louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05683379: AFFINITY BEYOND: Anti-AAV8 Antibody Assessment Study of Boys With DMD
Official title: Anti-AAV8 Antibody Assessment Study of Boys With Duchenne Muscular Dystrophy Aged 0 to <12 Years
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Duchenne Muscular Dystrophy
Keywords: DMD
Duchenne Muscular Dystrophy
Duchenne
Lead sponsor: REGENXBIO Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-13
Enrollment: 200
Sex: MALE
Minimum age (years): 0
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic, Musculoskeletal care, Neuromusculoskeletal care

Brief summary: This is an observational screening study to evaluate the prevalence of anti-adeno-associated serotype 8 (AAV8) antibodies in participants with Duchenne muscular dystrophy (DMD).

Detailed description: This is an observational screening study to evaluate the prevalence of anti-adeno-associated serotype 8 (AAV8) antibodies in participants with Duchenne muscular dystrophy (DMD). Information collected in this study may be used to identify potential participants for DMD investigational gene therapy clinical trials.

This study consists of:

* A phone/video interview to provide e-consent and medical history
* A single home health visit to collect blood sample for antibody testing
* A phone/video call for communication of AAV8 antibody test results

Eligibility criteria: Inclusion Criteria:

* Males at least 0 to \<12 years of age
* Diagnosis of DMD
* Provision of signed and dated informed consent form (ICF) and assent as required per local regulations or requirements

Exclusion Criteria:

* Prior participation in a gene therapy trial OR recipient of a gene therapy drug
* Other inclusion/exclusion criteria apply

Primary outcomes:
measure: Prevalence of anti-AAV8 antibodies in patients with DMD
timeFrame: 90 days
Secondary outcomes:
measure: Prevalence of anti-AAV9 antibodies in patients with DMD
timeFrame: 90 days
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Rare Disease Research
state: Georgia
Study officials:
References:
Clinical trial NCT05925179: Effects of Antibiotic Prophylaxis on the Healing Parameters Following Surgical Crown Lengthening
Official title: Effects of Pre-operative Antibiotics on the Wound Healing Following Clinical Crown Lengthening Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Tooth Diseases
Tooth Wear
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test the effects of prophylactic antibiotics in healthy individuals who are in need of surgical crown lengthening. The main question it aims to answer is if single dose antibiotics prior to surgical crown lengthening has any effects on the healing outcomes.

Participants will be asked to take either

* 2 g of amoxicillin + clavulanate, or
* placebo, one hour prior to surgery and without knowing what medicine they took.

Researchers will compare the wound healing and self-reported outcomes of the antibiotics group and placebo group.


Eligibility criteria: Inclusion Criteria:

* in need of surgical crown lengthening operation in one/two teeth

Exclusion Criteria:

* systemic diseases which may affect periodontal tissues and/or healing process such as diabetes mellitus
* antibiotic or anti-inflammatory drug use in the last 3 months
* pregnancy/lactation
* chronic steroid, immunosuppressant or NSAD use
* age \<18 years
* positive bleeding on probing at the surgical site and/or active periodontal disease
* \<2 mm keratinized mucosa at the surgical site following surgery (estimated surgical outcome before the operation)
* Miller 2 or 3 tooth mobility
* penicillin allergy
* unwilling to participate

Primary outcomes:
measure: Early healing index (inflammation phase)
timeFrame: at 3 days
measure: Early healing index (proliferation phase)
timeFrame: at 10 days
measure: Early healing index (remodeling phase)
timeFrame: at 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Hamzani Y, Chaushu G. Evaluation of early wound healing scales/indexes in oral surgery: A literature review. Clin Implant Dent Relat Res. 2018 Dec;20(6):1030-1035. doi: 10.1111/cid.12680. Epub 2018 Oct 15.
Clinical trial NCT06993779: Whole-slide Image and CT Radiomics Based Deep Learning System for Prognostication Prediction in Upper Tract Urothelial Carcinoma
Official title: Whole-slide Image and CT Radiomics Based Deep Learning System for Prognostication Prediction in Upper Tract Urothelial Carcinoma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: UTUC
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We included patients who had surgery only or who had neoadjuvant chemotherapy before surgery. We excluded patients with a postoperative diagnosis of non-urothelial carcinoma.

Brief summary: Upper Tract Urothelial Carcinoma (UTUC), characterized by its anatomical complexity and often aggressive clinical behavior, presents substantial difficulties in accurate diagnosis and reliable prognostication. The stratification of postoperative survival utilizing radiomics features derived from imaging and characteristics from whole slide images could prove instrumental in guiding therapeutic decisions to enhance patient outcomes. In this research, our objective is to construct a deep learning-based prognostic-stratification system designed for the automated prediction of overall and cancer-specific survival in individuals diagnosed with UTUC.

Detailed description: Upper Tract Urothelial Carcinoma (UTUC) can be challenging to accurately diagnose and its course difficult to predict, as the disease manifestations and aggressiveness can differ significantly among individuals. This research seeks to create an innovative system employing artificial intelligence to process patient data, encompassing images from diagnostic scans and surgical pathology slides. This system would then be capable of automatically forecasting a patient's overall survival and their specific likelihood of surviving UTUC. Such insights could empower clinicians to tailor more effective treatment strategies for each individual patient.

Eligibility criteria: Inclusion Criteria:

* Patients with Upper Tract Urothelial Carcinoma (UTUC) who had radical nephroureterectomy (RNU).
* Contrast-enhanced CT scan (e.g., CT urography) less than two weeks before surgery.
* Complete CT image data and clinical data.
* Complete whole slide image data.

Exclusion Criteria:

* Patients with a postoperative diagnosis of non-urothelial carcinoma.
* Poor quality of CT images and/or whole slide image data.
* Incomplete clinical and follow-up data.

Primary outcomes:
measure: Overall survival
timeFrame: up to 10 years
Secondary outcomes:
measure: Recurrence free survival
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Urology, The First Affiliated Hospital of Chongqing Medical University, chongqing, chongqing 400016 Recruiting
Study officials:
References:
Clinical trial NCT03072979: A Study to Quantify Tumour Perfusion for Spine Metastasis Treated With Stereotactic Body Radiotherapy (SBRT)
Official title: Reduction in Tumour Perfusion for Spine Metastasis Treated With Stereotactic Body Radiotherapy (SBRT)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spine Metastasis
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: National University of Singapore
First posted: 2017-03-08
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 18 patients from National University Hospital (NUH) will be enrolled. Informed consent will be taken from patients prior to trial entry at NUH.

Brief summary: Pre-clinical evidence suggests that radiotherapy reduces tumour-associated vasculature. The investigators will conduct a single-arm prospective study to quantify the reduction in tumour vasculature post-radiotherapy


Eligibility criteria: Inclusion Criteria:

* Age ≥21 years of age
* Proven metastatic disease, excluding haematological and germ cell neoplasms
* Life expectancy \>3 months, Eastern Cooperative Oncology group (ECOG) 0-2

Exclusion Criteria:

* The patient must not have an allergy to gadolinium contrast that will limit the ability to image the tumour by MRI safely even with the use of premedication
* eGFR \< 30 mL/min or if patient is suffering from acute renal insufficiency
* Prior radiotherapy to the specified region
* Recent surgery to affected spinal levels, or patients requiring immediate surgical intervention
* Spinal instability score (SINS) \>12
* Symptomatic cord compression (Bilksy grade 2 or 3), or worsening neurological deficits
* Body weight of more than 120kg
* Pregnancy

Primary outcomes:
measure: Reduction in vasculature
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References:
Clinical trial NCT01563679: Analysis of Percutaneous Ablations for Cancer Treatment
Official title: Prospective Analysis of Percutaneous Ablations for Cancer Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: cancer
locoregional therapies
RFA
Cryoablation
Microwave ablation
chemical ablation
Irreversible electroporation
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2012-03-27
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who undergo ablative therapy procedures, in the Interventional Radiology department as part of a clinical treatment for cancer.

Brief summary: This is a study involving patients with cancer who are referred by their treating physician for percutaneous locoregional therapies.

Patient's clinical and radiology findings, pathology findings, survival, treatment responses, and complications after their locoregional therapy will be studied.

Detailed description: The efficacy of the percutaneous and transarterial treatments for solid tumors will be studied. Prospective study on patients who receive percutaneous locoregional therapies, including radiofrequency ablation (RFA), cryoablation, microwave ablation, IRE and chemical ablation for treatment of cancer will be performed.

Preoperative clinic chart, procedure note, postoperative chart, pre- and post-operative CT, MRI or Ultrasound, angiographic findings, biopsy results and pathologic findings, will be reviewed. Patient survival, treatment responses, complications after the therapy will be collected from clinic visits and clinical encounters.

Patient overall performance status before and after procedures will be assessed using the Quality of Life questionnaire (SF-36™ Health Survey).

Eligibility criteria: Inclusion Criteria:

* 18yrs of age
* Cancer diagnosis
* Candidate for Locoregional therapy
* Willingness to sign informed consent

Exclusion Criteria:

* Unable to sign informed consent
* Patients not eligible for locoregional therapies

Primary outcomes:
measure: Effect of percutaneous and transarterial treatments for cancer in quality of life
timeFrame: 1 year
Secondary outcomes:
measure: response rate to percutaneous and transarterial treatment for cancer
timeFrame: 1 month, 3 months, 6 months, 1 year.
Other outcomes:
Locations:
city: Altanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Hyun S Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02471079: TOxicity After Radiotherapy in breAst CancEr Survivors (ThORACeS) - A Retrospective Cohort Study
Official title: TOxicity After Radiotherapy in breAst CancEr Survivors (ThORACeS) - A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Radiation-induced health problems
Cardiovascular events
Lung toxicity
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2015-06-15
Enrollment: 706
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult, female patients with stage I-III breast cancer, who were treated with breast-sparing surgery followed by radiation treatment.

Brief summary: Rationale:

The number of breast cancer (BC) patients at risk for long-term radiation-induced health problems is increasing, as their outcome is improving due to intensified treatment regimens, such as new systemic approaches and radiotherapy. Therefore, identifying BC survivors with the highest risk for radiation-induced health problems is crucial for developing strategies for primary and secondary prevention, which may contribute to healthy ageing.


Eligibility criteria: Inclusion Criteria:

* Female gender.
* Treated for stage I-III invasive adenocarcinoma of the breast or ductal carcinoma in situ (DCIS).
* Treated with curative breast-conserving surgery followed by radiotherapy of the breast, with or without irradiation of the regional lymph nodes.
* Start of radiotherapy is between 01-01-2005 and 31-12-2008.
* Available planning CT scan and dose distribution data of original breast cancer irradiation.

Exclusion Criteria:

* Any prior malignancy other than non-melanoma skin cancer or breast cancer.
* Prior radiotherapy treatments in the thoracic region.
* Treated with neoadjuvant chemotherapy.

Primary outcomes:
measure: Number of participants with cardiovascular events in relation with the received heart radiation dose
timeFrame: At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy
measure: Number of participants with secondary malignancies in relation with the received radiation dose
timeFrame: At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy
measure: Number of participants with radiation pneumonitis in relation with the received lung radiation dose
timeFrame: At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy
measure: Number of participants with hypothyroidism in relation with the received radiation dose
timeFrame: At time of data collection: minimum at 7 years and maximum at 10 years after completion of radiation therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References:
Clinical trial NCT01337479: A Phase IIIb: Long-Term Outcomes for Hepatitis B (HepB) Patients in Some Previous Entecavir (ETV) Trials
Official title: Long-Term Assessment of Treatment Outcomes With Entecavir and Lamivudine for Chronic Hepatitis B Infection in Patients Who Have Enrolled in Phase III Entecavir Trials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-04-19
Enrollment: 1097
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027.

Brief summary: The purpose of this study is to follow patients treated in entecavir Phase III and rollover studies for safety experience and Hepatitis B virus (HBV)-related complications.

Detailed description: Observational Model: Only subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027.

Number of groups/cohorts: 1 (All subjects were observed in the same manner).

Eligibility criteria: Inclusion Criteria:

* All subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027.

Primary outcomes:
measure: The proportion of subjects who have newly reported hepatitis B-related complications during AI463049 (reported by Phase III treatment groups)
timeFrame: data is collected every 6 months
Secondary outcomes:
measure: To determine the proportion of subjects who have a HBV Deoxyribonucleic acid (DNA) by Polymerase chain reaction (PCR) of < 300 copies/mL over the AI463049 follow-up period by the phase III treatment group
timeFrame: Every 6 months
measure: To determine the proportion of subjects who have Alanine transaminase (ALT) ≤ 1.0 x Upper limit of normal (ULN) over the AI463049 follow-up period by the phase III treatment group
timeFrame: Every 6 months
measure: To determine the proportion of subjects who were Hepatitis B e antigen (HBeAg) positive at the beginning of Phase III trials who have HBeAg loss or HBe seroconversion over the AI463049 follow-up period by the phase III treatment group
timeFrame: Every 6 months
measure: To determine the number of anti-HBV medications following enrollment in AI463049 by the phase III treatment group
timeFrame: Every 6 months
measure: To determine all cause mortality by the phase III treatment group
timeFrame: Every 6 months
measure: To determine HBV-related mortality by the phase III treatment group
timeFrame: Every 6 months
measure: To determine Non-hepatic malignancies by the phase III treatment group
timeFrame: Every 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06845579: Prediction of Blood Pressure Outcomes Following Renal Denervation (PREDICT-RDN)
Official title: Prediction of Blood Pressure Outcomes Following Renal Denervation (PREDICT-RDN)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Uncontrolled Arterial Hypertension
Lead sponsor: Heart Center Leipzig - University Hospital
Sponsor class: OTHER
Collaborators: name: Helios Health Institute GmbH
First posted: 2025-02-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, single arm trial to assess the effects of renal denervation on day-by-day blood pressure measurements and time in blood pressure target range, as well as establish a multivariate prediction model for blood pressure reduction after renal denervation.


Eligibility criteria: Inclusion Criteria:

1. Confirmed arterial hypertension with systolic or diastolic blood pressure \>140/90 mmHg in standardized office blood pressure measurement
2. Treatment with 3 to ≤5 antihypertensive drug classes
3. Age \>18 years
4. Written informed consent

Exclusion Criteria:

1. Age ≤ 18 years
2. anatomy unsuitable for renal denervation (i.e. renal artery stenosis, single functioning kidney)
3. pregnancy
4. patients under legal supervision or guardianship
5. participation in other trials that might interfere with the study outcome according to the opinion of one of the investigators.

Primary outcomes:
measure: Primary endpoint
timeFrame: target range between months 4 to 6 (before renal denervation) vs. 10 to 12 (4 to 6 months after renal denervation)
Secondary outcomes:
measure: Secondary endpoints
timeFrame: months 7 to 9
measure: Secondary endpoints
timeFrame: one week before renal denervation vs. 6 months after renal denervation
measure: Secondary endpoints
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz Kardiologie I
state: Rheinland Pflanz
city: Leipzig
country: Germany
facility: Heart Center Leipzig
state: Saxony
Study officials:
affiliation: Heart Center Leipzig
name: Karl Fengler, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03132779: Intralipid Related Effect on NKcells in Patients With Unexplained Recurrent Spontaneous Abortion
Official title: Intralipid Related Effect on NKcells in Patients With Unexplained Recurrent Spontaneous Abortions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Recurrent Miscarriage
Keywords: Intralipid
NK cells
Recurrent miscarriage
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
Collaborators: name: Ain Shams Maternity Hospital
First posted: 2017-04-28
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Women with unexplained recurrent spontaneous abortions having increased NKcells activity
Primary purpose: TREATMENT

Brief summary: Evaluating the effect of intralipid on the natural killer cells

Detailed description: This study will done on women with recurrent spontaneous abortions having increased NKCELLS activity and evaluate the effect of Intralipid on them after re-estimation of NKcells activity again after one week of Intralipid adminstration

Eligibility criteria: Inclusion Criteria:

* All women icluded having recurrent spontaneous abortions equal or more than twice.
* Alittle women having increased NKCELLS activity.

Exclusion Criteria:

* Any other diseases causing miscarriage as autoimmune (lupus erythematosus or antiphospholipid antibodies syndrome )or endocrinopathy (diabetes mellitus, thyroid disorders and hyperprolactinaemia)or thrombophilia (factor v leiden mutation, protein c or s deficiency, prothrombin G20210A mutation, antithrombin III deficiency ) or abnormal karyotyping to one or both of parents or previous history of hormonal contraception or intrauterine device usage at last 3 months or any contraindications for intralipid usage.

Primary outcomes:
measure: Change in NK cells activity after injection of intralipid
timeFrame: One week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hassan Tawfik office
name: Hassan T Khairy, Professor
role: STUDY_DIRECTOR
References: