louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00958802: Tissue Engineering Microtia Auricular Reconstruction: in Vitro and in Vivo Studies
Official title: Tissue Engineering Microtia Auricular Reconstruction: in Vitro and in Vivo Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Microtia
Keywords: tissue engineering
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2009-08-13
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Platelet-rich plasma (PRP) has mixed growth factors such as TGF-ß1 and TGF-ß2, vascular epithelial growth factor (VEGF), platelet-derived growth factor (PDGF), and insulin-like growth factor (IGF). These growth factors appear to play an important role in wound healing and are assumed as promoters of tissue regeneration. Moreover, PRP was used as injectable scaffold seeded with chondrocytes to regenerate cartilage. In their previous study, the investigators concluded that growth factors in PRP can effectively react as a growth factor cocktail to induce human nucleus pulposus proliferation and differentiation, and also promote tissue-engineered nucleus pulposus formation. The investigators also have a hypothesis that PRP can promote tissue-engineered microtia auricular cartilage formation. TGF- ß1 exists in the highest concentration and is more important among all of the growth factors released from PRP. So TGF- ß1 can be used as the core ingredient and the indicator for applying PRP in these studies. The aim of this study was to compare the histological and biochemical character of microtia chondrocytes treated with and without PRP.


Eligibility criteria: Inclusion Criteria:

* microtia patient

Exclusion Criteria:

* non microtia patient

Primary outcomes:
measure: The aim of this study was to compare the histological and biochemical character of microtia chondrocytes treated with and without PRP.
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University, Wan Fang Hospital
Study officials:
affiliation: Chia-Che Wu
name: Chia-Che Wu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03796702: Early Versus Late Closure of Preventive Ileostomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ileostomy, Rectal Cancer
Lead sponsor: Vilnius University
Sponsor class: OTHER
First posted: 2019-01-08
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed and performed as a prospective randomized controlled single-center study. Patients who underwent rectal resection with preventive ileostomy due to rectal cancer will be included. The study investigates the effect of reversing a temporary ileostomy after 30 vs 90 days.


Eligibility criteria: Inclusion Criteria:

* Patients with temporary ileostomy after rectal resection for rectal cancer
* Patients willing to participate in the study

Exclusion Criteria:

* Anastomosis insufficiency detected clinically or radiologically.
* Patients, who are physically and mentally unfit to undergo surgery or to be followed-up

Primary outcomes:
measure: Postoperative morbidity
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Hospitalization time after ileostomy closure
timeFrame: 30 days after surgery
measure: 30-days re-admission rate
timeFrame: 30 days after surgery
measure: Quality of life of patients after ileostomy closure
timeFrame: at 3, 6, 9 and 12 moths after surgery
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: National Cancer Institute
Study officials:
References:
Clinical trial NCT00993902: Double and Single Intrauterine Insemination In Controlled Ovarian Stimulation (COH) Cycles With Multifollicular Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: Double IUI
Intrauterine insemination
Unexplained infertility
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2009-10-14
Enrollment: 228
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our hypothesis is double insemination will improve pregnancy rates in coh cycles with more than one dominant follicles (\>16mm).

Detailed description: Metaanalysis for the effects of double IUI demonstrates that effects of this procedure is not different from single IUI. It is known that nearly 25% of coh cycles is evident by monofollicular development.For this reason it is possible that this monofollicular cycles in the studies could decrease the effects of double IUI.

Inclusion criteria:

1. Patients with unexplained infertility or mild male factor infertility whom admitted to the COH+IUI programme in our infertility unit.
2. Female age \<37 years old.
3. Baseline FSH \<12 mIU/L
4. Total antral follicle count\>6
5. During the first three cycles of COH+IUI
6. Minimum 2 follicles \>16 mm at the day of HCG.

Primary outcome:

Ongoing pregnancy rates

Secondary outcomes:

The effects of different coh regimens (CC,FSH,CC+FSH)on the outcomes.

Eligibility criteria: Inclusion Criteria:

* Unexplained and mild male factor infertile patients
* Minimum 2 follicles \>16 mm at the day of HCG
* First 3 cycles

Exclusion Criteria:

* Basal FSH \>12 mIU/L
* Total antral follicle count\<6
* Severe male factor infertility

Primary outcomes:
measure: ongoing pregnancy rates
timeFrame: pregnancy >12 weeks of gestation
Secondary outcomes:
measure: The effects of different coh regimens on outcomes
timeFrame: 14 days after IUI procedure
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Baskent University Medical Faculty Obstetric and Gynecelogy Department, Infertility and IVF unit
Study officials:
References:
citation: Bagis T, Haydardedeoglu B, Kilicdag EB, Cok T, Simsek E, Parlakgumus AH. Single versus double intrauterine insemination in multi-follicular ovarian hyperstimulation cycles: a randomized trial. Hum Reprod. 2010 Jul;25(7):1684-90. doi: 10.1093/humrep/deq112. Epub 2010 May 10.
Clinical trial NCT06112002: Evaluation of an Education Program to Increase Knowledge and Participation in Clinical Trials Among Racial/Ethnic and Rural Populations
Official title: Clinical Trial (CT) &Amp; Biospecimen Studies Participation Education Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This clinical trial evaluates a culturally tailored educational outreach intervention for increasing clinical trial knowledge, referral, and participation among racial/ethnic minority and rural populations. Clinical trials are research studies that involve people. Through clinical trials, researchers are able to determine whether new treatments are safe and effective and work better than current treatments. Clinical trials can also help find new ways to prevent and detect cancer and improve the quality of life for people during and after treatment. Recruitment and retention of underrepresented groups in clinical trials remains a challenge. Racial and ethnic minority groups bear a disproportionate burden of cancer compared with other groups yet these populations continue to be underrepresented in clinical trials. This clinical trial uses community health educators (CHEs) to facilitate individual and group education sessions to improve knowledge of what constitutes a clinical trial, the value of participating in clinical trials, and why it is important for racial/ethnic minorities to participate in clinical trials.

Detailed description: PRIMARY OBJECTIVE:

I. To implement culturally tailored educational outreach activities with the goal of increasing clinical trial (CT) knowledge, referral and participation among racial/ethnic and rural populations.

OUTLINE:

Participants attend an educational session with CHEs and receive educational materials on study.

Eligibility criteria: Inclusion Criteria:

* Adult males and females 18 years of age and older from Ohio
* Will not let anyone who is not cognitively able to give voluntary informed consent take part in the education sessions

Primary outcomes:
measure: Change in knowledge
timeFrame: Up to 1 year
measure: Prior clinical trial participation status
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Electra D Paskett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06154902: Real-World Outcomes in Relapsed/Refractory Multiple Myeloma Patients Treated, or Eligible for Treatment, With Idecabtagene Vicleucel
Official title: ABE-DESCART Study: Characterization and Outcomes of Patients With Relapsed and Refractory Multiple Myeloma Eligible for Treatment or Treated With Abecma© (Idecabtagene Vicleucel) in Real World Setting in France. A Database Analysis Based on the DESCAR-T Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Myeloma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-12-04
Enrollment: 350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in France with RRMM who are eligible for treatment with, or have been treated with, idecabtagene vicleucel

Brief summary: The purpose of this study is to describe demographic and disease characteristics, treatment patterns, and clinical outcomes in the real-world setting among participants in France with relapsed/refractory multiple myeloma (RRMM) who are eligible for treatment with, or have been treated with, idecabtagene vicleucel. This study will use both prospective and retrospective data from the DESCAR-T registry database.


Eligibility criteria: Inclusion Criteria:

* Patients with RRMM registered in the DESCAR-T registry and eligible for treatment or treated with idecabtagene vicleucel

Exclusion Criteria:

* Not registered with the social security in France

Primary outcomes:
measure: Overall survival
timeFrame: 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: DESCAR-T Registry
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00376402: Study of a Pandemic Influenza Vaccine in Elderly Participants
Official title: Phase II Study of a Pandemic Influenza Vaccine in Elderly Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Pandemic
Influenza
Prevention
Vaccine
Prevention of Pandemic Influenza
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2006-09-14
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza H5N1 virus strain is one of the leading candidates to cause the next influenza pandemic. The elderly are likely to be a special target group for vaccination; therefore, this study will test the safety and immunogenicity of a H5N1 pandemic influenza vaccine in a healthy elderly population.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female participants

Exclusion Criteria:

* History of clinically significant medical conditions
* History of Guillain-Barre syndrome or active neurological disease
* Resident of nursing home or long-term care facility

Primary outcomes:
measure: Safety and immunogenicity
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX, a division of IDT Australia
state: South Australia
city: Perth
country: Australia
facility: Princess Margaret Hospital for Children
state: Western Australia
Study officials:
affiliation: Princess Margaret Hospital for Children
name: Peter Richmond, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05286502: NW500 Non-Mydriatic Retinal Camera Clinical Performance Study
Official title: NW500 Non-Mydriatic Retinal Camera Clinical Performance Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fundus Photography
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2022-03-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects 18 years old or older.

Brief summary: Comparison of color fundus images acquired by the Topcon NW500 non-mydriatic retinal camera (investigational device) and the Topcon TRC-NW400 (predicate device)


Eligibility criteria: Inclusion Criteria:

* Subjects who are 18 years of age or older on the date of informed consent.
* Subjects who are able to understand the written informed consent and are willing to participate as evidenced by signing the informed consent.

Exclusion Criteria:

* Subjects who are unable to tolerate ophthalmic imaging.
* Subjects with poor fixation or ocular media not sufficiently clear to obtain acceptable images.
* Subjects who cannot follow instructions to complete the required testing.

Primary outcomes:
measure: fundus photo image quality
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Topcon Healthcare Solutions
state: New Jersey
Study officials:
References:
Clinical trial NCT00839202: Activity and Content of Factor VIII (FVIII) in Human Plasma: The Assessment of a Novel Immunoassay
Official title: Pharmacokinetic (PK) Analysis of a Novel Immunoassay in Hemophilia A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemophilia A
Keywords: factor VIII
hemophilia A
assay
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
Collaborators: name: University of Vermont
First posted: 2009-02-09
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: A novel immuno-assay is being evaluated for the measurement of Factor VIII. Current procedure measures a rate assay which is subject to much artefact. The hypothesis is that the new assay will give a reading of absolute quantities of FVIII which will provide a more suitable indicator of FVIII content for clotting factor manufacturers, physicians and patients.

Detailed description: Remnant samples collected in a clinical laboratory are assayed with the new procedure and compared with the standard functional activated partial thromboplastin time (APTT) assay. A PK study in seven study subjects with hemophilia A is being carried out using five different commercially licensed factor VIII concentrates and the blood samples drawn for the PK analysis are being measured for FVIII with the novel assay and compared with the standard APTT assay. The concentrates used in the PK studies are also being applied to the two assay systems to determine each product's specific activity.

Eligibility criteria: Inclusion Criteria:

* adults with hemophilia A
* factor VIII less that 2%
* informed consent signed
* absence of an inhibitor

Exclusion Criteria:

* history of a high responding inhibitor anemia

Primary outcomes:
measure: The level of Factor VIII in pMols
timeFrame: 48 hours
Secondary outcomes:
measure: The possible role of VWF, factor concentrate type and non-inhibitory antibody presence or absence on the FVIII antigen levels
timeFrame: 48 hours
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Department of Biochemistry University of Vermont
state: Vermont
Study officials:
affiliation: Children's Hospital Los Angeles
name: Edward D Gomperts, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Vermont
name: Kenneth G Mann, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06880302: Male Infertility and Assisted Reproductive Technologies Research Biobank
Official title: Male Infertility and Assisted Reproductive Technologies Research Biobank
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Male Infertility
Infertility (IVF Patients)
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 1000
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males that had previously provided male biological specimen for their infertility treatment that no longer wishes to keep their samples frozen

Brief summary: The objective of this research is to build a biobank of biological male specimens used for diagnostics and treatment of infertility or assisted reproductive technologies (ART).

Detailed description: The objective of this research is to build a biobank of biological male specimens used for diagnostics and treatment of infertility or assisted reproductive technologies (ART). These specimens include testicular tissue, sperm, semen samples, donor sperm or discarded sperm preps. These samples were possibly utilized for diagnostic testing such as semen analyses or DNA fragmentation testing or for ART procedures such as intrauterine insemination (IUI) in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) and are no longer needed clinically. Rather than discarding those samples the men who provided them or the sperm recipient in the case of donor sperm may elect to donate them for future research purposes. These samples will be used for future research regarding male infertility and assisted reproductive technologies.

Eligibility criteria: Inclusion Criteria:

* Males providing testicular tissue, sperm, semen samples, discarded sperm preps for IUI/IVF/ICSI or the sperm recipient for those utilizing donor sperm, for cryopreservation at the respective site(s) for either clinical use or preservation

Exclusion Criteria:

* Samples that are quarantined or in isolation dewars for infectious diseases

Primary outcomes:
measure: Biobank
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: RMANJ
state: New Jersey
Study officials:
References:
Clinical trial NCT01419002: Study to Evaluate if Neoadjuvant Radiotherapy Improves Recurrence Free Survival in Pancreatic Head Cancer
Official title: Neoadjuvant Radiotherapy in Patients With Primary Resectable Adenocarcinoma of the Pancreatic Head Plus Adjuvant Chemotherapy: a Randomized Controlled Phase III Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pancreatic Adenocarcinoma
Keywords: Pancreatic Cancer
Adenocarcinoma
Neoadjuvant Radiotherapy
Lead sponsor: CHIR-Net
Sponsor class: NETWORK
Collaborators: name: Technical University of Munich
First posted: 2011-08-17
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Net-Pac investigates if radiation prior to surgical resection improves survival in patients with pancreatic head cancer without metastases.

Detailed description: The trial is designed to show that neoadjuvant radiotherapy followed by surgery improves local recurrence free survival compared to surgery alone in patients with resectable adenocarcinoma of the pancreatic head.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the pancreatic head
* Age ≥ 18 years
* Signed informed consent
* ECOG performance status of 0-2

Exclusion Criteria:

* Curative resection is not feasible or presence of metastatic disease
* Patients not eligible for surgery (ASA ≥ 4)
* Participation in an other clinical trial
* Unable or unwilling to sign the informed consent

Primary outcomes:
measure: Local recurrence free survival
timeFrame: At 12 months postoperative
Secondary outcomes:
measure: Percentage of surgical R0-resections in both groups
timeFrame: Until 10 days postoperative
measure: 30-day morbidity and mortality
timeFrame: 30 day period after the operation
measure: Toxicity of preoperative Radiotherapy
timeFrame: Start of the radiotherapy until 12 months postoperative.
measure: Clinical response rate (RECIST-criteria) and histological response rate
timeFrame: Until 1 year postOP
measure: Time to tumor progression (local and systemic)
timeFrame: Until 1 year postoperative
measure: Quality of life
timeFrame: Until 12 months postoperative
measure: Overall survival after 1 year
timeFrame: Until 1 year postoperative
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar, Technische Universität München
Study officials:
affiliation: Technical University of Munich
name: Helmut M Friess, Prof. MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Technical University of Munich
name: Michael Molls, Prof. MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00858702: Calcium Channel Blockers (CCBs) or Diuretics as an Add-on to Olmesartan Medoxomil in Hypertension
Official title: Add-on Study of CCBs or Diuretics in Essential Hypertension Not Achieving Target Blood Pressure on Olmesartan Medoxomil Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Essential hypertension
Combination therapy
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2009-03-10
Enrollment: 105
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to test the efficacy and safety of the combination of Calcium Channel Blockers (CCBs)(of the dihydropyridine class) or Diuretics (of the thiazide class) and olmesartan medoxomil in essential hypertensive patients whose blood pressure is not adequately controlled with olmesartan medoxomil alone


Eligibility criteria: Inclusion Criteria:

* Mean seated blood pressure greater than or equal to 140/90 mmHg under circumstances in pre-treatment with olmesartan medoxomil
* Mean 24-hour blood pressure evaluated by ambulatory blood pressure monitoring greater than or equal to 135/80 mmHg under circumstances in pre-treatment with olmesartan medoxomil

Exclusion Criteria:

* Patients with secondary hypertension
* Any serious disorder which may limit the ability to evaluate the efficacy or safety of the test drugs

Primary outcomes:
measure: The Percentage of Patients Achieving Target Sitting Blood Pressure of Less Than 130/85
timeFrame: Baseline to week 8
Secondary outcomes:
measure: Percentage of Patients With Drug-related Adverse Events (Subjective Symptoms/Objective Findings)
timeFrame: At week 8
measure: Percent of Patients With Drug-related Adverse Events (Laboratory Changes in Clinical Laboratory Values)
timeFrame: At week 8
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Daiichi Sankyo Co., Ltd.
name: Research and Development Division
role: STUDY_DIRECTOR
References: