louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05293262: Endourological Management of Stones During COVID19
Official title: Definitive Endourological Interventions for Urolithiasis Management During COVID19- Outcomes From a Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urolithiasis
COVID-19
Keywords: endourology
pandemic
Lead sponsor: National University Health System, Singapore
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 158
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with obstructing urolithiasis who underwent decompression of ureteric stents, ureteroscopy or retrograde intrarenal surgery with laser lithotripsy during the period of study in our institution were included in the study

Brief summary: Guidelines for endourological procedures during COVID-19 have suggested deferring all elective procedures, while obstructed/ infected stones should undergo urgent decompression.

At our centre, screening protocols were implemented with prioritization strategies so that elective care could safely continue at deescalated rates. COVID or septic patients underwent emergency decompression, while non-COVID and non-septic patients underwent primary ureteroscopy (URS) or retrograde intrarenal surgery (RIRS).

We aim to report our experience with endourological surgery for stone disease during COVID-19.

Detailed description: We conducted a retrospective review of a prospectively maintained database of all endourological surgeries for stones in our centre during the first wave of COVID19.

Eligibility criteria: Inclusion criteria

- all patient with urolithiasis who underwent endourological interventions during COVID19 pandemic

Primary outcomes:
measure: Length of hospital stay
timeFrame: From admission to discharge from hospital, up to 3 months
measure: Complication rate
timeFrame: From admission up to 3 months post operatively
measure: Stone free rate
timeFrame: At follow up visit in clinic 3 months post procedure
Secondary outcomes:
measure: Readmission rate
timeFrame: From discharge up to three months post operatively
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Ng Teng Fong General Hospital, Singapore
Study officials:
affiliation: Ng Teng Fong General Hospital
name: Chin Tiong Heng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06393062: Gram Stain of the First Urine After Puncture in Percutaneous Nephrolithotomy
Official title: Gram Stain of the First Urine After Intraoperative Renal Puncture in Predicting the Systemic Inflammatory Response After Percutaneous Nephrolithotomy: A Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Percutaneous Nephrolithotomy
Keywords: fever
gram stain
percutaneous nephrolithotomy
Systemic inflammatory response syndrome (SIRS)
Lead sponsor: Adiyaman University
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients included in the study were randomized by a block randomization method by an independent researcher, hidden from the patients and the responsible clinicians, using a computerized number tool.
Primary purpose: PREVENTION

Brief summary: In this study, investigators compared the systemic inflammatory responses after percutaneous nephrolithotomy (PCNL) patients who were given an expanded empirical antibiotic regimen based on the prediction of the possibility of bacteria identified by Gram staining the first urine after renal puncture and patients whose antibiotic regimen was not performed and whose antibiotic regimen was adjusted according to patient symptoms and culture results. Investigators aimed to test its diagnostic value in predicting and preventing complications.


Eligibility criteria: Inclusion Criteria:

* patients with an indication for percutaneous nephrolithotomy due to kidney stone disease.

Exclusion Criteria:

* under 18 years old,
* having an active urinary tract infection before surgery and positive urine cultures,
* Patients with bilateral kidney stones,
* DJ stent or nephrostomy placement,
* Solitary kidney stones,
* Bleeding disorders,
* impaired kidney function,
* a history of antibiotic use for any reason within 2 weeks before randomization were excluded from the study.

Primary outcomes:
measure: Efficacy of Gram stain in predicting systemic inflammatory response after percutaneous nephrolithotomy.
timeFrame: immediately after the surgery
Secondary outcomes:
measure: Change of antibiotic regimen after bacterial estimation of Gram stain
timeFrame: immediately after the surgery
Other outcomes:
Locations:
city: Adıyaman
country: Turkey
facility: Adıyaman University, Medicine of Faculty
Study officials:
References:
Clinical trial NCT05328362: CanCope: Digital Intervention for Coping With Cannabis Craving
Official title: CanCope: Digital Intervention for Coping With Cannabis Craving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cannabis Use
Lead sponsor: Trustees of Dartmouth College
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2022-04-14
Enrollment: 53
Sex: ALL
Minimum age (years): 19
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Micro-Randomized Trial (MRT)
Primary purpose: TREATMENT

Brief summary: The CanCope Study is a micro-randomized trial conducted to gather evidence about and compare the effectiveness of a momentary intervention to help young adults cope with cannabis cravings as they attempt to reduce their use.

Detailed description: The CanCope Study is designed to test the effectiveness of two distinct strategies (mindfulness and distraction) to cope with cannabis cravings in young adults (19 - 25 years) who are attempting to reduce their cannabis use. Cannabis use is determined using a single-item question about the number of days out of the past 30 days the individual used cannabis. Young adults who reported using cannabis \>10 out of the past 30 days, who were not pregnant or breastfeeding, and who were not currently in treatment for problems related to substance use were eligible to enroll in this four-week study.

The CanCope intervention was delivered to participants through the MetricWire app, which was available for download on the participants' personal smartphones. Participants were asked to complete five ecological momentary assessments (EMA) per day, which asked questions related to cannabis use including one question about current level of craving on a scale of 0 - 10. If a participant reported a craving level \>4, a message was sent via the app encouraging the participant to try a mindfulness or distraction coping strategy, or the participant received a thank-you for completing the EMA which served as an attention control.

Eligibility criteria: Inclusion Criteria:

* Used cannabis at least 10 out of the past 30 days

Exclusion Criteria:

* Currently pregnant or breastfeeding
* Currently in treatment for problems related to substance use

Primary outcomes:
measure: Average Craving Level - Active vs. Control Messages
timeFrame: Minimum 2.8 hours after each decision point; Maximum 12.8 hours after each decision point
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Center for Technology and Behavioral Health
state: New Hampshire
Study officials:
affiliation: Dartmouth College
name: Catherine Stanger, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01024062: Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Non-Small Cell Lung Cancer (NSCLC)
Official title: Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Non-Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-12-02
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
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 efficacy and the safety of paclitaxel given weekly in patients with advanced or recurrent non-small cell lung cancer


Eligibility criteria: Inclusion Criteria:

* Patients with no prior chemotherapy who meet either of the listed below:
* Patient with stage IIIB or IV disease
* Patients with recurrent disease following potentially curative surgical resection
* Patients with previous chemotherapy up to one regimen

Exclusion Criteria:

* Patients with serious, uncontrolled medical illness
* Patients with previous therapy with taxanes

Primary outcomes:
measure: Response rate [defined as total number of patients with complete and partial response divided by number of response-evaluable patients] based on "Response Evaluation Criteria in Solid Tumors (RECIST)" in patients with no prior chemotherapy
timeFrame: Each 49 day course of treatment until withdrawal or unacceptable toxicity
measure: Safety: incidence and severity of adverse events, laboratory test abnormalities
timeFrame: Each 49 day course of treatment until withdrawal or unacceptable toxicity
Secondary outcomes:
measure: Duration of response, [measured from the time that measurement criteria are met for complete or partial response until the first date that recurrent or progressive disease is objectively documents]
timeFrame: Each 49 day course of treatment until withdrawal or unacceptable toxicity
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06183762: A Real-World Study of Treatment Patterns and Effectiveness in MET Mutation-Positive Advanced Lung Cancer
Official title: Real-World Treatment Patterns and Effectiveness of Targeted and Systemic Therapy in Patients With Advanced Lung Cancer Carrying MET Mutation-Positive
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Advanced Lung Cancer
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Advanced lung cancer, MET gene mutations

Brief summary: This is a descriptive observational study in which data are collected in an epidemiological manner. This study is not intended to alter or interfere with the current medical practice of the enrolled patients. Data will be collected in a forward-looking manner. This is a descriptive observational study in which data are collected in an epidemiological manner. This study is not intended to alter or interfere with the current medical practice of the enrolled patients. Data from patients on prior treatment will be collected retrospectively, and data from patients who will be treated later and included in the study will be collected in a prospective manner. The criteria for retrospective collection were consistent with those for prospective collection. Eligible patients will be enrolled after NGS analysis of tumor tissue and informed consent has been obtained. Information required for the study will be collected (every 3 months).


Eligibility criteria: Inclusion Criteria:

1. Patients must be ≥18 years of age.
2. Provision of fully informed consent prior to any study specific procedures.
3. Histologically or cytologically confirmed, unresectable stage IIIB/IIIC or stage IV NSCLC.
4. Genetic variants of tumor tissue detected by NGS.

Exclusion Criteria:

None.

Primary outcomes:
measure: Progression-Free-Survival
timeFrame: Assessed up to around 4.5 years
measure: Overall Survival
timeFrame: Assessed up to around 4.5 years
Secondary outcomes:
measure: Clinical relevance between genomic profiling and progression-free-survival
timeFrame: Assessed up to around 4.5 years
measure: Clinical relevance between genomic profiling and overall survival
timeFrame: Assessed up to around 4.5 years
measure: ORR
timeFrame: Assessed up to around 4.5 years
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Province Tumor Hospital
state: Hunan
Study officials:
References:
Clinical trial NCT00554762: Dose Response and Efficacy of GW842166 in Pain
Official title: A Phase I, Placebo Controlled, Randomised, Double Blind Two-way Crossover Study to Investigate the Dose Response and Efficacy of Single and Repeat Doses of GW842166 in Healthy Volunteers Using Pharmacodynamic Pain Assessments.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: mechanical pain,
heat pain,
dose,
efficacy
dose response,
GW842166,
Single,
pharmacodynamics,
repeat dose,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-11-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the dose response and efficacy of single and repeat doses of GW842166 in healthy volunteers using pharmacodynamic pain assessments.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects aged 18 to 50 years inclusive
* Body Weight \>50 Kg and BMI within the range 18.5 to 32 kg/m2 inclusive.
* Women who are not of child bearing potential

Exclusion Criteria:

* The subject has a positive pre-study urine screen for drugs of abuse or positive alcohol test.
* A positive pre-study (HIV), hepatitis B surface antigen or positive hepatitis C antibody result within 3 months of the start of the study.
* Abuse of alcohol defined as an average weekly intake of greater than 28 units (21 units for women) or an average daily intake of greater than 3 units (2 units for women). 1 unit is equivalent to a half-pint (220 mL) of beer or 1 (25 mL) measure of spirits or 1 glass (125 mL) of wine.
* Where participation in study would result in donation of blood in excess of 500 mL within a 56 day period.

Primary outcomes:
measure: • Heat pain threshold at 5 hours post dose
timeFrame: 5 Hours
Secondary outcomes:
measure: • Heat pain threshold at 3 hours post dose. • Mechanical pain threshold (using von Frey filaments) at 3 and 5 hours post dose.
timeFrame: 5 Hours
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02628262: Fundus Autofluorescence After Macular Hole Surgery
Official title: Fundus Autofluorescence Images in Gas-filled Eyes Immediately After Macular Hole Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Hole
Keywords: Macular hole
Lead sponsor: Kyorin University
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Optos ultrawide angle FAF images were taken in 27 eyes before and after MH surgery and compared with swept source optical coherence tomographic (SS-OCT) images.

Brief summary: Funds autofluorescence (FAF) indicates hyper fluorescence at the macular hole in the patients with macular hole. Investigators investigate the association between FAF and visual acuity, recovery of foveal microstructure, and FAF in surgically closed macular holes.

Detailed description: Ultrawide angle FAF images were taken in 27 eyes before and after macular hole surgery and compared with swept source optical coherence tomographic (SS-OCT) images.

Eligibility criteria: Inclusion Criteria:

* The patients were followed more than 6 months.

Exclusion Criteria:

* The patient were followed less than 6 months.

Primary outcomes:
measure: Visual acuity before and after surgery
timeFrame: Changes from baseline to 1,3, 6 months
Secondary outcomes:
measure: Fundus autofluorescence at the macula
timeFrame: Changes from baseline up to 6 months
Other outcomes:
Locations:
city: Mitaka
country: Japan
facility: Makoto Inoue
state: Tokyo
Study officials:
References:
Clinical trial NCT03644862: Study of Etafill in Patients With Cataract Surgery Via the Anterior Chamber
Official title: A Prospective, Single Center, Non-comparative, 90-day Follow-up, Postmarket Clinical Investigation of Etafill in Patients With Cataract Surgery Via the Anterior Chamber
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract Surgery
Lead sponsor: Croma-Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2018-08-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study patients will be recruited by the investigator, among patients scheduled to receive a standard cataract surgery taking inclusion and exclusion criteria into account. The investigator may also offer participation in the study to potential candidates identified in their patient database.

Brief summary: This prospective, single center, non-comparative, 90-day follow-up, post-market clinical investigation of etafill in patients undergoing cataract surgery.

The performance is measured by the preservation of endothelial cells measured by specular microscopy at the follow-up visit in comparison to baseline values.


Eligibility criteria: Inclusion Criteria:

* Patients indicated for cataract surgery via the anterior chamber
* A negative urine pregnancy test at Visit 1 or 2
* Capability to understand information about the investigation, including patients' obligations, and willingness to take part, as evidenced by signed and dated informed consent

Exclusion Criteria:

* Patients with a known hypersensitivity to HA or other components of the device.
* Patients with corneal scars or corneal dystrophies interfering with study measurements
* Abnormal intraocular pressure which would interfere with surgery and follow up (in opinion of the investigator)
* Any other condition that in the opinion of the investigator would interfere with the participation in this investigation
* Any person dependent on the investigator or employees of the investigation site institution or the Sponsor.
* Current or previous (within 30 days of enrollment) treatment with another investigational drug and/or medical device or participation in another clinical study
* Patients whose participation in clinical trials is prohibited by the Austrian Medical Devices Act

Primary outcomes:
measure: Specular microscopy to measure the preservation of endothelium cells
timeFrame: 90 days post surgery compared to baseline
Secondary outcomes:
measure: Specular microscopy to measure the corneal thickness
timeFrame: post surgery, 1 day and 90 days post surgery compared to baseline
measure: Intraocular pressure measurement
timeFrame: post surgery, 1 day and 90 days post surgery compared to baseline
measure: Questionnaire to assess the satisfaction with the application
timeFrame: day 0
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital
Study officials:
References:
Clinical trial NCT02961062: Study of SAF312 as an Eye Drop for Treatment of Eye Pain Following Photorefractive Keratectomy (PRK) Surgery
Official title: A Randomized, Vehicle-controlled, Subject and Investigator-masked, Proof-of-concept Study to Evaluate the Use of Topical Ocular SAF312 in the Treatment of Postoperative Ocular Pain in Patients Undergoing Photorefractive Keratectomy (PRK) Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Ocular Pain After PRK Surgery
Keywords: ocular pain
photorefractive keratectomy (PRK)
SAF312
corneal epithelial defect
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-11-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if SAF312 eye drops have an adequate safety and efficacy profile to justify further clinical development for the treatment of ocular pain associated with corneal epithelial defect such as after photorefractive keratectomy (PRK) surgery


Eligibility criteria: Inclusion Criteria:

* Normal eye exam except for refractive error at baseline.
* Myopia should not exceed -4.00 Diopters (sphere) and 3.00 diopters of astigmatism, with spherical equivalent not higher than -4.50, confirmed by manifest refraction at baseline.

Exclusion Criteria:

* Monocular patient (including amblyopia) or best corrected visual acuity score worse than 20/80 (Snellen) or 55 letters (EDTRS), at baseline.
* Any systemic or ocular disease that might affect wound healing (such as severe rheumatoid arthritis or diabetes or history of keloid formation) or a history of ocular trauma, uveitis, infection, or inflammation in the 6 months prior to baseline.
* Previous refractive or corneal surgery (such as LASIK, PRK, radial keratotomy, pterygium removal, corneal transplantation).
* Chronic pain of any etiology or any significant illness which has not resolved within two (2) weeks prior to initial dosing.

Other inclusion and exclusion criteria apply.

Primary outcomes:
measure: Visual Analog Scale (VAS) Pre-dose Pain Assessment
timeFrame: 6 hours
measure: Average Ocular Pain VAS Assessments
timeFrame: 12 hours
Secondary outcomes:
measure: Incidence of and Amount of Rescue Oral Analgesics (Number of Participants Who Did Not Use Oral Rescue Medication)
timeFrame: 6,12, 24, 48 and 72 hours post-operatievly
measure: VAS Pain Assessments
timeFrame: 72 hours
measure: Plasma Concentration of SAF312
timeFrame: day1, day 4
Other outcomes:
Locations:
city: Chevy Chase
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Sioux Falls
country: United States
facility: Novartis Investigative Site
state: South Dakota
city: Draper
country: United States
facility: Novartis Investigative Site
state: Utah
city: Norfolk
country: United States
facility: Novartis Investigative Site
state: Virginia
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: