louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04143399: HoLEP vs BPRP of a Large Volume BPH: a Randomised Controlled Trial
Official title: Holmium Laser Enucleation vs Bipolar Resection of a Large Volume BPH: a Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: BPH With Urinary Obstruction
Male
Keywords: BPH
enucleation
Large Prostate
LUTS
IPSS
quality of life
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 145
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare bipolar resection versus holmium laser enucleation for management of large BPH.

Detailed description: To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of large BPH (\> 75 gm).

Eligibility criteria: Inclusion Criteria:

* Patients suffering from LUTS secondary to infravesical obstruction from BPH
* failed medical treatment
* International Prostate Symptom Score (IPSS) \> 13
* a peak urinary flow rate (Qmax) \< 15 ml/sec
* a prostate size ≥ 75 gm

Exclusion Criteria:

* presence of a urethral stricture
* neurological disorder
* bladder cancer
* prostate cancer
* previous history of bladder neck surgery or TURP

Primary outcomes:
measure: hemoglobin drop postoperatively (gm/dL)
timeFrame: Immediate postoperatively
measure: operative duration in minutes
timeFrame: during surgery
measure: Hospital stay in days
timeFrame: immediately after surgery
Secondary outcomes:
measure: complications (%)
timeFrame: Two years
measure: urine flow
timeFrame: Two years
measure: post-voiding residual urine
timeFrame: Two years
measure: International prostate symptom score (IPSS)
timeFrame: Two years
measure: Quality of life (QoL)
timeFrame: Two years
measure: Catheter duration
timeFrame: immediate postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospitals
Study officials:
affiliation: Cairo University
name: enmar I Habib
role: STUDY_DIRECTOR
References:
citation: Habib EI, ElSheemy MS, Hossam A, Morsy S, Hussein HA, Abdelaziz AY, Abdelazim MS, Fathy H. Holmium Laser Enucleation Versus Bipolar Plasmakinetic Resection for Management of Lower Urinary Tract Symptoms in Patients with Large-Volume Benign Prostatic Hyperplasia: Randomized-Controlled Trial. J Endourol. 2021 Feb;35(2):171-179. doi: 10.1089/end.2020.0636. Epub 2020 Oct 29.
Clinical trial NCT02510599: Safety and Efficacy of Solithromycin in the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis
Official title: An Open Label, Proof of Principle Study to Evaluate the Efficacy and Safety of Solithromycin for the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nonalcoholic Steatohepatitis
Keywords: NASH
Liver disease
Lead sponsor: Melinta Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 evaluate the effects of solithromycin on hepatic histology and biomarkers in patients with nonalcoholic steatohepatitis.

Detailed description: Patients will be administered solithromycin for 13 weeks with regular safety visits and liver biopsies at baseline and after treatment.

Eligibility criteria: Inclusion Criteria:

* Histologic evidence of NASH based on liver biopsy obtained within 180 days
* NAS\> or = 5
* Able to swallow capsules intact

Exclusion Criteria:

* Symptoms of acute liver disease
* Cirrhosis on liver biopsy
* Positive HIV or Hepatitis tests
* Primary Biliary Cirrhosis
* Poorly controlled diabetes with HgA1C \>8.5%
* ALT \>4-fold upper limit of normal
* QTcF \>450 msec
* CrCl \<40 mL/min

Primary outcomes:
measure: To evaluate effects on hepatic histology in patients with NASH
timeFrame: 13 weeks
Secondary outcomes:
measure: Changes in Steatosis on liver biopsy
timeFrame: 13 weeks
measure: Changes in hepatocellular ballooning score on liver biopsy
timeFrame: 13 weeks
measure: Changes in inflammation on liver biopsy
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western University Hospitals
state: Ohio
Study officials:
affiliation: Melinta Therapeutics, Inc.
name: Robert Dobbins, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00167999: Study Evaluating Piperacillin-Tazobactam on Certain Bacteria in Hematology and Oncology Units
Official title: Effects of Piperacillin-Tazobactam Use on the Prevalence Rate of Extended-Spectrum Beta-Lactamase (ESBL) Producing Escherichia Coli and Klebsiella Pneumoniae in Hematology and Oncology Units.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gram-Positive Bacterial Infections
Escherichia Coli Infections
Klebsiella Infections
Keywords: Bacterial Infections
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: To determine the value of increasing use of piperacillin/tazobactam as empiric therapy and restricting extended-spectrum cephalosporins in reducing the cases of ESBL producing Escherichia coli and Klebsiella pneumoniae in hematology and oncology units


Eligibility criteria: Inclusion Criteria:

* Eligible patients of either sex, 15 years of age or older
* Patients who are admitted to the department of hematology and oncology
* Provide written informed consent

Exclusion Criteria:

* Patients who have hypersensitivity to β-lactam antibiotics
* Female who are pregnant or breast-feeding
* Any underlying conditions or non-infectious diseases that will be ultimately fatal within 30 days

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05365399: Evaluation of a Smartphone-based Screening Tool for Neonatal Jaundice in a Ugandan Population
Official title: Evaluation of a Smartphone-based Screening Tool for Neonatal Jaundice in a Ugandan Population
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neonatal Jaundice
Lead sponsor: Picterus AS
Sponsor class: INDUSTRY
Collaborators: name: Norwegian University of Science and Technology
First posted: 2022-05-09
Enrollment: 180
Sex: ALL
Minimum age (years): 24
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The general objective of this study is to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at HICH Mbarara.

Detailed description: The general objective of this study is to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at HICH Mbarara.

The specific objectives for this study are:

To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin measurements in serum in newborns with varying degree of jaundice To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns with varying degree of jaundice To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns with varying degree of jaundice

Eligibility criteria: Inclusion Criteria:

* Infants born with gestational age ≥37 weeks
* Birth weight ≥2000g and ≤4500g
* Age 1 - 14 days
* Infants requiring a blood sample (newborn screening / clinically suspected jaundice)

Exclusion Criteria:

* Infants transferred to the paediatric ward for advanced treatment.
* Infants with a skin rash or other disease that affects the skin where measurements are performed.
* Infants that receive or have received phototherapy in the last 24 hours.
* Infants with an inborn disease

Primary outcomes:
measure: Smartphone application sensitivity (bilirubin levels on newborns)
timeFrame: 5 minutes
Secondary outcomes:
measure: Smartphone application sensitivity (bilirubin levels on newborns with high melanin content) in the skin.
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mengo Hospital
Study officials:
References:
Clinical trial NCT00396799: Bioequivalence Study Of Bazedoxifene/Conjugated Estrogen Tablets In Postmenopausal Women
Official title: An Open-Label, Single-Dose, Randomized-to-Sequence, 2-Period, Crossover, Pivotal Bioequivalence Study Between Bazedoxifene Acetate/Conjugated Estrogens (Premarin Current Process) and Bazedoxifene Acetate/Conjugated Estrogens (Premarin New Process) Tablets Administered to Healthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Menopause
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-11-08
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective is to evaluate the bioequivalence between bazedoxifene/conjugated estrogens tablets produced using the current manufacturing process to bazedoxifene/conjugated estrogens tablets produced using a new manufacturing process


Eligibility criteria: Inclusion Criteria

* Healthy, postmenopausal women aged 35 to 70 years and weighing at least 50 kg (approx. 110 lbs).
* At least 6 months of spontaneous amenorrhea (with follicle-stimulating hormone levels of 39 mIU/mL or greater).
* Nonsmoker or smoker of fewer than 10 cigarettes per day, with ability to abstain for 5 days.

Exclusion Criteria

* Women with amenorrhea starting after 54 years of age.
* A history or active presence of clinically important medical diseases.
* Use of oral estrogen-, progestin, androgen-, or SERM-containing drug products within 30 days before receiving study drug.

Primary outcomes:
measure: Pharmacokinetic measures of blood levels of endogenous estrogen hormones, conjugated estrogens and bazedoxifene.
Secondary outcomes:
measure: Safety will be evaluated from reported signs and symptoms, scheduled physical examinations, gynecologic examinations, vital sign measurements, 12-lead ECG and clinical laboratory test results.
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01274299: Measurements of Facial Dimensions in Infants and Toddlers 0-4 Years of Age
Official title: Facial Dimensions in Infants and Toddlers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infant Development
Keywords: Infants
morphometry
face
3D
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2011-01-11
Enrollment: 300
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy infants

Brief summary: Anthropometric data of infants' face will be obtained using special 3D scanners and software.

Detailed description: A digital camera will be used to take a 3D picture the face of each infant. Off line measurements of landmarks on the face will be marked and dimensions will be calculated using a special analysis software.

Eligibility criteria: Inclusion Criteria:

* Healthy infants, 0-4 years of age

Exclusion Criteria:

* Facial anomalies

Primary outcomes:
measure: Facial Dimensions
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Safed
country: Israel
facility: Ziv Medical center
Study officials:
affiliation: Ziv Medical Center
name: Israel Amirav, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amirav I, Luder AS, Halamish A, Marzuk C, Daitzchman M, Newhouse MT. Computerized Dead-Space Volume Measurement of Face Masks Applied to Simulated Faces. Respir Care. 2015 Sep;60(9):1247-51. doi: 10.4187/respcare.03813. Epub 2015 May 5.
citation: Amirav I, Luder AS, Halamish A, Raviv D, Kimmel R, Waisman D, Newhouse MT. Design of aerosol face masks for children using computerized 3D face analysis. J Aerosol Med Pulm Drug Deliv. 2014 Aug;27(4):272-8. doi: 10.1089/jamp.2013.1069. Epub 2013 Sep 28.
Clinical trial NCT00971399: Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting
Official title: Phase III Prospective Randomized Trial Comparing Ramosetron Versus Ondansetron for Radiotherapy Induced Nausea and Vomiting in the Treatment of Gastrointestinal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Radiotherapy Induced Nausea and Vomiting
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-09-03
Enrollment: 172
Sex: ALL
Minimum age (years): 20
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:

1. To compare prophylactic effect of ondansetron versus ramosetron on radiotherapy induced nausea and vomiting in the treatment of gastrointestinal cancer.
2. To verify an improvement of 20% in complete response rate in term of radiotherapy induced nausea and vomiting (from 60% with ondansetron to 80% with ramosetron).


Eligibility criteria: Inclusion Criteria:

* AJCC 1-3 staged gastrointestinal cancer patient
* patient undergoing radiotherapy as treatment
* age 20 yr and higher
* ECOG 0-2

Exclusion Criteria:

* age \< 20
* ECOG 3-4
* patient experiencing nausea or vomiting prior to accrual
* patient under antiemetic medication
* patient under steroid medication (topical or inhalant steroid application are exceptional)
* patient under opioid medication

Primary outcomes:
measure: complete response of RINV (no vomiting and no rescue medication)
timeFrame: 4 weeks after medication
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Kim K, Chie EK, Jang JY, Kim SW, Oh DY, Im SA, Kim TY, Bang YJ, Ha SW. Ramosetron for the prevention of nausea and vomiting during 5-fluorouracil-based chemoradiotherapy for pancreatico-biliary cancer. Jpn J Clin Oncol. 2009 Feb;39(2):111-5. doi: 10.1093/jjco/hyn140. Epub 2008 Dec 5.
Clinical trial NCT01861899: Treatment of Sacroiliac Dysfunction With SI-LOK® Sacroiliac Joint Fixation SI-SI-LOK
Official title: Treatment of Sacroiliac Dysfunction With SI-LOK® Sacroiliac Joint Fixation System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Joint Dysfunction
Keywords: Sacro-iliac Joint
Lead sponsor: Globus Medical Inc
Sponsor class: INDUSTRY
First posted: 2013-05-24
Enrollment: 46
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be screened according to inclusion/exclusion criteria and will be selected for the treatment using the SI-LOK® system

Brief summary: The objective of this study is to gather clinical data on SI-LOK® for the treatment of sacroiliac joint dysfunction.

The purpose of this prospective study is to evaluate clinical and radiographic outcomes, intra-operative parameters, patient satisfaction and work status following a procedure using SI-LOK® for treatment of sacroiliac joint dysfunction with a minimum of three screws.

Detailed description: Clinical Research Forms will be completed at all pre-op, intra-op and post-op visits by either the surgeon, clinical coordinator or patient.

Forms completed by patients will be checked, initialed and dated by the site coordinator.

Data collected will be presented as mean +/- standard deviation. Statistical significance will be evaluated at the P \< 0.05 significance level.

Eligibility criteria: Inclusion Criteria:

* A maximum age of 70 years
* Diagnosis of SIJ dysfunction
* Ability to provide Informed Consent for study participation and to return for all follow-up visits

Exclusion Criteria:

* Previous documentation of osteopenia or osteomalacia
* History of metabolic bone disease (e.g. diabetes requiring daily insulin)
* Diagnosis of a condition or requires postoperative medication(s), which may interfere with bony/soft tissue healing
* Presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, HIV, long term use of steroids, etc.)
* History of substance abuse (drugs or alcohol)
* Condition that would preclude completing patient self assessment questionnaires
* Mentally incompetent or prisoner
* Currently a participant in another study

Primary outcomes:
measure: Radiographic Evaluation
timeFrame: 2 years
Secondary outcomes:
measure: Hospitalization Data
timeFrame: Intra-Operative
Other outcomes:
measure: Composite of Patient Self-Assessments
timeFrame: 2 years
Locations:
city: Saint Albans
country: United States
facility: Northwestern Medical Center
state: Vermont
Study officials:
affiliation: Northwestern Medical Center, St Albans, VT 05478
name: Michael Barnum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00284999: Soothe Versus Refresh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Syndromes
Lead sponsor: Pharmaceutical Research Network
Sponsor class: OTHER
First posted: 2006-02-01
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine the ocular efficacy and safety of Soothe and Refresh Tears.


Eligibility criteria: Inclusion Criteria:

* adults with a diagnosis of dry eyes
* Schirmer's with anesthesia grade between 1-7 mm inclusive after five (5) minutes in at least one eye
* a corneal staining grade of greater than or equal to 2 (scale 0-4) in the same qualifying eye as the Schirmer's test

Exclusion Criteria:

* contact lens use during the active treatment periods of the trial
* history of Sjogren's Syndrome
* temporary punctal occlusion that is still effective
* the current or anticipated use during the study of punctual plugs
* current treatment with Restasis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Coastal Research Associates, LLC
state: Georgia
city: Southfield
country: United States
facility: Michigan Cornea Associates
state: Michigan
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: Pharmaceutical Research Network, LLC
name: William C. Stewart, MD
role: STUDY_DIRECTOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Penny Asbell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Michigan Cornea Associates
name: Christopher Chow, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Coastal Research Associates, LLC
name: Douglas G. Day, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05305599: Different Doses of ZED1227 vs. Placebo in NAFLD
Official title: Double-blind, Randomized, Placebo-controlled, Phase II Dose-finding Study Comparing Different Doses of ZED1227 Capsules With Placebo in the Treatment of Non-alcoholic Fatty Liver Disease (NAFLD) With Significant Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: NAFLD
Liver Fibrosis
Lead sponsor: Dr. Falk Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2022-03-31
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double-blind, randomized, multicenter, placebo-controlled, comparative, exploratory phase II dose-finding trial. The trial will be conducted with four treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with daily doses of 20, 50, or 100 mg ZED1227 vs. placebo for the treatment of patients with NAFLD with fibrosis.


Eligibility criteria: Inclusion Criteria:

* Has provided signed informed consent
* Is a male or female ≥ 18 and \< 75 years of age
* Has diagnosed NAFLD
* Has diagnosed significant fibrosis (stages 2 or 3)

Exclusion Criteria:

* Has a history of significant alcohol consumption (an average of \> 20 g/d in females and \> 30 g/d in males)
* Has a history or presence of any other significant concomitant liver diseases
* Has diagnosed type 1 diabetes mellitus (T1DM)
* Has presence of cirrhosis

Primary outcomes:
measure: Relative change of PRO-C3 levels
timeFrame: 12 weeks
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: from baseline to 16 weeks
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Department of Medicine, University Medical Centre, Johannes Gutenberg University Mainz
state: Rheinland-Pfalz
Study officials:
References: