louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03223545: Stress Management to Support Women's Health
Official title: Stress Management to Support Women's Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Stress
Cardiovascular Diseases
Keywords: mindfulness-based cognitive therapy
Meditation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
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 evaluate a mindfulness-based cognitive therapy intervention delivered over the phone (MBCT-T) for women with prehypertension. MBCT-T is an evidence-based program that teaches meditation practices and cognitive strategies to reduce stress and negative emotions. It targets psychosocial risk factors that disproportionately affect women, including rumination (i.e., negative thinking) and low social support. Investigators plan to translate the established MBCT-T program into Spanish, conduct focus groups to inform cultural adaptations that may be needed for Latina women, and run a pilot randomized controlled trial to test the feasibility, acceptability and effects of MBCT-T on blood pressure and perceived stress in diverse women with prehypertension.

Detailed description: Chronic stress is associated with the development of hypertension and cardiovascular disease. Reducing stress may be a useful prevention strategy for people at elevated risk of hypertension, including those with prehypertension. Women report different types of stress than men and may need tailored stress management programs.

Eligibility criteria: Inclusion Criteria:

* Female
* English- or Spanish-speaking
* A current patient of NYU/Bellevue Hospital Center (BHC) for the NYU study site or San Ysidro Health Center (SYHC) for the UCSD study site
* BP measurement in prehypertensive range (SBP 120-139 mmHg or DBP 80-89 mmHg) recorded in EHR within past 6 months AND BP in prehypertensive range at screening
* Willing to provide informed consent and comply with all aspects of the protocol
* Willing to be audio-taped

Exclusion Criteria:

* Current use of antihypertensive medication
* Clinically significant depressive symptoms (PHQ-8 ≥10)
* Significant cognitive impairment, in the EHR or apparent during screening
* History of current diagnosis of schizophrenia or other psychotic disorders
* Current participation in another clinical trial

Primary outcomes:
measure: Blood pressure
timeFrame: 3 Months
Secondary outcomes:
measure: Perceived stress
timeFrame: 3 Months
measure: Measure of Depressive Symptoms using the PHQ-8
timeFrame: 3 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Tanya Spruill, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04543045: Qualitative Exploration of Head & Neck Cancer Patient Reported Experience of Radiotherapy
Official title: Qualitative Exploration of Head & Neck Cancer Patient Reported Experience of Radiotherapy With Focus on Restriction Anxiety & 'Claustrophobia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oncology
Head and Neck Cancer
Anxiety
Keywords: patient experience
claustrophobia
radiotherapy
radiotherapy moulds
radiotherapy masks
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Range of patients who have completed or partially completed radiotherapy treatment utilising a mask. This will include a range of patients (i) those who's records indicate, or patients report that they experienced severe difficulties tolerating the mask, (ii) those who could not complete the full course of radiotherapy; and (iii) those who experienced no difficulties at all.

Brief summary: The study aims to explore the experience of patients with Head and Neck Cancer, who are preparing for and/or completed radiotherapy treatment.

Detailed description: This is a non-interventional study using interviews to explore head and neck cancer patients' experience of preparing for and completing radiotherapy utilising an immobilisation mask.

The study will be conducted in 2 stages:

The first stage is Item generation. Approximately 20 interviews will be conducted with head and neck cancer patients who have completed or partially completed radiotherapy. The interviews will capture their experiences and views pertaining to mould making, scans and radiotherapy, reported associated fear of restriction, suffocation, loss of control and fear of public embarrassment during treatment.

The data from the interviews will be used to develop potential items for a screening tool for identification of those patients likely to experience anxiety and claustrophobia before they start their treatment.

The second stage is cognitive interviews. Approximately 5 patients included in Stage I will be invited to take part in a further interview to review the themes and potential questionnaire items identified from interviews.

Eligibility criteria: Inclusion Criteria:

* Aged over 18 (no upper age limit)
* Completed or partially completed radiotherapy treatment utilising a mask ≥ 6 weeks previous to study entry

Exclusion Criteria:

* Unable to understand and communicate in the English language
* Unable to provide written informed consent

Primary outcomes:
measure: Patient experience
timeFrame: within 6 weeks of using a mask
Secondary outcomes:
measure: potential items for a questionnaire
timeFrame: 2 months after completing or partially completing radiotherapy.
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation
Study officials:
affiliation: The Christie NHS Foundation Trust
name: Jacqui Stringer
role: STUDY_CHAIR
References:
Clinical trial NCT01831245: Right-sided Colon Tumor, Laparoscopic Versus Open Surgery, in an ERAS Protocol
Official title: Right-sided Colon Tumor, Laparoscopic and Open Surgery, in an ERAS Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Tumor
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Danderyd Hospital
name: Region Örebro County
name: Ersta Hospital, Sweden
First posted: 2013-04-15
Enrollment: 125
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: Right sided colom tumor or large benign adenoids

Brief summary: Register study. Patients who had been operated for right-sided colon tumor or benign adenoids between year 2011 to 2012. The study compare open surgery with laparoscopic surgery in an ERAS (Enhanced Recovery After Surgery) protocol.

Hypothesis:

Operation of right-sided colon tumor and large benign adenoids, a better selection of patients for open or laparoscopic surgery can improve short term results.


Eligibility criteria: Inclusion Criteria:

* right-sided colon tumor or large benign adenoids

Exclusion Criteria:

* none

Primary outcomes:
measure: Pathological Anatomic diagnosis (PAD) on a tumor biopsy
timeFrame: day of surgery
Secondary outcomes:
measure: Length of hospital stay, days
timeFrame: 30 days after surgery
measure: C - reactive protein
timeFrame: 1-7 days after surgery
Other outcomes:
measure: Immobilizing patient after surgery
timeFrame: 4 -10 hours after surgery
measure: Leakage of anastomosis
timeFrame: 0 - 30 days after surgery
Locations:
city: Stockholm
country: Sweden
facility: Ersta Hospital
city: Stockholm
country: Sweden
facility: Danderyds Hospital
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Ulf Gustafsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05696145: Aortic Stenosis Associated Left Ventricular Remodeling - An Investigation of Genetic and Gender Specific Differences in 170 Patients Undergoing Aortic Valve Replacement Surgery
Official title: Aortic Stenosis Associated Left Ventricular Remodeling - Impact of Genetic, Valvular and Non-valvular Factors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Valve Stenosis
Keywords: low flow low gradient aortic valve stenosis
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 170
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 referred for surgical aortic valve replacement at the department of Cardiothoracic and vascular surgery at Odense University Hospital, Denmark will be evaluated and if they meet the inclusion criteria they will be invited to participate in the study.

Brief summary: The goal of this study is to investigate the genetic and gender specific differences, in patients with low flow low gradient aortic stenosis and high flow high gradient aortic stenosis. Patients referred for surgical aorticvalve replacement will be offered to participarte in the study.

The main questions the study aims to answer are:

1. Low-gradient aortic stenosis is associated with differences in valvular concentration of the genes that code for mast-cell chymase, Angiotensin-II, ACE, ACE2 and Angiotensin receptor 1 and 2.
2. Low-gradient aortic stenosis is associated with differences in the genetic code of renin-angiotensin-aldosterone system.
3. Gender differences in LV remodelling associates with different levels of sexual hormones.

Patients participating in the study will be asked to undergo:

* Cardiac ultrasound, MR- and CT-scan prior to surgery
* Blooddraw prior to surgery.
* Heartmuscle biopsy during surgery
* Cardiac MR-scan 1 year after surgery.


Eligibility criteria: Inclusion Criteria:

1. Severe AS (estimated by the local heart team, aortic valve area\<1cm2) referred for AVR at the cardiology department at Odense University Hospital
2. Age \> 18 years
3. Signed informed consent

Exclusion Criteria:

1. Bicuspid aortic valve.
2. LV systolic dysfunction (LVEF\<50%).
3. Patients with concomitant moderate-severe aortic valve regurgitation.
4. Concomitant moderate-severe mitral valve regurgitation.
5. Moderate to severe nephropathy (s-creatinine \>200 mmol/l)
6. Unwilling to participate in the study.
7. Claustrophobia.
8. Permanent cardiac devices (pacemaker and ICD)

Primary outcomes:
measure: Genetic polymorphisms betweem low flow low gradient and high flow high gradient aortic stenosis patients
timeFrame: At the time of surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01993745: The Analysis of Heart Rate Variability With 24hrs Holter ECG and Serum Cardiac Fibrosis Markers in Critical Illness Patients Who Are With Cardiogenic Shock, With ECMO or IABP Support, or With APACH II Score >25)
Official title: The Analysis of Heart Rate Variability With 24hrs Holter ECG and Serum Cardiac Fibrosis Markers in Critical Illness Patients Who Are With Cardiogenic Shock, With ECMO or IABP Support, or With APACH II Score >25)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiogenic Shock,
With ECMO or IABP Support,
With APACH II Score >25)
Keywords: ECMO
APACH II score
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: adult age\>18 years old

Brief summary: The study is to show the prognostic factor of HRV parameter and cardiac fibrosis markers in critical illness patients

Detailed description: The analysis of Heart Rate Variability with 24hrs Holter ECG and serum cardiac fibrosis markers in critical illness patients who are with cardiogenic shock, with ECMO or IABP support, or with APACH II score \>25)

Eligibility criteria: Inclusion Criteria:

* critical illness patients who are with cardiogenic shock, with ECMO or IABP support, or with APACH II score \>25)

Exclusion Criteria:

* pacemaker rhythm, not sign the permit

Primary outcomes:
measure: Heart Rate Variability and serum cardiac fibrosis markers in critical illness patients
timeFrame: 2-4weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT05334745: Clinical Comparison of Topical Application of Alvogyl Versus Hyaluronic-Acid Gel in Management of Pain And Palatal Wound Healing
Official title: Clinical Comparison of Topical Application of Alvogyl Versus Topical Application of Hyaluronic-Acid Gel in Management of Pain And Palatal Wound Healing : A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Wound Healing
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effect of application of Alvogyl versus hyaluronic acid in decreasing postoperative pain and promoting healing in the palatal wound following the free gingival graft procedure

Detailed description: Postoperative pain and bleeding are the most common complications after palatal graft harvesting, also postsurgical swelling have been reported. Although hemostatic agents, mechanical barriers, bioactive materials, antibacterial and antiseptic agents and herbal products have been found effective in preventing such complications, an ideal support could not be specified for this purpose. Further, undesired side effects such as delayed wound healing/foreign body reaction have been reported .

No gold standard has been identified, thus there is a need for further investigations aiming to reach the best possible treatment modality for pain relief and prevention of reported complications following harvesting of palatal graft .

Eligibility criteria: Inclusion Criteria:

* Patients with mucogingival defects scheduled for free gingival graft
* Age from 18 years up to 60
* Medically healthy patient

Exclusion Criteria:

* Systemic diseases that may be a contraindication for any surgeries.
* Loss of maxillary premolars and molars.
* Pregnancy or lactation
* Smoking

Primary outcomes:
measure: postoperative pain
timeFrame: 7th days
Secondary outcomes:
measure: Wound healing
timeFrame: 7th, 14th, 21st and 30th days.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Egypt
Study officials:
References:
Clinical trial NCT06633445: Injecting Lateral Pterygoid Muscle by Botulinum Toxin Type A With 2 Different Methods : 3D Guided Appliance and Electromyography (EMG) .
Official title: Evaluation of 3D Guided Botulinum Toxin Type A Injection in Lateral Pterygoid Muscle for Management of Patients With Anterior Disc Displacement With Reduction ( a Randomized Controlled Clinical Trial )
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Disc Displacement
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate intra-oral botulinum toxin type A injection into lateral pterygoid muscle using a surgical guide synthesized by virtual planning based on CT with soft tissue window.

* To evaluate improvement of maximum interincisal opening (MIO) before and after injection.
* To assess change in disc position before and after injection.
* To evaluate recovery of symptoms as clicking, tenderness of TMJ and tenderness of lateral pterygoid muscle after injection.

Researchers will compare intra-oral botulinum toxin type A injection using a surgical guide synthesized by virtual planning based on CT with soft tissue window to conventional EMG guided botulinum toxin injection into lateral pterygoid muscle in patient with anterior disc displacement with reduction.

Participants will be injected with botulinum toxin type A by intraoral approach.


Eligibility criteria: Inclusion Criteria:

1. Patients of both sexes that are diagnosed with ADDWR according to DC/TMD.
2. Their age range between 20 and 45 years.
3. Angle class I maxilla-mandibular relation.

Exclusion Criteria:

1. Patients with degenerative joint disease, musculoskeletal, neuromuscular disorders, cardiovascular, bleeding disorders, breathing difficulties, neurological disorders.
2. Pregnancy and lactating women.
3. History of surgical TMJ intervention.
4. Botox hypersensitivity
5. History of tumors or maxillofacial trauma.
6. Posteriorly edentulous saddles or anterior open bite.
7. Patient contraindicated to MRI examination

Primary outcomes:
measure: • Maximum interincisal opening in millimeters.
timeFrame: 6 months
measure: clicking
timeFrame: 6 months
measure: temporomandiular joint tenderness
timeFrame: 6 months
measure: lateral pterygoid muscle tenderness
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: faculty of dentistry, Alexandria university
Study officials:
References:
Clinical trial NCT04032145: Characterization of Health Conditions of Visitors of the Montreal Museum of Fine Arts
Official title: Characterization of Health Conditions of Visitors of the Montreal Museum of Fine Arts: A Prevalence Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prevention
Health Promotion
Keywords: Prevention, museum, art
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2019-07-25
Enrollment: 316
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Montreal Museum's clients will be invited to participate in this study, and if they accept to be a part of it, we will ask them to fill out an online questionnaire.

Brief summary: This study evaluates the effects of arts on the Montreal Museum's clients.

Detailed description: Acting early in the process of weakening elders in order to keep them longer in good health and socially active is possible. During the past decade, museums have become involved in the care of patients by using art to improve their quality of life and well-being. Museums have, thus, emerged as new partners in public health. Very few programs developed by museums have focused on elders. Only one focused on elders in situation of early frailty and demonstrated that it was possible, through participatory visual art-based activities, to improve the health status of elders living at home.

Eligibility criteria: Inclusion Criteria:

* Being 50 years old
* Coming at Montreal Museum of Fine Arts for guided visits, arts activities, and so forth.

Exclusion Criteria

-No internet connection and electronic device like cell phone, Ipad or computer.

Primary outcomes:
measure: Health Condition
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: Olivier Beauchet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06131645: IASLC Grading System as a Predictor for EGFR-TKI Therapy
Official title: The IASLC Grading System as a Predictor for EGFR-TKI Therapy in EGFR-mutant Lung Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 2160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From January 2008 to April 2021, we consecutively collected lung adenocarcinoma patients who underwent complete resection at the Department of Thoracic Surgery, Fudan University Shanghai Cancer Center (FUSCC), Shanghai, China. The 8th TNM staging was used in this study. The study included three main subgroups: (1) patients with p-TNM stage Ib-III LADCs received adjuvant EGFR-TKI or chemotherapy (ADJUVANT subgroup, N=620), (2) patients developed post-operative recurrence and treated with either EGFR-TKI or chemotherapy (RECURRENCE subgroup, N=321), and (3) next-generation sequencing (NGS) was carried out which provided co-occurring mutation information (NGS subgroup, N=1158).

Brief summary: The investigators previously validated the grading system proposed by International Association for the Study of Lung Cancer (IASLC) for invasive nonmucinous lung adenocarcinoma (LADC) for its reproducibility, prognostication function and predictive value of adjuvant chemotherapy (ACT). In this exploratory study, the investigators aimed to investigate the role of IASLC grading system in EGFR tyrosine kinase inhibitor (TKI) therapy selection either as adjuvant or palliative therapy.


Eligibility criteria: Inclusion Criteria:

* invasive lung adenocarcinoma patients who underwent complete resection with positive EGFR mutations in exons 18-21.

Exclusion Criteria:

* adenocarcinoma in situ (AIS), minimally invasive adenocarcinoma (MIA), invasive mucinous adenocarcinoma and other variants of adenocarcinoma
* patients with pathologic slides unavailable for re-evaluation

Primary outcomes:
measure: Disease-free survival
timeFrame: 5 years
measure: Progression-free survival
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Chaoqiang Deng
state: Please Select
Study officials:
References: