louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03766022: Effect of Heavy Smoking on Hard and Soft Tissue Parameters Prospective Clinical Trial
Official title: Effect of Heavy Smoking on Hard and Soft Tissue Parameters Prospective Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Implants,Peri-implantitis,Smoking
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The Aim of this study randomized prospective clinical trial is to examine and compare periimplant tissue changes between heavy smokers and non-smokers at 12 months post loading using the alpha Bio Neo standard diameter implants with conical abutment.

Detailed description: Peri-implant marginal bone level is one of the most important references criteria to monitor peri-implant health.A radiographically measured marginal bone loss of up to 1.5 mm during the first year of loading, followed by a marginal bone loss of up to 0.2 mm for each succeeding year, is an acceptable criterion to determine implant success.

Smoking has been implicated in many adverse systemic outcomes, including tooth loss, alveolar bone loss and dental implant failure.

Platform switching, also known as platform shifting, is whenever an abutment is used that is smaller in diameter than the implant platform. Platform switching can help prevent crestal bone loss.

The hypothesis of the present study is that the use of conical abutment might reduce marginal bone loss around dental implants in both smokers and non-smokers alike.

Eligibility criteria: Inclusion Criteria:

1. Age between 20 - 85 years.
2. Written informed consent.
3. In need for a dental implant Adequate alveolar bone Intended to be restored with individual crowns.
4. Heavy smokers (20 Cig/d \> 5years) or non / former smokers (\> 5 years since cessation).

Exclusion Criteria:

1. Active periodontal disease.
2. Systemic condition and medication that may affect soft and hard tissue.
3. healing Parafunctional occlusal scheme and habits.
4. Pregnancy or intention to become pregnant in the following twelve months.
5. Patient not willing or able to meet the study schedule.
6. Patient in need for simultaneous bone graft or GBR using a membrane barrier.

Primary outcomes:
measure: marginal bone loss
timeFrame: 6 months and 18 months after implantation.
Secondary outcomes:
measure: Implants probing depth (IPD)
timeFrame: 4 months, 6 months and 16 months after implantation
measure: Bleeding on probing
timeFrame: 4 months, 6 months and 16 months after implantation
measure: Labial gingival recession
timeFrame: 4 months, 6 months and 16 months after implantation
Other outcomes:
measure: Implant stability
timeFrame: Immediatly after implant installation (day 0) and 4 months after implantation
Locations:
city: Haifa
country: Israel
facility: Rambam Hospital
Study officials:
affiliation: Rambam Health Care Campus
name: Hadar Zigdon, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03799822: Oral Anticoagulation in Hemodialysis
Official title: Safety and Efficacy of Vitamin K Antagonists Versus Rivaroxaban in Hemodialysis Patients With Atrial Fibrillation: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: hemodialysis
rivaroxaban
vitamin K2
Lead sponsor: Onze Lieve Vrouw Hospital
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators refer to the trial with clinicaltrials.gov indentifier NCT02610933 entitled Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients.

After termination of this trial, included patients will be asked to participate in the extension trial by continuing the treament of their respective allocation arm. No new intervention will be done.

Detailed description: The investigators refer to the trial with clinicaltrials.gov indentifier NCT02610933 entitled Effect on Vascular Calcification of Replacing Warfarin by Rivaroxaban With or Without VitK2 in Hemodialysis Patients.

After termination of this trial, included patients will be asked to participate in the extension trial by continuing the treament of their respective allocation arm. No new intervention will be done. Relevant endpoints like death, cardiovascular events and bleeding episodes will be registered.

Eligibility criteria: Inclusion Criteria:

* inclusion in the trial with clinicaltrials.gov identifier NCT02610933
* signed informed consent for this extension trial

Exclusion Criteria:

* none

Primary outcomes:
measure: composite of fatal and non-fatal stroke and other cardiovascular events
timeFrame: through study completion, on average 3 years
Secondary outcomes:
measure: death rate
timeFrame: through study completion, on average 3 years
measure: safety: incidence of life-threatening, major and minor bleeding
timeFrame: through study completion, on average 3 years
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Hospital
Study officials:
affiliation: OLV Hospital Aalst, Belgium
name: Rogier Caluwe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Vriese AS, Caluwe R, Van Der Meersch H, De Boeck K, De Bacquer D. Safety and Efficacy of Vitamin K Antagonists versus Rivaroxaban in Hemodialysis Patients with Atrial Fibrillation: A Multicenter Randomized Controlled Trial. J Am Soc Nephrol. 2021 Jun 1;32(6):1474-1483. doi: 10.1681/ASN.2020111566. Epub 2021 Mar 22.
Clinical trial NCT06416930: Study of Cadonilimab Combined With Chemotherapy in Recurrent / Refractory Pleural Mesothelioma
Official title: Study of Cadonilimab Combined With Chemotherapy in Recurrent / Refractory Pleural Mesothelioma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Pleural Mesothelioma
Keywords: Cadonilimab
pleural mesothelioma
Bispecific Antibody
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Akesobio
First posted: 2024-05-16
Enrollment: 59
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: This is a multicenter, single-arm, phase II clinical study to evaluate the safety and efficacy of Cadonilimab combined with gemcitabine, or vinorelbine, or pemetrexed in the treatment of patients with recurrent / refractory pleural mesothelioma.


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed advanced or metastatic pleural mesothelioma;
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
3. Participants must have previously failed to receive platinum-containing chemotherapy with or without bevacizumab, and have received at most two-line systemic therapy.
4. Measurable disease as per mRECIST v1.1 for assessment of response in malignant pleural mesothelioma.
5. Adequate haematological, renal and liver function.

Exclusion Criteria:

1. Primary mesothelioma of peritoneum, pericardium and testes
2. Active, untreated central nervous system (CNS) metastasis.
3. Use of Chinese herbal medicine or immunomodulatory agents with anti-tumor indications within 14 days prior to the first dose of study treatment.
4. Known active autoimmune diseases.
5. Presence of other uncontrolled serious medical conditions.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 2 year
Secondary outcomes:
measure: Disease Control Rate (DCR)
timeFrame: 2 year
measure: Progression Free Survival (PFS)
timeFrame: 2 year
measure: Duration of Response (DoR)
timeFrame: 2 year
measure: Overall Survival (OS)
timeFrame: 2 year
measure: Adverse Events (AEs)
timeFrame: 2 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06056648: Addressing Inequity in Dermatology
Official title: Skin Images and Nomenclature for Diverse Populations (SkIN DP)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dermatologic Disease
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: Dowager Countess Eleanor Peel Trust
First posted: 2023-09-28
Enrollment: 200
Sex: ALL
Minimum age (years): 7
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with dermatologist diagnosed dermatological condition with active disease and with clear morphology, of all ages and ancestries/ethnicity.

Brief summary: The objectives of this study are to understand the variation in dermatoses presenting in individuals from different ancestry backgrounds. This will be conducted at multiple NHS hospitals in England. The Investigators specifically aim to 1) assess features of dermatoses in individuals of different ancestry. 2) Understand the language used by patients describing their condition.


Eligibility criteria: Inclusion Criteria:

* Dermatologist diagnosed disease, with visible active dermatological disease

Exclusion Criteria:

* No dermatological disease, no active pathology identifiable, aged 18 and above but lacks capacity to consent.

Primary outcomes:
measure: Assess features of dermatoses in individuals of different ancestry
timeFrame: Baseline
measure: Asses the language used by patients when describing their skin condition
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
Study officials:
affiliation: University of Manchester
name: Chiedu Ufodiama, MBBS M.Sci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02949648: Electronic Cigarette Use and Quitting in Youth
Official title: A Pilot Study on Electronic Cigarette Use and Their Impact on Smoking and Quitting in Youth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking
Keywords: Electronic cigarette
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2016-10-31
Enrollment: 189
Sex: ALL
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Youth in Hong Kong

Brief summary: A mixed method (longitudinal, trajectory and qualitative studies) to provide comprehensive evidence on the impact of e-cigarette use on smoking and quitting among smoking youth in Hong Kong.

Detailed description: Subjects are from a cohort of Youth Quitline callers and smoking youth (N=200) in Hong Kong. The longitudinal study will investigate the effects of baseline e-cigarette use on quitting (including relapse), nicotine addiction and intention to smoke at 12-month telephone follow-up. A qualitative study will be conducted on 10 ex- and 10 current smokers to supplement and facilitate interpretation of the quantitative findings.

Eligibility criteria: Inclusion Criteria:

1. Ethnic Chinese
2. Cantonese speakers
3. Smoke at least 1 cigarette in the past 30 days

Exclusion Criteria:

1. Psychologically or physically unable to communicate
2. Undergoing other smoking cessation programme

Primary outcomes:
measure: 7-day point prevalence abstinence assessed in the telephone follow-up survey
timeFrame: 12 months after baseline survey
Secondary outcomes:
measure: Quit attempts assessed in the telephone follow-up survey
timeFrame: 12 months after baseline survey
measure: Intention to quit assessed in the telephone follow-up survey
timeFrame: 12 months after baseline survey
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Youth Quitline, School of Nursing, The University of Hong Kong
Study officials:
affiliation: mpwang@hku.hk
name: Man Ping Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01739530: Safety of Repaircell in Healthy Volunteers
Official title: Phase I Study to Evaluate Safety of Repaircell in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Anterogen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-12-03
Enrollment: 5
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Allogenic differentiated adipocytes (ANT-adip-AL) is produced by well-established techniques including cell harvesting from lipoaspirates obtained from healthy donors, expansion of adipose tissue derived stem cells, and differentiation into pure and immature adipocytes. This was an open-label study. Subjects were received subcutaneous injection of ANT-adip-AL and followed for 8 weeks according to the clinical trial protocol.


Eligibility criteria: Inclusion Criteria:

* male, 19 years of age or older
* volunteers in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine at the time of screening
* informed consent form signed

Exclusion Criteria:

* volunteers who have participated in other clinical studies related cell therapy within 30 days before this clinical trial
* volunteers who received any immune-suppressive drug, corticosteroid or cytotoxic drug within the previous 30 days
* volunteers who have tattoo or scar which disturb assessment of study at injection site
* volunteers who have Creutzfeldt Jacobs disease or related disease or family history
* volunteers who have allergy to bovine-derived materials
* volunteers who have infectious disease such as hepatitis B virus (HBV), hepatitis C virus (HCV)and HIV
* volunteers who have a symptom of septicemia or diagnosis of active Tuberculosis
* volunteers who have a clinically relevant history of abuse of alcohol or drugs
* volunteers who are considered not suitable for the study by investigator
* volunteers who have history of surgery for malignant cancer in the past 5 years
* volunteers who have congenital or acquired immunodeficiency syndrome
* volunteers who have horrible anemia or thrombopenia
* volunteers who have chronic disease such cardiovascular,renal and respirometer disease
* volunteers who were immunosuppressed by disease (ex: chronic heart failure)
* volunteers who were immunodepressed by treatment of medication
* volunteers who is being treated with blood derivatives/who is going to get a blood derivatives
* volunteers who have abnormal rage of CD4/CD8 ratio

Primary outcomes:
measure: Number of Adverse events
timeFrame: week 8
Secondary outcomes:
measure: Immunological response II
timeFrame: week 8
measure: Immunological response I
timeFrame: change from baseline CD4/CD8 ratio at week 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Sa-ik Bang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00205530: Evaluation of an Intervention Model for Family Crisis and Support
Official title: Evaluation of an Intervention Model for Family Crisis and Support (a Research Project Within the Traumatic Brain Injury Model System Grant)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Brain Injury, Chronic
Keywords: brain injury, family treatment
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2005-09-20
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Family members/caregiver friends and persons with ABI who are at least three months postinjury will be eligible to participate in the present investigation. ABI is defined as damage to brain tissue caused by stroke, aneurysm, anoxia, non-progressive brain tumor, infection, or an external mechanical force as evidenced by: loss of consciousness, post traumatic amnesia (PTA), objective neurological findings, or skull fracture. Penetrating wounds fitting the definition listed above will be included. Lacerations and/or bruises of the scalp or forehead without other criteria listed above will be excluded. All participants must be at least 18 years of age or older and able to understand and provide consent.

Brief summary: To learn more about how a family treatment program helps people after brain injury. Specifically, do families feel better and function better after going through the program, and do patients feel better and function better after going through the program.

Detailed description: To evaluate the efficacy of a structured outpatient family intervention program (BIFI) on family members' emotional well being, life satisfaction, needs, and family functioning; and to evaluate the impact of the BIFI on the emotional well being, life satisfaction, functional independence, vocational status, and neurobehavioral functioning of persons with acquired brain injury (ABI).

Eligibility criteria: Inclusion Criteria:

* Family members/caregiver friends and persons with acquired brain injury (ABI) who are at least three months postinjury. ABI is defined as damage to brain tissue caused by stroke, aneurysm, anoxia, or an external mechanical force as evidenced by: loss of consciousness, post traumatic amnesia (PTA), objective neurological findings, or skull fracture.

Exclusion Criteria:

* Families including individuals at imminent risk of psychiatric hospitalization, or in imminent danger of hurting themselves or others, as judged by the investigators.
* Individuals under 18 years of age.

Primary outcomes:
measure: Family Needs Questionnaire (FNQ)
timeFrame: pre-treatment, post-treatment, 3 mo. follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Jeffrey S Kreutzer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05851430: Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry
Official title: Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Soft Tissue Lesion
Keywords: Pulsed Electric Fields
Lead sponsor: Galvanize Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have had or who are scheduled to have soft tissue ablated by the Galvanize PEF technology

Brief summary: The goal of this observational registry is to assess the use and performance of Galvanize PEF technology in a real-world setting. The main questions it aims to answer are:

* PEF utilization and performance
* Monitor safety outcomes and inform future generation devices.

Participants will undergo the PEF procedure and be followed per institutional standard of care.

Detailed description: This is a multi-center, observational registry that follows patients for a total of 2 years from the date of the Pulsed Electric Field (PEF) procedure with the FDA cleared Galvanize Technology.

Patients will be enrolled and followed prospectively or enrolled retrospectively with prospective, longitudinal follow up.

Enrollment for this study will include up to 200 patients throughout the US who underwent or are scheduled to undergo PEF energy delivery.

Eligibility criteria: Inclusion Criteria:

1. Subject will undergo or has undergone PEF energy delivery utilizing Galvanize technology
2. Subject is expected to be available for follow-up per the enrolling physician's standard care practices
3. For prospective cohort, subject has a life expectancy of at least 3 months; for retrospective cohort, subject has completed at least three months of imaging following the PEF procedure
4. Signed informed consent is obtained, if required by IRB

Exclusion Criteria:

None

Primary outcomes:
measure: Anesthesia Type Usage for PEF Procedure
timeFrame: PEF procedure
measure: PEF Target Location
timeFrame: PEF procedure
measure: PEF Target Size
timeFrame: PEF procedure
Secondary outcomes:
measure: Incidence of SAEs
timeFrame: within 30 days of PEF energy delivery
measure: Unanticipated [not listed in the Instructions for Use (IFU)] adverse events
timeFrame: within 30 days of PEF energy delivery
Other outcomes:
Locations:
Study officials:
affiliation: Chief Medical Officer
name: William Krimsky, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01255930: Evaluation of Placenta Maturity by the Sonographic Textures
Official title: Evaluation of Placenta Maturity by the Sonographic Textures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnant Women
Keywords: Pregnant Women
Sonographic Textures
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-12-08
Enrollment: 150
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women

Brief summary: The aim of this study is to evaluate placenta maturity by the sonographic textures.The evaluation of placenta maturity by the sonographic textures is related to anticipative pregnancy and actual pregnancy . By analyzing this theory, the investigators want to bring up another objective and accurate analysis method in order to provide information for the evaluation of clinical trials.


Eligibility criteria: Inclusion Criteria:

* pregnant women
* Placenta Maturity by the Sonographic Textures

Exclusion Criteria:

* intrauterine-growth retardation(IUGR)
* Pre-eclampsia
* Higher Blood Pressure
* Fetal Distress during a labor

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University-WanFang Hospital
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Szu-Yuan Chou
role: PRINCIPAL_INVESTIGATOR
References: