louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01332487: Evaluating the Impact of Early Versus Delayed 5 Alpha Reductase Inhibitor Treatment on the Risk of Emergent Surgery in Men With Benign Prostatic Hyperplasia
Official title: Evaluating the Impact of Early Versus Delayed 5 Alpha Reductase Inhibitor Treatment on the Risk of Emergent Surgery in Men With Benign Prostatic Hyperplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Hyperplasia
Keywords: 5-alpha-reductase inhibitor
prostate surgery
alpha-blocker
enlarged prostate
acute urinary retention
Benign prostatic hyperplasia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-04-11
Enrollment: 4068
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male patients aged 50 years or older with a diagnostic claim for BPH; prescription claim for an AB and a 5ARI in the observation period

Brief summary: This retrospective study aims to assess the impact of early vs delayed 5-alpha-reductase inhibitor (5ARI) therapy in patients with BPH on alpha-blocker (AB) therapy and the risk of acute urinary retention (AUR), prostate-related surgery, and emergency surgery (defined as prostate surgery occurring within 30 days of AUR). The MarketScan database will be utilized for this study (2000-2008).


Eligibility criteria: Inclusion Criteria:

* Male
* aged 50 years or older
* diagnostic claim for BPH
* prescription claim for an AB and a 5ARI in the observation period (5ARI must occur within a 6-month window after the AB).
* continuously eligible for 6 months prior to and 12 months after index prescription date

Exclusion Criteria:

* prostate or bladder cancer during the study period
* any prostate-related surgical procedure within 5 months of the index prescription date
* prescription claim for finasteride 1 mg for male pattern baldness during the study period
* 5ARI therapy prior to initiation of AB therapy

Primary outcomes:
measure: Number of Participants Who Experienced Progression of Disease
timeFrame: Up to 5 months
Secondary outcomes:
measure: Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03428087: Prostate Impendance Test Project
Official title: Prostate Impendance Test Project (PROS.IT) in Prostate Cancer Diagnosis: a Cross-sectional Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostatic Neoplasms
PSA
Prostatic Biopsy
Impedance Test
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 100
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In order to build a two-pronged analysis of areas of confidence and tolerance, it is necessary to examine a fair number of potentially ill subjects and compare them with healthy subjects (controls). Past experiences indicate that about 100 measurements in each grop can create a sufficiently dense and significant cluster to be able to trace besides the "boundries" of 50%, 75%, and 95% even a 95% confidence center of small size suitable to establish an adequate significance.

Brief summary: Impedance-based analysis could provide an adequate response to the need to identify a safe and reliable tool alternative to bioptic diagnosis. Patients who are candidates for prostate biopsy as suffering from urinary symptoms accompanied by clinical suspicions such as high total PSA value and / or presence of prostate nodule and / or evidence of obvious lesion to available imaging methods will be subjected to impedance measurement. Aim of this study is to be able to structure a bivariate analysis of the distribution of impedances detected in patients with neoplasia in order to detect test median reference values.


Eligibility criteria: Inclusion Criteria:

1. age\> 45 years
2. up of total PSA values beyond the normal range (\> 4 ng / ml)
3. presence or absence of suspicious prostate nodule

Exclusion Criteria:

1. previous history of cancer
2. BMI\>30
3. patients with previous diagnosis of PIN HG at prostate core biopsy or in active surveillance

Primary outcomes:
measure: Impedance-based analysis based on phase-sensitive sensors
timeFrame: during rectal examination
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: AOUP Ospedale cisanello
state: Toscana
Study officials:
References:
Clinical trial NCT00356187: Beta Blockade in Critical Injury
Official title: Beta-blockade Reduces Catabolism in Severely Injured Trauma Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Trauma
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2006-07-25
Enrollment: 15
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: Critically injured patients endure a period of hypermetabolism/catabolism after being resuscitated. The metabolic cost of this may be measured in loss of lean body mass, poor wound healing, susceptibility to infection and long hospital stays. While there have been some data to suggest that hypermetabolism can be ameliorated in burn patients by beta blockade, to our knowledge, a prospective trial in trauma patients has not yet been done. Our hypothesis is that nonselective beta blockade will reduce catabolism, improve glucose control, blunt loss of lean body mass, decrease infections and improve outcome in a cohort of critically injured patients.


Eligibility criteria: Inclusion Criteria:

* ISS\>25, stable at 48 hours after injury
* Fully resuscitated
* Ventilated

Exclusion Criteria Include:

* Intracranial hypertension requiring active treatment
* Hypotension/Pressors
* Already on beta blocker for a standard indication

Primary outcomes:
measure: Change in REE vs. Controls
timeFrame: ICU admission date to ICU discharge or death
Secondary outcomes:
measure: Changes in Protein Metabolism Measurements
timeFrame: ICU admission date to ICU discharge or death
measure: Alterations in Neuroendocrine and Immunoinflammatory Measurements
timeFrame: ICU admission date to ICU discharge or death
measure: Clinical Outcome Measurements
timeFrame: ICU admission date to ICU discharge or death
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
Study officials:
References:
Clinical trial NCT00679887: Chronic Shoulder Pain Treated by Pressures With the Thumbs on the Trigger Points
Official title: Chronic Shoulder Pain of Myofascial Origin,a Randomised Clinical Trial Using Ischemic Compression Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Shoulder Pain
Keywords: chiropractic
myofascial trigger points
ischemic compression
shoulder pain
Lead sponsor: Guy Hains Chiropractor
Sponsor class: OTHER
First posted: 2008-05-19
Enrollment: 59
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find the efficacy of treating the trigger points located around the shoulder in patients suffering from chronic shoulder pain.

Detailed description: Chronic shoulder pain is a common condition which should be treated by surgery only wen conservative approaches have been tried. in the present trial the authors intend to find the effectiveness of treating the triggers points located in muscles, ligaments and tendons surrounding the shoulderin patients suffering from chronic shoulder pain.

The technique used in this trial is ischemic compression(thumb tip pressure) on the trigger points

Eligibility criteria: Inclusion Criteria:

* 30 to 60 years old.
* To have suffered from shoulder pain on a daly basis for at least 3 months
* Participants had to be able to raise the arm above ther head.
* They had accept to receive 15 chiropractic treatments without charge.

Exclusion Criteria:

* Past surgery to the arm.
* Injection to the shoulder in the month preceding the trial.
* A diagnosis of rheumatoid arthritis or any other systemic disorders affecting the joints.
* Shoulder pain from an herniated disc.

Primary outcomes:
measure: Shoulder Pain and Disability Index questionnaire
timeFrame: At baseline, after 15 treatments ,30 days aftr the treatments and 6 months later
Secondary outcomes:
measure: Pain visual analog scale
timeFrame: After 15 treatments, 30 days after the treatments and 6 months later.
Other outcomes:
Locations:
city: Trois-Rivières
country: Canada
facility: 2930 Cote Richelieu
state: Quebec
Study officials:
affiliation: UQTR
name: Guy Hains, DC
role: PRINCIPAL_INVESTIGATOR
affiliation: UQTR
name: Martin Descarreaux, DC, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT00785187: Affect of Dose Rate on UVR Induced Skin Erythema
Official title: Randomized Open Crossover Study Researching Affect of Dose Rate on UVR Induced Skin Erythema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erythema
Keywords: UVB induced skin erythema
Lead sponsor: Goldenhersh, Michael, M.D.
Sponsor class: INDIV
First posted: 2008-11-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Purpose of study: Evaluation of the affect of dose rate on UVR induced skin erythema.

Study design: A single-center, prospective, randomized, crossover, open study.

Number of patients: 20-40

Patient population: Healthy volunteers

Control: Different sites on patients body

Procedure duration: Total 3-5 hours (4 visits)

Duration of follow up: 4 days

Duration of study: Up to 6 months

Primary objectives: To examine the difference in erythemal response as a function of dose rate, and to assess the total amount of energy that is theoretically transmitted through a sunscreen within the range of SPF 2-10.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin types I-III.
* Age 18-60.
* Absence of obvious sun damage on the volar side of the forearm or other exposure sites.
* Absence of exposure of the arms or other exposure sites to sunlight for two weeks prior to the experiment.

Exclusion Criteria:

* History of skin cancer.
* Multiple nevi or atypical nevi on the forearm.
* Signs of sun damage on the volar side of the forearm or other exposure sites.
* Mentally incompetent.

Primary outcomes:
measure: To examine the difference in erythemal response as a function of dose rate, and to assess the total amount of energy that is theoretically transmitted through a sunscreen within the range of SPF 2-10
timeFrame: end of study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04250987: Exploratory Investigation of Data Obtained From a Sensor Connected to an Intermittent Catheter
Official title: Exploratory Investigation of Data Obtained From a Sensor Connected to an Intermittent Catheter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Compliance, Patient
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2020-01-31
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm - open-label study
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the investigational device in the proposed clinical investigation is to capture pressure data prior to and during voiding using a CE-marked commercially available catheter.

Detailed description: This clinical investigation is based on an open explorative design evaluating the sensor ability to record readable data in healthy volunteers and the extent of artifacts influencing data quality and readability in healthy volunteers.

Overall:

* Single arm. Open-labelled, not randomized
* Healthy volunteers

Duration:

Information visit:

Oral and written information about the evaluation is given by the PI or his/her representative. Subjects can continue to visit 0, inclusion visit, the same day - if the subject has decided on participation and if practically possible.

Visit 0 - Inclusion visit:

Informed consent signed. Subjects can continue to visit 1 - test visit the same day - if practically possible.

Visit 1 - test visit:

1h test visit at Rigshospitalet. Fertile females will be asked to perform a pregnancy test. Subject is asked about symptoms for urinary tract infections (frequent urination, stinging or pain at urination). If negative for these symptoms, the subject will be catheterised with (SpeediCath® Standard, male/female, Nelaton tip depending of the gender) with fitted pressure sensor. The urine is led into a standard urine flowmeter.

Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity

Exclusion Criteria:

1. Previous history of genitourinary disease in-cluding congenital abnormalities and surgical procedures performed in the urinary tract
2. Symptoms of urinary tract infections (fre-quent urination, stinging and pain at urina-tion)
3. Participation in any other clinical investiga-tions during this investigation (Inclusion → termination)
4. Known hypersensitivity toward any of the test products
5. Positive pregnancy tes for women

Primary outcomes:
measure: Number of Participants With Readability of Pressure Sensor Measurements
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Urology
Study officials:
affiliation: Head of Clinical Operations
name: Fredrik Ceder, M.Sc
role: STUDY_DIRECTOR
References:
Clinical trial NCT05881187: Pack Cross Linking for Infectious Keratitis
Official title: Analysis of the Outcomes of Photoactivated Chromophore for Keratitis Cross _linking for Treatment of Infectious Keratitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infectoius Keratitis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to investigate the efficiency of PACK_ CXL in treatment of infectious keratitis and analyze postoperative outcomes.


Eligibility criteria: Inclusion Criteria:

* are age ≥18 years, fungal, bacterial or mixed infectious keratitis, ulcer ≤ 4 mm in diameter and showing a maximum depth of 350 μm (as assessed by either optical coherence tomography (OCT))

Exclusion Criteria:

* age ≤18 years, viral infectious keratitis, non-infectiouskeratitis, melting corneal ulcers with impending perforation, corneal thickness \< 400 μm (including the corneal epithelium) and systemic diseases or systemic surgery, single-eyed and immunosuppressed patients.

Primary outcomes:
measure: corneal THICKNESS
timeFrame: within 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Cabrera-Aguas M, Khoo P, Watson SL. Infectious keratitis: A review. Clin Exp Ophthalmol. 2022 Jul;50(5):543-562. doi: 10.1111/ceo.14113. Epub 2022 Jun 3.
citation: Papaioannou L, Miligkos M, Papathanassiou M. Corneal Collagen Cross-Linking for Infectious Keratitis: A Systematic Review and Meta-Analysis. Cornea. 2016 Jan;35(1):62-71. doi: 10.1097/ICO.0000000000000644.
citation: Tabibian D, Mazzotta C, Hafezi F. PACK-CXL: Corneal cross-linking in infectious keratitis. Eye Vis (Lond). 2016 Apr 19;3:11. doi: 10.1186/s40662-016-0042-x. eCollection 2016.
citation: Kumar V, Lockerbie O, Keil SD, Ruane PH, Platz MS, Martin CB, Ravanat JL, Cadet J, Goodrich RP. Riboflavin and UV-light based pathogen reduction: extent and consequence of DNA damage at the molecular level. Photochem Photobiol. 2004 Jul-Aug;80:15-21. doi: 10.1562/2003-12-23-RA-036.1.
Clinical trial NCT06939387: Drug-induced Kidney Injury Model
Official title: Establishment, Evaluation and Treatment Strategy of Drug-induced Kidney Injury Model
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Kidney Injury
Keywords: acute kidney injury
drug
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Taizhou Enze Medical Center Group
name: Hangzhou Linping District first People's Hospital
name: Aksu district first People's Hospital
name: Ningbo Yinzhou District Second Hospital
name: Wucheng District First People's Hospital
First posted: 2025-04-22
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Drug-induced acute kidney injury

Brief summary: To establish the prediction model of renal dysfunction in patients with drug-induced renal injury and study the prognosis of different drug treatments


Eligibility criteria: Inclusion Criteria:

* Drug-induce acute kidney injury

Exclusion Criteria:

* 1.Dialysis patients; 2.No baseline creatinine; 3.Obstructive AKI; 4.Clinical data were incomplete.

Primary outcomes:
measure: Model performance metrics assessed by AUC-ROC, accuracy and F1-score using 10-fold cross-validation
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: The rate at which creatinine falls
timeFrame: 7 days, 1 month, 3 months after treatment
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT01285687: Acupuncture for Post-tonsillectomy Pain Control in Children
Official title: Acupuncture for Post-tonsillectomy Pain Control in Children: a Single-blinded, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tonsillectomy
Post-Operative Pain
Acupuncture
Keywords: Tonsillectomy
Post-Operative Pain
Acupuncture
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2011-01-28
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, controlled, single-blinded study comparing conventional postoperative analgesia with paracetamol-on-demand with the same regime plus acupuncture.

The hypothesis is that postoperative treatment of children undergoing tonsillectomy with acupuncture will reduce pain with minimal unwanted effects.

Detailed description: A randomized, controlled, single-blinded study comparing conventional postoperative analgesia with paracetamol-on-demand with the same regime plus acupuncture.

The study will be conducted in accordance with the ethical standards of the Helsinki Declaration and has been approved by the Human Experimentation Ethics Committee of the Ziv Medical Center and the Ministry of Health.

Patients will be recruited through the preoperative clinic conducted on the day before surgery. All parents and children will be given a full explanation of the study by an experienced member of the research team before randomization. The explanation will include the nature of acupuncture and the proposed treatment. Parents will sign an informed consent. Patients randomized to the acupuncture group will have a "trial run" at the time of consenting with a member of the research team experienced with performing acupuncture in children , in order to familiarize the child and family with the procedure.

Eligibility criteria: Inclusion Criteria:

• children aged 3-12 years undergoing tonsillectomy with or without adenoidectomy for tonsillar hypertrophy with suspected sleep disordered breathing and for recurrent tonsillar infections.

Exclusion Criteria:

* lack of parental consent
* skin lesions near acupuncture sites
* relevant psychiatric disorder
* coagulopathy
* drug allergies to regular analgesic treatment
* intake of medications possibly affecting postoperative pain
* any child who has received acupuncture treatment in the past or the parents or siblings have received such treatment.

Primary outcomes:
measure: Post-Operative Pain
timeFrame: 48 hours post-surgery
Secondary outcomes:
measure: Analgesic Drug Consumption
timeFrame: 48 hours post-surgery
Other outcomes:
Locations:
city: Safed
country: Israel
facility: Ziv Medical Center
Study officials:
References:
Clinical trial NCT02339987: Procure Tumor and Initiate Melanoma Tumor-Reactive Tumor Infiltration
Official title: Procure Tumor and Initiate Melanoma Tumor-Reactive Tumor Infiltration
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Melanoma
Lead sponsor: Saint John's Cancer Institute
Sponsor class: OTHER
First posted: 2015-01-16
Enrollment: 27
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cancer clinic

Brief summary: Procure Tumor and Initiate Melanoma Tumor-Reactive Tumor Infiltration Lymphocytes (TIL)

Detailed description: The purpose of this study is to allow the collection of tissue from subjects to be used in future research studies by scientists and to isolate tumor fighting cells for the future treatment of Melanoma.

Eligibility criteria: Inclusion Criteria:

1. Patients must have metastatic melanoma with a resectable metastasis who are undergoing resection for palliation, therapeutic or curative purpose.
2. Patients must be \> 15 years of age and must have metastatic melanoma.
3. Patients must meet standard pre-operative requirements as determined by the surgeon to be candidates for surgery.
4. Patients must be able to understand and sign the Informed Consent document.
5. Patients must be able to complete the supplemental data form

Exclusion Criteria:

1. women who are pregnant or breastfeeding
2. inability to give consent

Primary outcomes:
measure: Evaluate Feasibility of conducting TIL procurement in a single-site setting
timeFrame: 5 years
measure: Evaluate Safety of conducting TIL procurement in a single-site setting
timeFrame: 5 separate TIL procedures
Secondary outcomes:
measure: To determine whether TIL Procurement, isolation, testing tumor reactivity and cryopreservation can be performed at John Wayne Cancer Institute (JWCI) and Providence Saint John's Health Center (PSJHC) and infused into patients
timeFrame: 5 years
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute
state: California
Study officials:
affiliation: Saint John's Cancer Institute
name: Santosh Kesari, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: