louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06567353: A Multi-mode Thermophysical Immunotherapy Study for Breast Cancer Liver Metastases
Official title: A Multi-mode Thermophysical Immunotherapy Study for Breast Cancer Liver Metastases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Neoplasms
Liver Neoplasms
Metastasis
Keywords: Multi-mode Thermophysical Immunotherapy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-center, parallel-controlled clinical study designed to evaluate the safety, efficacy and impact on systemic anti-tumor immunity of a multi-mode integrated ablation system for the treatment of breast cancer liver metastases.

Detailed description: This is a single-center, parallel-controlled clinical study. The study plans to enroll 10 subjects, with 5 in the multi-mode ablation group (experimental group) and 5 in the conventional radiofrequency ablation group (control group). The entire study includes a screening period, treatment period and follow-up period. By comparing multi-mode ablation with conventional radiofrequency ablation, the study aims to observe the efficacy, safety of the multi-mode ablation technique in subjects and its impact on the systemic anti-tumor immunity of subjects.

Eligibility criteria: Inclusion Criteria:

1. Age 18-75 years, female gender;
2. Pathologically confirmed breast cancer liver metastases, in patients who are unable to tolerate or refuse surgical resection;
3. The number of lesions ≤ 3, with any single lesion diameter ≤ 4cm;
4. At least an interval of 1 month since the last local treatment;
5. Child-Pugh class A or B;
6. ECOG PS score ≤2, with an expected survival of \>3 months.

Exclusion Criteria:

1. Liver function Child-Pugh class C;
2. Systemic widespread metastasis, with an expected survival of \< 3 months;
3. History of esophageal (gastric fundus) variceal bleeding within the past month;
4. Dysfunction or failure of vital organs;
5. Presence of an active infection;
6. Irreparable coagulation abnormality;
7. Refractory massive ascites, pleural effusion or cachexia;
8. Pregnancy, altered consciousness or patients unable to cooperate with treatment;
9. Previously participated in other clinical studies and still within the follow-up period;
10. Any other factors deemed inappropriate for inclusion or that may affect the patient's participation in the study, as determined by the investigator.

Primary outcomes:
measure: Anti-tumor immune response
timeFrame: max 24 months
Secondary outcomes:
measure: 6-Month Local Control Rate
timeFrame: 6 months
measure: 6-Month Progression-Free Survival
timeFrame: 6 months
measure: 1-Year Progression-Free Survival
timeFrame: 1 year
measure: 1-Year Overall Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Study officials:
References:
Clinical trial NCT05956353: Stories for Change: Early Detection Can Save Lives
Official title: Stories for Change: Early Detection Can Save Lives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 51
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this study is to evaluate the Stories for Change (S4C) Cancer Prevention digital storytelling intervention for acceptability and socio-behavioral constructs to increase cancer screening among Hispanic or Latino individuals.


Eligibility criteria: Inclusion Criteria:

* Self-identify as Hispanic, Latino/a/x/e, or Chicano/a/x;
* For breast cancer screening: age 40-74 years; for cervical cancer screening: age 21-65 years; for colorectal cancer screening: age 45-75 year
* Receive primary care at either Hennepin Healthcare (HH) or Mountain Park Health Center (MPHC), or Mayo Clinic.
* At least one office visit within the previous 12 months to the primary care site.
* Eligibility for breast, cervical, or colorectal cancer screening documented in the electronic medical record (EMR).
* Intention to continue to receive medical care at HH, MPHC or Mayo Clinic for the next three months.

If a potential participant is eligible for more than one screening, they will be given the option of participating in multiple versions of the intervention.

Exclusion Criteria:

* Individuals with previous breast, cervical, or colorectal cancer diagnoses.
* For the participants in the colorectal cancer screening intervention, those under surveillance (i.e., did not have a cancer diagnosis but did have polyps) will also be excluded.

Primary outcomes:
measure: Number of participants screened and recruited
timeFrame: 1 year
Secondary outcomes:
measure: Constructs associated with effective implementation research
timeFrame: 1 year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Moutain Park Health Center
state: Arizona
city: Minneapolis
country: United States
facility: Hennepin Healthcare
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mark Weiland, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04117477: Xylitol - Healthcare Associated Infection Reduction in Stem Cell Transplant Patients
Official title: Healthcare Associated Infection Reduction in Stem Cell Transplant Patients: a Randomized, Double-blind, Placebo-controlled Study Evaluating Twice Daily Xylitol Administration
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Allogeneic Hematopoietic Cell Transplantation
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1, randomized, double-blind, placebo-controlled study
Primary purpose: PREVENTION

Brief summary: The central hypothesis is that daily dental xylitol wipes, in addition to current oral care practice, are effective at reducing BSI from oral organisms, and decreasing the incidence of gingivitis, oral plaque, and oral ulcerations after SCT.

Detailed description: Our long-term goal is to develop and disseminate clinically relevant, and easily adoptable strategies to prevent BSI and improve outcomes after SCT. The overall objective of this proposal is to identify a clinically effective strategy to prevent or reduce BSI secondary to bacterial translocation through oral injured mucosa .

Eligibility criteria: Inclusion Criteria:

* Patients of any age undergoing SCT.

Exclusion Criteria:

* Prior proton or photon radiation treatment for cancer of the oral cavity, head or neck; cranial boost in patients receiving total body irradiation; known history of allergy to xylitol; inability to use a mouth rinse or dental wipes.

Primary outcomes:
measure: Incidence of bacteremia in the first 30 days post-HSCT with oral organisms
timeFrame: 30 days
measure: Incidence of bacteremia in the first 30 days post-HSCT with any organism
timeFrame: 30 days
Secondary outcomes:
measure: Incidence of dental plaque
timeFrame: 30 days
measure: Incidence of gingival inflammation
timeFrame: 30 days
measure: Incidence of mucosal ulceration
timeFrame: 30 days
measure: Incidence of oral mucositis
timeFrame: 30 days
measure: Incidence of oral microbiome diversity
timeFrame: 30 days
measure: Incidence of oral pathogenic bacteria burden
timeFrame: 30 days
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT06790277: Polyurethane Foam-Pink Pad (RCT) Use in OR
Official title: Effectiveness of Polyurethane Foam (Pink Pad) Compared With Mepilex Dressing for Pressure Ulcer Prevention in Operating Room: A Randomized Control Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Surgery Subjects
Pressure Ulcer Prevention
Pressure Ulcer of Skin
Pressure Ulcer
Keywords: five layers sacral foam dressing
PINK PAD
pressure ulcers
Patients undergoing cardiac surgery
Mepilex dressing
Lead sponsor: King Abdullah Medical City
Sponsor class: OTHER_GOV
First posted: 2025-01-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: King Abdullah medical city has a cardiac center, and a lot of open-heart surgeries are performed there, and both polyurethane foam (pink Pad) and Mepilex dressing are applied to those patients. Therefore, the present study was designed to compare the effects of polyurethane foam (pink Pad) versus Mepilex dressing for prevention of pressure ulcer in operating room.

Detailed description: There are two types of intervention available in King Abdullah medical city for operating room pressure ulcer prevention. Polyurethane foams (Pink Pad) are a single use system for use in surgical procedures. The system consists of a proprietary formulation for the pink foam pad, non-woven lift sheet, body straps, head rests, and boot liners. It aids hospital facilities in providing a safe and effective method of management of the patient for pressure ulcers and non-movement for patients in the Trendelenburg position.

Mepilex Border Sacrum dressings are self-adherent, multilayer foam dressings designed for use on sacrum aiming to prevent pressure ulcers. The dressings are used in addition to standard care protocols for pressure ulcer prevention.

All included patients received standard PU prevention according to hospital protocols, based on contextualization and adaptation of International guidelines ( European Pressure Ulcer Advisory Panel, 2021 ), which involved: assessment of PU risk through the Braden Scale at hospital admission,

Eligibility criteria: Inclusion Criteria:

* Subjects ≥ 18.
* Willing to participate.
* Patients undergoing cardiac surgery.
* Patient who is at risk for PU development as measured with Braden scale.
* Patient who has skin intact and having a life expectancy greater than 72 hours as per clinical judgement.

Exclusion Criteria:

* Subjects under 17
* Not consenting to participate
* Patients with suspected hypersensitivity reactions to any of the dressing formulation's ingredients.
* Patients who are unable to continue the study because of death or change in the care setting.

Primary outcomes:
measure: Pressure ulcer incidence
timeFrame: 7 days
Secondary outcomes:
measure: occurrence of pressure ulcer
timeFrame: 7 days
Other outcomes:
Locations:
city: Mecca
country: Saudi Arabia
facility: King Abdulla Medical City in Holy capital
state: Western Reagan
Study officials:
References:
Clinical trial NCT02574377: myDC/pDC in Stage III Melanoma Patients
Official title: Myeloid and Plasmacytoid Blood Dendritic Cells for Immunotherapy of Stage III Melanoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Melanoma
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2015-10-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an interventional study to test the immunogenicity of combined adjuvant myDC and pDC vaccination versus adjuvant myDC or pDC vaccination alone in stage III melanoma patients.

Detailed description: Stage lll melanoma patients will receive pDC (arm A, n=10), myDC (arm B, n=10) or combined pDC/myDC (arm C, n=10). Subsequent vaccinations will be performed according to the protocol: 2 biweekly vaccinations of intranodal injections with pDC, myDC or the combination with pDC and myDC. After each vaccination the investigators will examine peripheral blood for proliferative and humoral KLH immune responses. After the vaccinations, a DTH with peptide loaded blood DC is performed from which biopsies are taken for T cell analysis. lf patients remain disease free, the investigators will repeat this cycle with a 6 months interval up to a total of three cycles. lf a tumor recurrence occurs a biopsy will be taken for laboratory evaluation.

Eligibility criteria: Inclusion Criteria:

* stage III melanoma
* WHO performance status 0-1
* radical lymph node dissection is schedule or performed within 12 weeks prior to start of study treatment

Exclusion Criteria:

* irresectable disease
* any concurrent adjuvant therapy
* concomitant use of oral immunosuppressive drugs
* autoimmune diseases

Primary outcomes:
measure: immunogenicity - type I IFN
timeFrame: up to 1.5 years
measure: immunogenicity - response to KLH
timeFrame: up to 1.5 years
measure: immunogenicity - T cells in DTH
timeFrame: up to 1.5 years
Secondary outcomes:
measure: biodistribution/localization of pDC and myDC in the lymph node
timeFrame: within 1 week after vaccination 1
measure: safety - Toxicity will be assessed according to the NCI Common Toxicity Criteria, CTC version 4.0
timeFrame: up to 1.5 years
measure: quality of life
timeFrame: 5 years
measure: progression-free survival
timeFrame: 5 years
measure: overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Medical Center
name: Winald Gerritsen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02365077: GWAS Identified Susceptibility Loci for Glucocorticoid-induced FHN in the Chinese Population
Official title: Genome-wide Association Study Identified Susceptibility Loci for Glucocorticoid-induced Femur Head Necrosis in the Chinese Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Femur Head Necrosis
Adverse Effect of Glucocorticoids and Synthetic Analogues
Keywords: Adverse Effect of Glucocorticoids
Femur Head Necrosis
Susceptibility
GWAS
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2015-02-18
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients coming from the Department of Dermatology Xijing Hospital, Fourth Military Medical University Xi'an, China

Brief summary: This is a observation clinical trial. We are collecting the patients with glucocorticoid. They were divided into the experiment group (with femur head necrosis) and control group (without femur head necrosis).Then, we will analyse the patients' genome with genome-wide association study (GWAS). Our purpose is to find susceptibility loci for glucocorticoid-induced femur head necrosis in the Chinese population.


Eligibility criteria: Inclusion Criteria:

1. Subject has given the written informed consent voluntarily;
2. Male or female between 18\~60 years;
3. Candidate is clinically diagnosed as avascular osteonecrosis of the femoral head (ONFH), in reference to the diagnostic criteria set forth by Experts' Consensus on the Diagnosis and Treatment of Osteonecrosis of the Femoral Head in Adults (edition 2012);
4. Patient with history of glucocorticoid therapy, in form of oral, muscular or vascular administration, should have total dose equivalent to ≧2000 mg of Prednisone, and maintain on that dose for ≦3 months.

Exclusion Criteria:

1. Subject is not in conformity with diagnostic criteria for ONFH;
2. Patient has a history of trauma in the lower limbs or pelvis;
3. Prolonged addiction to alcohol;
4. Concurrent with renal failure, organ transplant, graft versus host disease, inflammatory bowel disease, HIV infection or leukemia;
5. Patient with familial idiopathic ONFH;
6. Subject suffers from a fatal disease, with life expectancy \< 2 months;
7. Woman of child-bearing potential, who is pregnant, in preparation of pregnancy or breast-feeding during the study period;
8. Other patients deemed ineligible at the discretion of the investigator.

Primary outcomes:
measure: Glucocorticoid-induced femur head necrosis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospitial
state: Shaanxi
Study officials:
References:
Clinical trial NCT00377377: Oral Ghrelin Agonist in Healthy Subjects
Official title: Pharmacokinetics and Pharmacodynamic Effects of an Oral Ghrelin Agonist in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: GH release
Pharmacokinetics
Safety
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2006-09-18
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: EP01572 is a peptidomimetic growth hormone secretagogue, which has potent GH-releasing activity after intravenous administration.It is an analogue of the natural compound ghrelin. Since an oral delivery system would be preferable in many of the possible therapeutic indications, the pharmacological profile and the GH-releasing activity of increasing single, oral doses of EP01572 in healthy volunteers will be evaluated. In addition, the pharmacokinetics and pharmacological effects of EP01572 will be investigated after intraduodenal administration.

Detailed description: EP01572 willbe given orally to 36 male subjects; the treatment will consist of one oral dose of either EP01572 or placebo (0.005, 0.05 and 0.5 mg/kg body weight). Subjects will receive one dose of EP01572 and placebo. Six subjects will receive two additional oral doses of EP01572: 0.125 and 0.25 mg/kg body weight. In another part, 6 subjects will receive the following treatments in a randomized order: 1) administration of a bolus of saline (placebo) to the small intestine; 2) intraduodenal (ID) administration of a bolus of EP01572 at 0.2 mg/kg body weight; 3) ID perfusion of a bolus of EP01572 at 0.35 mg/kg body weight; 4) ID perfusion of a bolus of EP01572 at 0.5 mg/kg body weight.

Eligibility criteria: Inclusion Criteria:

* Healthy males

Exclusion Criteria:

* Females

Primary outcomes:
measure: Growth hormone release
measure: Pharmacokinetics
Secondary outcomes:
measure: Safety
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, 4031 Basel Switzerland
name: Christoph Beglinger
role: PRINCIPAL_INVESTIGATOR
References:
citation: Piccoli F, Degen L, MacLean C, Peter S, Baselgia L, Larsen F, Beglinger C, Drewe J. Pharmacokinetics and pharmacodynamic effects of an oral ghrelin agonist in healthy subjects. J Clin Endocrinol Metab. 2007 May;92(5):1814-20. doi: 10.1210/jc.2006-2160. Epub 2007 Feb 6.
Clinical trial NCT00946777: Barrier Function Measurement in Dry Eye Patients After Using Systane Ultra for 30 Days
Official title: Barrier Function Measurement in Dry Eye Patients After Using Systane Ultra for 30 Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Dry Eye Signs
barrier function
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-07-27
Enrollment: 19
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: The primary objective is to determine if there is a correlation between reductions in corneal staining and improvements in corneal barrier function.


Eligibility criteria: Inclusion Criteria:

* Patients must have moderate corneal staining and exhibit a need to use artificial tears.

Exclusion Criteria:

* Patients can not participate in any other ophthalmic drug or device clinical trial within 30 days of the baseline visit.

Primary outcomes:
measure: Percent change from baseline of corneal fluorescein
timeFrame: 30 days
Secondary outcomes:
measure: Adverse event occurence
timeFrame: 30 Days
Other outcomes:
Locations:
Study officials:
References:
citation: Fernandez KB, Epstein SP, Raynor GS, Sheyman AT, Massingale ML, Dentone PG, Landegger LD, Asbell PA. Modulation of HLA-DR in dry eye patients following 30 days of treatment with a lubricant eyedrop solution. Clin Ophthalmol. 2015 Jun 24;9:1137-45. doi: 10.2147/OPTH.S81355. eCollection 2015.
Clinical trial NCT04013477: Single-ascending Dose Phase 1 Clinical Trial to Evaluate the Safety and PK of DA-5207 TDS in Healthy Adults
Official title: A Single-blinded, Placebo- and Active-controlled, Parallel, Single-ascending Dose Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetics of DA-5207 Transdermal Delivery System in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-07-09
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A single-blinded, placebo- and active-controlled, parallel, single-ascending dose phase 1 clinical trial to evaluate the safety and pharmacokinetics of DA-5207 transdermal delivery system in healthy adults


Eligibility criteria: Inclusion Criteria:

* Health Male Volunteers (Age : 19\~55 years)
* Body Weight : Male≥55kg, Female≥50kg
* 18.5≤BMI\<25.0

Exclusion Criteria:

* Galactose intolerance, Lapp lactase deficiency, Glucose-galactose malabsorption
* Allergy or Drug hypersensitivity
* Clinically significant Medical History
* AST, ALT \> Upper Normal Range\*1.25, eGFR\<60mL/min/1.73m²
* Heavy alcohol intake (more than 210g/week)
* Heavy smoker (more than 10 cigarettes/day)
* Heavy caffeine intake

Primary outcomes:
measure: AUC
timeFrame: patch : 21days, oral : 11days
measure: Cmax
timeFrame: patch : 21days, oral : 11days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Trials Center, Severance Hospital
Study officials:
References: