louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00238797: A Phase II Exploratory, Multicentre, Open-label, Non-comparative Study of ZD1839 (Iressa) and Radiotherapy in the Treatment of Patients With Glioblastoma Multiforme
Official title: A Phase II Exploratory, Multicentre, Open-label, Non-comparative Study of ZD1839 (Iressa™) and Radiotherapy in the Treatment of Patients With Glioblastoma Multiforme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glioblastoma
Keywords: Glioblastoma multiforme
Brain tumour
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the efficacy of gefitinib (IressaTM) in combination with radiotherapy on patients with glioblastoma multiforme.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* histologically-or cytologically-confirmed glioblastoma multiforme
* age 18 years or older

Exclusion Criteria:

* Have had prior radiation therapy, immunotherapy, gene therapy and/or chemotherapy for the glioblastoma
* co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
* known severe hypersensitivity to ZD1839 or any of the excipients of this product.

Primary outcomes:
measure: Objective tumour response at 6 months after the end of combination treatment by computerized tomography scan or magnetic resonance imaging of the brain according to Macdonald criteria.
Secondary outcomes:
measure: Disease control rate at 6 months after the combination treatment, clinical or radiological progression-free-survival, overall survival and safety of ZD1839 in combination with radiotherapy.
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Umeå
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Medical Science Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06737497: Analysis of the Effectiveness and Safety of RIRS Under Local Anesthesia and Its Influencing Factors
Official title: Analysis of the Effectiveness and Safety of Retrograde Intrarenal Surgery (RIRS) Under Local Anesthesia and Its Influencing Factors
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Urolithiasis
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with upper urinary tract stones who are willing to undergo RIRS under local anesthesia.

Brief summary: Retrograde intrarenal surgery (RIRS) is a well-established technique and is the first-line treatment option for upper urinary tract stones \<2cm. Currently, most ureteroscopic procedures are performed under general or epidural anesthesia, both of which are safe and feasible. In recent years, more and more studies have shown that retrograde intrarenal surgery (RIRS) under local anesthesia is safe and feasible. However, we can see that the current studies on RIRS under local anesthesia are mostly case reports, and there is a lack of systematic studies on the safety and effectiveness of RIRS under local anesthesia and its influencing factors. Therefore, the researchers hope to conduct a single-center prospective observational study to explore the safety, effectiveness and influencing factors of RIRS under local anesthesia, so as to optimize the surgical process of RIRS under local anesthesia, improve the surgical success rate and ensure surgical safety。


Eligibility criteria: Inclusion Criteria:

1. Kidney stones or upper ureteral stones 1-4cm;
2. Age 18-70 years old;
3. American Society of Anesthesiologists(ASA) score Ⅰ, Ⅱ and Ⅲ;

Exclusion Criteria:

1. Surgical operations other than RIRS are required for patients with middle and lower ureteral calculi;
2. There are anatomical abnormalities, such as ureteral stenosis, urine flow diversion, ectopic kidney, horseshoe kidney, duplicate kidney, etc.
3. Severe heart, brain and lung diseases;
4. Pregnancy.

Primary outcomes:
measure: pain score
timeFrame: 1 day after sugery
measure: Operative time
timeFrame: During surgery
Secondary outcomes:
measure: stone-free rate
timeFrame: From enrollment to the end of treatment at 1 month
measure: stone-free rate
timeFrame: From enrollment to the end of treatment at 24 hours
measure: Complication rate
timeFrame: 1 month after sugery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT03514797: Combined Dental Bleaching Protocols and Time Required to Achieve Satisfactory Color
Official title: Effect of a Single Prior Session of In-office Dental Bleaching on Time Required to Obtain Satisfactory Tooth Color With At-home Bleaching
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tooth Discoloration
Keywords: Tooth bleaching
Hydrogen peroxide
Carbamide peroxide
Tooth Bleaching Agents
Lead sponsor: Universidade Federal de Sergipe
Sponsor class: OTHER
First posted: 2018-05-02
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This parallel, randomized, and controlled clinical trial will assess the effect of a single prior session of in-office dental bleaching on time required to achieve satisfactory tooth color with at-home bleaching. Participants enrolled will randomly allocated to receive or not a single session of dental bleaching with 35% hydrogen peroxide applied for 45 min. Following, all participants will use customized trays filled with 10% carbamide peroxide for 1h per day until obtain satisfactory results. The primary outcome will be the number of days necessary to obtain satisfactory tooth color. Furthermore, tooth sensitivity and color changes measured with spectrophotometer will be assessed.


Eligibility criteria: Inclusion Criteria:

* Good general and oral health;
* Upper canines darker than the tab 2.5M2 at VITA Bleachedguide 3D-MASTER® (Vita-Zahnfabrik, Bad Sackingen, Germany) scale.

Exclusion Criteria:

* Presence of non-treated caries or periodontal disease;
* Prior tooth hypersensitivity;
* Presence of gingival recession;
* Teeth with cracked enamel or any hypoplasia;
* Patients using oral removable or fixed orthodontic appliances;
* Patients were pregnant or breastfeeding.

Primary outcomes:
measure: Time to tooth color satisfaction
timeFrame: up to 1 month after beginning the tooth bleaching procedures
Secondary outcomes:
measure: Color change
timeFrame: up to 1 month after beginning the tooth bleaching procedures
measure: Tooth sensitivity
timeFrame: 1, 2, 3, and 4 week after beginning the tooth bleaching procedures
Other outcomes:
Locations:
city: Aracaju
country: Brazil
facility: Universidade Federal de Sergipe
state: SE
Study officials:
References:
citation: Rezende M, Ferri L, Kossatz S, Loguercio AD, Reis A. Combined Bleaching Technique Using Low and High Hydrogen Peroxide In-Office Bleaching Gel. Oper Dent. 2016 Jul-Aug;41(4):388-96. doi: 10.2341/15-266-C. Epub 2016 Feb 26.
citation: Cardoso PC, Reis A, Loguercio A, Vieira LC, Baratieri LN. Clinical effectiveness and tooth sensitivity associated with different bleaching times for a 10 percent carbamide peroxide gel. J Am Dent Assoc. 2010 Oct;141(10):1213-20. doi: 10.14219/jada.archive.2010.0048.
Clinical trial NCT00691197: Safety and Acceptability of Using a Rewetting Drop With Contact Lens Wear
Official title: Safety and Acceptability of Using a Rewetting Drop With Contact Lens Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Ametropia
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2008-06-05
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Testing the Safety and Acceptability of Using a Rewetting Drop with Contact Lenses


Eligibility criteria: Inclusion Criteria:

* Adapted contact lens wearer

Exclusion Criteria:

* Monovision lens wearer, ocular or systemic disease, pregnant or planning to become pregnant

Primary outcomes:
measure: Best Corrected Visual Acuity
timeFrame: Change from Baseline at Day 90
Secondary outcomes:
measure: Corneal Staining
timeFrame: Day 90
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_CHAIR
References:
Clinical trial NCT02521883: Transcranial Direct Current Stimulation (tDCS) as an add-on Therapy for Treatment of Major Depressive Disorder. (DEPTDCS2014)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Depression
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Tampere University Hospital
name: Sooma Oy
First posted: 2015-08-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim is to investigate the safety and effectiveness of transcranial Direct Current Stimulation (tDCS) in patients with moderate to severe major depression compared to patients treated with conventional therapy. The tDCS will be used as add-on to conventional therapy.

This is a randomized 2-arm parallel, double blind study comparing 2 groups of 60 patients.


Eligibility criteria: Inclusion Criteria:

* Fulfils the ICD-10 diagnostic criteria for moderate or severe major depressive episode (F32), or recurrent major depressive episode (F33)
* Able to understand the purpose and potential risks of the study
* Able to sign informed consent

Exclusion Criteria:

* intracranial metal implants or other foreign intracranial metal object
* history of neurological conditions e.g. epilepsy, stroke (ischemic or haemorrhagic); brain tumor; increased intracranial pressure etc.
* schizophrenia
* bipolar disorder
* psychotic disorder
* substance abuse or dependency
* contra-indications to tDCS
* personality disorder that may prevent him/her to commit to the study
* skin lesion in the area of stimulation
* planned treatment of current depressive episode with ECT or rTMS

Primary outcomes:
measure: Change from baseline in Montgomery-Åsberg depression scale (MADRS)
timeFrame: baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months
Secondary outcomes:
measure: Dichotomised response measured with MADRS.
timeFrame: baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months
measure: Change from baseline in Beck Depression Inventory (BDI) scale.
timeFrame: baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months
measure: Dichotomised remission measured with MADRS.
timeFrame: baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months
Other outcomes:
Locations:
city: Lahti
country: Finland
facility: PHSOTEY, Psykiatrian tulosalue, ECT-yksikkö
city: Lieto
country: Finland
facility: VSSHP Psykiatria, Liedon aikuispsykiatrian poliklinikka
city: Turku
country: Finland
facility: Turku University Hospital
city: Stockholm
country: Sweden
facility: Sektionen för affektiva sjukdomar, Norra Stockholms Psykiatri, Stockholms läns sjukvårdsområde
state: Stockholms Län
Study officials:
affiliation: Turku University Hospital
name: Tero Taiminen, MD, docent
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02619383: HBOT Application in Erectile Dysfunction
Official title: Hyperbaric Oxygen Can Improve Erectile Dysfunction and Induce Penile Angiogenesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Erectile Dysfunction
Hyperbaric Oxygen Therapy
Keywords: HBOT
hyperbaric oxygen
DCE
ED
erectile dysfunction
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-12-02
Enrollment: 37
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Recent studies have shown that hyperbaric oxygen therapy (HBOT) can induce angiogenesis and improve impaired organ function. HBOT was also recently suggested as a possible therapy for ED due to surgical injuries. However, the effect of HBOT on non-surgical related ED has not been investigated to date.

The objective in this study was to assess the effect of HBOT on patients with ED by means of sexual function questionnaires and novel imaging techniques.

Detailed description: A prospective analysis of men, age 18 years or older, with a clinical diagnosis of erectile dysfunction, reporting decreased and weakened nocturnal penile tumescence of six months duration or longer.

Patients were treated at The treatment comprised 40 daily hyperbaric sessions, 5 days a week, in a multiplace hyperbaric chamber (HAUX-Life-Support GmbH). Each session consisted of 90 minutes of exposure to 100% oxygen at 2 ATA with 5 minutes air breaks every 30 minutes and 1 meter per minute compression and decompression.

Sexual function Efficacy of the treatment was assessed using the International Index of Erectile Function (IIEF) questionnaire which was filled by all patients at baseline and within 2 weeks of the last HBOT session. In addition, assessing efficacy was the global efficacy question (GEQ) ("Did the treatment improve your erections?"), with a response of yes or no.

Six patients underwent two MRI scans 1-2 weeks prior to and after HBOT. Imaging was conducted in using a 3Tesla system (MAGNETOM Skyra, Siemens Medical Solutions, , Germany). The MRI protocol included anatomic T1 and T2 sequences and DCE. The MRI DCE sequence parameters are detailed in supplementary section.

Eligibility criteria: Inclusion Criteria:

* age 18 years or older
* clinical diagnosis of erectile dysfunction
* reporting decreased and weakened nocturnal penile tumescence of six months duration or longer

Exclusion Criteria:

* penile anatomical defects,
* any active or history of malignancy including prostate cancer
* spinal cord injury
* any major psychiatric disorder uncontrolled with treatment
* claustrophobia
* chronic lung disease
* chronic middle ear or sinus diseases.

Primary outcomes:
measure: Sexual function
timeFrame: 3 months
measure: Sexual function
timeFrame: 3 months
Secondary outcomes:
measure: Imaging of penile perfusion
timeFrame: 3 months
measure: Adverse events
timeFrame: 3 months
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf-Harofeh Medical Center
Study officials:
References:
Clinical trial NCT04608383: Laparoscopy and COVID-19 Contamination
Official title: Laparoscopy and COVID-19 Contamination
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: LAPAROSCOPY
pneumoperitoneum
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any adult requiring a laparoscopic procedure with a positive or suspected Covid19 status.

Brief summary: The aim of the study is to search the presence of the SARS-COV-2 virus (COVID19) in the pneumoperitoneum of patients with a positive (or suspected) COVID19 status during a routine laparoscopy.


Eligibility criteria: Inclusion Criteria:

* Patient of legal age
* Indication for laparoscopy
* Positive (past or current) or suspected Covid19 status (cough, fever, suggestive radiological images, etc.)
* Lack of opposition to participating in the study

Exclusion Criteria:

* Patient under legal protection
* Covid19 status negative, (former or current) and not suspected
* Patient unable to object
* Patient with no social security care

Primary outcomes:
measure: The main objective of the study is to demonstrate the presence of SARS-COV-2 in the exsufflated gas at the end of laparoscopy.
timeFrame: Day 1 , at the end of the surgery
Secondary outcomes:
measure: The secondary objective of the study is to demonstrate the presence of SARS-COV-2 in the peritoneal fluid during laparoscopy
timeFrame: Day 1 , at the end of the surgery
Other outcomes:
Locations:
city: Le Kremlin Bicêtre
country: France
facility: AP-HP, Bicêtre Hospital, Anesthesia Department
city: Le Kremlin Bicêtre
country: France
facility: AP-HP, Bicêtre Hospital, Gynecology department
city: Le Kremlin-Bicêtre
country: France
facility: AP-HP, Bicêtre Hospital, Department of Digestive and Oncological Surgery
city: Le Kremlin-Bicêtre
country: France
facility: AP-HP, Bicêtre Hospital, Urology Department
Study officials:
References:
Clinical trial NCT02018783: Single Application of Desensitizing Pastes as Dentin Sensitivity Treatment
Official title: Clinical Evaluation of the Effectiveness of Immediate Relief Obtained With Desensitizing Creams - A Controlled, Randomized, Triple Masked, Split-Mouth Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentine Hypersensitivity
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 138
Sex: ALL
Minimum age (years): 22
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the efficacy of three desensitizing toothpastes for immediate and intermediate-term relief of CDH, when compared with a control toothpaste. One hundred and thirty-eight hypersensitive teeth were diagnosed and randomized into four groups according to the therapeutic agent of each desensitizing cream tested: 1) strontium acetate and calcium carbonate, 2) calcium carbonate and arginine 8%, 3) calcium phosphate nanoparticles and 4) a control toothpaste. The desensitizing creams were applied according to the manufacturer's instructions. Cervical dentin hypersensitivity was assessed at baseline, immediately, 24 hours and 30 days after the treatment. Cold and evaporative tests were used to assess the sensitivity level.


Eligibility criteria: Inclusion Criteria:

* subjects 18 years or older
* in good general and oral health; have complaint of CDH in teeth distributed in all 4 quadrants
* not making use of desensitizing agents
* not having undergone periodontal treatment over the past 3 months
* respond to evaporative stimulus with a score ≥ 1.5 cm on VAS

Exclusion Criteria:

* patients who presented restorations and caries near the exposed dentin of the hypersensitive teeth
* who made frequent use of painkillers, anti-inflammatory and antidepressants drugs

Primary outcomes:
measure: cervical dentin hypersensitivity
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Diamantina
country: Brazil
facility: Periodontics Clinic, Department of Dentistry
state: Minas Gerais
Study officials:
affiliation: Federal University of São Paulo
name: Olga D Flecha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03162783: A Randomized, Double Masked, Clinical Study of Subjects With Dry Eye Syndrome
Official title: A Single-Center, Phase 2a, Randomized, Double Masked, Clinical Study to Assess the Safety, Tolerability, and Pharmacodynamic Activity of ADX-102 Ophthalmic Solution in Subjects With Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndromes
Keywords: Aldeyra
Lead sponsor: Aldeyra Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-05-22
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this study is to evaluate the safety, tolerability, and pharmacodynamic activity of ADX-102 Ophthalmic Solutions and ADX-102 Ophthalmic Lipid Solution in subjects with dry eye syndrome.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age of either gender and any race;
* Have a reported history of dry eye for at least 6 months prior to Visit 1;
* Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1;

Exclusion Criteria:

* Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
* Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
* Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
* Have used cyclosporine 0.05% or lifitegrast 5.0% ophthalmic solution within 45 days of Visit 1;
* Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within the last 6 months;
* Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;

Primary outcomes:
measure: Efficacy of ADX-102 on Ocular Discomfort Using the Ora Calibra® Ocular Discomfort Scale.
timeFrame: Efficacy assessment period (Day 1 through Day 29), Day 29 reported.
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
References:
citation: Clark D, Sheppard J, Brady TC. A Randomized Double-Masked Phase 2a Trial to Evaluate Activity and Safety of Topical Ocular Reproxalap, a Novel RASP Inhibitor, in Dry Eye Disease. J Ocul Pharmacol Ther. 2021 May;37(4):193-199. doi: 10.1089/jop.2020.0087. Epub 2021 Jan 15.