louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04502160: The Northern Ireland Haemodialysis Vascular Access Database
Official title: The Northern Ireland Haemodialysis Vascular Access Database
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemodialysis Access Failure
Arteriovenous Fistula
Lead sponsor: Belfast Health and Social Care Trust
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 16
Maximum age (years): 105
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals undergoing AVF creation between January 2009 and December 2020 in a single centre (Belfast City Hospital

Brief summary: This is database designed to explore clinical outcomes related to vascular assess in the population of Northern Ireland with CKD Stage 5 and End-stage Renal Failure.

Detailed description: Vascular access is the conduit by which blood is transferred from the patient to the dialysis machine and back to the patient during therapy. There are three types of vascular access: Arteriovenous fistulas (AVF), Central venous catheters (CVC) and Arteriovenous grafts (AVG).

AVFs are associated with the best patient survival in individuals undergoing dialysis therapy. However, Up 30-50% of AVFs thrombose or fail to mature sufficiently to support dialysis.

The aim of this database is to further research in the area of AVF outcomes using routinely collected clinical data..

Eligibility criteria: Inclusion Criteria:

* Individuals attending Nephrology undergoing AVFcreation between January 2009 and December 2019 in a single centre (Belfast City Hospital

Exclusion Criteria:

* None

Primary outcomes:
measure: Rates of Arteriovenous Fistula Failure to Mature
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
state: Antrim
Study officials:
affiliation: Belfast Health and Social Care Trust
name: Jennifer Hanko
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00169260: Proactive Health Intervention for Tobacco Users (Get PHIT)
Official title: Proactive Cessation Intervention With Biomarker Feedback
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Smoking
Keywords: smoking
tobacco
behavior therapy
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 536
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to understand how information about smokers' health risks affects their attitudes, mood, and behavior.

Detailed description: The current study will test a community-based, tobacco intervention. The project will compare the effects of a proactive, personally-tailored, biologically-based motivational intervention to those of a proactive, generic motivational intervention for smoking cessation. The biologically-based motivational treatment will include feedback on participants' carbon monoxide (CO) exposure (expired CO and estimated carboxyhemoglobin levels), pulmonary functioning assessed via spirometry, and self-reported smoking-related symptoms. All participants will be given equal access to action-oriented treatment.

Eligibility criteria: Inclusion Criteria:

* 18 years old,
* smoke greater than or equal to 15 cigarettes a day,
* have an expired CO level greater than or equal to 10 ppm,
* are not currently being treated for smoking cessation,
* can read and write in English,
* provide contact information,
* agree to the study requirements,
* have no medical contraindications for spirometry assessment,
* and no an obvious cognitive or physical impairment that would preclude their ability to comprehend or fully participate in the study.

Exclusion Criteria:

-

Primary outcomes:
measure: Motivation to quit smoking, utilization of available resources, smoking cessation rate
timeFrame: 1 year
Secondary outcomes:
measure: Measurement of emotional distress, and mediators/moderators of primary outcomes
timeFrame: 1 year
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Group Health Cooperative
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Jennifer B McClure, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: McClure JB, Ludman EJ, Grothaus L, Pabiniak C, Richards J. Impact of spirometry feedback and brief motivational counseling on long-term smoking outcomes: a comparison of smokers with and without lung impairment. Patient Educ Couns. 2010 Aug;80(2):280-3. doi: 10.1016/j.pec.2009.11.002.
citation: McClure JB, Ludman EJ, Grothaus L, Pabiniak C, Richards J. Impact of a brief motivational smoking cessation intervention the Get PHIT randomized controlled trial. Am J Prev Med. 2009 Aug;37(2):116-23. doi: 10.1016/j.amepre.2009.03.018. Epub 2009 Jun 12.
Clinical trial NCT06385860: Prediction Model for Early Biliary Stasis After Bariatric Surgery
Official title: Research on the Prediction Model for Early Biliary Stasis After Bariatric Surgery Based on Machine Learning Algorithms
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obesity
Diabetes
Gallstones
Biliary Stasis
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study aims to include patients who will undergo bariatric surgery.

Brief summary: Developing and validating a predictive model to estimate the risk of early biliary stasis following bariatric surgery

Detailed description: This study aims to create and validate a model that predicts the likelihood of early biliary stasis in obese patients following bariatric surgery (sleeve gastrectomy and Roux-en-Y gastric bypass)

Eligibility criteria: Inclusion Criteria:

1. BMI ≥32.5 kg/m2 with one or more obesity-related comorbidities.
2. BMI \>35 kg/m2 without coexisting medical problems
3. complete preoperative and follow-up data.

Exclusion Criteria:

1. other bariatric procedures.
2. contraindications for bariatric surgery.

Primary outcomes:
measure: early biliary stasis
timeFrame: one month
measure: prediction model
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03355560: Adjuvant Nivolumab After Salvage Resection in Head and Neck Cancer Patients Previously Treated With Definitive Therapy
Official title: A Single Arm Phase 2 Study of Adjuvant Nivolumab After Salvage Resection in Head and Neck Squamous Cell Carcinoma Patients Previously Treated With Definitive Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Head and Neck Cancer
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2017-11-28
Enrollment: 39
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: The purpose of this research study is to test the safety and efficacy of nivolumab after salvage resection in head and neck cancer in patients that have previously received definitive radiation with or without chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Prior definitive therapy with radiation (with or without prior surgical resection and/or chemotherapy) who have underwent salvage resection with curative intent and have no other curable options
* Pre-operative scans including chest imaging preferably PET/CT and CT neck w/contrast. MRI neck is acceptable if contrast contraindicated.
* Able to provide archived biopsy or resected tissue.
* Adequate performance status and labs.

Exclusion Criteria:

* Patients who did not receive at least radiotherapy as prior definitive treatment.
* Patients who have gross measurable residual disease after surgery or those who underwent surgery for palliative purposes i.e. for symptom control.
* Has nasopharyngeal or sinonasal carcinoma.
* Has confirmed metastatic disease.

Primary outcomes:
measure: Percentage of patients with Grade 3 and 4 adverse events of nivolumab
timeFrame: 28 weeks
Secondary outcomes:
measure: Percentage of patients any grade adverse events of nivolumab
timeFrame: 28 weeks
measure: Disease free survival
timeFrame: 1 year
measure: Disease free survival
timeFrame: 2 year
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Cincinnati
country: United States
facility: UC Health
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Trisha Wise-Draper, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leddon JL, Gulati S, Haque S, Allen C, Palackdharry S, Mathews M, Kurtzweil N, Riaz MK, Takiar V, Nagasaka M, Patil Y, Zender C, Tang A, Cervenka B, McGrath J, Korn WM, Hinrichs BH, Jandarov R, Harun N, Sukari A, Wise-Draper TM. Phase II Trial of Adjuvant Nivolumab Following Salvage Resection in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck. Clin Cancer Res. 2022 Aug 15;28(16):3464-3472. doi: 10.1158/1078-0432.CCR-21-4554.
Clinical trial NCT01835860: Prostatic Artery Embolization for Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Benign Prostate Hyperplasia
Keywords: BPH
Lead sponsor: Saskatchewan Health Authority - Regina Area
Sponsor class: OTHER
First posted: 2013-04-19
Enrollment: 13
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate whether Prostatic Artery Embolization (PAE) might be an effective alternative treatment option for benign prostatic hyperplasia (BPH), in comparison to current gold standard surgical treatment- Transurethral Resection of Prostate (TURP).


Eligibility criteria: Inclusion Criteria:

1. Moderate to severe lower urinary tract symptoms (i.e. International prostate symptom score IPSS\>8) who are bothered by their symptoms (i.e., interfere with the daily activities of living)
2. Urinary retention (related to BPH) leading to catheterization.
3. Refractory to medical treatment or patient is not willing to consider medical treatment
4. Pre trans-urethral resection of prostate (TURP) to reduce the size of prostate gland if prostate is too big for TURP surgery.

Exclusion Criteria:

1. Mild symptoms (IPSS \<8)
2. Moderate to severe lower urinary tract symptoms (i.e. IPSS\>8) who are not bothered by their symptoms (i.e., symptoms do not interfere with the daily activities of living).
3. Suspected malignancy.
4. Any of the following clearly related to BPH- bladder stones, recurrent UTIs, and renal insufficiency.
5. Advanced atherosclerosis and unsuitable vascular access.
6. Allergy to intravenous contra

Primary outcomes:
measure: Change from baseline in symptom severity at 1, 3, 6 and 12 months follow-up, as measured by International prostate symptoms score (IPSS).
timeFrame: 1, 3, 6 and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Regina
country: Canada
facility: Regina General Hospital
state: Saskatchewan
Study officials:
References:
Clinical trial NCT03304860: Child-Physician Recommendation on Parental Adherence to Colorectal Cancer Screening
Official title: Child-Physician Recommendation on Parental Adherence to Colorectal Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-10-09
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Physician recommendation has been shown to be one of the most significant predictors for colorectal cancer (CRC) screening. This study aims to identify the amount of parents of internal medicine residents at NYU who are eligible for CRC screening but have not received it. Investigators will perform an intervention and quantify the amount of parents eligible for CRC screening after the intervention. This study will entail sending 2 brief surveys (one before the intervention and one after) which determine if the parents of the residents are eligible for CRC screening. The intervention will be asking the residents with eligible parents to have a discussion with their parents about CRC screening options and to address their concerns. Investigators will provide a one page document the residents can give their parents as a reference as part of the intervention.


Eligibility criteria: Inclusion Criteria:

* Internal medicine residents at NYU - PGY1, PGY2, and PGY3 during 2017-2018 academic year

Primary outcomes:
measure: Change in CRC screening rate of eligible parents of internal medicine residents at NYU from before to after the intervention
timeFrame: Baseline to 6 Months
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: Mark Pochapin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06201260: Effects of Intermittent Pneumatic Compression Following Exercise-induced Muscle Damaged
Official title: Effects of Intermittent Pneumatic Compression Following Exercise-induced Muscle Damaged
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Physical Therapy
Lead sponsor: University of Maia
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 33
Sex: MALE
Minimum age (years): 18
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to assess the recovery kinetics following an exercise-induced muscle damage activity (using flywheel) on active healthy university students.

The main questions are:

- Is intermittent pneumatic compression superior to a placebo recovering from EIMD? Participants will perform a fatiguing protocol using flywheel and recover with either intermittent pneumatic compression or with a placebo treatment (micro-current treatment, but the device turned off). They will perform several performance tests before, following the recovery period, and at the 24h and 48h following the intervention


Eligibility criteria: Inclusion Criteria:

* To be eligible for participating in this study, participants should not have been recently injured, and should engage physical activity regularly (\>3 times/week).

Exclusion Criteria:

* Inactive participants
* Younger than 18 years old or older than 27 years old

Primary outcomes:
measure: Maximal voluntary contraction (knee extension)
timeFrame: 10 minutes before the fatigue protocol, following the recovery protocol (30 minutes post), 24 hours and 48 hours post intervention
measure: Countermovement jump
timeFrame: 10 minutes before the fatigue protocol, following the recovery protocol (30 minutes post), 24 hours and 48 hours post intervention
measure: Broad Jump
timeFrame: 10 minutes before the fatigue protocol, following the recovery protocol (30 minutes post), 24 hours and 48 hours post intervention
measure: Soreness scale
timeFrame: 10 minutes before the fatigue protocol, following the recovery protocol (30 minutes post), 24 hours and 48 hours post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Maia
country: Portugal
facility: University of Maia
Study officials:
References:
Clinical trial NCT00006060: Diagnostic Study of Quantitative Imaging and Spectroscopy in Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
neurologic and psychiatric disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Pennsylvania
First posted: 2000-07-06
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: OBJECTIVES: I. Determine by quantitative magnetic resonance imaging measurements the change in the total volume of brain parenchyma as well as its gray and white matter, T2 and enhanced T1 lesion volume, and the magnetization transfer ratio histogram parameters, and correlate these measurements with clinical measures of disability in patients with multiple sclerosis.

II. Measure the quantity of whole brain N-acetylaspartate in patients with multiple sclerosis and compare these values to those from age matched controls.

III. Determine the correlation between specific neuropsychological tests which assess global cognitive functioning and the quantitative measurements taken in these patients in this study.

Detailed description: PROTOCOL OUTLINE:

Patients undergo magnetic resonance imaging and spectroscopy with standard gadolinium contrast followed by neuropsychological testing every 6 months for 5 years. An equal number of age and sex matched healthy patients act as a control group and undergo magnetic resonance imaging and spectroscopy without standard gadolinium contrast every 6 months for 5 years.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of multiple sclerosis Relapsing-remitting defined as 2 exacerbations and a worsening of neurologic function over 1 day followed by at least 30 days of no progression OR Secondary-progressive defined as increase of at least 1.0 unit on Expanded Disability Status Scale (EDSS) in past 2 years with or without exacerbations

--Prior/Concurrent Therapy--

* Biologic therapy: Prior interferon beta 1A, 1B, or glatiramer acetate No concurrent interferon beta 1A, 1B, or glatiramer acetate
* Endocrine therapy: Concurrent oral and IV corticosteroids allowed

--Patient Characteristics--

* Performance status: EDSS no greater than 7.0
* Hematopoietic: No hematologic dysfunction including hemolytic anemia
* Hepatic: No hepatic dysfunction
* Renal: No renal dysfunction
* Cardiovascular: No cardiac pacemaker
* Other: Not pregnant or nursing Negative pregnancy test No intracranial clips, metal implants, or external clips within 10 mm of head No metal in eyes No known gadolinium texaphyrin allergy No known claustrophobia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Medical Center
state: New York
Study officials:
affiliation: New York University
name: Robert I. Grossman, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01732094: Corifollitropin Alfa Followed by hpHMG in a Long GnRH Agonist Protocol for the Treatment of Poor Ovarian Responders
Official title: Phase II Study of Corifollitropin Alfa Followed by hpHMG in a Long GnRH Agonist Protocol for the Treatment of Poor Ovarian Responders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infertility
Poor Ovarian Response
Keywords: Poor ovarian response
Poor ovarian responders
Bologna criteria for poor ovarian response
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2012-11-22
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the present study is to examine the level of ovarian response and the pregnancy rates among poor ovarian responders treated with a novel treatment protocol with 150μg corifollitropin alfa followed by 300IU hMG in a long GnRH agonist protocol.

Detailed description: Corifollitropin alfa reaches maximum concentrations (Cmax), between 25 and 45 h after injection , a time interval which is significantly shorter as compared to treatment with rFSH. The investigators hypothesized that this rapid increase in the serum FSH concentration may result in a significantly higher exposure of the small antral follicles to constant high levels of FSH during the early follicular phase, securing not only the recruitment of the follicles, but also the continued growth.

In the current study the investigators examine whether administration of corifollitropin followed by 300IU hMG in a long GnRH agonist protocol may result in acceptable pregnancy rates in poor ovarian responders fulfilling the "Bologna criteria"

Eligibility criteria: Inclusion Criteria:

Patients should fulfill the "Bologna criteria" for poor ovarian response

At least two of the following three features must be present:

i. Advanced maternal age (≥40 years) or any other risk factor for POR (poor ovarian response); ii. A previous POR (≤3 oocytes with a conventional stimulation protocol); iii. An abnormal ovarian reserve test (i.e. AFC \<7 follicles or AMH \<1.1 ng/ml).

Two episodes of POR after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal ORT (ovarian reserve test).

Exclusion Criteria:

-

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 10 to 12 weeks of gestation
Secondary outcomes:
measure: Number of oocytes retrieved
timeFrame: Day of oocyte retrieval
measure: Cycles with oocyte retrieval
timeFrame: Day of oocyte retrieval
measure: Cycles with embryo transfer
timeFrame: Day of Embryo transfer
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Centre for Reproductive Medicine UZ Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Nikolaos P. Polyzos, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: