief summary: Chronic low back pain is defined as pain that lasts for more than 3 months or exceeds the expected recovery time.

Detailed description: Chronic low back pain is defined as pain that lasts for more than 3 months or exceeds the expected recovery time.

Eligibility criteria: Inclusion criteria:

* Individuals between the ages of 18-65
* Individuals with low back pain for at least 3 months for the first group
* Not undergoing surgery related to the lumbar region
* Cases without lumbar steroid injection in the last 3 months
* Not having visual and hearing loss
* Having low back pain
* Cases without neurological problems
* Cases without tumor and infection in the lumbar region
* Exclusion criteria:
* Individuals under the age of 18
* Individuals with low back pain for less than 3 months for the first group
* Not having a musculoskeletal or neuromuscular disease that limits mobility,

Primary outcomes:
measure: Pressure Pain Threshold Algometer
timeFrame: 1 day
measure: Examining the Scapular Position
timeFrame: 1 day
measure: Evaluation of Balance
timeFrame: 1 day
measure: Proprioception Evaluation
timeFrame: 1 day
measure: Evaluation of Functionality
timeFrame: 1 day
measure: Waist Awareness Assessment
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: HAZAL genç
state: None Selected
Study officials:
References:
Clinical trial NCT05063890: Comparison of Muscle Specific and Movement Specific Muscle Energy Technique in the Management of Mechanical Neck Pain: a Randomized Controlled Trial.
Official title: Comparison of Muscle Specific and Movement Specific Muscle Energy Technique in the Management of Mechanical Neck Pain: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: neck pain
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 66
Sex: ALL
Minimum age (years): 19
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the purpose of this study is to compare the effects of muscle-specific muscle energy technique and movement-specific muscle energy technique in terms of pain, function and cervical range of motion in persons with mechanical neck pain.


Eligibility criteria: Inclusion Criteria:

Mechanical neck pain ranging from 40-80 mm on visual analogue scale (VAS) Age between 19-44 years Pain or limitation on cervical motion

-

Exclusion Criteria:

History of fracture, surgery or trauma in the neck Cervical radiculopathy Myelopathy Spondylosis Syringomyelia Thoracic outlet syndrome Infection Malignancy Inflammatory or rheumatic disorders Vascular syndromes

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 5 days
measure: Neck Disability Index
timeFrame: 5 days
measure: Cervical Range of Motion
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University Institute of Rehabilitation Sciences.
state: Federal
Study officials:
References:
Clinical trial NCT00529490: Efficacy, Safety of Hypertonic Lactate Soln. as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG Pats
Official title: The Efficacy and Safety of Hypertonic Lactate Solution as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG (Coronary Artery Bypass Grafting) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Cardiac Output
Keywords: coronary
artery
bypass
grafting
I.V.
cardiac output
Lead sponsor: Innogene Kalbiotech Pte. Ltd
Sponsor class: INDUSTRY
First posted: 2007-09-14
Enrollment: 230
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: TREATMENT

Brief summary: Prospective, randomized, open-label study to assess the efficacy and safety of hypertonic lactate solution, compared to Ringer's Lactate as fluid resuscitation to maintain hemodynamic stability in post-coronary artery bypass grafting(CABG) patients. Patients who were eligible received either hypertonic lactate solution or Ringer's Lactate post-CABG in the ICU when fluid resuscitation was needed.

Detailed description: Prospective, randomized, open-label study to assess the efficacy and safety of hypertonic lactate solution, compared to Ringer's Lactate as fluid resuscitation to maintain hemodynamic stability in post-coronary artery bypass grafting(CABG) patients. Patients who were eligible received either hypertonic lactate solution or Ringer's Lactate post-CABG observed in the first 12 hours in the ICU when fluid resuscitation was needed.

Eligibility criteria: Inclusion Criteria:

* Patients who have given their written informed consent.
* Male or female, aged 18-75 years.
* Post-operative CABG on pump or off pump in ICU.
* Patients who need fluid resuscitation.

Exclusion Criteria:

* Combined operations.
* Need for intra aortic balloon pump (IABP).
* Patients with severe arrhythmia (VT, AF rapid response, heart block).
* Severe hemodynamic imbalance.
* Severe bleeding and/or re-operation.
* Liver dysfunction(SGOT and SGPT 2x normal).
* Renal failure (Creatinine \>2 mg%).

Primary outcomes:
measure: hemodynamic stability
timeFrame: 12 hours post-CABG surgery
Secondary outcomes:
measure: Safety of hypertonic sodium lactate for maintaining the hemodynamic stability
timeFrame: 12 hours post-CABG surgery
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: National Cardiac Center, Department of Surgery and Intensive Care Unit, Harapan Kita Hospital
Study officials:
affiliation: National cardiac Centre, Harapan Kita Hospital, Dept. of Anaesthesiology, Intensive Care Unit, Jakarta, Indonesia
name: Iqbal Mustafa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Director, INSERM-E0221-Bioenergetique Fondamentale et Appliquée Université, Joseph Fourier, France
name: Xavier Leverve, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01530490: Cabergoline and Hydroxyethyl Starch in Ovarian Hyperstimulation Syndrome Prevention
Official title: Prevention of Ovarian Hyperstimulation Syndrome in GnRH Agonist IVF Cycles: Randomized Study Comparing Hydroxyethyl Starch Versus Cabergoline and Hydroxyethyl Starch
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Complications Associated With Artificial Fertilization
Disorder of Endocrine Ovary
Keywords: IVF
ovarian hyperstimulation syndrome
cabergoline
hydroxyethyl starch
prevention
Lead sponsor: Hospital de Cruces
Sponsor class: OTHER
First posted: 2012-02-10
Enrollment: 80
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: The purpose of this study is to assess whether, in GnRH agonist in vitro fertilization (IVF) cycles, where there is a risk of ovarian hyperstimulation syndrome (OHSS), the addition of cabergoline to the hydroxyethyl starch infusion could decrease OHSS incidence and severity.

Detailed description: Women undergoing IVF cycles with GnRH agonist protocols, at risk of OHSS (more than 20 follicles observed larger than 12 mm in diameter and/or estradiol levels of 3000-5000 pg/mL).

Slow infusion of 500 ml of 6% HES during follicular aspiration alone or combined with 0.5 mg cabergoline administration for 8 days, starting on the day of hCG administration.

Eligibility criteria: Inclusion Criteria:

* to be at risk of OHSS were invited to participate in the study

Exclusion Criteria:

* age \> 40 years

Primary outcomes:
measure: risk of ovarian hyperstimulation syndrome
timeFrame: 12 days
Secondary outcomes:
measure: pregnancy rate
timeFrame: 15 days
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Cruces
name: Roberto Matorras, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matorras R, Andres M, Mendoza R, Prieto B, Pijoan JI, Exposito A. Prevention of ovarian hyperstimulation syndrome in GnRH agonist IVF cycles in moderate risk patients: randomized study comparing hydroxyethyl starch versus cabergoline and hydroxyethyl starch. Eur J Obstet Gynecol Reprod Biol. 2013 Oct;170(2):439-43. doi: 10.1016/j.ejogrb.2013.07.010. Epub 2013 Aug 8.