louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06730815: Body Image and Physical Activity of Women with Breast Cancer
Official title: Body Image and Physical Activity of Women with Breast Cancer Self-developed Questionnaire-based Follow-up Clinical Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer Female
Physical Inactivity
Quality of Life
Body Image
Keywords: body image after breast cancer
physical activity
life quality
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In the Department of Oncotherapy in the University of Pécs at the Medical School

Brief summary: The goal of this self-initiated questionnaire-based follow-up clinical trial is to map the body image and physical activity of Hungarian women treated for breast cancer.

The main questions it aims to answer are:

1. How body image changes during different treatments among women treated for breast cancer?
2. How is physical activity among Hungarian women treated for breast cancer?

Detailed description: The aim of our research is to assess the changes in physical activity and body image of women with breast cancer and the impact of these changes on their quality of life using subjective measures, through cross-sectional research and validation of the Body Image After Breast Cancer questionnaire in Hungarian.

Eligibility criteria: Inclusion Criteria:

* Adult women diagnosis of breast carcinoma

Exclusion Criteria:

* neuromuscular diseases
* severe congenital musculoskeletal and other disorders
* other surgical procedures within 1 year

Primary outcomes:
measure: Body Image After Breast Cancer
timeFrame: 1 day
measure: Global Physical Activity Questionnaire
timeFrame: 1 week
Secondary outcomes:
measure: Patient Health Questionnaire-9
timeFrame: 2 weeks
measure: Rosenberg Self-Esteem Scale
timeFrame: 1 day
measure: Quality of life of cancer patients or survivors (EORTC QLQ-C30)
timeFrame: 1 week
measure: Quality of life of cancer patients or survivors (EORTC QLQ-BR23)
timeFrame: 4 weeks
measure: Body Attitudes Test (BAT)
timeFrame: 1 day
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: Vörösmarty utca 4.
state: Baranya
city: Pécs
country: Hungary
facility: Édesanyák útja 17.
state: Baranya
Study officials:
References:
Clinical trial NCT06534515: The Effect of Tomatis Auditory Stimulation in Children and Adolescents With NDDs
Official title: The Effect of Tomatis Auditory Stimulation in Children and Adolescent With Neurodevelopmental Disorders (TomatisOn)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurodevelopmental Disorders
Keywords: Tomatis
children
adolescents
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a two-arm, randomized controlled trial exploring whether the Tomatis training could improve the components of auditory processing in children with NDDs referred to a Romanian Child and Adolescent Psychiatric Unit. Outcomes assessment will be conducted at baseline (T1), immediately after the training (T2).
Primary purpose: TREATMENT

Brief summary: The current study aims to explore the preliminary efficacy of the Tomatis method on auditory processing in children with NDDs.

Detailed description: This will be a two-arm, randomized controlled trial exploring whether the Tomatis training could improve the components of auditory processing in children with Neurodevelopmental Disorders referred to a Romanian Child and Adolescent Psychiatric Unit. Outcomes assessment will be conducted at baseline (T1), immediately after the training (T2).

Eligibility criteria: Inclusion Criteria:

- neurodevelopmental disorder

Exclusion Criteria:

* intellectual disability

Primary outcomes:
measure: Air conduction thresholds
timeFrame: Change from baseline AC (time 0) at immediately after the intervention (time 1)
measure: Bone conduction thresholds
timeFrame: Change from baseline BC(time 0) at immediately after the intervention (time 1)
Secondary outcomes:
measure: Developmental Disability Children's Global Assesment Scale total score
timeFrame: Change from baseline DD_CGAS (time 0) at immediately after the intervention (time 1)
Other outcomes:
Locations:
city: Floresti
country: Romania
facility: Andeea Robe
state: Cluj
Study officials:
affiliation: UBB
name: Andreea Robe
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gerritsen, J. (2009). A Review of Research Done on Tomatis Auditory Stimulation.
citation: Gilmor, T. (1999). The Efficacy of the Tomatis Method for Children with Learning and Communication Disorders: A Meta-Analysis. International Journal of Listening, 13(1), 12-23. https://doi.org/10.1080/10904018.1999.10499024
Clinical trial NCT05276115: PTSD Interview Regarding Future Study Design and Equipment.
Official title: An Experiential, One-to-one Interview Process Examining the Perception of Research Assessments and Equipment From Individuals With Post-traumatic Stress Disorder (PTSD)
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Ptsd
Lead sponsor: Life University
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be included if they meet the following criteria:

* Self-identify as having been diagnosed with PTSD.
* Between the ages 21-65 years old.
* Total of 15 individuals

Brief summary: To gain insight and perspective unique to individuals with a diagnosis of PTSD, this study will utilize an experiential one-to-one interview format. During the interview, an investigator will walk the participants through several aspects of an ANS battery of tests, provide a tour and information about other equipment in the research lab and discuss tools and procedures associated with the application of chiropractic care. The aim of this research is to provide insight for future study designs that assess or provide care to individuals with PTSD.


Eligibility criteria: Inclusion Criteria:

* Self-identify as having been diagnosed with PTSD.
* Between the ages 21-65 years old.

Exclusion Criteria:

-

Primary outcomes:
measure: Interview
timeFrame: 1-2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Dr. Sid E. Williams Center for Chiropractic Research
state: Georgia
Study officials:
affiliation: Life University
name: Stephanie Sullivan, DC, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00262015: Kinetic of Immune Memory Response After Re-Vaccination With Meningococcal Vaccine
Official title: A Phase IV, Single Center, Open-Label, Controlled, Randomized Study to Evaluate the Memory Response of Children Previously Vaccinated With Chiron Meningococcal C Conjugate Vaccine, Menjugate® and Describe the Kinetic of the Antibody Response and Maturation on Days 2-7 and 28 After Challenge With Pasteur Merieux Meningococcal A/C Polysaccharide Vaccine or Menjugate®
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Meningococcal Disease; Meningococcal Meningitis
Lead sponsor: Chiron Corporation
Sponsor class: INDUSTRY
First posted: 2005-12-06
Enrollment: 264
Sex: ALL
Minimum age (years): 13
Maximum age (years): 15
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine when a memory immune response after re-vaccination with Meningococcal C conjugate vaccine (Menjugate) or challenge with Meningococcal A/C polysaccharide vaccine can be observed, after initial vaccination with Meningococcal C conjugate vaccine during the UK immunization campaign


Eligibility criteria: Inclusion Criteria:

* Healthy adolescents between and including 13-15 years of age, who provide written informed consent and who received one immunization with Chiron Meningococcal C Conjugate vaccine (Menjugate) during the UK immunization campaign and for which documentation can be provided.

Exclusion Criteria:

* Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease

Primary outcomes:
measure: To measure immunological memory response to N. meningitidis serogroup C after those who received a partial dose of Meningococcal A/C Polysaccharide vaccine and in subjects who received a dose of Chiron Meningococcal C conjugate vaccine.
Secondary outcomes:
measure: To assess the immunological response to N. meningitidis serogroup C in those challenged with meningococcal A/C polysaccharide vaccine and in those who received a dose of Chiron Meningococcal C conjugate vaccine.
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: University of Oxford, The Oxford Vaccine Group
Study officials:
affiliation: University of Oxford
name: Andrew J. Pollard, MBBS, FRCPCH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04552015: Microneedles for Diagnosis of LTBI
Official title: Pilot Study for Development of Microneedles for Diagnosis of Latent Tuberculosis Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Latent Tuberculosis
Lead sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Sponsor class: OTHER
Collaborators: name: National Nanotechnology Center (NANOTEC), The National Science and Technology Development Agency (NSTDA)
First posted: 2020-09-17
Enrollment: 4
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will evaluate new technique, microneedle, to detect latent tuberculosis (TB) in healthy volunteers

Detailed description: The cross-sectional study to investigate the effect of microneedle formulations and lengths of Tuberculin PPD microneedles on the delayed-type hypersensitivity response in healthy volunteers.

Eligibility criteria: Inclusion Criteria:

1. Sex : Male and Female
2. Age : 20-60 years
3. TB contacts or those at risk of TB e.g. health-care workers
4. HIV-negative healthy individuals

Exclusion Criteria:

1. Presence of an acute infection, as determined by investigators
2. Receiving immunosuppression drugs e.g. steroids
3. Having autoimmune diseases e.g. SLE (Systemic Lupus Erythematous)
4. Being pregnant or breastfeeding

Primary outcomes:
measure: size of induration at 48 hours post-PPD injection
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Chulalongkorn University
Study officials:
affiliation: The HIV Netherlands Australia Thailand Research Collaboration
name: Sivaporn Gatechompol, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: King Chulalongkorn Memorial Hospital
name: Jeerapond Leelawattanachai, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: King Chulalongkorn Memorial Hospital
name: Saradee Warit, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00944515: Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children
Official title: Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children : A Prospective, Randomized, Double-blind, Placebo Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinusitis
Keywords: sinusitis
azithromycin
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2009-07-23
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate efficacy of azithromycin prophylaxis in preventing recurrent acute sinusitis in children.

Detailed description: A Prospective, Randomized, Double-blind, Placebo Controlled Trial of azithromycin in preventing recurrent acute sinusitis in children

Eligibility criteria: Inclusion Criteria:

* children between the age of 5 years and 15 years with the diagnosis of recurrent acute sinusitis who are attending the outpatient pediatric department, pediatric allergy clinic, and the ear, nose, throat clinic.

Exclusion Criteria:

* patients who have allergic rhinitis, chronic sinusitis, a history of allergic reactions to azithromycin or macrolides, treatments with immunotherapy or IVIG or gentamycin solution or pneumococcal vaccine during study period.

Primary outcomes:
measure: frequence of acute sinusitis during 12 mouths of study period
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Siriraj Hospital
name: Orathai - Piboonpocanun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05226715: Effect of Lower Extremity Joint Manipulation on a Lower Extremity Somatosensory Illusion
Official title: Immediate Effect of Lower Extremity Joint Manipulation on a Lower Extremity Somatosensory Illusion: a Preliminary, Randomized, Controlled Crossover Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coordination and Balance Disturbances
Healthy
Lead sponsor: Parker University
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to examine the influence of extremity manipulation on individual's center of pressure after they adapt to an ankle based illusion.


Eligibility criteria: Inclusion Criteria:

* No previous surgeries
* Not knowingly pregnant
* No neuromusculoskeletal injuries or systemic diseases that could affect an individual's ability to stand on an incline for 3 minutes with their eyes closed.

Exclusion Criteria:

- Weight over the force plate operating limit of 440 lbs

Primary outcomes:
measure: Center of pressure position
timeFrame: baseline, immediately post-intervention, same day
Secondary outcomes:
measure: Pathlength
timeFrame: baseline, immediately post-intervention, same day
measure: RMS
timeFrame: baseline, immediately post-intervention, same day
measure: Mean velocity
timeFrame: baseline, immediately post-intervention, same day
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Synapse Laboratory
state: Texas
Study officials:
affiliation: Parker University
name: Christopher A Malaya, DC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00233415: Cyberknife Radiosurgery for Locally Advanced Pancreatic Cancer
Official title: Phase II Study to Evaluate the Efficacy of Conventional Chemoradiotherapy Followed by Stereotactic Radiosurgery for Locally Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-10-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the trial is to test the efficacy of combining conventional chemoradiotherapy with radiosurgery for locally advanced pancreas cancer.

Detailed description: The purpose of the trial is to test the efficacy of treating locally advanced pancreatic cancer with 5FU and concurrent conventional radiotherapy followed by precisely administered single fraction of high-energy radiation using a radiosurgical technique.

Eligibility criteria: Inclusion Criteria:- Pancreatic tumors not to exceed 7.5 cm.

* Histologically confirmed malignancies of the pancreas, (ampulla of Vater or periampullary duodenum, tumors may be included when the head of pancreas is secondarily involved and unresectable criteria are met).
* Unresectable by CT criteria or unresectable at exploratory laparotomy or laparoscopy. CT criteria for unresectability include encasement of the superior mesenteric vein (SMV), portal vein (PV) or invasion of the celiac artery or superior mesenteric artery (SMA).
* Patients with metastatic disease may be treated if they are symptomatic from the primary tumor.
* Eastern Clinical Oncology Group performance status 0, 1 or 2. Exclusion Criteria:Chemotherapy within 1 month of registration.

Primary outcomes:
measure: Efficacy of Conventional Chemoradiotherapy Followed by Stereotactic Radiosurgery
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Albert Koong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01402115: A 12-week Human Trial to Compare the Efficacy and Safety of Polycan on Bone Metabolism
Official title: Efficacy and Safety Study of Polycan on Bone Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Bone Health in Perimenopausal Women
Keywords: Polycan
Bone metabolism
Osteocalcin
Deoxypyridinoline
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2011-07-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Beta-glucans are polysaccharides consisting of glucose residue jointed by beta linkage. They are found at a high level in the cell wall of fungi, yeast, oat, barley, bacteria, as well as various mushroom. Studies have reported that extract of mushroom (Pleurotus eryngii) can prevent the bone loss caused by estrogen deficiency. Furthermore, polycan (a purified β-glucan from Aureobasidium pullulans) has been reported to exhibit osteoporosis preventing effects. However, no investigation has been conducted on the effect of polycan on bone health in perimenopausal women.

Therefore, in this study, we investigated the effect of polycan on biochemical markers of bone metabolism in Korean perimenopausal women.


Eligibility criteria: Inclusion Criteria:

* They were required to have reduced bone density but no evidence of osteoporosis or osteopenia by Dual-emission X-ray absorptiometry (DEXA) scan (T ≥ -1.0 in the lumbar spine).
* Perimenopausal women : aged 40-70

Exclusion Criteria:

* Women with a body mass index (BMI) \>30 kg/m2 or who were being treated with estrogens, corticosteroids, or bisphosphonates, or who had significant illness affecting bone metabolism were excluded

Primary outcomes:
measure: Changes in DPD(Deoxypyridinoline)
timeFrame: 12weeks
measure: Changes in OSC(Osteocalcin)
timeFrame: 12weeks
Secondary outcomes:
measure: Changes in CTx(Collagen Type 1 Cross-linked C-telopeptide)
timeFrame: 12weeks
measure: Changes in bALP(Bone-specific Alkaline Phosphatase)
timeFrame: 12weeks
measure: Changes in PTH(Parathyroid Hormone)
timeFrame: 12weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Healthcare claims and management; Chonbuk National university
state: Jeollabuk-do
Study officials:
affiliation: Chonbuk National University Hospital
name: Dal-Sik Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02226315: Clinical Performance of the MaterniT21 PLUS LDT in Multiple Gestation Pregnancies
Official title: A Retrospective Analysis of Fetal Outcome Compared to Massively Parallel Sequencing Test Results Obtained From Multiple Gestation Pregnancies at Increased Risk for Fetal Chromosomal Aneuploidy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Down Syndrome
Edwards Syndrome
Patau Syndrome
Turner Syndrome
Keywords: noninvasive prenatal testing
Lead sponsor: Sequenom, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Friends Research Institute, Inc.
First posted: 2014-08-27
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with a multiple gestation who were evaluated with the MaterniT21 PLUS LDT and have passed their Estimated Date of Delivery (EDD).

Brief summary: This study will evaluate the clinical performance of massively parallel sequencing (MPS) using the MaterniT21 PLUS LDT in the detection of fetal aneuploidy in circulating cfDNA extracted from a maternal blood sample obtained from women pregnant with a multiple gestation who were at increased risk for fetal aneuploidy.


Eligibility criteria: Inclusion Criteria:

* Subject was pregnant with a multiple gestation and received NIPT with the MaterniT21 PLUS LDT and a valid test result is available;
* Subject was 18 years of age or older at the time of NIPT;
* Subject provides signed and dated informed consent in English;

Exclusion Criteria:

* Subjects' treating physician is not located in the United States.

Primary outcomes:
measure: Clinical Performance (Sensitivity/Specificity) of MaterniT21 PLUS LDT Assay
timeFrame: Subjects contacted within 3 years after pregnancy is completed
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Presbyterian/St. Luke's Medical Center
state: Colorado
Study officials:
affiliation: Presbyterian/St. Luke's Medical Center
name: Richard Porreco, MD
role: PRINCIPAL_INVESTIGATOR
References: