louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01106781: A Non-interventional Survey on the EGFR (Epidermal Growth Factor Receptor) Mutation Status in Completely Resected Chinese Non-Small Cell Lung Cancer (NSCLC) Patients With Adenocarcinoma Histology
Official title: A Non-interventional Survey on the Epidermal Growth Factor Receptor (EGFR) Mutation Status in Completely Resected Chinese Non-Small Cell Lung Cancer (NSCLC) Patients With Adenocarcinoma Histology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer
Keywords: EGFR mutation test
NSCLC
Non-Interventional Study
EGFR mutation status
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-04-20
Enrollment: 591
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from Thoracic surgery department

Brief summary: This is a descriptive observational study. The primary objective is to explore the EGFR gene mutation status in early stage NSCLC with adenocarcinoma histology after complete resection. The patients should be histological confirmed adenocarcinoma of the lung, have received complete resection and tested for EGFR mutation in regular medical practice.


Eligibility criteria: Inclusion Criteria:

* Histological diagnosed as adenocarcinoma type of non-small cell lung cancer
* Have completed lung cancer operation
* The tumour EGFR gene mutation status test was performed as regular medical practice

Exclusion Criteria:

* Patients who disagree to participate this study

Primary outcomes:
measure: type and prevalence of EGFR mutation
timeFrame: up to 3 months
Secondary outcomes:
measure: Operation type and adjuvant treatment type
timeFrame: up to 3 months
measure: Disease Free Survival rate
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Chongqing
country: China
facility: Research Site
state: Chongqing
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Suzhou
country: China
facility: Research Site
state: Jiangsu
city: Changchun
country: China
facility: Research Site
state: Jilin
city: Shenyang
country: China
facility: Research Site
state: Liaoning
city: Qingdao
country: China
facility: Research Site
state: Shandong
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Chengdu
country: China
facility: Research Site
state: Sichuan
city: Tianjin
country: China
facility: Research Site
state: Tianjin
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
Study officials:
affiliation: Astrazeneca China R&D
name: Karen Atkin
role: STUDY_DIRECTOR
affiliation: Guangdong Provincial People's Hospital
name: Wu Yilong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03604081: Effectiveness of Modified Constraint Induced Movement Therapy to Improve Lower Extremity Function in the Acute and Subacute Stroke Patients by Providing 1 Hour of Intense Massed Practice in the Form of Shaping or Task Practice
Official title: Effectiveness of Modified Constraint Induced Movement Therapy to Improve Lower Extremity Function in the Acute and Subacute Stroke Patients by Providing 1 Hour of Intense Massed Practice in the Form of Shaping or Task Practice, 7 Times Per Week for 2 Weeks.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke
Keywords: Constraint Induced Movement Therapy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 0
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized control trial of patients with unilateral impairment of the lower extremity after stroke. Patients will be randomized to intervention group and control group. Intervention group will receive one hour of intense massed practice of lower extremity either in the form of shaping or task practice. Control group will receive conventional physical therapy for 1 hour as per current standard of care that follows stroke clinical practice guideline.


Eligibility criteria: Inclusion Criteria:

* Age 55 or older
* new ischemic stroke as revealed by CT scan or MRI of a brain or as per updated definition by American heart and American stroke association (Sacco et al., 2013)
* Manual muscle testing with grad of \> 1+ in hip and knee joint musculature
* able to walk atleast 10 feet indoors with or without assistance and assistive device.
* Motivated to participate and some initiation of flexion and extension movement in hip, knee and ankle joints.
* Ability to follow visual/verbal instructions as assessed by a minimum score of 24/30 points on the minimental state examination
* Fairly intact sensation

Exclusion Criteria:

* Serious cardiac or pulmonary condition or other medical condition that make it difficult or risky to participate in intensive training
* Severe joint pain or degenerative disease to the musculoskeletal system of the lower extremity
* other neurological disease 4) problems with following instructions.

Primary outcomes:
measure: Cycle time as measured by GAITRite.
timeFrame: 2 Weeks
measure: step length as measured by GAITRite.
timeFrame: 2 Weeks
measure: Stride length as measured by GAITRite.
timeFrame: 2 Weeks
measure: velocity as measured by GAITRite
timeFrame: 2 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Nada Abou-Fayssal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04268381: Oral and Systemic aMMP-8 in Periodontal Disease
Official title: Local And Systemic Levels of aMMP-8 in Gingivitis and Stage 3 Periodontitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Periodontal Inflammation
Keywords: periodontitis
gingivitis
matrix metalloproteinases
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
Collaborators: name: Giresun University
First posted: 2020-02-13
Enrollment: 83
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy controls (n=23) includes volunteers with clinically healthy periodontium who had BOP \< 10% and PD ≤ 3 mm, no sites with \> 1 mm attachment loss, no radiographic sign of alveolar bone destruction and no history of periodontitis. Gingivitis patients (n=20) shows PD ≤ 3 mm with BOP \> 50% in the entire mouth as well as no clinical attachment loss or alveolar bone loss. Periodontitis patients (Generalized Stage 3) have interdental CAL ≥ 5 mm at least 2 non-adjacent teeth, PD ≥ 6 mm and radiographic bone loss affecting 30% of the teeth or more.They show also no more than 4 teeth loss due to periodontitis.

Brief summary: Periodontal disease is an inflammatory process that can result in tooth loss and also is considered a modifying factor for systemic health. Matrix metalloproteinase (MMP)-8 is the major collagenase of periodontal tissue breakdown. The aim of the present study is to analyze active (aMMP-8) levels in gingival crevicular fluid (GCF), saliva and serum in the context of new criteria of gingivitis and stage 3 grade C periodontitis.


Eligibility criteria: Inclusion Criteria:

* systemically healthy and non-smoker individuals aged 25 to 50 years
* having ≥20 teeth present (except third molars)
* individuals with periodontally healthy, gingivitis and stage 3 periodontitis diagnoses

Exclusion Criteria:

* having any systemic disease
* smoking
* pregnancy or lactation
* using antibiotic or any anti-inflammatory drug or any periodontal treatment within the past 6 months.

Primary outcomes:
measure: Oral (GCF and saliva) and serum levels of aMMP-8 in periodontitis and gingivitis
timeFrame: through study completion, an average of 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Aydin Adnan Menderes University
Study officials:
affiliation: Department of Periodontology, School of Dentistry, Giresun University
name: Zeynep Pinar Keles Yucel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00447681: Study of the Safety, Tolerability, Pharmacokinetics and Pharmcodynamics of ILV-094 in Healthy Subjects
Official title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetiks, and Pharmacodynamics of ILV-094 Administered Intravenously and One Dose of ILV-094 Administered Subcutaneously to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-03-15
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This a randomized, double-blind placebo-controlled inpatient/outpatient, sequential group study of ascending single IV doses of ILV-094, an investigational drug, administered to healthy subjects. In addition, there will be one sub-cutaneous dose cohort, which will follow the 25 mg IV dose.


Eligibility criteria: * Healthy subjects (Men or women of nonchildbearing potential ), aged 18 to 50 years.
* Body mass index in the range of 18 to 30 Kg/m2 and body weight greater than 50 Kg.
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram.

Primary outcomes:
measure: To evaluate the safety, tolerability, pharmacokinetics and pharmcodynamics
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
state: Pennsylvania
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00205010: Laparoscopic Sentinel Lymph Node Localization in Operable Cervix Cancer
Official title: Laparoscopic Sentinel Lymph Node Localization in Patients With Operable Cervical Cancer - A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to evaluate the feasibility, safety and efficacy of laparoscopic ovarian transposition in women less than 40 years of age with locally advanced cervical squamous cell carcinoma


Eligibility criteria: Inclusion Criteria:

* Stage IAI to IIA cervix cancer undergoing primary surgical management

Exclusion Criteria:

* Previous pelvic dissection
* Previous para-aortic lymph node dissection
* Evidence of distant mets

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: David M Kushner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kushner DM, Connor JP, Wilson MA, Hafez GR, Chappell RJ, Stewart SL, Hartenbach EM. Laparoscopic sentinel lymph node mapping for cervix cancer--a detailed evaluation and time analysis. Gynecol Oncol. 2007 Sep;106(3):507-12. doi: 10.1016/j.ygyno.2007.04.031. Epub 2007 Jun 8.
Clinical trial NCT05935410: Diabetes Education/Skills Training and Social Needs Resolution Intervention
Official title: Combined Diabetes Education/Skills Training and Social Needs Resolution Intervention for Older African Americans With Poorly Controlled Type 2 Diabetes (DM Social Needs)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will test the preliminary efficacy of a nurse case-manager, telephone-delivered intervention that provides diabetes self-management education and skills training and resolves the unmet social needs of older African Americans with poorly controlled type 2 diabetes by randomizing 100 African Americans aged 50 years and older with poorly controlled type 2 diabetes to the Combined Diabetes Education/Skills Training and Social Needs Resolution (DM Social Needs) Intervention (n=50) and usual care (n=50) arms.

The aims of this study are:

Aim 1: Test the preliminary efficacy of the DM Social Needs intervention on clinical outcomes in older AAs with uncontrolled type 2 diabetes.

Aim 2: Test the preliminary efficacy of the DM Social Needs intervention on patient reported outcomes in older AAs with uncontrolled type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

1. Age 50 and older;
2. self-identified as African American or Black;
3. self-reported diagnosis of T2DM;
4. HbA1C \>=8% at the screening visit.

Exclusion Criteria:

1. self-reported participation in other diabetes clinical trials;
2. alcohol or drug abuse or dependency as assessed by the CAGE-AID;
3. Mental confusion at screening assessment suggesting significant dementia;
4. life expectancy \< 6 months at screening assessment.

Primary outcomes:
measure: Glycemic Control (Hemoglobin A1C [HbA1C])
timeFrame: Change in baseline HbA1C at 6 months post intervention follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Aprill Dawson
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Aprill Z Dawson, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05808010: Clinical Study of Umbilical Cord Blood Mononuclear Cell Therapy for the Treatment of Chronic Atrophic Gastritis
Official title: Clinical Study of Umbilical Cord Blood Mononuclear Cell Therapy for the Treatment of Chronic Atrophic Gastritis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Atrophic Gastritis
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2023-04-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of umbilical cord blood mononuclear cells in the treatment of chronic atrophic gastritis.


Eligibility criteria: Inclusion Criteria:

1. Subjects voluntarily participated in the study and signed an informed consent.
2. The age is 18-65 years old, regardless of gender.
3. Patients with chronic atrophic gastritis by gastroscopy and pathological examination.
4. Patients with a negative C13 breath test or have eradicated Helicobacter pylori infection.
5. Patients without contraindications to submucosal injection of umbilical cord blood derived mononuclear cells.

Exclusion Criteria:

1. Patients with gastric ulcer, erosive gastritis, active upper gastrointestinal bleeding, gastric varices, or other gastric tumors.
2. Patients who are taking or have taken proton pump inhibitors, antibiotics, glucocorticoids, nonsteroidal anti-inflammatory drugs and immunosuppressants in the last six months.
3. People who have had gastric surgery or required gastric surgery during the study.
4. Patients with severe systemic diseases (diseases of cardiovascular, liver, blood, kidneys, lungs or liver).
5. Pregnant or nursing females.
6. Patients who are reluctant to accept endoscopy and treatment.

Primary outcomes:
measure: Change from baseline OLGA/OLGIM stages of gastric mucosa
timeFrame: At the first, seventh and thirteenth month of treatment
measure: Change from baseline gastric mucosal status under gastroscope
timeFrame: At the first, seventh and thirteenth month of treatment
Secondary outcomes:
measure: Change from baseline blood test result
timeFrame: At the first, seventh and thirteenth month of treatment
measure: Incidence of adverse reactions
timeFrame: Through follow-up period completion, an average of 1 year
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
Study officials:
affiliation: Shandong Provincial Hospital
name: hongwei Xu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03262610: Setmelanotide in a Single Patient With Partial Lipodystrophy
Official title: Expanded-access for the Use of Setmelanotide in a Single Patient With Partial Lipodystrophy (LD) Associated With Leptin Deficiency and Multiple Autoimmune Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertriglyceridemia
Obesity
Lead sponsor: Rhythm Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-25
Enrollment: 1
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this single patient study is to assess the safety and efficacy of setmelanotide as a treatment of severe metabolic abnormalities resulting from LD, especially refractory hypertriglyceridemia leading to recurrent bouts of pancreatitis.

Detailed description: This is a single-patient study to assess the safety and efficacy of setmelanotide in a unique patient with partial LD and severe metabolic abnormalities, most notably refractory hypertriglyceridemia leading to recurrent pancreatitis despite ongoing plasmapheresis treatment.

Eligibility criteria: Inclusion Criteria:

1. Signed written informed consent
2. Ability to comply with visits and procedures required by program.
3. Has physician-confirmed partial lipodystrophy and the following characteristics:

   * Has atypical lipodystrophy.
   * Has presence of neutralizing antibody to metreleptin
   * Patient has life threatening hypertriglyceridemia and has had \>8 episodes of pancreatitis, requiring weekly plasmapheresis
   * Has Type 1 diabetes mellitus with HbA1c \> 10%.
4. Female, under the age of 18 years

Exclusion Criteria:

1. Diagnosis of schizophrenia, bipolar disorder, personality disorder or other Diagnostic and Statistical Manual of Mental Disorders (DSM-III) disorders that the investigator believes will interfere significantly with study compliance. Neurocognitive disorders affecting ability to consent will not be disqualifying as long as an appropriate guardian able to give consent has been appointed.
2. History or close family history (parents or siblings) of skin cancer or melanoma, or patient history of ocular-cutaneous albinism.
3. Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions, determined as part of a screening comprehensive skin evaluation performed by a qualified dermatologist.
4. Significant hypersensitivity to study drug.
5. Inability to comply with QD injection regimen.

Primary outcomes:
measure: Fasting Triglycerides (TG) levels
timeFrame: 12 to 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: Chief Medical Officer, Rhythm Pharmaceuticals, Inc
name: Linda Shapiro, M.D., Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03986710: Feasibility and Performance of a Novel 3D Virtual Treatment Planning Software: Single Surgeon Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthognathic Surgery
Keywords: 3D virtual planning software
timing
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive orthognathic patients operated and planned by a single surgeon (GS)

Brief summary: Background Three-dimensional (3D) imaging and subsequent 3D virtual treatment planning are becoming state of the art in orthognathic surgery. However, current available software is still too time-consuming. KLS Martin (Tuttlingen, Germany) has currently completed the preclinical phase of their novel 3D virtual planning software, "IPS (Individual Patient Solutions) CaseDesigner (IPSCD)".

Objectives The authors aim to test pre-release versions of the IPSCD software under real-world working conditions by a single surgeon.In specific, the authors aim to demonstrate that the IPSCD will ensure a significant reduction in treatment planning time.

Study design closed beta-phase Patients presenting at the division of maxillofacial surgery at the different hospital centers, for an orthognathic-related problem will receive a complete routine work-up, including a cone-beam CT (CBCT) according to the IPSCD protocol. The same surgeon will run all the virtual planning steps with both conventional software (Maxilim) and the novel software. Timing of the eight major steps will be measured with a digital chronometer.


Eligibility criteria: Inclusion Criteria:

* Patients of all ages
* Patients of both genders
* Patients should present themselves at the division of Maxillofacial surgery
* Patients should receive standardized cone-beam computed tomography (CBCT) image acquisition, according to the IPSCD protocol
* Preoperative 3D virtual planning should be performed by the same surgeon

Exclusion Criteria:

* All patients that do not fit the abovementioned description
* Patients with posttraumatic deformity
* Patients with congenital deformity
* Patients with pre-prosthetic indication

Primary outcomes:
measure: duration of total 3D virtual treatment planning time
timeFrame: preoperative
Secondary outcomes:
measure: duration of 8 major steps in 3D virtual treatment planning
timeFrame: preoperative
Other outcomes:
Locations:
Study officials:
affiliation: AZ Sint-Lucas Brugge
name: Gwen Swennen
role: PRINCIPAL_INVESTIGATOR
References: