louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00583687: Pulse Contour Analysis and Tissue Oxymetry in Changing Vascular Tone
Official title: Pulse Contour Analysis and Tissue Oxymetry in Changing Vascular Tone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Output, High
Cardiac Output, Low
Vasodilation
Vasoconstriction
Hemodynamics
Keywords: Arterial pulse contour cardiac output
Changing vascular tone
Tissue Oxymetry
Prediction of Fluid Responsiveness
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Edwards Lifesciences
First posted: 2007-12-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare changes of minimally invasive arterial pulse contour cardiac output with changes of intermittent and continuous thermodilution cardiac output by pulmonary artery catheter in hemodynamic unstable patients with rapid changing vascular tone (changing dosage of vasoactive drugs or inotropics, or volume challenge). Simultaneously, global parameters of oxygen delivery and consumption will be compared with regional flow parameters and tissue oxymetry (near infrared spectrometry and laser-Doppler). While continuous thermodilution cardiac output is used for patient management, pulse contour cardiac output, intermittent thermodilution cardiac output and tissue oxymetry is only used for monitoring.


Eligibility criteria: Inclusion Criteria:

* Indication for invasive hemodynamic monitoring with pulmonary artery catheter and arterial catheter
* Hemodynamic instability (need for vasoactive drugs, inotropics or volume).

Exclusion Criteria:

* Age \< 18.
* Patient with contraindications for the placement of arterial cannula.
* Patient with history or clinical findings of aortic valve regurgitation.
* Atrial fibrillation.
* Patient being treated with an intra-aortic balloon pump.
* Limitation of therapy due to bad prognosis

Primary outcomes:
measure: Changes of cardiac output measured by three different techniques during changes of vascular tone
timeFrame: 2 hours
Secondary outcomes:
measure: Prediction of fluid responsiveness with minimally invasive arterial pulse contour analysis in hemodynamic unstable patients.
timeFrame: 2 hours
measure: Comparison of global parameters of oxygen delivery and consumption with local parameters of flow and tissue oxymetry during changes of vascular tone.
timeFrame: 2 hours
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Intensive Care Medicine, University Hospital Inselspital, Berne
Study officials:
affiliation: Department of Intensive Care Medicine, University Hospital, Inselspital, Berne
name: Christoph C Ganter, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06061887: Factors Associated With Recurrent Falls in Stroke Patients
Official title: Frequency of Falls in Stroke Patients and Factors Associated With Recurrent Falls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fall
Stroke
Lead sponsor: Bozyaka Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 18 and over, hospitalized in the neurology service with the diagnosis of acute stroke

Brief summary: The goal of this observational study is to learn about the recurrent falls in patients with acute stroke. The main question\[s\] it aims to answer are:

* what is the frequency of recurrent falls
* which factors are associated with recurrent falls in patients with acute stroke.

Participants will be evaluated in terms of

* frequency of recurrent falls within the six months after stroke
* fear of falling
* the stroke severity (Canadian Neurological Scale),
* ambulation level (Functional Ambulation Classification),
* functional disability (Functional Independence Scale)
* Postural control and balance
* functional status (Modified Rankin Scale)

Detailed description: Falling is common in stroke patients both in the hospital and at home after discharge. As a result, physical problems such as fractures and psychological problems such as fear of falling, limitation of physical activity and social isolation occur. Identifying the factors that cause falls after stroke will contribute to the recovery process by preventing complications by taking the necessary precautions and increasing the patient's participation in rehabilitation. This study was planned to determine the frequency of falls in patients with acute stroke and to determine the risk factors associated with recurrent falls within the first six months after stroke.

Eligibility criteria: Inclusion Criteria:

1. Having an acute stroke over the age of 18
2. To have a cognitive situation to understand and answer questions

Exclusion Criteria:

1. Patients with bilateral hemiplegia
2. Patients without motor involvement
3. Those with a history of stroke
4. Patients with severe cognitive impairment
5. Patients in need of intensive care

Primary outcomes:
measure: Frequency of fall
timeFrame: Six month
Secondary outcomes:
measure: Factors related with recurrent falls
timeFrame: Six month
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: University of Health Sciences Turkey
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Altınay Göksel Karatepe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Samuelsson CM, Hansson PO, Persson CU. Determinants of Recurrent Falls Poststroke: A 1-Year Follow-up of the Fall Study of Gothenburg. Arch Phys Med Rehabil. 2020 Sep;101(9):1541-1548. doi: 10.1016/j.apmr.2020.05.010. Epub 2020 Jun 1.
Clinical trial NCT06583187: Effect of Mandala Coloring of Circumcised Children
Official title: Effect of Mandala Coloring on Fear, Anxiety, Emotional Symptoms and Postoperative Pain of Circumcised Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Circumcision
Keywords: anxiety
child
circumcision
emotional manifest
fear
pain
mandala painting
Lead sponsor: Artvin Coruh University
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 78
Sex: MALE
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to determine the effect of mandala painting on fear, anxiety, emotional symptoms and postoperative pain of circumcised children.

Detailed description: 78 volunteer children between the ages of 6-12 who come for circumcision surgery will be randomly divided into two groups: mandala painting group and control group. Children will be evaluated before, during and after the procedure. Pain related to the circumcision procedure will be assessed using FLACC Pain Scale, fear will be assessed using High Fear Scale, anxiety will be assessed using Child Anxiety-State Scale and emotional state will be assessed using Emotional Indicators Scale. In addition, children\&#39;s demographic data will be recorded in the Information Form.

Eligibility criteria: Inclusion Criteria:

Children between the ages of 6-12, Written and verbal consent given by their legal guardians, Can speak and are literate in Turkish, Have sufficient mental development to answer questions

Exclusion Criteria:

Children with congenital urological anomalies, Children with who did not agree to participate in the study and who were not in the specified age group

Primary outcomes:
measure: Child Information Form
timeFrame: Baseline
Secondary outcomes:
measure: The Wong-Baker Faces Pain Rating Scale
timeFrame: Baseline
Other outcomes:
measure: Children&#39;s Fear Scale
timeFrame: Baseline
measure: Children&#39;s Emotional Manifestation Scale
timeFrame: Baseline
measure: Children&#39;s Anxiety State Scale
timeFrame: Baseline
Locations:
city: Gümüşhane
country: Turkey
facility: Gümüşhane Hospital Pediatric Clinic
Study officials:
affiliation: Gümüşhane Universıty
name: Hatice OĞUZHAN, Lecturer
role: STUDY_CHAIR
References:
citation: Yeniay D, Tamdo An L, Yucak Ozdemir A, Ak An LO, Kay R SU. Effects of Videos and Therapeutic Music on Preoperative Anxiety and Postoperative Anxiety and Pain Levels in Boys Who Undergo Circumcision. J Perianesth Nurs. 2023 Dec;38(6):918-924. doi: 10.1016/j.jopan.2023.04.007. Epub 2023 Aug 16.
Clinical trial NCT05077787: Tactile and Kinaesthetic Stimulation in Neonates With Hyperbilirubinaemia
Official title: Tactile and Kinaesthetic Stimulation in Preterm Neonates With Hyperbilirubinaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Hyperbilirubinemia
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 68
Sex: ALL
Minimum age (years): 24
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hyperbilirubinemia is the most common problem seen in neonates, owing to severe complications in their lifetime. The study design of the study is pretest - a posttest experimental design. Criterion-based purposive sampling will be used for recruiting the neonates. In the study neonates will be selected according to the selection criteria and will be allocated into two groups using computer-based randomization.The Intervention group - neonates will receive tactile and kinesthetic stimulation for 15 minutes for 3 consecutive days, 1 hour after feeding twice daily along with Phototherapy, Control group - Phototherapy alone will be given along with conventional NICU care. Total serum bilirubin will be assessed as outcome measures daily once. Transcutaneous bilirubin will be assessed after every intervention.


Eligibility criteria: 1. New born in Neonatal Intensive Care Unit
2. Stable vitals
3. Full Term and Preterm neonates
4. Gestational age 34 weeks to 40 weeks
5. Birth weight -1800 - 3000 g
6. APGAR Score at birth of 8 -10
7. Total serum bilirubin levels \> 10 mg/dL

Primary outcomes:
measure: Total Serum Bilirubin (TSB)
timeFrame: Changes in the Total Serum Bilirubin level will be measured at baseline and at the end of three days intervention
measure: Transcutaneous Bilirubin (TcB)
timeFrame: Changes in the Transcutaneous Bilirubin level will be measured daily for three days before and after intervention
measure: Weight Gain
timeFrame: Changes in the weight will be measured at baseline and at the end of three days intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ropar
country: India
facility: Civil Hospital
state: Punjab
Study officials:
affiliation: Maharishi Markendeshawar (Deemed to be University)
name: Saumya Kothiyal, MPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rahmawati D, Sampurna MTA, Etika R, Utomo MT, Bos AF. Transcutaneous bilirubin level to predict hyperbilirubinemia in preterm neonates. F1000Res. 2020 Apr 28;9:300. doi: 10.12688/f1000research.22264.2. eCollection 2020.
citation: Lin CH, Yang HC, Cheng CS, Yen CE. Effects of infant massage on jaundiced neonates undergoing phototherapy. Ital J Pediatr. 2015 Nov 25;41:94. doi: 10.1186/s13052-015-0202-y.
citation: Field T. Pediatric Massage Therapy Research: A Narrative Review. Children (Basel). 2019 Jun 6;6(6):78. doi: 10.3390/children6060078.
citation: Niemi AK. Review of Randomized Controlled Trials of Massage in Preterm Infants. Children (Basel). 2017 Apr 3;4(4):21. doi: 10.3390/children4040021.
Clinical trial NCT03788187: Persistant Organics Pollutants in Breast Cancer.
Official title: Role of Persistant Organics Pollutants in the Metastatic Potential of Malignant Breast Tumor.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Persistant Organic Pollutants
Lymph Node Metastases
Lead sponsor: European Georges Pompidou Hospital
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: ONIRIS
First posted: 2018-12-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Persistant Organics Pollutants (POP) accumulate in the adipose tissue (AT) and could modulate tumor progression as part of the microenvironment. The investigators tested the hypothesis that POPs exposure may be associated with breast cancer metastasis analyzing the concentrations of 46 POPs in both adipose tissue and serum samples from breast tumor patients (benign, malignant with and without lymph node metastasis)

Detailed description: The investigators set up a longitudinal prospective monocentric cohort study in the gynecologic-oncologic surgery department of European Hospital Georges-Pompidou, with patients undergoing partial or total mastectomies, lymph node biopsies or axillary lymph node removal and sampling of the adipocytic tumour microenvironment to measure POPs using gas chromatography coupled to high-resolution mass spectrometry. The objective is to analyze the concentrations of 46 POPs including polychlorinated dibenzo(p)dioxins and furans (PCDD/Fs), polychlorinated biphenyls (PCBs), polybromodiphenyl ethers (PBDEs) and polybromobiphenyls (PBBs) in both adipose tissue (AT) and serum samples from breast tumor patients (benign, malignant with and without lymph node metastasis).

Eligibility criteria: Inclusion Criteria:

* Patient with breast tumor: benign or malignant
* Tumor size at least 1cm or palpable tumor
* Undergoing a breast surgery in European Georges Pompidou hospital
* Understanding the protocol and who signed a written consent

Exclusion Criteria: patients unable to give informed consent

* Dementia
* Guardianship

Primary outcomes:
measure: Metastatic lymph node status based of persistant organic pollutants level measured by by gas chromatography coupled to high-resolution mass spectrometry.
timeFrame: Sampling the day of surgery
Secondary outcomes:
measure: Pro metastatic genes messenger ribonucleic acid (mARN) expression in the tumor based of metastatic lymph node status and persistant pollutants level.
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: European Hospital Georges Pompidou
name: Anne-Sophie BATS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01141387: Outcomes in MEasurement-Based Treatment
Official title: Clinical Outcomes in MEasurement-Based Treatment (COMET)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Disorder, Major
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2010-06-10
Enrollment: 914
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: Primary care clinic

Brief summary: The primary objective for this study is to assess the impact of a measurement based treatment program (MBT) on Major Depressive Disorder (MDD) remission rates in patients whose primary care provider (PCP) receives monthly patient-reported depression severity reports compared to patients whose PCP does not receive monthly reports.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old
* Diagnosis of major depressive disorder
* Prescribed a new prescription for an antidepressant medication on the date of study enrollment and currently taking the medication 'New' is defined as no antidepressant use in the previous 120 days
* Primary depression management is performed by the primary care provider
* Capable of self-management (i.e., taking medications and independently responding to follow-up contacts)
* Able to provide informed consent to participate
* Sufficient ability as judged by the physician to read, understand and complete survey instruments written in English and phone interviews spoken in English

Exclusion Criteria:

* History psychotic disorder or bipolar disorder
* Diagnosis of current postpartum depression
* Diagnosis of bereavement less than 8 weeks duration
* Currently pregnant
* History of suicide attempts or current suicide plan
* Need for psychiatric hospitalization at enrollment visit
* History of adjunctive treatments including electroconvulsive treatment (ECT), vagus nerve stimulation (VNS), transcranial magnetic stimulation (TMS), magnetic seizure therapy (MST), or deep brain stimulation (DBS)

Primary outcomes:
measure: Remission rate assessed by the Patient Health Questionnaire - 9 item (PHQ-9) instrument
timeFrame: Measured at baseline
measure: Remission rate assessed by the Patient Health Questionnaire - 9 item (PHQ-9) instrument
timeFrame: Follow-up upto 6 months
Secondary outcomes:
measure: Response rate assessed by the PHQ-9 instrument
timeFrame: 6 months
measure: The medication prescribed including refills, dose titrations, switching and augmentation
timeFrame: 6 months
measure: Health care utilizations including office visits, emergency room visits and hospitalization
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02107287: Hypofractionated Intensity Modulated Radiation Therapy Plus Hormonal Therapy in Patients With High Risk Prostate Cancer
Official title: Hypofractionated Intensity Modulated Radiation Therapy Plus Hormonal Therapy in Patients With High Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Risk Prostate Cancer
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 105
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Considering the promising results with hypofractionated in low and intermediate risk prostate cancer, our proposal is to translate this experience to patients with high risk prostate cancer. Patients with high risk disease would receive hypofractionated RT to the prostate and to the external and internal iliac lymph nodes using IMRT plus long-term hormonal therapy. The objective of the study is to show that long term grade\>2 late toxicity is acceptable and similar to published data using hypofractionated technique in the prostate only.


Eligibility criteria: Inclusion Criteria:

* pathologically proven diagnosis of adenocarcinoma of the prostate meeting one of the following conditions:
* Clinical Stage \>T3 or
* Gleason Score 8 or higher, or
* PSA level \>20ng/ml
* Study entry PSA must be obtained within 6 weeks prior to protocol entry
* ECOG \<2
* Age \>18
* History and physical examination within 3 months
* Bone scan and CT scan of the abdomen and pelvis within 3 months with no evidence of bone metastases and no pelvic lymph nodes larger than 1.0cm, unless biopsy negative.
* CBC with differential within 6 weeks prior to protocol entry
* Absolute neutrophil count \>2000cells/mm3
* Hemoglobin \>8.0 g/dl (the use of transfusion to increase the Hg is acceptable)
* Testosterone level within 6 weeks of protocol entry
* Liver function tests
* Signed informed consent
* Prior use of hormonal therapy for prostate cancer is acceptable if less than 2 months.

Exclusion Criteria:

* Prior use of hormonal therapy for prostate cancer for more than 2 months. Previous use of finasteride or dutasteride is allowed.
* Prior invasive malignancy (except non-melanoma skin) unless disease-free for more than 5 years.
* Prior radiotherapy to the pelvis
* Life expectancy of less than 2 years.

Primary outcomes:
measure: Toxicity
timeFrame: First 3 months (acute toxicity)
Secondary outcomes:
measure: Freedom from biochemical failure, patterns of failure.
timeFrame: At 5 years
Other outcomes:
measure: Toxicity
timeFrame: 3 years
measure: Toxicity
timeFrame: 3 years
measure: Rate of failure
timeFrame: 5 years
measure: Quality Assurance
timeFrame: 5 years
Locations:
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Sergio Faria, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06919887: A Randomized Controlled Trial of Menopausal Tool/App for Women
Official title: Evaluation of a Mobile Phone Application Tool for Menopause Symptom Management
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Menopausal Symptoms
Menopause Symptom Management
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 450
Sex: ALL
Minimum age (years): 24
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is about assessing the utilization of a mobile phone application (app), designed to improve the menopause experience of midlife women experiencing related symptoms and its association with menopause-related health care utilization


Eligibility criteria: For Patient Enrollment:

Inclusion Criteria:

* Women between the ages of 45 and 55
* English speaking (app only available in English)
* Able to provide informed consent
* Experiencing menopause symptoms, which will be assessed by a Menopause Rating Scale (MRS) survey score of ≥ 5
* Has an upcoming Mayo Clinic primary care appointment within 3 weeks of the enrollment and the MRS survey

Exclusion Criteria:

* Lack of willingness to engage with app
* Inability to provide informed consent

Primary outcomes:
measure: Frequency of app logins among intervention group.
timeFrame: Up to 6 weeks
measure: Compare differences in rates of menopause treatment among intervention and comparison groups.
timeFrame: Up to 6 weeks
measure: Mean score on a validated survey assessing perceived importance and availability of healthcare services for women's health conditions/concerns related to menopause
timeFrame: through study completion, an average of 1 year
measure: Percentage of healthcare professionals reporting 'high' & 'low' confidence in diagnosing and managing menopause symptoms
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References: