louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00067548: Study Evaluating EKB-569 in Advanced Non-Small Cell Lung Cancer
Official title: A Phase 2 Study of EKB-569 in Subjects With Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small-Cell Lung Carcinoma
Carcinoma, Non-Small Cell Lung
Lung Neoplasms
Keywords: Advanced Non-Small Cell Lung Cancer
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2003-08-25
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This non-randomized, open-label, outpatient clinical trial is designed to assess the safety and efficacy of daily orally administered EKB-569 in subjects with advanced non-small cell lung cancer. Patients must have been previously treated with a platinum- and docetaxel-based therapy either given concurrently or as separate regimens.

The primary objective of the study is to assess the clinical activity of EKB-569 administered orally as a second-line or later stage treatment in subjects with advanced non-small cell lung cancer. Secondary objectives include:

* To further evaluate the safety of EKB-569
* To explore additional clinical activity parameters
* To explore subject survival
* To evaluate the pharmacokinetics of EKB-569
* To assess subject reported outcomes

EKB-569 will be administered orally as a single-agent. Eligible subjects will take EKB-569 daily as long as they do not have progressive disease and are tolerating treatment.


Eligibility criteria: Inclusion Criteria:

* Signed and dated, institutional review board (IRB) or independent ethics committee (IEC)-approved informed consent form before any protocol-specific screening procedures
* Histologic and/or cytologic diagnosis of locally-advanced or metastatic non-small cell lung cancer in subjects who are not curable by conventional therapy

Exclusion Criteria:

* Chemotherapy, radiotherapy, anticancer immunotherapy, or investigational agents within 4 weeks of treatment day 1 (6 weeks if the previous regimen included mitomycin or nitrosoureas)
* Prior radiotherapy to \>25% of bone marrow
* Prior epidermal growth factor receptor-targeting therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02810548: Evaluation of Platelets Rich Fibrin and Nanohydroxyapatite in the Treatment of Intrabony Defects
Official title: Clinical and Biochemical Evaluation of Platelets Rich Fibrin (PRF) and Nanohydroxyapatite in the Treatment of Intrabony Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Bony Defects
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: the ultimate goal of periodontal therapy is the regeneration of periodontal tissues. Researches had demonstrated the benefits of platelet concentrates bine grafts in osseous regeneration in the areas of periodontal surgery.

Aim of the study: to evaluate the effect of PRF with/without nanohydroxyapatite in periodontal intrabony defects.

Detailed description: Background: the ultimate goal of periodontal therapy is the regeneration of periodontal tissues. The regenerative and wound healing potential of platelets has attracted much attention over the last few years. Researches had demonstrated the benefits of platelet concentrates in osseous regeneration in the areas of periodontal surgery and implantology. In addition, nanohydroxyapatite was shown to be unsheathed by newly formed bone and partly replaced by it, but resorbed very slowly, as shown in animal experiments after 9 months or in clinical studies after a 6-month observation period. The clinical and biochemical studies evaluating the regenerative effect of PRF alone or in combination with nanohydroxyapatite in periodontal intrabony defects are still deficient.

Aim of the study: to evaluate clinical and biochemical effect of PRF with/without nanohydroxyapatite in treatment of human intrabony defects.

Eligibility criteria: Inclusion Criteria:

* All patients are free from systemic illness.
* All patients should be diagnosed as having chronic periodontitis.
* Patients should be cooperative, motivated and willing to follow our treatment protocol and follow up visits.
* Patients selected had not received antibiotics or anti-inflammatory therapy in the 6 months prior to examination.

Exclusion Criteria:

* Presence of areas of periodontal pocket of (probing depth ≥5 and clinical attachment level (CAL) ≥ 3).
* Patients who have received any type of periodontal treatment in the past 6 months prior to examination.

Primary outcomes:
measure: Changes in Gingival crevicular fluid (GCF)
timeFrame: up to 3 weeks.
Secondary outcomes:
measure: Changes in Gingival index
timeFrame: up to 3 months
measure: Changes in level of attachment loss
timeFrame: up to 3 months
measure: Changes in probing pocket depth
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdelaziz University. Faculty of dentistry
Study officials:
affiliation: King Abdelaziz University
name: Maha A Bahammam, DSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05670548: Early Prediction of Postpartum Glucose Metabolism Abnormalities in Gestational Diabetes Mellitus
Official title: Early Prediction of Postpartum Glucose Metabolism Abnormalities in Gestational Diabetes Mellitus Based on Gestational Metabolic Profile and Lipid Profile
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gestational Diabetes Mellitus
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This project intends to recruit pregnant women with GDM who go to the research center for routine prenatal examination and OGTT screening at 24-28 gestational weeks.

Brief summary: This project is expected to screen reliable serum markers in pregnant women with gestational diabetes mellitus (GDM) by using metabolic profiling and lipid profiling clinical high-throughput mass spectrometry technology. We intend to build an early pregnancy prediction model for postpartum glucose metabolism abnormalities of GDM. At the same time, this project plans to develop a predictive management system based on this model, so that it can be widely used in clinical detection process, realize the advance of the early warning window period of abnormal glucose metabolism, and provide theoretical guidance for the early postpartum blocking of GDM to the outcome of abnormal glucose metabolism.


Eligibility criteria: Inclusion Criteria:

* Plan to have routine prenatal examinations and give birth in the research center
* GDM was diagnosed at 24-28 gestational weeks
* Singleton pregnancy
* Without other pregnancy complications
* Willing to cooperate with the hospital to follow up

Exclusion Criteria:

* Have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy, such as diabetes, heart disease, liver and kidney diseases, thyroid diseases with drug, autoimmune diseases, malignant tumors, AIDS, etc.
* Fetus has a known deformity or genetic defects
* Incomplete clinical data

Primary outcomes:
measure: Serum lipidomics
timeFrame: During the 24-28 geatational weeks.
measure: Serum metabolomics
timeFrame: During the 24-28 geatational weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Women's Hospital School Of Medicine Zhejiang University
state: Zhejiang
Study officials:
affiliation: Women's Hospital School Of Medicine Zhejiang University
name: Zhaoxia Liang, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04819048: Efficacy of Acupuncture and Low-Level Laser in Temporomandibular Disorders
Official title: Efficacy of Acupuncture and Low-Level Laser in Temporomandibular Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Temporomandibular Joint Disorders
Keywords: Low-Level Laser Therapy
acupuncture
Lead sponsor: Beijing Hospital of Integrated Traditional Chinese and Western Medicine
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Temporomandibular joint disorders (TMD) , a musculoskeletal condition , includes a series of clinical problems involving the temporomandibular joint (TMJ), the masticatory muscles, and related structures.This study evaluates the efficacy of integrated traditional Chinese and western medicine in the treatment of TMD.

Detailed description: In this study, 84 patients ranging in age from 18 to 65 years with diagnoses of TMD will be randomly divided into two groups: an experimental group (EG) who will receive the integrated traditional Chinese and western medicine treatment group(with Low-Level Laser Therapy+acupuncture) and a control group who will receive the only western medicine treatment(with Low-Level Laser Therapy).Both approaches will be applied 3times a week for 3 weeks.

Eligibility criteria: Inclusion Criteria:

1. diagnosis of TMD according to the Diagnostic Criteria for TMD Research Diagnostic Criteria (DC/TMD）which are manifested as joint pain during mouth opening and chewing, mouth opening limitation (\<40mm), joint clanging, masticatory creatine distension and weakness, which affects normal eating.
2. Aged 18-65;
3. Unilaterally;
4. No any other treatment on TMD in the last 3 months;

Exclusion Criteria:

1. there are tumors, joint degeneration and other serious lesions ;
2. Patients with a history of TMJ trauma or surgery,joint anatomical variation;
3. women pregnant and suckling period;
4. serious systemic diseases of bone and joint, such as rheumatoid arthritis

Primary outcomes:
measure: Visual analogue scale(VAS)
timeFrame: Change from baseline Visual analogue scale at week 3
Secondary outcomes:
measure: Tempommandibular Opening Index(TOI)
timeFrame: Change from baseline Tempommandibular Opening Index at week 3
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital of Integrated Traditional Chinese and Western Medicine
state: Beijing
Study officials:
References:
Clinical trial NCT04312048: the Effect of Isosorbide Mononitrate in Reducing Pain During Cooper Intrauterine Device Insertion
Official title: the Effect of Vaginal Isosorbide Mononitrate Administration in Reducing Pain During Cooper Intrauterine Device Insertion in Nulliparous Women : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: IUD Insertion Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 110
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to evaluate the efficacy of isosorbide mononitrate vaginal administration in reducing pain during copper IUD insertion in nulliparous women


Eligibility criteria: Inclusion Criteria:

* nulliparous women requesting copper IUD device insertion

Exclusion Criteria:

* parous women, contraindications to IUD insertion, allergy or contraindication to isosorbide mononitrate, uterine anomaly

Primary outcomes:
measure: pain during IUD insertion
timeFrame: 5 minutes
Secondary outcomes:
measure: duration of IUD insertion
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ahmed Samy
Study officials:
affiliation: Cairo University
name: Mahmoud alalfy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02936648: Hepatitis C Testing in VA Community-Based Outpatient Clinics
Official title: Hepatitis C Testing in VA Community-Based Outpatient Clinics (QUE 15-284)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Keywords: Hepatitis C
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-10-18
Enrollment: 2209
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The VISN1 VA Hepatitis C Testing and Linkage to Care Quality Improvement project aims to increase the proportion of Veterans tested for HCV in those born between 1945-1965 and in vulnerable, high-risk groups.

Detailed description: The VISN1 VA Hepatitis C Testing and Linkage to Care Quality Improvement project aims to: (1) increase the proportion of Veterans tested for HCV in those born between 1945-1965 and in vulnerable, high-risk groups, (2) Increase linkage to specialized HCV care among VISN 1 VA Veterans diagnosed with HCV infection, and (3) Evaluate whether race, ethnicity, gender, or other markers of social disparity influence completion of HCV testing and linkage to specialty care, and whether disparities are reduced by the planned VISN 1 VA HCV Quality Improvement (QI) program. The central focus is to reduce delays in diagnosis and linkage to treatment evaluation, management of comorbidities and contraindications, and subsequent initiation.

Eligibility criteria: Inclusion Criteria:

* Veterans
* Born in the period of 1945-1965 ("birth cohort")
* With an outpatient visit in primary care at a VISN1 facility in FY 2016

Exclusion Criteria:

* N/A

Primary outcomes:
measure: HCV Antibody Test
timeFrame: within 30 days of outpatient primary care visit
Secondary outcomes:
Other outcomes:
Locations:
city: Bedford
country: United States
facility: Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
state: Massachusetts
Study officials:
affiliation: Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
name: Allen L. Gifford, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
name: Mari-Lynn Drainoni, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yakovchenko V, DeSotto K, Drainoni ML, Lukesh W, Miller DR, Park A, Shao Q, Thornton DJ, Gifford AL. Using Lean-Facilitation to Improve Quality of Hepatitis C Testing in Primary Care. J Gen Intern Med. 2021 Feb;36(2):349-357. doi: 10.1007/s11606-020-06210-5. Epub 2020 Sep 15.
Clinical trial NCT00214448: Reproducibility of the Array-Based Comparative Genomic Hybridization (aCGH) System Using Whole Blood Samples
Official title: Reproducibility of the GeneTrait™ CGH Microarray System DX Using Whole Blood Samples
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Genetic Disorders
Keywords: Multiple genetic conditions will be studied
Lead sponsor: Abbott Molecular
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 4
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The objective of this study is to validate the performance characteristics of the GeneTrait CGH Microarray System DX. Reproducibility among sites, lots, and operators will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Must be able to donate at least 10 mL of whole blood
* Must be able to provide consent, or parental consent and patient assent (if applicable)
* Must be currently followed as a patient of a genetic clinic or counselor at one of the recruiting sites
* Must have at least one chromosomal change that is detectable by the GeneTrait CGH Microarray System DX as determined by karyotype and/or fluorescence in situ hybridization (FISH) analysis (within any of the 73 critical regions)

Exclusion Criteria:

* Unable to donate at least 10 mL of whole blood
* Unable to provide consent, or parental consent and patient assent (if applicable)
* Not currently followed as a patient of a genetic clinic or counselor at one of the recruiting sites
* Does not have at least one chromosomal change that is detectable by the GeneTrait CGH Microarray System DX as determined by karyotype and/or FISH analysis (within any of the 73 critical regions)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03038048: 30g vs 33g Needle for Intravitreal Injections
Official title: Intravitreal Injection Using 33-gauge Versus 30-gauge Needles: Comparison of Patients' Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age Related Macular Degeneration
Diabetic Macular Edema
Retinal Vein Occlusion
Lead sponsor: Wills Eye
Sponsor class: OTHER
Collaborators: name: Mid Atlantic Retina
First posted: 2017-01-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We are comparing the patient experience between the standard 30 g needle to the smaller 33 g needle for intravitreal injections of ranabizumab or aflibercept for age related macular degeneration, diabetic macular edema, or retina vein occlusions.

Detailed description: This is a prospective, randomized, interventional pilot study, which seeks to compare the patient experience using 30-gauge versus 33-gauge needle for bilateral same-day intravitreal injections of ranibizumab or aflibercept for the treatment of wet age-related macular degeneration (AMD), diabetic macular edema (DME), or macular edema associated with retinal vein occlusion (RVO). The null hypothesis is that there is no difference in patient discomfort or pain with the 30-gauge needle compared to the 33-gauge needle.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing bilateral, same-day, intravitreal injections of either ranibizumab oraflibercept for the diagnosis of wet AMD, DME, or RVO-associated macular edema

Exclusion Criteria:

* 1) Patients who do not receive Betadine ophthalmic solution prior to intravitreal injection due to documented allergy 2) Patients who are receiving intravitreal bevacizumab (this medication iscompounded into pre-filled 1-mL tuberculin syringes).

Primary outcomes:
measure: Difference in discomfort between 30g and 33g needle
timeFrame: Day 1
Secondary outcomes:
measure: Intraocular pressure 5 minutes post injection
timeFrame: Day 1
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Mid Atlantic Retina- Wills Eye Hospital
state: Pennsylvania
Study officials:
affiliation: Mid Atlantic Retina
name: Allen Chiang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04802148: Alveolar Ridge Preservation in Molar Extraction Sockets With an Open Healed Collagen Membrane: A Randomized Clinical Trial.
Official title: Alveolar Ridge Preservation in Molar Extraction Sockets With an Open Healed Collagen Membrane: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Extraction
Keywords: ridge preservation, tooth extraction, collagen membrane, cone-beam computed tomography
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The resorption of alveolar ridge after tooth extraction develop difficulty in restoring the extraction area with implant or bridge. Therefore, try to preserve the alveolar ridge width and height at extraction socket and gaining its bone volume in maximal is worth for clinical investigation. There are several method to deal with alveolar ridge preservation (ARP), the most popular way for its approach, the trend is toward to minimally invasive treatment. Alveolar ridge preservation which is done with open-healed wound without primary closure is the key for minimally invasive approach.

This three-armed randomized clinical trial would like to determine the effect of applying ribose cross-linked collagen membrane without primary flap closure in molar extraction sockets for alveolar ridge preservation. The procedure is for implant site development.

Three groups were designed as test group1 was grafted with freeze dried bone allograft (FDBA) and covered by ribose cross-linked collagen membrane (OSSIX® PLUS). In test group2 sockets filled with collagen plug(Teruplug®) and sockets healed naturally as control group. Cone-beam computed tomography(CBCT) scans are obtained immediately and 4 months after ARP as the primary outcome and secondary outcome. A biopsy from implant site and histomorphometric analysis will be done as well. The change of marginal bone level and the width/height of keratinized mucosa are measured.


Eligibility criteria: Inclusion Criteria:

* Age\>20
* according to periapical film, the bone defect over bucco-lingual and mesio-distal direction less than 50%
* patient agreed to undergo implant therapy after tooth extraction

Exclusion Criteria:

* systemic diseases which will affect wound healing (ex. Diebetes)
* heavy smoker (10 cigarette/day)
* patient who underwent oral-maxillary surgery or who diagnosed with oral cancer
* patient who is pregnant or who is breast-feeding
* patient who is allergic to Lidocaine
* patient who cannot cooperate the study design

Primary outcomes:
measure: alveolar ridge width and height in three plane
timeFrame: four months after surgery
Secondary outcomes:
measure: gingival thickness
timeFrame: four months after surgery
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: