louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00293891: A Study to Assess the Safety and Effectiveness of Tacrolimus Cream in the Treatment of Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Treatment Outcome
Tacrolimus
Safety
Psoriasis
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2006-02-20
Enrollment: 658
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to assess the safety and effectiveness of tacrolimus cream in the treatment of psoriasis.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of plaque psoriasis

Exclusion Criteria:

* Skin disorder other than plaque psoriasis in the areas to be treated.
* Disease on only elbows, knees, and scalp

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Miami
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Newnan
country: United States
state: Georgia
city: Indianapolis
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: N. Andover
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Port Huron
country: United States
state: Michigan
city: St. Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: New York City
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Knoxville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Surrey
country: Canada
state: British Columbia
city: Moncton
country: Canada
state: New Brunswick
city: Laval
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
Study officials:
affiliation: Astellas Pharma US, Inc.
name: J. Rico, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01899391: Periperal Blood Lymphocytes During Prostate RT
Official title: A Pilot Study of Gamma H2AX DNA Repair Foci Kinetics in Peripheral Blood Lymphocytes During Prostate Cancer Radiotherapy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostate Cancer
Keywords: Prostate cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2013-07-15
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with intermediate-risk prostate cancer

Brief summary: Right now it is not possible to predict which patients are going to react more to RT. Many things could affect patient's response to radiation. One of the factors is whether the person can repair damage to the genetic material (DNA/RNA) caused by the RT. There is some evidence that a certain protein called Gamma H2AX is involved in DNA damage and repair and this can be used to predict the sensitivity of individual patients. The investigators will be studying this protein: Gamma H2AX) in the blood samples of prostate cancer patients exposed to both computed tomography (CT) scan and RT treatment. This will help us to understand why different individuals show differences in side effects following RT.


Eligibility criteria: Inclusion Criteria:

* Intermediate-risk prostate cancer patients (T1/T2N0M0 with either GS \< 7 and PSA between 10-20 ng/ml or GS 7 and PSA less than 20 ng/ml).
* Planned for radical RT to the prostate with IMRT planning (79Gy/39fractions or 60 Gy/20 fractions).
* No contraindications to diagnostic CT scanning.
* Prostate volumes will be less than 80 cc to control the planning dose volume histogram (DVH) as much as possible in terms of rectal and bladder volumes.
* No known DNA repair disorders (e.g. family history of AT, BRCA1/2 or Li Fraumeni syndrome) or contraindications to radical pelvic RT.

Exclusion Criteria:

* Inability to provide informed consent.
* Patient having contraindications to diagnostic CT scan.
* Patients who have unobtainable data regarding previous therapy and their clinical outcome.
* Patients should not have any diagnostic X-rays or CAT scans 2 weeks prior to their enrollment into the study.

Primary outcomes:
measure: Gamma H2AX in peripheral blood lymphocytes.
timeFrame: 1 year
Secondary outcomes:
measure: Gamma H2AX following RT planning (CT scan).
timeFrame: 1 year
measure: Gamma H2AX during RT
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: University Health Network, Princess Margaret Hospital
name: Robert Bristow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01293994: A Study of Genetic Variation Influencing Pain and Response to Opioid Medications
Official title: A Study of Genetic Variation Influencing Pain and Response to Opioid Medications in Patients With Chronic Pain
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pain
Keywords: Chronic Pain, Genetic Variation, Opioid Medications, Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2011-02-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any gender, ages 18-70, of any ethnic background

Brief summary: The investigators will be collecting saliva DNA samples from chronic back pain patients. The investigators hope to find candidate genes associated with response to opioid medication by correlating molecular genetics data with pain measurement and opioid responsiveness data including opioid hyperalgesia and opioid analgesic tolerance.

Detailed description: The investigators hope to find a genetic association with various physiologic responses to opioid medication in patients who suffer from chronic pain (e.g. OIH vs. analgesic tolerance, baseline pain sensitivity, etc.). This has never been done before, and if it proves successful, it could provide physicians a greater understanding of why some chronic opioid users continue needing increased doses of opioids. This data may also help predict which patients will do well with chronic opioid therapy and which ones may not. Initial data with OPRM1 gene analysis in humans already implicates certain SNPs with opioid responsiveness and there have been suggestions for screening patients for OPRM1 prior to initiating opioid therapy in order to optimize their treatment response (Reynolds et al., 2008).

Clin Lab Med. 2008 Dec;28(4):581-98. The value of CYP2D6 and OPRM1 pharmacogenetic testing for opioid therapy. Reynolds KK, Ramey-Hartung B, Jortani SA.

Eligibility criteria: Inclusion Criteria:

1. Adult patient, aged 18-71
2. Recipient of chronic opioid therapy
3. Patient is able to produce a saliva sample
4. If a past study participant, patient will have agreed to be contacted for future studies.

Exclusion Criteria:

a. not meeting inclusion criteria

Primary outcomes:
measure: Genetic association with various physiologic responses to opioid medication in patients
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Dr Larry Fu-nien Chu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06724094: Artificial Intelligence to Detect Early Total Knee Replacement Implant Failure
Official title: Using Machine Learning to Detect and Predict Loosening NexGen Total Knee Replacement
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Aseptic Loosening of Prosthetic Joint
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 2105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will be adults who had the recalled a NexGen Total Knee Replacement with a standard tibial tray. It will include adults only, who has the TKR at University Hospitals Southampton between 2003 and 2022.

Brief summary: The goal of this trial is to investigate whether Machine Learning (ML) can be used to detect small degrees of loosening, lucent zones, or any other changes on radiographs that might predict early failure following NexGen total knee replacement.

Researchers will identify plain AP and lateral plain film radiographs from two groups of patients. Those who has NexGen total knee replacements (TKRs) that went on to failure, and those who has well performing TKRs. Radiographs from these two groups will be labelled as 'failure' and 'well performing' and will be processed through a machine learning algorithm.

The algorithm will be successful if it is able to detect a NexGen TKR that went on to failure or went on to perform well. This will be determined by using a test set.

The population will be adults who had the recalled a NexGen Total Knee Replacement with a standard tibial tray. It will include adults only, who has the TKR at University Hospitals Southampton between 2003 and 2022.

Failure will be defined as revision of tibial or femoral components which is likely due to aspectic loosening. It will exclude washouts, exchange of poly, peri-prosthetic fractures, microbiologically confirmed infection.

Well performing TKRs will be defined as patients who have had their TKR in situ for 10 years and have reported no significant symptoms.


Eligibility criteria: Inclusion Criteria:

* Had a NexGen TKR between 2003 and 2022.

Exclusion Criteria:

* Below 18 yrs old.
* Revision surgery for any reason other than aseptic loosening
* patients who have not had a revision but who do not have a well functioning TKR.

Primary outcomes:
measure: Predictive accuracy of machine learning model
timeFrame: Up to 21 years. Data starts from 2003.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04926194: Decidual Stromal Cells to Treat Graft-vs-Host Disease After Stem Cell Transplant for Myelodysplastic Syndrome/Myeloproliferative Neoplasm
Official title: Decidual Stromal Cells (DSC) in Treatment of Steroid-Refractory Graft-vs-host Disease in a Recipient of Matched Related Donor Allogeneic Hematopoietic Cell Transplant for Myelodysplastic Syndrome/Myeloproliferative Neoplasm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myelodysplastic/Myeloproliferative Neoplasm
Steroid Refractory GVHD
Allogeneic Hematopoietic Cell Transplant
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2021-06-15
Enrollment: 1
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 single participant study of decidual stromal cells (DSC) for the treatment of steroid refractory graft-versus-host disease (GVHD) in a patient with myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN).


Eligibility criteria: A single participant with myelodysplastic syndrome/myeloproliferative neoplasm located at Princess Margaret Cancer Centre who experienced steroid-refractory graft-vs-host disease after receiving an allogeneic hematopoietic cell transplant and have no standard treatment options available.

Primary outcomes:
measure: Eastern Cooperative Oncology Group Performance Status Score
timeFrame: 6 weeks
measure: Karnofsky Performance Score
timeFrame: 6 weeks
measure: Graft-Versus-Host Disease Severity
timeFrame: 6 weeks
measure: Aspartate Transaminase levels
timeFrame: 6 weeks
measure: Alanine aminotransferase levels
timeFrame: 6 weeks
measure: Alkaline phosphatase levels
timeFrame: 6 weeks
measure: Bilirubin levels
timeFrame: 6 weeks
measure: C-reactive protein levels
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Princess Margaret Cancer Centre
name: Ivan Pasic, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00552994: Comparison of Coronary Xience V and the Cypher Select+ Stents in Diabetic Patients
Official title: A Danish Prospective Randomized Multicenter Comparison of the Xience V and the Cypher Select+ Stents in Unselective Patients With Diabetes Mellitus. An Intravascular Ultrasound Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Drug eluting stent
Diabetics
Intravascular ultrasound
Pathophysiologic (neointimal hyperplasia and peri-stent remodeling)
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2007-11-02
Enrollment: 150
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: In stent neointimal hyperplasia may be less in the Cypher select plus stent compared to the Xience V stent in diabetic patients.


Eligibility criteria: Inclusion Criteria:

* All diabetic patients treated with one or more drug eluting stents in the coronary arteries at one of the 5 heart centres in Denmark (Gentofte, Rigshospitalet, Odense, Skejby, Aalborg) can be included in the study.

Exclusion Criteria:

* The patient will not participate
* The patient participates in other randomised stent studies
* Expected survival \< 1 year
* Allergy to Aspirin, Clopidogrel or Ticlopidine
* Allergy to Sirolimus or ABT-578

Primary outcomes:
measure: In stent neointimal hyperplasia
timeFrame: Within 10 months
Secondary outcomes:
measure: Peri-stent remodeling - Edge response to Cypher Select plus and Xience V stent - Malapposition - Angiographic late lumen loss
timeFrame: Within 10 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Per Thayssen, MD DMSci
role: PRINCIPAL_INVESTIGATOR
References:
citation: Antonsen L, Maeng M, Thayssen P, Christiansen EH, Hansen KN, Kaltoft A, Hansen HS, Thuesen L, Lassen JF, Jensen LO. Intimal hyperplasia and vascular remodeling after everolimus-eluting and sirolimus-eluting stent implantation in diabetic patients: the randomized Diabetes and Drug-Eluting Stent (DiabeDES) IV Intravascular Ultrasound trial. Catheter Cardiovasc Interv. 2014 May 1;83(6):864-72. doi: 10.1002/ccd.25180. Epub 2013 Sep 30.
Clinical trial NCT02237794: Effect of Medical Treatment on Longitudinal Function of the Heart
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Function
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-09-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalized in an Internal Medicine Department of the Hillel Yaffe Medical Center having a variety of medical conditions and treated with a variety of medications including Beta Blockers, Calcium Channel Blockers, Angiotensine Converting Enzyme Inhibitors and diuretics and do not suffer from overt heart conditions.

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Brief summary: The purpose of this study is to determine the effect of medical treatment on longitudinal myocardial function. Patients who have been hospitalized for reasons other than heart disease will be examined with Transthoracic Cardiography before and after medical treatment to determine change in myocardial function.


Eligibility criteria: Inclusion Criteria:

* Hospitalized patients receiving above-mentioned medications

Exclusion Criteria:

* Patients suffering from heart conditions
* Patients unable to undergo Echocardiography
* Pregnancy

Primary outcomes:
measure: Longitudinal Myocardial Function
timeFrame: Two Years
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: David Blondheim, MD
role: STUDY_CHAIR
affiliation: Hillel Yaffe Medical Center
name: Said Younis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01742494: Comparison Study of Conventional POEM and Hybrid POEM for Esophageal Achalasia
Official title: Peroral Endoscopic Myotomy for Esophageal Achalasia: Randomized Comparison of Water-Jet Assisted Versus Conventional Dissection Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Achalasia
Keywords: Esophageal Achalasia,
Peroral endoscopic myotomy,
Water-jet assisted
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Peroral endoscopic myotomy (POEM) has recently been introduced as promising alternative to laparoscopic Heller myotomy for patients with idiopathic achalasia. Several technical modifications have been proposed but have not yet been tested in randomized trials.

Detailed description: Objective: To evaluate efficacy and safety of water-jet assisted POEM (WJ) versus the conventional technique (C).

Interventions: Patients with achalasia diagnosed by symptoms, endoscopy and barium swallow eligible for POEM were randomized to either the use of Erbe Hybrid knife (WJ group) or the conventional technique using injection and triangle tip knife interchangeably (C group).

Main outcome measurements: Procedure time in both groups; secondary outcomes were clinical efficacy and safety (bleeding complications, pneumothorax or pleural effusion requiring intervention)

Eligibility criteria: Inclusion Criteria:

* With an Eckardt symptom score ≥ 4
* The diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the LES on established methods (barium swallow, manometry, esophagogastroduodenoscopy)
* Informed patient consent was obtained

Exclusion Criteria:

* Severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk
* Pseudoachalasia
* Megaesophagus (diameter of \> 7 cm)

Primary outcomes:
measure: Procedure time in both groups
timeFrame: during POEM procedure
Secondary outcomes:
measure: clinical efficacy and safety
timeFrame: during hospital stay and up to 1 year
Other outcomes:
measure: Therapeutic success
timeFrame: Every 3 months after innitial intervention via telephone questionnaires during follow-up up to 1 year
Locations:
city: Shanghai
country: China
facility: Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Ping-Hong Zhou, M.D., PhD
role: STUDY_DIRECTOR
References:
citation: Cai MY, Zhou PH, Yao LQ, Xu MD, Zhong YS, Li QL, Chen WF, Hu JW, Cui Z, Zhu BQ. Peroral endoscopic myotomy for idiopathic achalasia: randomized comparison of water-jet assisted versus conventional dissection technique. Surg Endosc. 2014 Apr;28(4):1158-65. doi: 10.1007/s00464-013-3300-1.
Clinical trial NCT01689194: Efficacy Study of Genexol-PM and Cisplatin in Locally Advanced Head and Neck Cancer
Official title: A Phase II Study of Genexol-PM and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Clinical Research Center for Solid Tumor, Korea
First posted: 2012-09-21
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical trial is Phase II trial for evaluating efficacy of induction chemotherapy using Genexol-PM + cisplatin for locally advanced head and neck cancer. The investigators try to evaluate response rate of Genexol-PM + cisplatin chemotherapy, and safety profile.


Eligibility criteria: Inclusion Criteria:

* locally advanced head and neck squamous cell carcinoma
* oral cavity, oropharynx, hypopharynx, larynx
* measurable lesion
* unresectable
* age 18 or more
* ECOG 0 or 1

Exclusion Criteria:

* distant metastasis
* pregnancy
* prior chemotherapy or radiation therapy
* 2ndary malignancy
* other unfit medical condition

Primary outcomes:
measure: response rate
timeFrame: every 2 cycles, 6wk later after chemotherapy
Secondary outcomes:
measure: Locoregional control rate
timeFrame: every 3wk (every cycle)
measure: Quality of life
timeFrame: every 3wk (every cycle)
measure: safety
timeFrame: every 3wk (every cycle)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Se-Hoon Lee, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Keam B, Lee KW, Lee SH, Kim JS, Kim JH, Wu HG, Eom KY, Kim S, Ahn SH, Chung EJ, Kwon SK, Jeong WJ, Jung YH, Kim JW, Heo DS. A Phase II Study of Genexol-PM and Cisplatin as Induction Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma. Oncologist. 2019 Jun;24(6):751-e231. doi: 10.1634/theoncologist.2019-0070. Epub 2019 Feb 22.