louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05879211: Goal Concordant Care Learning Laboratory
Official title: Palliative Care Learning Laboratory
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cancer
Heart Failure
Copd
Dementia
Keywords: palliative care
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Several interventions will be tested, at the patient and provider levels
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal-concordant care lab will develop and test strategies to optimize communication in advanced serious illness.

Detailed description: The goal-concordant care lab will develop and test strategies to optimize communication in advanced serious illness. The lab will test a variety of interventions, including triggered conversations and feedback to healthcare providers.

Eligibility criteria: Inclusion Criteria:

* Duke Health patient

Exclusion Criteria:

* None

Primary outcomes:
measure: Frequency of goals of care communication
timeFrame: 2 years
measure: Timing of goals of care communication
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Health
state: North Carolina
Study officials:
References:
Clinical trial NCT06160011: Epicondylar Muscle Activation in Tennis Players
Official title: Effectiveness of Electrical Dry Needdling on Epicondylar Muscle Activation by EMG in Tennis Players. Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epicondylitis, Lateral
Keywords: Electrical dry needling
EMG
Tennis
Physiotherapy
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 48
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Epicondylitis is one of the most common pathologies in tennis players. The search for an effective treatment is necessary for the relief of symptoms and the return to sports practice. Therefore, a ddry needling treatment in combination with electricity is postulated as an alternative to isolated dry needling treatment or conventional physiotherapy treatment. Data will be collected in relation to pain and muscle activation by EMG in order to check the effectiveness of these techniques as well as the muscle activation that is generated.


Eligibility criteria: Inclusion Criteria:

* tennis players of both sexes
* federated and non-federated of Castilla y León
* playing tennis for at least 2 years
* presence if one trigger point in epicondilar musculature

Exclusion Criteria:

* not informed consent signature
* nervous, vascular, articular or musculoskeletal system alterations
* tests or techniques performed fear (belonephobia)
* pregnancy
* allergic to any type of metal or body oil
* active febrile proces
* current pain treatments in the area involved
* surgery in the last year for upper limb pathologies
* cognitive alterations
* taking painkillers or anti-inflammatory drugs 24 hours before the start of the study or taking them during the duration of the study

Primary outcomes:
measure: Muscular activation
timeFrame: 30 minutes
measure: Subjective Pain
timeFrame: Initial, up to 2 weeks, and up to 6 weeks
measure: Algometry
timeFrame: Initial, up to 2 weeks, and up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Universidad de Salamanca
Study officials:
References:
Clinical trial NCT05967611: Hip Abductor Function During Trendelenburg Test
Official title: Electromyographic Evaluation of Hip Abductors During the Trendelenburg Test
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Weakness, Muscle
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy men and women aged 18-45 recruited from the local community.

Brief summary: This study will use electromyography and dynamometry to evaluate gluteal muscle activation during the Trendelenburg hip abduction test in different hip positions.

Detailed description: The Trendelenburg test is commonly used to assess hip abductor weakness. However, it is unclear which hip position during this test best isolates gluteal muscle function. This study will measure gluteus medius and minimus activation and hip abduction force in 30 healthy participants performing the Trendelenburg test. Different hip flexion, extension, adduction and abduction angles will be evaluated to determine which position optimally targets the gluteal muscles. Results may enhance utilization of the Trendelenburg test in clinical practice.

Eligibility criteria: Inclusion Criteria:

* Healthy adults aged 18-45 years
* No history of hip disorders

Exclusion Criteria:

* Contraindications to EMG
* Neurological or muscular disorders

Primary outcomes:
measure: Gluteus Medius Activation
timeFrame: Baseline
Secondary outcomes:
measure: Gluteus Minimus Activation during Trendelenburg Test
timeFrame: Baseline
measure: Hip Abduction Strength during Trendelenburg Test
timeFrame: Baseline
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.d
role: STUDY_DIRECTOR
References:
Clinical trial NCT04704011: Evaluating the Impact of Basic Needs Assessment and Support to Improve Colposcopy Show Rates: The BASICS Trial
Official title: Evaluating the Impact of Basic Needs Assessment and Support to Improve Colposcopy Show Rates: The BASICS Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colposcopy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized controlled, single-site study hopes to determine the effectiveness of a tailored phone call reminder to improve low-income patients' adherence to colposcopy.


Eligibility criteria: Inclusion Criteria:

* Female

  -≥ 21 years of age
* English speaking
* Able to provide verbal consent

Exclusion Criteria:

* Male
* Incarcerated
* Unable to consent
* Does not have access to a working contact phone number

Primary outcomes:
measure: Adherence to colposcopy visit
timeFrame: Within 6 weeks of study enrollment
Secondary outcomes:
measure: Number and type of unmet basic needs as measured by Unmet Basic Needs Survey
timeFrame: At the time of enrollment; at least 2 weeks prior to colposcopy appointment
measure: General distress scores as measured by NCCN Distress Thermometer
timeFrame: At the time of enrollment
measure: Causes of distress as measured by NCCN Distress Problem List
timeFrame: At the time of enrollment
measure: Distress scores related to indications for colposcopy
timeFrame: At the time of enrollment
measure: Patient self-reported use of 2-1-1 services as measured by 2-1-1 Survey
timeFrame: After or within 1 week after colposcopy visit (estimated to be 6 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Lindsay M Kuroki, M.D., MSCI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02088411: The Safety and Efficacy of an Enzyme Combination in Managing Knee Osteoarthritis Pain in Adults
Official title: The Safety and Efficacy of an Enzyme Combination in Managing Knee Osteoarthritis Pain in Adults: a Randomized, Double-blind, Placebo-controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Wobenzym
Osteoarthritis
Lead sponsor: Atrium Innovations
Sponsor class: INDUSTRY
Collaborators: name: Mucos Pharma GmbH, Oberhaching, Germany
First posted: 2014-03-17
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized, double-blind, placebo-controlled, comparator-controlled trial was to evaluate the safety and efficacy of an enzyme combination, as Wobenzym®, in adults with moderate-to-severe osteoarthritis (OA) of the knee.


Eligibility criteria: Inclusion Criteria:

* Knee osteoarthritis confirmed by radiography or tomography
* Lequesne Functional Index score of 10-14
* WOMAC-A pain subscale score greater than or equal to 25

Exclusion Criteria:

* History of knee trauma
* History of joint infection
* History of joint surgery
* History of intra-articular injection (viscotherapy)
* History of gastrointestinal diseases
* Use of corticosteroids
* Use of COX-II inhibitors
* Use of glucosamine/chondroitin
* Known sensitivity to paracetamol
* Known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs)
* Known sensitivity to oral enzymes

Primary outcomes:
measure: Lequesne Functional Index
timeFrame: Change from baseline to 12 weeks
Secondary outcomes:
measure: Western Ontario and McMaster Universities Index version 3.0 subscale for pain (WOMAC-A)
timeFrame: Change from baseline to 12 weeks
measure: Western Ontario and McMaster Universities Index version 3.0 subscale for joint stiffness (WOMAC-B)
timeFrame: Change from baseline to 12 weeks
measure: Western Ontario and McMaster Universities Index version 3.0 subscale for joint function (WOMAC-C)
timeFrame: Change from baseline to 12 weeks
measure: Paracetamol Consumption
timeFrame: Change from baseline to 12 weeks
measure: Indices of systemic inflammation
timeFrame: Change from baseline to 12 weeks
measure: Adverse Events
timeFrame: Through baseline to 12 weeks
Other outcomes:
Locations:
city: Oberhaching
country: Germany
facility: Mucos Pharma GmbH & Co
Study officials:
References:
Clinical trial NCT01236911: Prognosis Association of Hypocalcemia on Moderate-severe TBI, COHORTE STUDY
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Calcium , Prognosis in Patients
Keywords: Calcium , TBI,complications, days in hospital
Lead sponsor: Universidad Autonoma de San Luis Potosí
Sponsor class: OTHER
First posted: 2010-11-09
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients bettween 16 and 65 years old with moderate -severe TBI with less as 24 hours , without administration of steroids or statins

Brief summary: Will have bad prognosis the patients with low calcium (less of 24 hrs of te admission in hospital)after moderate - severe TBI that the patients that do not developed this condition?

Detailed description: Through the years the investigators have seen that the patients with low calcium after moderate-severe TBI had bad prognosis including more complications, and more days in hospital. The investigators want to make an association between the patients that developed this condition and the patients that do not developed this condition

Eligibility criteria: Inclusion Criteria:

* Man - woman between 16-65 years old with moderate -severe TBI less as 24 hrs,Count with tomographic study

Exclusion Criteria:

* Use of steroids, use of statins, Administration of Tromethamine, calcium antagonists, fibrates, niacin, cyclosporine, macrolides.
* Unclassifiable lesions in brainstem

Primary outcomes:
measure: Establishment an association between the patients that developed Hypocalcemia less 24 hrs after moderate-severe TBI with patients that did not develop this condition
timeFrame: 2 years
Secondary outcomes:
measure: Identify the more relevant prognosis factors
timeFrame: 2 years
Other outcomes:
Locations:
city: San Luis Potosi
country: Mexico
facility: Juan Manuel Viñas Rios
Study officials:
References:
Clinical trial NCT02869711: Impact of a Training-action About Projects Leading for the Improvement of Care Quality in Managing Practice of Health Executive
Official title: Impact of a Training-action About Projects Leading for the Improvement of Care Quality in Managing Practice of Health Executive
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Health Care Quality Management (no Condition).
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health Executive volunteers

Brief summary: The present study focuses on the quality of care and how the health executives can bring it to a central place in their management. A training-action has been set-up at the Health Executive training institute (University Hospital Grenoble) to improve care quality. Reports prepared by students (tutored projects) related to operational diagnosis and action plans about care quality improvement are given to health executives. The objective is to evaluate how the health executive will use the tutored project to improve care quality and set-up actions.The hypothesis is that the health executive will use the tutored project to improve project management.

Detailed description: Every year, 9 voluntary health executives will be included and followed during 1 year. The experience will be done 3 times (3 years).

It is a qualitative study using 3 forms to recover data: group focus, individual interviews, project monographs. Speeches coding will enable to test the hypothesis from 2 analysis points: place of health executive and place of tutored project.

The study will be resulting in recommendations to health executives for their management methods and taken into account to define training.

Eligibility criteria: Inclusion Criteria:

* The volunteers are health executives with diploma

Exclusion Criteria:

Primary outcomes:
measure: Change in the managerial practices of health executives about health care quality management after tutored projects.
timeFrame: 1 year for each volunteer.
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Pierre-Philippe DUJARDIN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03012711: The Effects of Neuromuscular Exercise Training on Core Stability and Hip Strength in Healthy Adolescent Females
Official title: The Effectiveness of Neuromuscular Exercise Training on Core Stability and Hip Strength in Healthy Adolescent Females
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Injury
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 40
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is an evaluation of the effects of a Neuromuscular training program on hip strength and core stability. It is a randomized clinical trial evaluating pre and post scores.


Eligibility criteria: Inclusion Criteria:

* healthy adolescent females between 12 and 18 years old

Exclusion Criteria:

* lower body injuries in the last 6 months or lower body injuries that they are currently receiving treatment
* inability to participate in 5 week NME training program

Primary outcomes:
measure: Hip Strength - Hand Held Dynamometry
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Core Stability - Dynamic Stability Sit test
timeFrame: up to 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03539211: Clinical Assessment and Thickness Changes of the Oblique and Multifidus Muscles
Official title: Clinical Assessment and Thickness Changes of the Oblique and Multifidus Muscles Using a Novel Screening Tool and Exercise Program: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Muscles
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2018-05-29
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study evaluates the effect of a rotation based exercise program on core muscle thickness. Additionally, a second aim is to demonstrate the ability of a clinical assessment tool to identify muscle thickness changes. Half of participants receive the rotation based exercises, while the other half perform a traditional core exercise program. It was hypothesized that the rotation based exercises would result in greater changes in muscle thickness.

Detailed description: A number of exercise programs and assessment tools have been evaluated for their ability to influence and measure the core muscles. Inefficient stability and asymmetrical muscle activity of the core have been linked to a wide range of lower extremity injuries. Training of the abdominal muscles to obtain symmetrical recruitment for optimal trunk stabilization is a widespread clinical practice, however valid and reliable assessment tools and effective intervention protocols are lacking. This study uniquely uses both a clinical assessment tool and musculoskeletal ultrasound to measure changes in the core muscles following an exercise intervention. The overall purpose of this study was to design a valid and reliable assessment tool and an effective training protocol to activate the core muscles.

Eligibility criteria: Inclusion Criteria:

° Undergraduate and graduate subjects from the University of the Delaware student community.

Exclusion Criteria:

* You could be excluded if you have recently undergone surgery in the last 6 months.
* Currently suffering from low back pain.
* Or have a history of a neurological condition.

Primary outcomes:
measure: Changes in Muscle Thickness
timeFrame: Baseline and 10 minutes post intervention
Secondary outcomes:
measure: Changes in Clinical Muscle Assessment Using the Novel Sling Screen
timeFrame: Baseline and 10 minutes post intervention
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: Neumann University
name: Andrea DiTrani, PhD, ATC
role: STUDY_DIRECTOR
References:
Clinical trial NCT00252811: A Study of ZD1839 Effects on Cell Proliferation in Breast Cancer
Official title: A Phase II, Randomised, Double-Blind, Placebocontrolled Study To Investigate The Effects Of ZD1839 (IRESSA™) On Cell Proliferation In Oestrogen And Progesterone Receptor Negative Breast Cancer Prior To Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-15
Enrollment: 60
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: This is a Phase II, randomised, double-blind, placebo-controlled study. Subjects with histologically-confirmed oestrogen receptor negative (ER-), progesterone receptor negative (PgR-) primary breast cancer breast cancer will be randomly assigned in a 2:1 ratio to receive ZD1839 250 mg once daily or matching placebo for a total period of 5 weeks. Surgical intervention will take place after 4 weeks (on Day 29) and treatment will continue for 1 week after surgery.


Eligibility criteria: Inclusion Criteria:

* Histologically-confirmed ER- and PgR- primary breast cancer
* Stage T .5 cm, N0-1, M0
* No previous treatment for breast cancer

Exclusion Criteria:

* ALT or AST greater than 2.5 times the ULRR
* Metastatic disease

Primary outcomes:
measure: Estimate the effect of ZD1839 compared with placebo on the change in tumour cell proliferation in patients who have completely ER negative & PgR negative breast cancer
measure: Aassessment of biomarker Ki-67 in breast cancer tissue at baseline by core biopsy and after 4 weeks on the surgical specimen
Secondary outcomes:
measure: To assess the effect of 4 weeks of ZD1839 on the change in tumour size as assessed by ultrasounds.
measure: To correlate the expression of tissue biomarkers (HER family and epidermal growth factor [EGF] related pathways) in the baseline biopsy sample and in the surgical (endpoint) specimen with the anti-proliferative effect of ZD1839.
measure: To determine the effect of ZD1839 on HER-2 phosphorylation and other biomarkers in the surgical (endpoint) specimens when compared with the baseline biopsies
measure: To assess the effect of ZD1839 on apoptosis as assessed by TUNEL in the surgical (endpoint) specimens when compared with the baseline biopsies
measure: To determine plasma trough concentrations of ZD1839 and correlate these with molecular biomarkers detected in breast cancer tissue.
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Italy Medical Director, MD
role: STUDY_DIRECTOR
affiliation: Istituto Europeo di Oncologia di Milano
name: A Decensi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05188911: Analysis of Next Generation PET and Liquid Biopsy to Monitor mCRPC Treated With Abiraterone: ANGELA Trial
Official title: Analysis of Next Generation PET and Liquid Biopsy to Monitor mCRPC Treated With Abiraterone: ANGELA Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Castration-resistant Prostate Cancer
Metastatic Disease
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Metastatic castration-resistant prostate cancer

Brief summary: By incorporating dual-tracer PET/CT (PSMA and FDG) and ctDNA, we aimed to evaluate lesion heterogeneity and genomic change of mCRPC patients receiving novel hormonal therapy. The relationship between treatment response and different molecular characterization, as well as imaging features would also be evaluated.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed as mCRPC according to EAU-ESTRO-SIOG 2016 and PSA \> 10ng/ml;
2. No previous treatment with novel hormonal therapy;
3. ECOG 0-2;
4. Normal organ function, WBC \>= 3000/mm3 or Neutrophil \>= 1500/mm3;
5. Aged 18 to 85 years old when issuing written informed consent;
6. Life expectancy \> 12 months.
7. Consent and able to carry out follow-up visit and cooperate with all other study procedures.

Exclusion Criteria:

1. Severe disease or other medical conditions suggesting a high risk of death within 1 year, which may interfere with follow-up. Decided by investigator;
2. Diagnosed with any other malignant tumor within 3 years before enrollment;
3. Unable to provide necessary follow-up information;
4. Other conditions that are judged as ineligible by the investigator.

Primary outcomes:
measure: Lesion heterogeneity on dual-tracer PET/CT
timeFrame: 90 days
measure: Genomic change
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: