louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00194571: Enhancing Connections: Helping the Mother With Breast Cancer Support Her Child
Official title: Helping the Mother With Breast Cancer Support Her Child
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: breast cancer,
child functioning,
parenting,
self-efficacy,
psychoeducational intervention
counseling
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-09-19
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This is a 6-state randomized controlled trial (RCT) that uses a behavioral intervention to enhance parenting skills for school age children when a mother is recently diagnosed with early stage breast cancer. Efficacy analyses will include measures of the child's and mother's psychosocial adjustment, including enhanced parenting quality and skills related to the cancer.

Detailed description: This is a Phase 3 randomized clinical trial of recently diagnosed mothers with local or regional breast cancer and their school age child. After baseline measures are taken, mothers are randomized into either intervention and control group. Intervention participants are given 5, 1-hour at home educational counseling sessions by a specially trained nurse. Control participants are mailed an educational booklet whose content focuses on supportive parenting behaviors that are part of the face to face sessions given to the experimental group.

The theoretical framework for the study derives from Bandura's Social Cognitive Theory, a contextual model of parenting, and stress and coping theory. Efficacy is evaluated through standardized valid and reliable questionnaires of psychosocial functioning in the mother (affect, mood, self-efficacy) and psychosocial functioning in the child (cognitive-emotional functioning, including behavioral problems, anxiety, depressed mood, and cancer-related concerns). Primary study hypotheses will be evaluated comparing pre-posttest measures of the intervention compared to controls at post-test and 1-year follow up.

Eligibility criteria: Inclusion Criteria:

* Local or regional breast cancer recently diagnosed
* Able to read and write English
* Has one or more school age child(ren) living at home
* Married to a man or in a committed long-term intimate relationship with a male partner

Exclusion Criteria:

* Non-English speaking
* Advanced stage breast cancer
* Not recently diagnosed
* Single mother

Primary outcomes:
measure: Increased parenting skills and confidence by diagnosed mothers
timeFrame: 1-year
Secondary outcomes:
measure: Decreased anxiety and depressed mood in diagnosed mothers
timeFrame: 1 year
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Frances M Lewis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02303171: Use of Warfarin After the First Trimester in Pregnant Women With APS
Official title: Use of Warfarin After the First Trimester in Pregnant Women With Antiphospholipid Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Recurrent Miscarriage
Antiphospholipid Syndrome
Keywords: Antiphospholipid syndrome
APS
Warfarin
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2014-11-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluation of shifting to oral vitamin K antagonist after the first trimester instead of using low molecular weight heparin (LMWH) throughout pregnancy in pregnant women with antiphospholipid syndrome (APS)

Detailed description: Women will be randomly divided into two groups; one will be subjected to anticoagulant therapy by Enoxaparin throughout pregnancy and the other will be subjected to anticoagulant therapy by Enoxaparin in the first trimester then Warfarin after the first trimester until termination of pregnancy.

Eligibility criteria: Inclusion Criteria:

* Pregnant women with APS diagnosed according to the revised classification criteria for APS in 2006 in Sydney, Australia
* Early pregnancy body weight is 50-90 Kg

Exclusion Criteria:

* Women with systemic lupus erythematosus (SLE)
* Women with active thromboembolic disorders
* Women with history of previous thromboembolic disorders

Primary outcomes:
measure: Fetal loss
timeFrame: From 12 weeks to 42 weeks gestational age
Secondary outcomes:
measure: Preterm delivery
timeFrame: From 20 weeks to 34 weeks gestational age
measure: Intrauterine growth restriction (IUGR)
timeFrame: At birth
measure: Congenital fetal malformations
timeFrame: At birth
Other outcomes:
measure: Hemorrhagic complications
timeFrame: After 12 weeks gestational age up to birth
measure: Thromboembolic complications
timeFrame: After 12 weeks gestational age up to birth
Locations:
city: Mansourah
country: Egypt
facility: Obstetrics and Gynecology Department in Mansoura University Hospital
state: Dakahlia
city: Mansourah
country: Egypt
facility: Private practice settings
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Mohamed I Eid, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University
name: Mohamed S Abdelhafez, Dr
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Abdelmageed F Mashaly, Prof
role: STUDY_CHAIR
References:
citation: Hamulyak EN, Scheres LJ, Marijnen MC, Goddijn M, Middeldorp S. Aspirin or heparin or both for improving pregnancy outcomes in women with persistent antiphospholipid antibodies and recurrent pregnancy loss. Cochrane Database Syst Rev. 2020 May 2;5(5):CD012852. doi: 10.1002/14651858.CD012852.pub2.
Clinical trial NCT04130971: Predicting Colorectal Cancer - Tissue Samples to Evaluate Tumour Characteristics and Treatment Response
Official title: Predict - a Translational Study to Predict Tumour Response to Neoadjuvant Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Neoplasms
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Göteborg University
First posted: 2019-10-18
Enrollment: 800
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: All patients with a diagnosis of colorectal cancer are eligible.

Brief summary: All adult patients with colorectal cancer presenting within the Sahlgrenska University Hospital or treated at any time at Sahlgrenska University Hospital are eligible and will be asked to participate. We already have biopsies taken at surgery in patients that receive surgery, but this study will include all patients and the biopsies will be taken during endoscopy for diagnosis of the primary tumour. Biopsies will then be taken during follow-up exams prior surgery but after neoadjuvant treatment. Biopsies will also be taken during surgery and in cases where surgery is not necessary biopsies will be taken regularly during follow-up exams.

Blood samples and in relevant cases urinary samples and mouth swabs will be taken at all timepoints when biopsies are taken. If it is not possible to take biopsies prior treatment blood samples will still be drawn.


Eligibility criteria: Inclusion Criteria:

* Colorectal cancer

Exclusion Criteria:

* Not colorectal cancer

Primary outcomes:
measure: Tumour response to treatment
timeFrame: 1-2 months after initiated treatment
Secondary outcomes:
measure: Normal tissue response to treatment
timeFrame: 1month -3 years after treatment
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Dept. of Surgery, Sahlgrenska University Hospital/Ostra
Study officials:
References:
Clinical trial NCT05440071: PoSt-market Assessment on Safety and Performance of J-sHAPed xFINE Lead
Official title: PoSt-market Assessment on Safety and Performance of J-sHAPed xFINE Lead
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bradycardia
Lead sponsor: MicroPort CRM
Sponsor class: INDUSTRY
First posted: 2022-06-30
Enrollment: 129
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: Subject indicated for a de novo implantation of a dual chamber (DR) pacemaker as per Guidelines on cardiac pacing and cardiac resynchronization therapy.

Brief summary: The primary objective of this study is to evaluate the safety and the electrical performances of the right atrial J-shape (JX model) XFINE endovascular passive lead at 3 months post implant.


Eligibility criteria: Inclusion Criteria:

1. Subject has reviewed, signed and dated the informed consent form
2. Subject newly implanted (de novo) with a JX XFINE within 10 days, connected to a dual chamber (DR) pacemaker from MicroPort CRM S.r.l and any commercially available IS-1 right ventricular lead
3. Subject is willing and capable of participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol.

Exclusion Criteria:

1. Subjects with documented permanent or persistent AF
2. Included in another clinical study that could confound the results of this study such as studies involving intra-cardiac device
3. Subject has had any pacing or ICD system implants
4. Patient implanted despite a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient contraindicated for a single dose of 310 μg of dexamethasone sodium phosphate, patient implanted with a tricuspid replacement heart valve or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery)
5. Age less than 18 years old, incapacitated or under guardianship or kept in detention
6. Life expectancy less than 1 year

Primary outcomes:
measure: Safety of the right atrial J-shape (JX model) XFINE endovascular passive lead at 3 months post implant.
timeFrame: 3 months
measure: Electrical performances of the right atrial J-shape (JX model) XFINE endovascular at 3 months
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03340571: Blood Biomarker of Alzheimer's Disease (AD)
Official title: mtDNA Damage in Alzheimer's Disease (AD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Keywords: Alzheimer's Disease
biomarkers
blood
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 21
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The research coordinator(s) will review the clinic schedule in the Memory Disorders clinic at Duke University for potential patients who meet the basic inclusion/exclusion criteria who have appointments that day.

While consenting AD potential subjects, the study team may also ask their caregivers who accompany the AD patient to the clinic if they would also like to be part of the study and possibly enroll as a Healthy Control subject.

Brief summary: Currently, no cures or disease modifying therapies exist for Alzheimer's disease (AD). This is partially due to the inability to detect the disease before it has progressed to a stage where there are clinical manifestations. The identification and validation of high throughput biomarkers to measure disease progression (as well as identify pre-clinical disease onset) is critical to the development of disease-modifying or even preventative therapies. In this study, we are testing a blood biomarker for stratification of Alzheimer's disease patients and healthy volunteers. This study may lead to future blood tests that may help earlier diagnosis of Alzheimer's disease and detect the disease progression.


Eligibility criteria: Inclusion Criteria:

Alzheimer's Disease Patients:

* 50 years and older
* AD patient who is seen at the Memory Disorders Clinic
* AD diagnosis
* Non smoking
* No cancer treatment in the last 5 years
* Informed consent from the patient or the patient's legally authorized representative (LAR)
* Patient and/or LAR able to read and speak English

Healthy Control Participants:

* 50 years and older
* Non smoking
* No cancer treatment in the last 5 years
* Age matched to AD subject
* Able to read and speak English

Exclusion Criteria:

Alzheimer's Disease Patients:

* Known additional neurological disease

Healthy Control Participants:

* Neurological degenerative diseases (such as Parkinson's, Alzheimer's or Huntington's)

Primary outcomes:
measure: Biological marker of Alzheimer's disease
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Assistant Professor
name: Laurie Sanders, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03246971: Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain
Official title: A Phase 2, Multiple-Dose Study of The Efficacy and Safety of Wafermine™ (Sublingual Ketamine) in Participants Experiencing Acute Post-Operative Bunionectomy or Abdominoplasty Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Pain
Bunion
Abdominoplasty
Lead sponsor: iX Biopharma Ltd.
Sponsor class: OTHER
First posted: 2017-08-11
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the safety and effectiveness of Wafermine™ for post-bunionectomy or post-abdominoplasty pain over a 24 hours period. For subjects undergoing bunionectomy, 2 out of 3 subjects will receive Wafermine™ and 1 out of 3 subjects will receive placebo. For subjects undergoing abdominoplasty, 3 out of 4 subjects will receive Wafermine™ and 1 out of 4 subjects will receive placebo.


Eligibility criteria: Inclusion Criteria:

* Scheduled for a bunionectomy or mini abdominoplasty with no additional planned procedures.
* Good general health without clinically significant renal, hepatic, cardiac or respiratory disease, as determined by the Investigator.

Exclusion Criteria:

* For those undergoing bunionectomy, other painful conditions involving the surgical foot.
* Positive lab values for Hepatitis B or C or HIV

Primary outcomes:
measure: Summed Pain Intensity Differences (SPID) using a Numerical Rating Scale
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Lotus Clinical Research
state: California
Study officials:
References:
Clinical trial NCT02856971: Knee Hinge Prosthesis Following TKA Infection
Official title: Rotating Hinge Knee Arthroplasty for Septic Revision After Total Knee Arthroplasty: a Retrospective Cohort About 50 Patients With 2 Years Follow up
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: TKA Infection
Keywords: Hinge Knee Prosthesis
TKA infection
rotating hinge prosthesis
hinge knee arthroplasty
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 49
Sex: ALL
Minimum age (years): 45
Maximum age (years): 91
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having a hinge knee prosthesis following an infection on a total knee prosthesis .

Pre-operative characteristics studied :

Clinical characteristics : medical and surgical history on the index knee included the strategy of the infection treatment (one step treatment vs two steps treatment)and general contributing factors of infection, frontal laxity, join motions, initial constraint of the infected TKA, skin condition ( skin necrosis, fistula, flap need, scar condition) paraclinical characteristics : bone defects, condition of knee extensor system ( continuance, height of patella, joint space height (when possible to measure)), prosthethic sealing or unsealing on CT-scan or scintigraphy, causal germ(s)

Brief summary: Between 2009 and January 2016, the investigators included 49 patients from four hospitals in Lyon who had a Total Knee Arthroplasty (TKA) infection and who benefited of a knee arthroplasty revision with a rotating hinge prosthesis. This retrospective and descriptive cohort aims at studying the functional results after 2 years follow up.


Eligibility criteria: Inclusion Criteria:

- All the patients who had a rotating hinge knee arthroplasty for septic revision after total knee arthroplasty, proved by bacteriological samples or purulent drainage at involved site or other obvious clinical signs or radiological signs of infection

Exclusion Criteria:

- Patients who benefited of a hinge prosthesis following a unicompartmental prosthesis, following a mechanical issue on a total prosthesis

Primary outcomes:
measure: functional results
timeFrame: at two years follow up
measure: functional results
timeFrame: at two years follow up
Secondary outcomes:
measure: infection control
timeFrame: after 2 years follow up
Other outcomes:
Locations:
city: Lyon cedex 04
country: France
facility: Centre de reference des infections ostéo-articulaires de Lyon,Groupement Hospitalier Nord - Hôpital de la Croix-Rousse - Bât. B, niveau 3 103 Grande-Rue de la Croix-Rousse
Study officials:
affiliation: Hôpital de la Croix-Rousse
name: Tristan Ferry, Pr, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05251571: The Efficiency of Video-Based Exercises in Individuals With Stroke
Official title: Efficacy of Video-Based Balance and Coordination Exercises in Individuals With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Telerehabilitation
Balance
Coordination
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Controlled Trial
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the video-based balance coordination exercise program and the video-based conventional exercise program in patients with subacute stroke.

Detailed description: Thanks to telerehabilitation, it will be possible for individuals to learn the exercise programs in the most appropriate way and to communicate easily with their physiotherapists with video images. In this way, it will be ensured that individuals can perform their exercises at the optimum level in non-clinical environments. The aim of the study is to compare the conventional home exercise program performed with video-based telerehabilitation and the balance coordination program in subacute stroke patients.

Eligibility criteria: Inclusion Criteria:

* Male and female patients aged 40 - 65 years
* Having been diagnosed with stroke by a specialist physician and at least 3 months and maximum 6 months have passed since the diagnosis
* No serious medical complications
* Being able to understand verbal and visual commands
* Getting at least 24 points on the mini mental state test
* Able to walk at least 10 m without assistance using crutches or a walker
* Having signed the consent form

Exclusion Criteria:

* Situations that will prevent assessments or communication with the individual
* Being on psychotropic medication
* People with ataxia or any other cerebellar symptoms
* Other problems that would preclude evaluation and/or treatment

Primary outcomes:
measure: FES-I
timeFrame: Change from Baseline FES-I at 6 weeks
measure: ABC
timeFrame: Change from Baseline ABC at 6 weeks
measure: SSEQ
timeFrame: Change from Baseline SSEQ at 6 weeks
Secondary outcomes:
measure: TSQ
timeFrame: Change from Baseline TSQ at 6 weeks
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Hospital Neurology Polyclinic
state: Bornova
Study officials:
affiliation: Ege University
name: Mehmet Özkeskin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University
name: İsmet Tümtürk, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University
name: Bedriye Karaman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00156871: Individualized Exercise Program for Treatment of Fatigue in Patients After Hematologic Stem Cell Transplant (HSCT)
Official title: Individualized Exercise Program for Treatment of Fatigue in Patients After Hematologic Stem Cell Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Keywords: transplant
fatigue
exercise
Malignant disease
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Cancer Foundation
First posted: 2005-09-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the impact of fatigue in severely affected transplant patients.

Detailed description: Investigates impact of a monitored program in kinesiology lab at the University of Calgary on fatigue in severely affected transplant patients.

Eligibility criteria: Inclusion Criteria:

* Severe fatigue post transplant

Exclusion Criteria:

* Other conditions contributing to fatigue (graft versus host disease)

Primary outcomes:
measure: Fatigue score
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: James Russell
role: STUDY_DIRECTOR
affiliation: University of Calgary
name: Nicole Colos-Reed, Phd
role: PRINCIPAL_INVESTIGATOR
References: