louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06140550: Clinical Trial of Biolimus-coated Intracranial Balloon Dilation Catheter
Official title: Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Effectiveness and Safety of Biolimus-coated Intracranial Balloon Dilation Catheter Treatment of Patients With Symptomatic Intracranial Atherosclerotic Stenosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intracranial Atherosclerotic Stenosis
Keywords: Intracranial balloon
stenosis
Lead sponsor: Bochang
Sponsor class: INDUSTRY
Collaborators: name: Xuanwu Hospital, Beijing
name: First Affiliated Hospital Xi'an Jiaotong University
name: First People's Hospital of Hangzhou
name: Jinan Central Hospital
name: The Affiliated Hospital of Qingdao University
name: Beijing Geriatric Hospital
First posted: 2023-11-20
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Ratio of control group to test group 1:1
Primary purpose: TREATMENT

Brief summary: This test took the target lesion restenosis rate 6 months after the operation as the main endpoint to verify the effectiveness of the intracranial balloon expansion catheter of Biolimus coating. After completing the follow-up 6 months after the operation, a clinical summary report was issued for the registration application of the product, and on this basis, 12 months of postoperative follow-up was carried out to evaluate the mid-term curative effect.


Eligibility criteria: Inclusion Criteria:

* 18 to 80 years old;
* Symptomatic intracranial artery stenosis, and the degree of visual stenosis of target blood vessels under intracranial angiography is 70\~99%(WASID method);

Exclusion Criteria:

* Target blood vessels are seriously calcified and distorted, and it is difficult to put the interventional instruments in place or recover;
* Ischemic cerebral infarction occurred 3 weeks before surgery;
* Cerebral hemorrhage 3 months before operation;

Primary outcomes:
measure: 6-month target lesion restenosis rate
timeFrame: 6-month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05092750: Magnetic Particle-ICG Lymph Node Mapping in Colorectal Cancer
Official title: Magnetic Particle-ICG Lymph Node Mapping in Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Colorectal Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Study to determine the feasibility of Sentinel Lymph Node (SLN) mapping using novel magnetic tracers (FerroTrace) and indocyanine green (ICG) for colorectal cancer; and to evaluate safety by assessing short term toxicity associated with colonoscopic peritumoral injection of novel magnetic nanoparticles (FerroTrace) and ICG for colorectal cancer.

Detailed description: PRIMARY:

1. To determine the feasibility of Sentinel Lymph Node (SLN) mapping using novel magnetic tracers (FerroTrace) and indocyanine green (ICG) for colorectal cancer.
2. To evaluate safety by assessing short term toxicity associated with colonoscopic peritumoral injection of novel magnetic nanoparticles (FerroTrace) and ICG for colorectal cancer.

SECONDARY:

1. To determine the additional positive diagnostic value of adding sentinel lymph node mapping to lymphadenectomy by assessing the SLNs with detailed immunochemistry versus the normal H\&E staining pathology tests.

PRIMARY END POINTS:

1. Feasibility: Number of registered patients who complete all study procedures with at least one sentinel node identified.
2. Safety: Rate of any grade III or greater toxicity attributable to FerroTrace injection, evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0. Adverse events according to general peri-operative complications.

SECONDARY ENDPOINTS:

1. The identification rate and number of FerroTrace-positive lymph nodes for each patient.
2. Incidence of pathological upstaging of LN metastasis status by the addition of (non-routine) serial H\&E and immunohistochemistry in the pathological assessment of identified FerroTrace-positive lymph nodes.

Eligibility criteria: Inclusion criteria:

* Age 18 or older
* Willing to provide informed consent
* Biopsy proven colon or rectal cancer
* No distant metastases

Exclusion criteria:

* Serious medical comorbidities or other contraindications to surgery +/- adjuvant therapy as determined by the treatment team
* Previous pelvic radiotherapy or radiotherapy planned prior to surgery
* Allergy or intolerance to iron oxide compounds
* Iron overload disorder
* Allergy or intolerance to iodides
* Pregnant or lactating women\*

Primary outcomes:
measure: To assess the feasibility how the Sentinel Lymph Node (SLN) mapping by using novel magnetic tracers (FerroTrace) and using the indocyanine green (ICG) for colorectal cancer.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: M.D. Anderson Cancer Center
name: George Chang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06040450: The Impact of Outdoor Sports Practice on the Well-Being of Disabled People
Official title: The Impact of Outdoor Sports Practice on the Well-Being of Disabled People : a Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Disability or Chronic Disease Leading to Disablement
Keywords: Physical activities, Outdoor sports, Disability
Lead sponsor: Institut de Sante Parasport Connecte Synergies
Sponsor class: OTHER
Collaborators: name: Fédération Française Handisport (FFH)
name: Université de Montpellier - UMR Santé, Education et Situations de Handicap (SANTESIH)
First posted: 2023-09-15
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Members of the French Handisport Federation practicing outdoor sports

Brief summary: Survey of the members of the French Handisports Federation (FFH) practicing outdoor sports.

Detailed description: This is a national cross-sectional study to investigate the impact of outdoor sports practice on the well-being and self-esteem of people with disabilities.

The study is based on a survey of FFH members practicing outdoor sports. The survey will be distributed between October and November 2023 via the federation's internal communication system. Data will be collected on outdoor sports activity, psychological impact and barriers to practice.

Analyses will be made between able-bodied and disabled members, between types of disability, and between types of outdoor sport practiced (water, land and air).

Analysis will be based on anomysed data and will respect the MR004 methodology.

Eligibility criteria: Inclusion Criteria:

* Being a member of the French Handisport Federation between September 2022 and August 2023
* Practicing outdoor sports

Exclusion Criteria:

* Persons who have objected to be contacted by e-mail

Primary outcomes:
measure: Impact of my outdoor sports on my well-being
timeFrame: Baseline
Secondary outcomes:
measure: Impact of my outdoor sports on my self-esteem
timeFrame: Baseline
Other outcomes:
Locations:
city: Paris
country: France
facility: French Handisport Federation
Study officials:
affiliation: Institut de Sante Parasport Connecte Synergies
name: Vincent T. Carpentier, MD-MSc
role: STUDY_DIRECTOR
affiliation: Montpellier University - SANTESIH
name: Eric Perera, PhD
role: STUDY_DIRECTOR
affiliation: French Handisport Federation
name: Emmanuel Buchoud
role: STUDY_DIRECTOR
References:
Clinical trial NCT06343623: Superiorly Based Pharyngeal Flap Versus Myomucosal Resection and Direct Closure
Official title: Superiorly Based Pharyngeal Flap Versus Myomucosal Resection and Direct Closure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Velopharyngeal Insufficiency
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 150
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients were classified into two groups. Group (A) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected by the superiorly based pharyngeal flap. Group (B) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected with myomucosal resection and direct closure of the posterior pharyngeal wall

Detailed description: Patients were classified into two groups. Group (A) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected by the superiorly based pharyngeal flap. Group (B) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected with myomucosal resection and direct closure of the posterior pharyngeal wall

Eligibility criteria: Inclusion Criteria:

* - Patients have velopharyngeal insufficiency.
* Age range 4-10 years

Exclusion Criteria:

* - Syndromic patients.

Primary outcomes:
measure: Improvement in the speech outcome
timeFrame: 4 years
Secondary outcomes:
measure: obstructive sleep apnea
timeFrame: 3 years
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of medicine
Study officials:
References:
Clinical trial NCT05899023: ED Diabetes Screening and Outpatient Care
Official title: Identifying Risk Factors for Poor Glycemic Control Among Emergency Department Patients and Improving Linkage to Outpatient Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Non Insulin Dependent Diabetes Mellitus
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-06-12
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This goal of this NIH funded R01 study is to identify risk factors for not being able to follow-up for a new diagnosis of diabetes in the emergency department and improve linkage of these newly diagnosed patients to appropriate outpatient care. Its three aims will be accomplished through 1) a retrospective chart review of emergency department (ED) patients screened for diabetes, 2) a series of prospective qualitative interviews among ED patients with newly diagnosed diabetes who fail to follow-up for outpatient care, and 3) a simple randomized controlled trial to test the efficacy of telehealth bridge visits to connect ED patients with newly diagnosed diabetes to outpatient primary care.


Eligibility criteria: Inclusion Criteria:

* Emergency patient receiving lab tests with an initial HbA1c test result of ≥ 6.5%
* Residential address in New York City or Long Island
* Primary language is English or Spanish
* Able to provide informed consent

Exclusion Criteria:

* No prior history of diabetes
* No medical condition that would result in a spurious HbA1c test (e.g., sickle cell, recent blood loss)

Primary outcomes:
measure: Percent of Patients who Complete at least One In-Person Follow-up Outpatient Visit
timeFrame: Up to Month 6 Post-Diagnosis
Secondary outcomes:
measure: Percent of Patients who Complete at least One Follow-Up Hemoglobin A1C (HbA1c) Test within 6 Months of Diagnosis
timeFrame: Up to Month 6 Post-Diagnosis
measure: Percent of Patients who Complete at least One Follow-Up Hemoglobin A1C (HbA1c) Test within 12 Months of Diagnosis
timeFrame: Up to Month 12 Post-Diagnosis
measure: Percent of Patients who Start on Diabetes Medications within 6 Months of Diagnosis
timeFrame: Up to Month 6 Post-Diagnosis
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: David C. Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01247623: Trial With Telomerase Peptide Vaccine In Combination With Temozolomide in Patients With Advanced Malignant Melanoma
Official title: Trial With Telomerase Peptide Vaccine In Combination With Temozolomide in Patients With Advanced Malignant Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Malignant Melanoma
Keywords: Non-resectable, advanced malignant melanoma.
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2010-11-24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT

Brief summary: Primary objective: Determination of safety and tolerability of GV1001 administration combined with Temozolomide (based on blood samples and adverse events).

Feasibility of combining active immunisation with Temozolomide treatment. Determination of immunological response after administration of GV1001 and Temozolomide as measured by presence of DTH skin test reaction and specific T-cell responses.

Secondary: Evaluation of objective tumour response

The trial is an exploratory study which main objective is to estimate safety and feasibility of combining active immunisation with chemotherapy. However, the trial may also indicate the efficacy of the combination.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of malignant melanoma.
* Previously untreated and non-resectable disease
* Measurable or evaluable tumour.
* Age ≥ 18 and ≤ 75 years.
* Performance status ECOG-WHO 0, 1 and 2 (Appendix III)
* Written informed consent (Appendix II)
* Adequate bone marrow liver, heart and renal function:
* WBC count \>3.0 x 109/L and platelets count \>100 x 109/L.
* ASAT, ALAT \<2 x upper normal laboratory value.
* Serum creatinine \<2 x upper normal laboratory value.

Exclusion Criteria:

* Previous treatment with chemotherapy.
* Clinical signs of brain metastases.
* Severe cardiac insufficiency (NYHA III or IV) with uncontrolled and/or unstable cardiac or coronary artery disease.
* Severe active infections such as HIV or hepatitis B or Hepatitis C.
* Medication for severe intercurrent disease which might affect immunocompetence (e.g. immunosuppressants, systemic corticosteroids).
* Pregnancy, breast-feeding or absence of adequate contraception for fertile patients.
* Simultaneously participation in other clinical studies.
* Any reason why, in the opinion of the investigator, the patient should not participate.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
state: Postbox 4953
Study officials:
References:
Clinical trial NCT06777823: Rejection Sensitivity and Puberty in Mental Health Vulnerability to Social Media Experiences in Early Adolescent Girls
Official title: Rejection Sensitivity and Puberty in Mental Health Vulnerability to Social Media Experiences in Early Adolescent Girls
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rejection Sensitivity
Puberty
Psychopathology
Keywords: puberty
rejection sensitivity
psychopathology
social media
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: St. Louis University
name: Northeastern University
First posted: 2025-01-16
Enrollment: 250
Sex: FEMALE
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This longitudinal study is designed to test bidirectional relationships between preteen girls' mental health and social media experiences. We will explore how pubertal development and experiences of rejection influence these relationships.


Eligibility criteria: Inclusion Criteria:

* female aged 10-11 years
* engagement in social media use
* proficient in the English language
* family/personal device that can complete daily diaries

Exclusion Criteria:

* previously diagnosed chronic medical illness
* autism spectrum disorder
* significant developmental or speech delay
* endocrine disorder
* not assigned female at birth (AFAB)

Primary outcomes:
measure: Psychopathology symptoms parent report
timeFrame: "Through study completion, an average of two years"
measure: Psychopathology symptoms child report
timeFrame: "Through study completion, an average of two years"
measure: Daily Diary Social Media experiences
timeFrame: Through study completion, an average of two years
measure: MicroEMA Social Media experiences
timeFrame: Through study completion, an average of two years
measure: Social Media experiences child report
timeFrame: Through study completion, an average of two years
measure: Social Media experiences parent report
timeFrame: Through study completion, an average of two years
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References:
Clinical trial NCT02815423: Safety and Exploratory Efficacy Study of UCMSCs in Patients With Fracture and Bone Nonunion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Fracture
Bone Nonunion
Lead sponsor: South China Research Center for Stem Cell and Regenerative Medicine
Sponsor class: OTHER
Collaborators: name: Guangzhou Panyu Central Hospital
First posted: 2016-06-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the present study is to evaluate the safety and exploratory efficacy of the umbilical cord mesenchymal stem cells for patients with fracture and bone nonunion.


Eligibility criteria: Inclusion Criteria:

* Every patient with non union in the site of bone fracture and nonunion.
* Age more than 18 and less than 60 years old.
* Nonunion or delayed union.

Exclusion Criteria:

* Diagnosis of cancer.
* Pregnancy or breastfeeding.
* Patient positive by serology or PCR for HIV, hepatitis B or C infection the patient with Accompanied fracture such as hip fracture that could not weight bearing.
* Any medical or psychiatric condition that in the researcher´s opinion could affect the patient´s ability to complete the trial or hamper the participation in the trial.
* Patients do not sign the consent forms

Primary outcomes:
measure: Radiological progression of bone fusion
timeFrame: 12 months
Secondary outcomes:
measure: Comparison of the rate of complications between the 2 groups
timeFrame: 12 months
measure: Incidence of increased temperature sensitivity by questionnaire
timeFrame: 6 months
measure: Incidence and severity of infections at grafting sites by questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00172523: Metabolic Disorders in Polycystic Ovarian Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polycystic Ovary Syndrome
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of this study is to elucidate the significance of adipocytokine in women with PCOS among adiposity, hyperandrogenism and insulin resistance.

Detailed description: Polycystic ovary syndrome (PCOS) is the most common endocrinopathy in women of reproductive age with a probable prevalence of 5% to 10%. PCOS is characterized by chronic anovulation, menstrual irregularities, evidence of hyperandrogenism (either clinical, manifested as hirsutism, acne, male pattern balding, or biochemical, manifested by elevated serum adrenal and/or ovarian androgen concentration). Fifty percent of all patients with PCOS are obese, and the presence of obesity affects the clinical manifestations of PCOS. The underlying pathogenic mechanisms appear to involve insulin resistance and hyperinsulinemia, the magnitude of which is greater in obese than in non-obese women with PCOS.

Eligibility criteria: Inclusion Criteria:

* 1. Oligomenorrhea ( less than 6 times spontaneous MC per year) or Amenorrhea. 2. Hyperandrogenism (either clinical or biochemistry. 3. PCO by ultrasound. 4.After menarche, before menopause.

Exclusion Criteria:

* 1. hormone therapy in the past 6 months. 2. Pregnancy in the past 6 months 3.Acute illness found in the past 3 months. 4.Systemic disease including autoimmune disease, malignancy, hepatic, renal or CVS disease, and ever received chemotherapy or immunosuppressive agents.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Obstetrics and Gynecology, National Taiwan University Hospital
Study officials:
affiliation: NTUH
name: Horng-Nerng Ho, M.D.
role: STUDY_DIRECTOR
References:
citation: Yang PK, Chou CH, Chang CH, Chen SU, Ho HN, Chen MJ. Changes in peripheral mitochondrial DNA copy number in metformin-treated women with polycystic ovary syndrome: a longitudinal study. Reprod Biol Endocrinol. 2020 Jul 13;18(1):69. doi: 10.1186/s12958-020-00629-5.
citation: Yang PK, Hsu CY, Chen MJ, Lai MY, Li ZR, Chen CH, Chen SU, Ho HN. The Efficacy of 24-Month Metformin for Improving Menses, Hormones, and Metabolic Profiles in Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2018 Mar 1;103(3):890-899. doi: 10.1210/jc.2017-01739.