louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00132795: Using Telephone Technology to Prevent Relapse After Alcoholism Treatment
Official title: Therapeutic IVR to Augment CBT in Alcohol Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcoholism
Keywords: Cognitive Therapy
Recurrence
Prevention
Educational Technology
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2005-08-22
Enrollment: 158
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether a telephone based self-help program will prevent relapse among individuals undergoing standard substance abuse treatment.

Detailed description: Relapse rates in the first few months following substance abuse treatment are as high as 50%, in spite of the immediate effectiveness of treatments such as Cognitive Behavioral Therapy (CBT). Continuing use of therapy skills following treatment is associated with maintenance of treatment gains. We have programmed a telephone to deliver pre-recorded summaries and rehearsal sessions of skills learned in therapy. The system also includes monthly feedback messages from therapists. We expect that this ad-lib access to therapy skills would allow patients to generalize skills to their personal post-treatment lives. It would also allow individuals in remote or rural areas to obtain access to assistance without travel barriers.

Comparison(s): patients completing group CBT for substance abuse will be randomly assigned to two conditions. In one condition, patients will have unlimited access to the therapeutic telephone system for 4 months. The other condition is standard care (i.e., no formal relapse prevention).

Eligibility criteria: Inclusion Criteria:

* Meets current DSM-IV criteria for alcohol dependence
* Active drinking during the three months prior to entry into treatment
* Minimum age of 19
* Minimum sixth grade reading level.

Exclusion Criteria:

* Meets criteria for a current psychotic illness
* Imminent plans to move or be incarcerated
* Presence of such severe hearing, visual, or cognitive deficit(s) that participation in CBT or use of an Interactive Voice Response (IVR) system are not possible
* Inability to identify at least one "locator" person to assist in tracking for follow-up assessments
* Does not have telephone service within the home
* Incarceration while in active protocol in the study
* Attendance of less than 8 of 12 CBT sessions

Primary outcomes:
measure: Amount of alcohol and use
timeFrame: 4 months and one year
Secondary outcomes:
measure: Utilization of the telephone system components during the study
timeFrame: 4 months and one year
Other outcomes:
Locations:
city: Burlington
country: United States
facility: UVM Health Behavior Research Center
state: Vermont
Study officials:
affiliation: University of Vermont
name: John E. Helzer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03632395: Early Detection of Postoperative Anastomotic Leak by CT
Official title: Early Detection of Postoperative Anastomotic Leak by CT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anastomotic Leak
Keywords: gastric cancer
postoperative complication
anastomotic leak
oral contrast agent
computed tomography
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent gastric cancer surgery.

Brief summary: Postoperative anastomotic leak is rare but life threatening complication after gastric cancer surgery. Early diagnosis is key to minimize other hazards which are caused by anastomotic leak. Investigators introduced a novel method to detect early diagnosis of anastomotic leak after gastric cancer surgery.

Detailed description: Postoperative anastomotic leak is rare but life threatening complication after gastric cancer surgery. Early diagnosis is key to minimize other hazards which are caused by anastomotic leak. Investigators introduced a novel method to detect early diagnosis of anastomotic leak after gastric cancer surgery. Oral contrast agent is used for CT. Investigators carefully collected all the data prospectively and standard definition of anastomotic leak was applied.

Eligibility criteria: Inclusion Criteria:

Patients with gastric cancer surgery

Exclusion Criteria:

Patients with non gastric cancer surgery

Primary outcomes:
measure: Diagnosis of anastomotic leak
timeFrame: 5-10 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: BIRENDRA K SAH, Ph D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05241795: Knee vs. Ankle Training on Knee Mechanics After ACLR
Official title: Crossover Effect of Knee and Ankle Joint Training on Knee Mechanics After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ACL Tear
ACL Sprain
Anterior Cruciate Ligament Rupture
Anterior Cruciate Ligament Injuries
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 48
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to investigate if there is any difference between starting rehabilitation program after ACL reconstruction with knee joint training followed by ankle joint training and starting it with ankle joint training followed by knee joint training (crossover effect) on gait parameters of the knee joint.


Eligibility criteria: Inclusion Criteria:

* ACL reconstruction with a hamstring tendon autograft participated in this study.
* Score 7 on Tegner activity scale.

Exclusion Criteria:

* Patients with bilateral knee injury
* History of surgery or traumatic injury to the uninvolved lower extremity or to the hip or ankle of the involved lower extremity
* History of ACL reconstruction on the ipsilateral side and other knee ligament injuries requiring surgery.

Primary outcomes:
measure: Change in Knee joint flexion torques (Nm/kg) in the supporting (stance) phase at baseline and 6 weeks posttreatment
timeFrame: baseline and 6 weeks posttreatment
measure: Change in Knee joint extension torques (Nm/kg) in the supporting (stance) phase at baseline and 6 weeks posttreatment
timeFrame: baseline and 6 weeks posttreatment
Secondary outcomes:
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: October 6 University Hospital
state: Giza
Study officials:
References:
Clinical trial NCT04455295: Testing the Noradrenergic Hypothesis of Transcutaneous Vagus Nerve Stimulation
Official title: Testing the Noradrenergic Hypothesis of Transcutaneous Vagus Nerve Stimulation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: no Condition
Electroencephalography
Pupil Diameter
Lead sponsor: Arkansas Tech University
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates the capacity of non-invasive vagus nerve stimulation, applied at the ear, to alter to measures of locus coeruleus output pupil diameter and EEG alpha power. Non-invasive alteration in locus coeruleus output is of interest in regard to basic science and has potential clinical implications in a number of conditions.


Eligibility criteria: Inclusion Criteria:

* Healthy, 18 years of age or older.

Exclusion Criteria:

* self-report of mood disorders, prescription and non-prescription drug use which includes stimulants including caffeine and nicotine

Primary outcomes:
measure: Pupil Diameter
timeFrame: Within single one hour session
measure: EEG Alpha power.
timeFrame: Within single one hour session
Secondary outcomes:
Other outcomes:
Locations:
city: Russellville
country: United States
facility: Arkansas Tech University
state: Arkansas
Study officials:
References:
Clinical trial NCT01015495: Ranibizumab Therapy for Choroidal Neovascularization (CNV) Asociated With Angioid Streaks
Official title: Ranibizumab Therapy for Choroidal Neovascularization Associated With Angioid Streaks
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Angioid Streaks
Keywords: angioid streaks
CNV
intra vitreal ranibizumab
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2009-11-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether injections of ranibizumab into the eye are safe and well tolerated when given to subjects in multiple doses.

Detailed description: Choroidal neovascularization is a hallmark of angioid streaks, and presumably VEGF-driven. Ranibizumab has been shown to be effective in CNV secondary to age-related macular degeneration. Therefore, we hypothesize that ranibizumab may be efficacious in the treatment of CNV secondary to angioid streaks

Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \> 18 years
* Angioid streaks
* Subfoveal CNV of recent onset with the following characteristics
* Absence of subfoveal fibrosis
* Fibrosis less than 25% of the lesion
* Presence of blood, subretinal fluid, and/or lipid
* New onset symptoms within 12 weeks
* Visual acuity 20/40 to 20/800 on an ETDRS chart

Exclusion Criteria:

* Prior treatment of subfoveal CNV in the study eye
* Age-related macular degeneration
* Uncontrolled glaucoma
* High myopia (\> -10.00 D spherical equivalent)
* Prior retinal detachment
* Media opacity preventing adequate view of the retina
* Planned cataract surgery in the next 3 months
* Current chemotherapy for cancer
* Immunocompromised state
* Pregnancy (positive pregnancy test) or lactation
* Premenopausal women not using adequate contraception.
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
* Participation in another simultaneous medical investigation or trial
* History of any previous treatment for angioid streaks

Primary outcomes:
measure: The primary outcome measures for safety and tolerability are the following: • Incidence and severity of ocular adverse events, as identified by eye examination (including visual acuity testing)
timeFrame: Month 12
Secondary outcomes:
measure: Proportion of patients that lose fewer than 15 letters from baseline at months 6 and 12 as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters at months 6 and 12
timeFrame: Month 6 and 12
Other outcomes:
Locations:
Study officials:
affiliation: UIC Eye and Ear Infirmary
name: Jennifer I Lim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03408795: Assessing the Surgical Skills of Trainees in Learning the LDG
Official title: Assessing the Surgical Skills of Trainees in Learning the Laparoscopic Distal Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrostomy
Surgical Procedure, Unspecified
Assessment, Self
Lead sponsor: Nagasaki University
Sponsor class: OTHER
Collaborators: name: Hokkaido University
First posted: 2018-01-24
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Laparoscopic distal gastrectomy (LDG) is a common surgery in the surgical trainees. However, there is no assessment system to measuring the surgical skill of surgical trainees. The novel surgical assessment system, which called Japanese Operative Rating Scale for Laparoscopic Distal Gastrectomy (JORS-LDG) by the task analysis and the Delphi method have been developed. This study describes assessing the development of surgical skill by JORS-LDG in the initial experience of LDG.


Eligibility criteria: Inclusion Criteria:

* Laparoscopic distal gastrectomy to early gastric cancer
* D1 plus or D2 lymphadenectomy
* Provide signed informed consent

Exclusion Criteria:

* postoperative conditions affecting LDG
* pregnancy
* advanced gastric cancer
* D1 lymphadenectomy
* Total or subtotal gastrectomy
* unsuitable condition

Primary outcomes:
measure: Assessing the development of surgical skill by JORS-DG in the initial experience of LDG.
timeFrame: Participants will be followed for the duration of the educational study for 3 years.
Secondary outcomes:
measure: Assessing the value of surgical skill by JORS-DG in the initial experience of LDG and surgical outcome.
timeFrame: Participants will be followed for the duration of the educational study for 3 years.
measure: Assessing the value of surgical skill by JORS-DG in the initial experience of LDG and surgical outcome.
timeFrame: Participants will be followed for the duration of the educational study for 3 years.
Other outcomes:
Locations:
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
Study officials:
References:
Clinical trial NCT02311595: A Phase II Clinical Trial of Reduced Port Totally Laparoscopic Distal Gastrectomy With D2 Lymph Node Dissection
Official title: A Phase II Clinical Trial of Reduced Port Totally Laparoscopic Distal Gastrectomy With D2 Lymph Node Dissection for Gastric Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: gastric cancer
laparoscope
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 67
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if reduced port totally laparoscopic distal gastrectomy with complete D2 lymph node dissection for gastric cancer is safe and oncological feasible.

67 patients with gastric cancer with preoperative staging from T1 to T3 will undergo reduced port totally laparoscopic distal gastrectomy.

The primary end point of this study is to measure compliance rate with pathology report and compare with previous compliance rate data.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed adenocarcinoma of the stomach
* Eastern Cooperative Oncology Group Eastern Cooperative Oncology Group performance status 0-1,
* signed informed consent
* location of the primary tumor in the antrum, angle and lower body
* no evidence of distant metastasis or invasion to adjacent organs or serosal infiltration

Exclusion Criteria:

* metastatic disease
* previous history of malignancy in any organ
* any co-morbidity obviating major surgery

Primary outcomes:
measure: Compliance rate (Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping)
timeFrame: 1 month after enrollment of the patients
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Samsung Medical Center
name: Jun Ho Lee, M.D. ph.D
role: STUDY_CHAIR
References:
citation: Lee JH, Kim YW, Ryu KW, Lee JR, Kim CG, Choi IJ, Kook MC, Nam BH, Bae JM. A phase-II clinical trial of laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for gastric cancer patients. Ann Surg Oncol. 2007 Nov;14(11):3148-53. doi: 10.1245/s10434-007-9446-0. Epub 2007 Aug 20.
citation: Kim SM, Lee JH, Lee SH, Ha MH, Seo JE, Kim JE, Choi MG, Sohn TS, Bae JM, Kim S. Techniques of reduced PRT laparoscopy-assisted distal gastrectomy (duet LADG). Ann Surg Oncol. 2015 Mar;22(3):793. doi: 10.1245/s10434-014-4087-6. Epub 2014 Sep 17.
citation: Bonenkamp JJ, Hermans J, Sasako M, van de Velde CJ, Welvaart K, Songun I, Meyer S, Plukker JT, Van Elk P, Obertop H, Gouma DJ, van Lanschot JJ, Taat CW, de Graaf PW, von Meyenfeldt MF, Tilanus H; Dutch Gastric Cancer Group. Extended lymph-node dissection for gastric cancer. N Engl J Med. 1999 Mar 25;340(12):908-14. doi: 10.1056/NEJM199903253401202.
Clinical trial NCT01057095: Studying Gene Expression in Tissue Samples From Patients With Acute Myeloid Leukemia
Official title: Mechanisms of PLAGL2-Induced Leukaemogenesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with del(5q)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia in remission
recurrent adult acute myeloid leukemia
untreated adult acute myeloid leukemia
childhood acute myeloid leukemia in remission
recurrent childhood acute myeloid leukemia
untreated childhood acute myeloid leukemia and other myeloid malignancies
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-01-27
Enrollment: 20
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of acute myeloid leukemia

Brief summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at gene expression in tissue samples from patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:

* Screen acute myeloid leukemia (AML) samples to correlate high relative expression levels of PLAGL2 and putative PLAGL2 target genes (implicated in microarray study) with potential pathogenic relevance with respect to AML development.

OUTLINE: Cryopreserved mRNA from diagnostic samples is analyzed for gene expression by reverse transcriptase-PCR.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia, including inv(16)(p13;q22) abnormalities

  * No t(15;17)(q22;q12) or t(8;21)(q22;q22) abnormalities

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Correlation of high relative expression levels of PLAGL2 and putative PLAGL2 target genes with potential pathogenic relevance
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Soheil Meshinchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01336595: Comparison of Total Knee Arthroplasties With Oxidized Zirconium and Cobalt Chromium Femoral Components
Official title: Comparison of Total Knee Arthroplasties With Oxidized Zirconium and Cobalt Chromium Femoral Components in the Same Patients: A Prospective, Double Blinded, and Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: total knee arthroplasty
oxidized zirconium
genesis II
femoral component
cobalt chrome
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
First posted: 2011-04-18
Enrollment: 331
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if there are any clinical or radiographic differences in cemented total knee arthroplasty with an oxidized zirconium and a cobalt-chromium femoral knee component.

Detailed description: Although it has been claimed that total knee arthroplasties with an oxidized zirconium femoral knee component had beneficial wear properties in vitro, there are conflicting clinical results. The purpose of the present study was to compare the clinical, subjective, and radiographic results as well as the weight, size and shape of polyethylene wear particles in the patients with an oxidized zirconium and a cobalt-chromium femoral knee component.

Eligibility criteria: Inclusion Criteria:

* End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease

Exclusion Criteria:

* Inflammatory disease
* patient with other Lower extremity disease which may affect functional outcome
* Neurologic disease effecting patients lower extremity
* Revision surgery
* Patient not medically cleared for bilateral surgery

Primary outcomes:
measure: Improvement in Knee Society Knee Score
timeFrame: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery
Secondary outcomes:
measure: Improvement in the range of motion
timeFrame: Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hosptial
Study officials:
affiliation: Ewha Womans University Mokdong Hospital
name: Jang-Won Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ezzet KA, Hermida JC, Colwell CW Jr, D'Lima DD. Oxidized zirconium femoral components reduce polyethylene wear in a knee wear simulator. Clin Orthop Relat Res. 2004 Nov;(428):120-4. doi: 10.1097/01.blo.0000148576.70780.13.
citation: Good V, Ries M, Barrack RL, Widding K, Hunter G, Heuer D. Reduced wear with oxidized zirconium femoral heads. J Bone Joint Surg Am. 2003;85-A Suppl 4:105-10. doi: 10.2106/00004623-200300004-00013. No abstract available.