louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02723097: A Pilot Test of the Relaxation Response Resiliency Program (3RP) in Spanish Speaking World Trade Center Survivors With Post Traumatic Stress Disorder (PTSD)
Official title: A Pilot Test of the Relaxation Response Resiliency Program (3RP) in Spanish Speaking World Trade Center Survivors With Post Traumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder (PTSD)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-03-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this protocol is to test the feasibility and acceptability of the Relaxation Response Resiliency Program (3RP), a psychotherapy treatment providing a variety of mind body skills and interventions to decrease medical and mental health symptoms and build resilience, in Spanish-speaking World Trade Center (WTC) survivors, and to examine its clinical effectiveness to reduce Post Traumatic Stress Disorder (PTSD), depression, anxiety, and lower respiratory symptoms (LRS) and improve psychosocial functioning.


Eligibility criteria: Inclusion Criteria:

* score \> or = 44 on the PTSD Checklist PCL, considered the broad definition of PTSD syndrome71
* report at least one LRS symptoms (i.e., shortness of breath, wheezing, dyspnea or cough).
* Spanish Speaking

Exclusion Criteria:

* regular practice of eliciting relaxation response (i.e., meditation, yoga) in the past 6 months,
* serious unmanaged mental illness including bipolar disorder, psychosis, and active substance misuse disorders;
* inability to participate in consecutive sessions over 3-month period.

Primary outcomes:
measure: Structured Clinical Interview (SCID-NP) for Diagnostic and Statistical Manual DSM-IV
timeFrame: 1 Month
measure: Symptom Severity using PTSD Checklist
timeFrame: 1 Month
measure: Assessment of Anxiety Symptoms using Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: 1 Month
measure: Measure of Functional Impairment using the Range of Impaired Functioning Tool (RIFT)
timeFrame: 1 Month
measure: Assessment of Mindful attention using Mindful Attention Awareness Scale (MAAS)
timeFrame: 1 Month
measure: Health Promoting Behaviors will be assessed with the Health Promoting Lifestyles Profile-II (HPLP-II)
timeFrame: 1 Month
measure: Measure of treatment expectancy using the Treatment Credibility/Expectancy Questionnaire.
timeFrame: 1 Month
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Lucia Ferri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03727997: Epidemiology and Long Term Outcome of Critically Ill Patients Requiring Renal Replacement Therapy in Southeast Asia and India (InSEA-RRT Registry)
Official title: Epidemiology and Long Term Outcome of Critically Ill Patients Requiring Renal Replacement Therapy in Southeast Asia and India (InSEA-RRT Registry)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Kidney Injury
Keywords: Acute kidney injury
Renal replacement therapy
Intensive Care Unit
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2018-11-01
Enrollment: 5000
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 who are admitted in intensive care units who are diagnosed with acute kidney injury by KDIGO criteria (cr or urine output criteria) stage 3

Brief summary: Acute kidney injury is associated with increased short-term and long-term morbidity and mortality. Long-term data is lacking in low to middle-income countries. Our study aims to follow the acute kidney injury patients stage 3 in intensive care units for 2 years to observe mortality and associated factors.


Eligibility criteria: Inclusion Criteria:

* AKI stage 3
* At least 18 years old

Exclusion Criteria:

* ESRD patients (eGFR \< 15 mL/min/1.73 m2)

Primary outcomes:
measure: 2-year mortality
timeFrame: 2-year
Secondary outcomes:
measure: Hospital mortality
timeFrame: 28-day
measure: RRT rate
timeFrame: 28-day
measure: Renal recovery
timeFrame: 28-day
measure: 2-year major adverse kidney events
timeFrame: 2-year
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Chulalongkorn University
state: Pathumwan
Study officials:
References:
Clinical trial NCT01865097: Relaxation Guided Imagery for Treatment of Pain in Parkinson's Disease
Official title: Pilot Study of Relaxation Guided Imagery for Treatment of Pain in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Parkinson's Disease
Keywords: Imagery
Pain
Depression
Non-Motor
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2013-05-30
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Parkinson's disease patients may have severe non-motor symptoms. A common and troublesome non-motor symptom is pain. Currently these symptoms are treated with medication with limited success. Our study aims to determine whether relaxation guided imagery can alleviate pain in Parkinson's disease patients.

Detailed description: Parkinson's disease patients with severe pain without dementia will participate in this study aimed to examine a possible beneficial effect of relaxation guided imagery on pain. This will be a phase I, controlled, single blind and randomized efficacy study in 2 parallel groups. The study will include a baseline assessment of pain severity where after the intervention group will undergo relaxation guided imagery and the control group will listen to relaxing music. After these relaxation session patients will receive a CD with either relaxation guided imagery or relaxing music to listen to at home. Pain severity will be recorded for the following 6 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients with idiopathic Parkinson's disease suffering from significant pain.

Exclusion Criteria:

* Dementia
* Hearing impairment

Primary outcomes:
measure: Pain scores on the visual analog scale
timeFrame: 6 weeks
Secondary outcomes:
measure: The brief Pain Inventory
timeFrame: 6 weeks
Other outcomes:
measure: Health status measured by Parkinson's Disease Questionnaire 39(PDQ39)
timeFrame: 6 weeks
measure: Depression scores on Beck Depression Inventory (BDI)
timeFrame: 6 weeeks
measure: Non-motor symptom screening questionaire
timeFrame: 6 weeks
Locations:
Study officials:
affiliation: Rambam Health Care Campus, Haifa, Israel
name: Ilana Schlesinger, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03792997: A Therapeutic Protocol in Previous Failed ART Patients With High Total NK Cells
Official title: A Therapeutic Protocol in Previous Failed ART Patients With High Total NK Cells: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Unexplained Infertility
Lead sponsor: Benha University
Sponsor class: OTHER
Collaborators: name: Hawaa Fertility Center
First posted: 2019-01-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: patients with previous failed ART cycles with high peripheral NK cells will be divided into 2 groups: one group of patients with previous failed ART cyles will undergo standard treatment but the other group will have in addition lipid emulsion \&prednisolone \& LMWH

Detailed description: patients with previous failed ART cycles with high peripheral NK cells will be divided into 2 groups: one group of patients with previous failed ART cyles will undergo standard treatment but the other group will have in addition lipid emulsion begin in the cycle before embryo transfer \&prednisolone begin with the start of lipid emulsion \& LMWH begin with the day of ET

Eligibility criteria: Inclusion Criteria:

* patients with high peripheral NK cells \> 10% unexplained infertility cases cases with endometriosis

Exclusion Criteria:

* uterine factors poor responders\< 3 MII oocytes severe male factor \& Azospermia

Primary outcomes:
measure: chemical pregnancy rate
timeFrame: 14 days
Secondary outcomes:
measure: clinical pregnancy rate
timeFrame: 6 weeks of pregnancy
Other outcomes:
Locations:
city: Banha
country: Egypt
facility: Banha University- Hawaa Fertility center
state: Qalyubiya
Study officials:
affiliation: Hawaa Fertility Center
name: ahmed sa saad, MD, ph D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02635997: Antiresorptive Effects of a 6-m Treatment Course With Ibandronate Plus Supplementation of Vitamine D and Calcium in Central America
Official title: Antiresorptive Effects of a 6-m Treatment Course With Ibandronate Plus Supplementation of Vitamine D and Calcium in Central America
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Keywords: osteoporosis
ibandronate
vitamine D
calcium
bone mineral density
health-related quality of life
Lead sponsor: Pontifical Catholic University of Argentina
Sponsor class: OTHER
First posted: 2015-12-21
Enrollment: 425
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postmenopausal women with a diagnosis of osteoporosis o with a high risk of developing it in the near future.

Brief summary: Ibandronate is a third-generation biphosphonate with recognized antiresorptive efficacy by several international, randomized, double-blind, controlled trials. These studies have not included patients from central america, to the best of our knowledge. Therefore, this open-label, uncontrolled study, was set out to assess the clinical effects of a 6-m treatment course with Ibandronate plus vitamine D and Calcium on bone mineral density and health-related quality of life.


Eligibility criteria: Inclusion Criteria:

* Women with a diagnosis of osteoporosis of at-Risk
* Have a medical indication to receive Ibandronate+Vitamine D+Calcium

Exclusion Criteria:

* Osteoporosis due to secondary causes

Primary outcomes:
measure: Bone Mineral Density
timeFrame: 6 months
measure: Health-Related Quality of Life
timeFrame: 6 months
Secondary outcomes:
measure: Adverse Events
timeFrame: 6 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Catholic University
Study officials:
References:
Clinical trial NCT03499197: Heart TIMING - Heart Transplantation IMagING
Official title: Morphological and Functional Changes After Heart Transplantation - Role of Noninvasive Imaging in the Early Detection of Cardiac Allograft Rejection and Vasculopathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Transplant Failure and Rejection
Magnetic Resonance Imaging
Lead sponsor: Semmelweis University Heart and Vascular Center
Sponsor class: OTHER
Collaborators: name: National Research, Development and Innovation Fund of Hungary, Project no. NVKP_16-1-2016-0017
First posted: 2018-04-17
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: PROBABILITY_SAMPLE
Study population: Patients who underwent first cardiac transplantation.

Brief summary: The cardiac allograft rejection (CAR) and cardiac allograft vasculopathy (CAV) significantly affect the prognosis of patients after heart transplantation. The aim of the present study is to investigate and differentiate the adaptive and pathological cardiovascular changes after heart transplantation using different modalities. The investigator's main purpose is to define the role of the cardiovascular imaging methods and biomarkers in the early diagnosis of CAR and CAV.

Detailed description: 1. 12-lead ECG - Resting standard 12-lead digital ECG will be recorded. Extended analysis will be performed according to the latest recommendations.
2. Holter ECG - 24 hour Holter ECG will be recorded. Extended Holter ECG analysis will be performed.
3. Life quality questionnaire, patient history - Detailed questionnaire about personal and family history, general symptoms and life quality.
4. Laboratory biochemical examination - Besides the regular routine laboratory parameters, several specific parameters are planned to be measured, such as cardiac biomarkers.
5. Endomyocardial biopsy
6. Detailed transthoracic echocardiography including strain analysis and 3D measurement
7. Detailed cardiac magnetic resonance (CMR) examination
8. Coronary imaging - invasive coronarography and intravascular ultrasound (IVUS) and/or optical coherence tomography (OCT)
9. Invasive pressure measurement - Measurement of coronary flow reserve (CFR) and microcirculation resistance index (IMR)

Eligibility criteria: Inclusion Criteria:

* First heart transplantation

Exclusion Criteria:

* Cardiogenic shock on/after day 28 after heart transplantation
* Lack of consent
* Lack of cooperation

Primary outcomes:
measure: Coronary allograft vasculopathy
timeFrame: 5 years
measure: Coronary allograft rejection
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Heart and Vascular Center, Semmelweis University
Study officials:
References:
Clinical trial NCT04522583: Increased CRP Concentrations in Patients Admitted to the Emergency Department With Troponin Elevation Aids to Rule Out Coronary Ischemia
Official title: Increased C-reactive Protein Concentrations in Patients Admitted to the Emergency Department With Troponin Level Elevations Aids to Rule Out Coronary Ischemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Ischemia
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-08-21
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to the ED at the Hillel Yaffe Medical Center, Hadera, during the period 2016-2019 with cTn level higher than the 99th percentile of cTn concentration in the normal population (\>0.014 nanogram/milliliter).

Brief summary: The investigators hypothesized that the CRP/troponin ratio measured in patients presenting to the ED with elevated troponin levels could differentiate between patients with cardiac ischemia and those who present due to a systemic inflammatory or infectious disease. The aim of the study was to determine the necessary CRP/troponin ratio required to rule out cardiac ischemia in a large ED population and determine its impact on long-term prognosis.


Eligibility criteria: Inclusion Criteria:

* All patients admitted to the ED in the period 2016-2019 with cTn level higher than the 99th percentile of cTn concentration in the normal population (\>0.014 nanogram/milliliter).

Exclusion Criteria:

* None

Primary outcomes:
measure: Accuracy of the CRP/Troponin ratio
timeFrame: Within 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hille Yaffe Medical Center
Study officials:
References:
Clinical trial NCT04032483: A Survey of Financial Toxicity in Rural Cancer Patients
Official title: A Survey of Financial Toxicity of Radiation Treatment in Rural Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Financial Toxicity
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2019-07-25
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: With 100 participants, we are trying to show the prevalence of financial toxicity in radiation patients and make our findings as generalizable as possible to the broader population of rural radiation oncology patients in the US.

Brief summary: This project aims to elucidate the prevalence of financial toxicity, identify significant risk factors for toxicity, and understand the burdens of the specific St. Johnsbury rural population. These data will drive future, larger studies to investigate how to alleviate the burden of financial toxicity, especially in vulnerable patient populations.

Detailed description: "Financial toxicity" refers to a side effect of cancer treatment that is financial in nature, and has become increasingly important to oncologists, patients, and researchers because of its implications in adverse social outcomes for patients. Financial toxicity in the context of cancer care is the monetary cost, and subsequent social implications of the cost, on patients undergoing cancer treatment. Although financial toxicity for patients undergoing cancer treatment has some research attention, financial toxicity associated with radiation therapy for cancer patients has not. There is preliminary data that has shown that there are two forms of financial toxicity: the direct cost of cancer therapy (medical services) and the indirect costs (gas for travel, lost wages for sick days, etc.). However, the degree of cost and sources have not been fully investigated. Specifically, financial toxicity in the context of cancer patients from rural populations (such as those at NCCC) has not been fully explored. This project will attempt to understand the salient factors, costs, and magnitudes of financial toxicity in radiation therapy that will allow for more targeted studies to investigate vulnerable patient populations who experience greater financial toxicity.

Study recruitment temporarily halted due to COVID-19.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Undergoing treatment at Norris Cotton Cancer Center North, St. Johnsbury, VT
* Current radiation/oncology patient
* Ability to speak or write in English

Primary outcomes:
measure: Financial toxicity
timeFrame: The time frame will once a week for 3-9 weeks, dependent on the treatment duration of the patient.
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Johnsbury
country: United States
facility: Norris Cotton Cancer Center
state: Vermont
Study officials:
References:
Clinical trial NCT02368483: Conservative Treatment in Patients With Symptomatic Femoroacetabular Impingement
Official title: The Effectiveness of Neuromuscular Training of the Lower Limb Muscles in Reducing the Hip Symptoms in Patients With Symptomatic Femoroacetabular Impingement: a Prospective Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Symptomatic Femoroacetabular Impingement
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2015-02-23
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-group, prospective, intervention study. A total of 30 participants with unilateral symptomatic femoroacetabular impingement will be included into the study. The intervention consists in neuromuscular training for the lower limb muscles (12 weeks, 2 times/week supervised training, 2 times/week home training). The training includes physical exercises routinely used worldwide in clinical settings. No control intervention group was included into the study because nowadays there is no standard conservative treatment for patients with symptomatic femoroacetabular impingement. Assessments will be performed at (1) baseline, (2) mid-intervention, (3) end-intervention, and (4) follow-up. Clinical, functional, neuromuscular and self-reported parameters will be collected during assessments.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of unilateral symptomatic FAI according to clinical, radiographic and magnetic resonance imaging criteria
* Living place: Canton of Zurich or neighbouring Cantons
* Signed written informed consent to participate into the study

Exclusion Criteria:

* Previous hip surgery
* Any surgery to the lower limbs in the prior 6 months
* Congenital/developmental dysplasia
* Hip osteoarthritis
* Initiation of opioid analgesia and corticosteroid injection for hip pain within the prior 30 days
* BMI \>35 kg/m2
* Significant cardiorespiratory diseases

Primary outcomes:
measure: Hip Function as measured using the Hip Outcome Score questionnaire
timeFrame: Change from Baseline in Hip Function at 12 weeks
Secondary outcomes:
measure: Hip Muscle Strength as measured using dynamometry
timeFrame: Change from Baseline in Hip Muscle Strength at 12 weeks
measure: Movement Control Quality as measured using a visual rating scale
timeFrame: Change from Baseline in Movement Control Quality at 12 weeks
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Schulthess Clinic
Study officials:
References:
citation: Casartelli NC, Bizzini M, Maffiuletti NA, Sutter R, Pfirrmann CW, Leunig M, Naal FD. Exercise Therapy for the Management of Femoroacetabular Impingement Syndrome: Preliminary Results of Clinical Responsiveness. Arthritis Care Res (Hoboken). 2019 Aug;71(8):1074-1083. doi: 10.1002/acr.23728. Epub 2019 Jul 9.
Clinical trial NCT02527083: Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain
Official title: Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Pain
Chronic Pain
Hernia
Anesthesia, Intravenous
Anesthesia, Intratracheal
Lead sponsor: VA Pittsburgh Healthcare System
Sponsor class: FED
First posted: 2015-08-18
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Research suggests that the type of anesthesia used for surgery may affect intraoperative stress hormone levels. There is also data to support that an increased level of stress hormones leads to increased pain after surgery. The primary aim of this study is to determine the effect of anesthesia type on long term pain after hernia surgery. In this study, patients undergoing inguinal hernia repair will be randomized to an anesthetic group, either Total Intravenous Anesthesia (TIVA) maintained with propofol or Balanced Inhaled Anesthesia (BIA) maintained with sevoflurane. This will allow us to look at any differences in short and long-term pain after hernia repair depending on type of anesthesia received.


Eligibility criteria: Inclusion Criteria:

* All male patients undergoing herniorrhaphy surgery that requires general anesthesia.

Exclusion Criteria:

* Subjects unable to communicate directly with the investigators, due to being non-English speaking, loss of hearing, or incompetence.
* A history of malignant hyperthermia, pseudocholinesterase deficiency, or other disease that prevents anesthetic randomization.
* Pain-related disorders such as fibromyalgia or other chronic pain syndromes.
* Emergency surgery.

Primary outcomes:
measure: Change in Chronic Pain, as measured by the Pain Quality Assessment Scale
timeFrame: 1 month, 3 months, 6 months, 12 months
Secondary outcomes:
measure: Change in Acute Pain, as measured by the Verbal Response Scale (0-10)
timeFrame: Within 30 minutes after arrival to Post-Operative Care Unit (recovery unit), 1 day
Other outcomes:
Locations:
Study officials:
References: