louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02146794: Renal Denervation in Chronic Heart Failure
Official title: Renal Denervation in Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heart Failure
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2014-05-26
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Renal denervation can be carried out for heart failure

Detailed description: There are theoretical reasons why renal denervation might be beneficial for patients with chronic heart failure. It is not known whether they would suffer large drops in blood pressure which might compromise safety.

This pilot study required patients to remain in hospital for one week during which they had careful monitoring of blood pressure with the ability to halt the trial if any patient suffered any dangerous effect such as a large drop in blood pressure. It also monitored blood pressure after discharge for six months.

Eligibility criteria: Inclusion Criteria:

-Patients were required to have chronic symptomatic systolic heart failure (NYHA class III or IV) on maximal tolerated medical therapy, including beta-blocker, ACE inhibitor or angiotensin receptor blocker, and spironolactone.

Exclusion Criteria:

* Clinically unstable patients or those with significant valvular disease
* An estimated glomerular filtration rate \<35 ml/min
* Unfavourable renal anatomy
* Tortuous femoral arteries were not eligible

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 6 months
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: 6 months
measure: Serum Creatinine
timeFrame: 6 months
measure: Serum sodium
timeFrame: 6 months
measure: Serum potassium
timeFrame: 6 months
measure: 6 minute walk distance
timeFrame: 6 months
Other outcomes:
measure: Left ventricular ejection fraction by Echocardiography
timeFrame: 6 months
Locations:
Study officials:
affiliation: Imperial College London
name: Darrel P Francis, MD
role: STUDY_CHAIR
affiliation: Imperial College London
name: Justin E Davies, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shun-Shin MJ, Howard JP, Francis DP. Removing the hype from hypertension. BMJ. 2014 Mar 6;348:g1937. doi: 10.1136/bmj.g1937. No abstract available.
citation: Howard JP, Cole GD, Sievert H, Bhatt DL, Papademetriou V, Kandzari DE, Davies JE, Francis DP. Unintentional overestimation of an expected antihypertensive effect in drug and device trials: mechanisms and solutions. Int J Cardiol. 2014 Mar 1;172(1):29-35. doi: 10.1016/j.ijcard.2013.12.183. Epub 2014 Jan 8.
citation: Davies JE, Manisty CH, Petraco R, Barron AJ, Unsworth B, Mayet J, Hamady M, Hughes AD, Sever PS, Sobotka PA, Francis DP. First-in-man safety evaluation of renal denervation for chronic systolic heart failure: primary outcome from REACH-Pilot study. Int J Cardiol. 2013 Jan 20;162(3):189-92. doi: 10.1016/j.ijcard.2012.09.019. Epub 2012 Sep 29.
Clinical trial NCT04192994: Evaluation do Early Pars Plana Vitrectomy in Acute Endophthalmitis
Official title: Evaluation do Early Pars Plana Vitrectomy in Acute Endophthalmitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endophthalmitis
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Vinicius Campos Bergamo
name: Nilva Simeren Bueno de Moraes
name: Luis Filipe Nakayama
name: Natasha Ferreira Santos da Cruz
name: Murilo Ubukata Polizelli
First posted: 2019-12-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: Intravitreal Antibiotic: Group 1a: intravitreal antibiotic isolated; group 1b: intravitreal antibiotic isolated + oral moxifloxacin.

Group 2: PPV: Group 2a: PPV + intraoperative intravitreal antibiotic ; group 2b: PPV + oral moxifloxacin.
Primary purpose: TREATMENT

Brief summary: Our study will evaluate the efficacy of early PPV in acute endophthalmitis and attempt to prove its greater effectiveness for combating infection when compared to eyes that received only intravitreal antibiotic therapy

Detailed description: Endophthalmitis, a severe inflammatory ocular condition with profound visual impairment that can lead to irreversible visual loss, requires immediate treatment.

The only multicenter randomized trial of different forms of acute endophthalmitis treatment was the Endophthalmitis Vitrectomy Study. The study concluded that intravitreal antibiotic injection improves visual prognosis, and pars plana vitrectomy (PPV) improves the final visual acuity (VA) when performed in patients with light perception or worse VA.

Our study will evaluate the efficacy of early PPV in acute endophthalmitis and attempt to prove its greater effectiveness for combating infection when compared to eyes that received only intravitreal antibiotic therapy.

Primary Endpoint: The final VA, ocular anatomy, retinal layer anatomy, and ERG response in the intravitreal injection group will be compared with the PPV group.

Secondary Endpoint: The final VA, eyeball anatomy, retinal layer anatomy, and ERG response in the group that underwent PPV will be compared with and without oral moxifloxacin therapy.

Eligibility criteria: Inclusion Criteria:

* Patients with acute endophthalmitis with a history of ocular surgical procedures and a follow-up time of less than 6 weeks will be included.

Exclusion Criteria:

* Patients with endophthalmitis lasting more than 6 weeks and no history of eye surgery will be excluded.

Primary outcomes:
measure: Best Correct Visual Acuity
timeFrame: 1 year
measure: Ocular Anatomy
timeFrame: 1 year
measure: Electroretinography Response (ERG Response)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Dept of Ophthalmology - UNIFESP/Hospital São Paulo
state: SP
Study officials:
References:
Clinical trial NCT01117194: Effect on Shoulder Training Using Rehabilitation Robot for Stroke Patients
Official title: Rehabilitation Robot for Upper Limbs, Component Project 5: Effect on Shoulder Training Using Rehabilitation Robot for Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Stroke
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2010-05-05
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose is to study the effect of rehabilitation robot on shoulder training for stroke patients.


Eligibility criteria: Inclusion Criteria:

* stroke (1-3 months)
* Brunnstrom Stage II-III
* single, unilateral

Exclusion Criteria:

* aphasic
* shoulder impairment
* severe osteoporosis

Primary outcomes:
measure: Barthel index,
timeFrame: 1 year
measure: Modified Asworth Scale
timeFrame: 1 year
measure: STREAM and PASS scales
timeFrame: 1 year
Secondary outcomes:
measure: shoulder range of motion, VAS
timeFrame: 1 year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Dpt. Physical Medicine and Rehabilitation, NTUH
Study officials:
affiliation: Dpt. Physical Medicine and Rehabilitation, NTUH Taipei, Taiwan
name: Wen-Shiang Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04384094: Defining the Operating Parameters for a Rebound-esthesiometer
Official title: Rebound Esthesiometer Phase 2 Protocol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Corneal Sensation Reduced
Corneal Dystrophy
Corneal Degeneration
Corneal Transplant Failure
Herpetic Keratitis
Keywords: esthesiometry
corneal sensitivity
Lead sponsor: Icare Finland Oy
Sponsor class: INDUSTRY
First posted: 2020-05-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects entering ocular primary care examination site and patients entering eye hospital for several medical reasons.

Brief summary: The purpose of this study is to define the operating parameters for a new method to measure corneal sensitivity.

Detailed description: Corneal sensitivity is the most important protective mechanism of the eye. Thus, measuring it at any given time gives important indicators of corneal physiology, especially in the diagnostics of corneal and systemic diseases (e.g. diabetes, herpes simplex and keratitis) and recovery from ocular surgery. Current commercial measurement methods are outdated, non-quantitative and uncomfortable to use, hence left unused. This results in suboptimal, even poor, diagnosis and treatment for patients.

In this study the operating parameters for a state-of-the-art esthesiometer are defined. The operating principle is based on existing rebound technology which is already approved for IOP measurement.

Eligibility criteria: Inclusion Criteria:

* Age \>= 18
* Informed consent signed

Exclusion Criteria:

* Signs of infectious or inflammatory disease of anterior eye at the time of presentation.
* During last two weeks, any of the following events or conditions occurred or was present: inflammatory or infectious ocular condition, surgical or other intervention or therapy, other abnormal ocular event.
* Unable to give informed consent.
* Directly or indirectly indicated vunerability.

Primary outcomes:
measure: Rebound esthesiometer operating threshold
timeFrame: 2020-2021
measure: Rebound esthesiometer operating parameters
timeFrame: 2020-2021
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Optika Mesec
name: Matjaz Mihelcic, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05912894: Anatomical Variation in Rouvière's Sulcus
Official title: Anatomical Variation in Rouvière's Sulcus: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rouvière's Sulcus
Keywords: Prevalence Rouvière's Sulcus
Anatomical variations Rouvière's Sulcus
Lead sponsor: University Of Perugia
Sponsor class: OTHER
Collaborators: name: Giovanni Domenico Tebala
name: Luca Properzi
name: Nereo Vettoretto
name: Matteo Matteucci
name: Antonio Pesce
name: Carlo Boselli
name: Antonia Rizzuto
name: Augusto Lauro
First posted: 2023-06-22
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Laparoscopic cholecystectomy

Brief summary: Rouvière's sulcus is a 2-5 cm fissure lying on the lower face of the liver, between the right lobe and caudate process. Due to its extrabiliary location, Rouvière's Sulcus could be used as an anatomical landmark for safe laparoscopic cholecystectomy. In literature there's an high variability about Rouvière Sulcus prevalence and its anatomical variants.

Detailed description: The goal of this observational study is to evaluate the presence of Rouvière Sulcus in patients underwent laparoscopic cholecystectomy. The main questions it aims to answer are the prevalence and the anatomical variations of Rouvière's Sulcus and the variants of Rouvière's Sulcus which are catheghorized according to Singh and Prasad criteria.

The following were considered secondary outcome: operative time expressed in minutes, biliary tract injuries according to Stewart's classification and Vascular injuries.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing videolaparoscopic cholecystectomy

Exclusion Criteria:

* If the lower face of the right hepatic lobe and the main elements of the biliary tract cannot be clearly analyzed patients will be excluded.

Primary outcomes:
measure: Prevalence of Rouvière's Sulcus
timeFrame: 2 years
measure: Anatomical variations in Rouvière's Sulcus
timeFrame: 2 years
Secondary outcomes:
measure: Operative time
timeFrame: 2 years
measure: Biliary tract injuries
timeFrame: 2 years
measure: Vascular injuries
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
citation: Singh M, Prasad N. The anatomy of Rouviere's sulcus as seen during laparoscopic cholecystectomy: A proposed classification. J Minim Access Surg. 2017 Apr-Jun;13(2):89-95. doi: 10.4103/0972-9941.201731.
citation: Stewart L. Iatrogenic biliary injuries: identification, classification, and management. Surg Clin North Am. 2014 Apr;94(2):297-310. doi: 10.1016/j.suc.2014.01.008.
citation: Pesce A, Fabbri N, Feo CV. Vascular injury during laparoscopic cholecystectomy: An often-overlooked complication. World J Gastrointest Surg. 2023 Mar 27;15(3):338-345. doi: 10.4240/wjgs.v15.i3.338.
Clinical trial NCT00529594: Analgesic Effect of Etoricoxib (ARCOXIA®) 120MG During Retinal Laser Photocoagulation
Official title: Analgesic Effect of Etoricoxib (ARCOXIA®) 120MG During Retinal Laser Photocoagulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proliferative Diabetic Retinopathy
Keywords: Laser Photocoagulation
Pain relief
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2007-09-14
Enrollment: 44
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study wants to show if the medication etoricoxib 120 mg have reduces the patients pain during the laser photocoagulation, for diabetic retinopathy.

Detailed description: To do so we compare two group of patients, randomized 1:1, one use the medication(etoricoxib) and other use placebo and they quantify the pain using the Pain visual analogue scale

Eligibility criteria: Inclusion Criteria:

* Patients with diabetic retinopathy that needs laser photocoagulation for the first time

Exclusion Criteria:

* Younger than 17
* Signs and symptoms of liver dysfunction or abnormal liver function tests
* Gastrointestinal diseases
* Pregnant women
* Edema
* Pre-existing cardiac insufficiency

Primary outcomes:
measure: The group taking the etoricoxib feel less pain then the group taking placebo
timeFrame: After each laser session
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Clinica Oftalmologica do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
state: SP
Study officials:
affiliation: Clinica Oftalmologica do Hospital das Clinicas da Universidade de São Paulo
name: Vinicius P Nascimento, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02309294: 14-Day Cumulative Irritation Patch Test in Subjects With Normal Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cumulative Irritation
Keywords: Patch Test
Lead sponsor: Church & Dwight Company, Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-05
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The objective of this study is to determine the ability of the study material to cause irritation to the skin of humans under controlled patch test conditions. Substances that come into contact with human skin need to be evaluated for their propensity to irritate and/or sensitize. This testing is a modified primary irritancy patch test that can detect weak irritants that require multiple applications to cause a skin reaction.


Eligibility criteria: Inclusion Criteria:

* Are a male or female, 18 years of age or older, in general good health;
* Have normal skin;
* Are free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, will interfere with the study results or increase the risk of adverse events;
* Are of any skin type or race providing the skin pigmentation will allow discernment of erythema;
* Complete a medical screening procedure; and
* Read, understand, and sign an informed consent.

Exclusion Criteria:

* Have any visible skin disease at the study site which, in the opinion of the investigative personnel, will interfere with the evaluation;
* Are receiving systematic or topical drugs or medication which, in the opinion of the investigative personnel, will interfere with the study results;
* Have psoriasis and/or active atopic dermatitis/eczema; and/or
* Have a known sensitivity to cosmetics, skin care products, or topical drugs as related to the material being evaluated.

Primary outcomes:
measure: Number of Subjects That Showed no Significant Irritation
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fair Lawn
country: United States
facility: TKL Research, Inc.
state: New Jersey
Study officials:
References:
Clinical trial NCT03064594: Comparison of Laparoscopic Cornuostomy and Wedge Resection for Interstitial Pregnancy
Official title: Comparison of Laparoscopic Cornuostomy and Wedge Resection for Interstitial Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cornual Pregnancy
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2017-02-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the cases with cornual pregnancy

Brief summary: This retrospective study is to find out the best way to treat patient with cornual pregnancy in the aspect of further pregnancy outcome.

Detailed description: To find out the best way to treat patient with cornual pregnancy in the aspect of further pregnancy outcome, the investigators compared the outcomes of laparoscopic wedge resection (LWR) and laparoscopic cornuostomy (LC) by the retrospective chart review.

Eligibility criteria: Inclusion Criteria:

* All women with cornual pregnancy who were admitted to the Department of Obstetrics and Gynecology of the Far Eastern Memorial Hospital for laparoscopic surgeries between January 2008 and June 2016 were enrolled

Exclusion Criteria:

* The person who was pregnant at the time of the operation
* After receiving IVF course of treatment
* Patients with uterine horns undergoing open surgery

Primary outcomes:
measure: pregnancy rate
timeFrame: 9 years
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
state: Banqiao
Study officials:
References:
Clinical trial NCT02996760: Influence Instillation Plasma Rich in Growth Factors in Endometrial Cavity Endometrial Development in Assisted Reproduction.
Official title: Influence Instillation Plasma Rich in Growth Factors in Endometrial Cavity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Endometrial Development
Lead sponsor: IVI Bilbao
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Women in assisted reproduction treatment they receive own or donated embryos and presenting an endometrial development less than 5 mm despite having received treatment with estrogen therapy knowing the clinical value of using the PRGF-Endoret therapy and endometrial level applications to improve endometrial thickness endometrial preparations for embryo transfer.


Eligibility criteria: Inclusion Criteria:

* Women receiving cycle of oocytes outside or embryos (own / others), in the treatment of substituted cycle type.
* Less than 5mm despite 10 days with standard doses of estrogen therapy (6mg / 24h) Endometrio

Exclusion Criteria:

* History of pelvic inflammatory disease
* Risk of infection

Primary outcomes:
measure: To evaluate the growth of endometrial thickness
timeFrame: During ovarian stimulation protocol 8-12 days
Secondary outcomes:
measure: Analyze the impact of using platelet plasma on rates of implantation and pregnancy.
timeFrame: During ovarian stimulation protocol 8-12 days
Other outcomes:
Locations:
city: Leioa
country: Spain
facility: IVI Bilbao
state: Vizcaya
Study officials:
References:
Clinical trial NCT06194760: Evaluation of Vitrectomy With ILM Peeling in Myopic Macular Hole With Only Posterior Retinal Detachment
Official title: Evaluation of Vitrectomy With ILM Peeling in Myopic Macular Hole With Only Posterior Retinal Detachment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Retinal Detachment
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 13
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Retinal detachment (RD) resulting from the macular hole (MH), also known as MH-induced RD (MHRD), most commonly occurs in eyes with high myopia and results in irreversible visual disorders. Although ILM peeling for MHRD reportedly achieves a high retinal reattachment rate that ranges from 70% to 100%, the MH closure rate is relatively low, ranging from 10% to 70%.


Eligibility criteria: Inclusion Criteria:

* patients with high myopia (a spherical equivalent refractive error of at least -6.0 diopters (D) and an axial length of at least 26.5 mm).
* Macular hole and only posterior retinal detachment

Exclusion Criteria:

* Other causes of RD
* Patients with a history of trauma, choroidal neovascularization, coexistence with a peripheral retinal break or proliferative vitreoretinopathy
* History of any vitreoretinal surgery prior to MHRD and less than 36 months of follow-up after the surgery

Primary outcomes:
measure: Closure of macular hole
timeFrame: 6 months post operative
measure: BCVA
timeFrame: baseline
measure: BCVA
timeFrame: 6 months postoperative
measure: BCVA
timeFrame: 12 months postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Damieta
country: Egypt
facility: Ehab tharwat
state: New Damietta
Study officials:
References: