louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06636461: Assessment of Dimensional Changes Following Grafting With Microfragmented Adipose Tissue Loaded on Allograft on Ridge Preservation
Official title: Assessment of Dimensional Changes Following Grafting With Microfragmented Adipose Tissue Loaded on Allograft on Ridge Preservation Versus Allograft Only for Subsequent Implant Placement in the Maxillary Posterior Region, a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hopeless Tooth
Keywords: hopeless tooth lesion or affected periodontium
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of maxillary alveolar ridge changes (bone quantity and quality as revealed by radiographic and Histomorphometry ) utilizing microfragmented adipose tissue loaded on allograft versus allograft only for maxillary posterior ridge preservation

Detailed description: All patients involved in this study will be divided into two groups; each group will receive a different graft of bone augmentation: Adipose tissue loaded on allograft will be utilized for the study group and allograft only for the control group.

After 3-6 months, assessment of dimensional changes ( RG height \& width) on CBCT is performed and Histomorphometry will be evaluated via core biopsy at the time of implant placement in both groups.

Radiographic assessment that will be achieved by CBCT scan will be used to calculate the changes of bone height and width from base line (1week) to 3-6 months postoperatively.

Eligibility criteria: Inclusion Criteria:

* Patients requiring implant treatment after tooth extraction due to either unrestorable caries lesions or affected periodontium.

Age group: above 18 years

• Remaining natural teeth have good periodontal tissue support and occlusion showed sufficient inter arch space for future prosthesis.

Exclusion Criteria:

* • General contraindications to implant surgery.

  * Subjected to irradiation in the head and neck area less than 1 year before implantation.
  * Poor oral hygiene and motivation.
  * Severe bruxism or clenching.
  * Systemic, immunologic or debilitating diseases that could affect normal bone healing \& local pathosis.
  * Treated or under treatment of intravenous amino-bisphosphonates.
  * Active infection or severe inflammation in the area intended for implant placement.
  * Patients participating in other studies, if the present protocol could not be properly followed.
  * Heavy somkers

Primary outcomes:
measure: Alveolar ridge hight (bone quantity )
timeFrame: Alveolar ridge hight (bone quantity ) by CBCT after 3-6 months
Secondary outcomes:
measure: Alveolar ridge width.
timeFrame: Alveolar ridge width. by CBCT after 3-6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo Universty
state: Giza
Study officials:
References:
Clinical trial NCT00162461: Evaluation of CYP2C9 Activity
Official title: The Use of Phenytoin Metabolic Ratio as a Putative Marker of CYP2C9 Activity In-vivo
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Healthy Volunteers
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: United States - Israel Binational Science Foundation
First posted: 2005-09-13
Enrollment: 1200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The use of phenytoin metabolism to produce S-HPPH accounts for more than 85% of its metabolism. This metabolic pathway is mediated by the activity of CYP2C9.

The purpose of the present study is:

1. To confirm the use of phenytoin metabolic ratio as a marker of CYP2C9 activity
2. To correlate phenytoin metabolic ratio with CYP2C9 genotype
3. To study the frequency distribution of CYP2C9 activity in-vivo


Eligibility criteria: Inclusion Criteria:

* Age range of 20-50 years old
* Absence of significant disease states

Exclusion Criteria:

* The presence of significant disease states
* The use of drugs (including birth control pills)

Primary outcomes:
measure: Correlation between phenytoin metabolic ratio and CYP2C9 genotype
timeFrame: 24 hours
measure: Frequency distribution of phenytoin metabolic ratio in the population
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Yoseph Caraco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004761: Establishment of the National Epidermolysis Bullosa Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epidermolysis Bullosa
Keywords: dermatologic disorders
epidermolysis bullosa
genetic diseases and dysmorphic syndromes
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: Rockefeller University
First posted: 2000-02-25
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: NATURAL_HISTORY
Time perspective: OTHER

Brief summary: OBJECTIVES: I. Develop a large roster of well-characterized patients with various forms of inherited and acquired epidermolysis bullosa (EB).

II. Generate a large data bank of clinical, historical, and genetic information concerning these patients.

III. Accumulate donated tissue specimens, including selected cells and DNA, from selected patient subsets for the establishment of permanent tissue cell banks.

IV. Promote and facilitate research in EB.

Detailed description: PROTOCOL OUTLINE: Patients are enrolled by mail or clinic visit at 1 of 4 clinical centers. Clinical, epidemiological, and laboratory data are collected.

Medical and family histories are obtained in a detailed interview in person, by phone, or by mail. Diagnostic studies to confirm the type of epidermolysis bullosa are performed as indicated. A pedigree chart is completed on the first affected family member entered.

Selected patients are followed at least biannually. A study duration of approximately 10 years is anticipated.

Eligibility criteria: * Clinical diagnosis of epidermolysis bullosa

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rockefeller University
name: James G. Krueger
role: STUDY_CHAIR
References:
citation: Lin AN, Carter DM: Epidermolysis Bullosa: Basic and Clinical Aspects. New York: Springer Verlag, 1992.
Clinical trial NCT02159261: Assess Satisfaction of Patients and Physicians With Results of Yaz Plus Treatment for 13 Cycles
Official title: A Prospective Multicenter Non-interventional Study on Patients and Physicians Satisfaction of Yaz Plus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Keywords: Personal Satisfaction
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-06-09
Enrollment: 1500
Sex: FEMALE
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: Female patients ≥ 18 years old requiring contraception, treated with Yaz Plus for the first time and for which the inclusion and exclusion criteria are fulfilled, are eligible for enrolment into the study.

Brief summary: Local prospective multicenter non-comparative non-interventional observational study. It's planed to assess satisfaction of patients and physicians with results of Yaz Plus treatment for 13 cycles in real practice.

Detailed description: Non-interventional, Yaz Plus, Contraception, Assess satisfaction, Russian Federation.

Eligibility criteria: Inclusion Criteria:

* Female patients ≥ 18 years old
* Requiring contraception
* Prescribed with Yaz Plus for the first time

Exclusion Criteria:

* Contraindications for the use of Yaz Plus in accordance with the local product information

Primary outcomes:
measure: Satisfaction measured with a Likert response scale (from 1 - poor to 5 - excellent)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Changes in EVAPIL scale for assessment of tolerability of oral contraceptives.
timeFrame: Baseline to 12 months
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Many Locations
country: Russian Federation
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05007561: Understanding How Opioids Affect the Experiential and Neural Signatures of Social Experiences
Official title: Understanding How Opioids Affect the Experiential and Neural Signatures of Social Experiences
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Naltrexone
Placebo
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-08-16
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study is a randomized, placebo-controlled design with the opioid antagonist, oral naltrexone. Following random assignment, participants will take 50mg of naltrexone or placebo once a day for 7 days. On days 1 - 7, participants complete reports of their feelings of social connection and mood in order to assess more naturalistic feelings in response to opportunities for social connection outside of the laboratory setting. Additionally, at the end of each day, they complete a physical symptoms questionnaire. On the 7th day, participants will come to the SDSU MRI scanning facility to complete tasks designed to elicit feelings of social connection in the fMRI scanner. After the scan, feelings in response to the scanner tasks will be collected.


Eligibility criteria: Inclusion Criteria:

* good health
* English fluency
* willing to provide contact information for 4-6 close others
* willing to provide digital photographs of 2 close others
* own a smartphone

Exclusion Criteria:

* presence of medical devices, implants, or other metal objects in or on the body that cannot be removed
* tattooed eyeliner
* a body habitus prohibiting MRI scanning
* claustrophobia
* self-reported chronic mental or physical illness
* current and regular use of prescription medication
* previous history of having difficulty taking pills
* current use of opioid analgesics
* depressive symptoms above a 9 on Patient Health Questionnaire
* excessive alcohol use
* positive urine drug test
* body mass index (BMI) greater than 35
* pregnancy or plans to become pregnant in next 6 months
* positive urine pregnancy test

Primary outcomes:
measure: Daily feelings of social connection via ecological momentary assessment
timeFrame: post-treatment, change across 7 days
measure: Bold Oxygen-level Dependent (BOLD) Activations in Prespecified ROIs
timeFrame: Day 7, approximately 60 mins after taking study drug
measure: feelings in response to neuroimaging tasks
timeFrame: Day 7, approximately 150 minutes after taking study drug
Secondary outcomes:
measure: physical symptoms via daily diary
timeFrame: end of day on days 1-7
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
affiliation: San Diego State University
name: Tristen Inagaki, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02109861: Microdose Study of Melphalan, Bortezomib and Dexamethasone
Official title: Phase 0 Microdose Study to Evaluate the Effect of Melphalan, Bortezomib and Dexamethasone on Cellular Gene-expression in Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Phase 0 study
Microdose study
Micro array
Gene expression profiling
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2014-04-10
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to identify specific genes that are up- or downregulated in multiple myeloma patients who receive a microdose of either Melphalan (Alkeran®), Bortezomib (Velcade®) or Dexamethasone (Dexaven®). The study treatment constitutes 1% of the planned standard myeloma treatment and will be given two hours prior to standard treatment. Blood samples are taken at baseline, 15, 30, 60 and 120 minutes for microarray analysis.


Eligibility criteria: Inclusion Criteria:

* Planned treatment for Multiple Myeloma (newly diagnosed as well as relapse and refractory disease) with one of the following chemotherapy regimens: 1) Highdose melphalan, 2) Bortezomib or 3) Dexamethasone
* 18 years or older.
* Understand and have the will to sign the informed consent.

Exclusion Criteria:

* Prior treatment with the study drug
* Received treatment with biphosphonates in the week prior to study treatment

Primary outcomes:
measure: Change from baseline in gene expression at 15, 30, 60, 120 minutes upon microdose drug exposure.
timeFrame: Prior to microdose and 15, 30, 60 and 120 minutes post-microdose
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Haematology, Aalborg University Hospital
Study officials:
affiliation: Aalborg University Hospital, Department of Haematology, 9000 Aalborg, Denmark
name: Henrik Gregersen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01225861: Prospective Study on the Use of Transdermal Analgesic Buprenorphine Patches for Chronic Pain in the UK
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Lead sponsor: Mundipharma Research Limited
Sponsor class: INDUSTRY
First posted: 2010-10-21
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients experiencing pain. They may be from primary or secondary care.

Brief summary: The primary objective of the study is the descriptive analysis of incidence \& severity of side effects \& reasons for discontinuation of the treatment of chronic pain with transdermal analgesic Buprenorphine patches.

Detailed description: 750 patients that are treated with transdermal Buprenorphine patches for chronic pain will be included in the study. About 20% of patients are aimed to be patch-naive, ie have received their first prescription of transdermal analgesic patches within 1 month before inclusion in this observational study. Furthermore the study should not include more than 25% of cancer patients that are treated for chronic pain in order to ensure an appropriate mix of patient population.

Eligibility criteria: Inclusion Criteria

* Patient age \> 18
* Patient is treated with transdermal Buprenorphine
* The patient is able to answer the patient's survey \& has an estimated overall survival of minimum 6 months
* The patient gives his/her informed, written consent to participate in the study

Exclusion Criteria

* Patient Age \< 18
* Patient has less than 6 months survival expectancy
* Patient is unable to answer the patient survey for whatever reason in any feasible form

Primary outcomes:
measure: The incidence and severity of side effects
timeFrame: patients observed for 6 months
Secondary outcomes:
measure: Treatment patterns
timeFrame: patients observed for 6 months
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Western Infirmary, Terrent Institute
Study officials:
References:
citation: Serpell M, Tripathi S, Scherzinger S, Rojas-Farreras S, Oksche A, Wilson M. Assessment of Transdermal Buprenorphine Patches for the Treatment of Chronic Pain in a UK Observational Study. Patient. 2016 Feb;9(1):35-46. doi: 10.1007/s40271-015-0151-y.
Clinical trial NCT03142061: Electrochemotherapy for the Inoperable Vulva Carcinoma
Official title: Prospective Evaluation of Clinical Efficacy and Symptom Control Using Electrochemotherapy for the Inoperable Advanced Vulva Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Inoperable Vulva Carcinoma
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Electrochemotherapy (ECT) with Bleomycin in non-operable advanced vulva carcinoma

Detailed description: Prospective evaluation of tumor response towards ECT by photo documentation. In addition prospective documentation of life quality after ECT treatment as well as evaluation of pain. .

Eligibility criteria: Inclusion Criteria:

* informed consent
* age ≥ 55 years (postmenopausal)
* histologically proved cutan accessible vulva carcinoma
* a maximum of 5 lesions ≥1 - ≤ 5 cm diameter; a maximum thickness of 3 cm
* applied electrochemotherapy with electroporation

Exclusion Criteria:

* Non compliant patients
* Patients with symptomatic or rapidly progredient metastasis outside of the vulva

Primary outcomes:
measure: local tumor control
timeFrame: Baseline
measure: Symptom control
timeFrame: Baseline
Secondary outcomes:
measure: Life quality
timeFrame: Baseline, 3, 6 months
measure: Pain
timeFrame: Baseline, 3, 6 months
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Department of Women's Health
Study officials:
References:
Clinical trial NCT00085761: Study of NGX-4010 for Treatment of Painful HIV-Associated Neuropathy
Official title: An International, Multicenter, Randomized, Double-Blind, 12-Week Controlled Study of NGX-4010 for Treatment of Painful HIV-Associated Neuropathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: HIV Infections
Peripheral Nervous System Diseases
Pain
Keywords: Dermal assessment
Pain measurement
Diary
Neuropathy
Analgesics/*therapeutic use
Capsaicin/*administration & dosage/adverse effects
HIV Infections/*complications/*drug therapy
Pain
Complementary Therapies
Lead sponsor: NeurogesX
Sponsor class: INDUSTRY
First posted: 2004-06-17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine if an investigational drug, NGX-4010 (high-concentration capsaicin patch), is safe, tolerable and effective in treating painful HIV-associated neuropathy.


Eligibility criteria: Key Eligibility Criteria:

* Must have had HIV-associated neuropathy for at least 2 months, with moderate to severe pain in both feet.
* Must not have significant pain in feet due to other causes (for example, arthritis).
* Must have intact skin at the treatment area.
* Must be prepared to remain on the same pain medications at the same doses as before the study for the entire duration of the study (12 weeks).
* Must not use topical pain medications for HIV-associated neuropathy.
* Must be able to comply with study requirements such as completing daily pain diary and attending study visits.
* Must be at least 18 years old, not pregnant, and be able to take care of self independently, with only occasional assistance if needed.
* No significant medical problems of the heart, kidneys, liver or lungs, or cancer.
* No history or current problem with substance abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: NeurogesX Investigational Site
state: Florida
city: Annandale
country: United States
facility: NeurogesX Investigational Site
state: Virginia
Study officials:
References:
Clinical trial NCT04516161: EPIX, a Study to Gather More Information About Characteristics of Patients and Other Factors Which May Contribute to Survival Over a Long Period of Time in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Treated With Radium-223 (Xofigo)
Official title: Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC) Treated With Radium-223 (Xofigo): Patient Characteristics and Predictors of Long-term Survival
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Castration Resistant Prostate Cancer (mCRPC)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-08-18
Enrollment: 1180
Sex: ALL
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: Patients with mCRPC who received Ra-223 from the Bayer Flatiron Xofigo Registry database (BFXR, Version Mar, 2020 with a data cutoff date of Dec, 2019). The database currently includes 1,372 patients with mCRPC who received Ra-223.

Brief summary: In this observational study researchers want to gather more information about the characteristics of patients treated with Radium-223 (Xofigo) who had survived over a long period of time prostate cancer that had spread to other places in the body and keeps growing even when the amount of testosterone in the body is reduced to very low levels (metastatic castration-resistant prostate cancer, mCRPC). In addition researchers want to identify the factors which may contribute to survival over a long period of time in those patients. Radium-223 (Ra-223) is an alpha particle-emitting radioactive agent approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC).


Eligibility criteria: Inclusion criteria

* Adult patients with documented diagnosis of mCRPC (≥18 years at diagnosis), and
* Received Ra-223 as one of the therapies between Jan 1, 2013 and Jun 31, 2019 after diagnosis of mCRPC

Exclusion criteria

- Patients involved in clinical trials

Primary outcomes:
measure: Overall survival from initiation of Ra-223
timeFrame: Retrospective analysis from Jan 2013 to Dec 2019
Secondary outcomes:
measure: Percentage of Prostate Specific Antigen (PSA) (unit: µg/L) response after Ra-223
timeFrame: Retrospective analysis from Jan 2013 to Dec 2019
Other outcomes:
Locations:
city: Whippany
country: United States
facility: Bayer Flatiron Xofigo Registry database
state: New Jersey
Study officials:
References:
citation: George DJ, Agarwal N, Sartor O, Sternberg CN, Tombal B, Saad F, Miller K, Constantinovici N, Guo H, Reeves J, Jiao X, Sandstrom P, Verholen F, Higano CS, Shore N. Real-world patient characteristics associated with survival of 2 years or more after radium-223 treatment for metastatic castration-resistant prostate cancer (EPIX study). Prostate Cancer Prostatic Dis. 2022 Feb;25(2):306-313. doi: 10.1038/s41391-021-00488-0. Epub 2022 Feb 21.