louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03116035: Impact of Pre-Operative Web-based Breast Cancer Information on the Quality of Patient Decision-Making
Official title: A Randomized Controlled Trial Evaluating the Impact of Pre-Operative Web-based Breast Cancer Information on the Quality of Patient Decision-Making
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Knowledge, Attitudes, Practice
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 244
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a prospective randomized control trial to compare the impact of two different types of pre-operative web-based breast cancer information on the quality of patient decision making. Patients are emailed web-based information prior to the surgical consultation. Outcomes are assess at multiple time points: 1) prior to the surgical consultation, 2) immediately following the consultation.


Eligibility criteria: 1. \>18 years of age
2. Newly diagnosed stage 0-3 breast cancer
3. English speaking
4. Has an email address
5. No prior recent contact with the breast surgeon

Primary outcomes:
measure: Knowledge using the Breast Cancer Decision Quality Instrument
timeFrame: immediately prior to the surgical consultation
Secondary outcomes:
measure: Decisional concordance using the Breast Cancer Decision Quality Instrument
timeFrame: immediately prior to the surgical consultation
measure: Perceived communication with the breast surgeon using the Breast Cancer Decision Quality Instrument
timeFrame: following the surgical consultation but prior to the surgery
measure: Breast surgeon and staff (nurse, mid-level provider) assessment of how the web-based decision aid versus standard high-quality breast cancer websites influenced their patient interactions, based on Practitioner Opinion Survey
timeFrame: at completion of patient accrual, estimated to be 2 years after initiating study
Other outcomes:
Locations:
Study officials:
References:
citation: Tucholka JL, Yang DY, Bruce JG, Steffens NM, Schumacher JR, Greenberg CC, Wilke LG, Steiman J, Neuman HB. A Randomized Controlled Trial Evaluating the Impact of Web-Based Information on Breast Cancer Patients' Knowledge of Surgical Treatment Options. J Am Coll Surg. 2018 Feb;226(2):126-133. doi: 10.1016/j.jamcollsurg.2017.10.024. Epub 2017 Dec 12.
Clinical trial NCT05714735: SMCV Assessment on Brain Swelling in Patients With SAH From Ruptured Artery Aneurysm
Official title: Assessment of Superficial Cerebral Venous Structures in Brain Swelling in Patients With Subarachnoid Hemorrhage From Anterior Communicating Artery Aneurysmal
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arterial Aneurysm
Keywords: Brain Swelling,Subarachnoid Hemorrhage,Artery Aneurysmal
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: The People Hospital of Baoan Shenzhen
First posted: 2023-02-06
Enrollment: 198
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 anterior circulation aneurysmal subarachnoid hemorrhage

Brief summary: Superficial cerebral veins findings in assessment of brain swelling in patients with aneurysmal subarachnoid hemorrhage who underwent intravenenous DSA examinations

Detailed description: Superficial cerebral veins findings in assessment of brain swelling in patients with aneurysmal subarachnoid hemorrhage who underwent intravenenous DSA examinations.To explore the relationship between the structure of middle and superficial cerebral veins in cerebral angiography and cerebral edema after ischemia-reperfusion of anterior circulation with large core infarction.

Eligibility criteria: Inclusion criteria:

* age 18-70 years;
* Hunt-Hess grade IV-V on admission; single aneurysm in the anterior circulation; interventional embolization of aneurysm is the first choice, and preoperative ventricular puncture drainage and intracranial pressure probe placement.

Exclusion criteria:

* Hunt-Hess grade I-III on admission;
* patients with blood bubble-like aneurysm or accompanying intracranial hematoma who are not suitable for interventional embolization; those who directly choose craniotomy and clipping;
* poor general condition or combined with pregnancy , malignant tumors, etc.

Primary outcomes:
measure: Death
timeFrame: One year
measure: Bleeding events
timeFrame: One year
Secondary outcomes:
measure: Brain swelling
timeFrame: One year
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: The People Hospital of Shenzhen Baoan
state: Guangdong
Study officials:
affiliation: The People Hospital of Shenzhen Baoan
name: qiaoyu huang, M.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT01286935: 18-month Study of Long-term Efficacy & Safety of Safinamide as add-on Therapy in Patients With Mid-late Stage PD
Official title: A Phase III, Double-blind, Placebo-controlled, 18-mon Ext Study Long-term Efficacy & Safety of 50 & 100mg/Day Doses of Safinamide, as add-on Therapy, in Idiopathic PD Pts With Motor Fluctuations, Treated With Levodopa, Who May be Receiving DA, and/or Anticholinergic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
PD
Levodopa
Patients with idiopathic Parkinson's Disease with motor fluctuations,
Lead sponsor: Newron Pharmaceuticals SPA
Sponsor class: INDUSTRY
First posted: 2011-01-31
Enrollment: 544
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the long-term efficacy and safety of two doses of safinamide (50 and 100 mg/day, p.o), compared to placebo, as add-on therapy in patients with idiopathic Parkinson's disease with motor fluctuations, who are currently receiving a stable dose of levodopa.


Eligibility criteria: Inclusion Criteria:

* The patient completed 24 weeks of treatment in Study 016, or, if the patient discontinued prematurely, he/she returned for scheduled efficacy evaluations at Weeks 12 and 24, as part of the Retrieved Dropout (RDO) population.
* The patient was compliant with taking study medication in Study 016.
* The patient is willing to participate in the study and signed an approved Informed Consent form.

Exclusion Criteria:

* The patient is experiencing clinically significant adverse events that would put the patient at risk for participating in the study.
* The patient has shown clinically significant deterioration during participation in Study 016, and has reached Hoehn and Yahr Stage V.
* The patient discontinued Study 016 prematurely for any reason, and did not return for scheduled efficacy evaluations at Weeks 12 and 24.

Primary outcomes:
measure: Mean change in the dyskinesias rating scale (DRS) during "on" time
timeFrame: Up to 104 weeks (from baseline 016 to EOS study 018)
Secondary outcomes:
measure: Endpoints include 'ON time', responder rates and UPDRS IV change
timeFrame: Up to 104 weeks (from baseline 016 to EOS study 018)
Other outcomes:
Locations:
Study officials:
affiliation: PI's are the same as for study NW-1015/016/III/2006
name: See Study 016 for details
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03911635: Selective Criteria and a Modified Technique of Applying "URAGPI" Technique for More Proximal Degree of Hypospadias
Official title: Applying of Urethral Advancement, Glanuloplasty and Preputioplasty Technique for More Proximal Degrees of Hypospadias. Selective Criteria and a Modified Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypospadias
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 75
Sex: MALE
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hypospadias is a condition in which the location of the urethral meatus is on the ventral aspect of the penis.

Hypospadias is the most common congenital anomaly of urogenital organs in boys, with an incidence of approximately 1 in 250 newborns. Recently, case selection has been advised to avoid possible complications and limitations \[1\]. The meatal advancement and glanuloplasty (MAGPI) procedure was first described in 1981 for the repair of distal hypospadias. An excellent surgical result requires careful case selection, avoiding cases with thin or rigid ventral para-meatal skin or a meatus too proximal or too wide. The glans wrap to support the advanced ventral urethral wall requires a solid tissue approximation in two layers to prevent regression of the meatus. Meatal stenosis can be avoided by assuring an adequate dorsal Heineke- Mikulicz tissue rearrangement and making an incision from within the urethral meatus well distally into the urethral groove. . The overall success rate with the MAGPI procedure suggests that it should continue to be used in the repair of distal hypospadias \[2\]. The advantage of Urethral advancement, Glanuloplasty, and Preputioplasty \&quot; URAGPI\&quot; versus MAGPI Is that A) Applicability to almost any type of distal hypospadias regardless of the severity of glanular ventriflexion.

B) Normal appearance of the penis. C) Good functional results.


Eligibility criteria: Inclusion Criteria:

* All patient with hypospadias from 1 to 12 years with penile selection according to Wang YN et. al

Exclusion Criteria:

* circumcised patients
* sever degrees of chordae
* previous surgical repair
* meatal stenosis

Primary outcomes:
measure: Assessment of the patient immediately after removal of the catheter at the 7th day and after 3 weeks
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01806935: Xerotic Dermatitis in Aged People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Itching Symptoms
Xerotic Dermatitis
Keywords: associated
aged population
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2013-03-07
Enrollment: 442
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the the effect of the study product on itching symptoms associated with xerotic dermatitis in aged population


Eligibility criteria: Inclusion Criteria:

* Aged from 70 years
* With xerotic dermatitis, clinically assessed ,
* At least on the anterior part of lower and/or upper limbs,
* Presenting itching xerotic dermatitis evolving from at least 3 weeks
* Intensity of itching ≥ 4 on VAS (0-10) at th inclusion time
* With MMSE score ≥ 20 dating less than 6 months
* Affiliated to a social security system, or is a beneficiary (as applicable in the national regulation)

Exclusion Criteria:

* Criteria related to pathologies

  * Severe form of other dermatitis requiring either systemic treatment

    -- Itching xerotic dermatitis from iatrogenic origins
  * Dermatological disease other than xerotic dermatitis which could interfere with the assessment,
  * Systemic disease that may generate xerotic dermatitis and /or pruritus
  * Immunosuppression condition,
  * History of serious disease considered by the investigator hazardous for the patient or incompatible with the study.
* Criteria related to treatment

  - Use of treatment which could interfere with the evaluation of the disease or the course of the disease
* Criteria related to the population

  * Ongoing participation to another clinical trial or participation in the previous month before the inclusion
  * Patient under guardianship or trusteeship

Primary outcomes:
measure: Itching symptoms intensity change
timeFrame: From Day 1 to 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: 0521
city: Angers
country: France
facility: 0523
city: Cugnaux
country: France
facility: 0520
city: Le Fousseret
country: France
facility: 0517
city: Muret
country: France
facility: 0518
city: Muret
country: France
facility: 0519
city: Saint Orens de Gameville
country: France
facility: 0515
city: Saint Orens de Gameville
country: France
facility: 0516
city: Seysses
country: France
facility: 0511
city: Seysses
country: France
facility: 0512
city: Seysses
country: France
facility: 0513
city: Seysses
country: France
facility: 0514
city: Tierce
country: France
facility: 0522
city: Toulouse
country: France
facility: 0501
Study officials:
affiliation: Hôpital Purpan CHU TOULOUSE, France
name: Yves Rolland
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01004835: The Migraine and Pain Study GeneBank at Scripps Clinic Registry (MAPS)
Official title: The Migraine and Pain Study GeneBank at Scripps Clinic Registry (MAPS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine Disease
Keywords: migraine
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
First posted: 2009-10-30
Enrollment: 61
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the Migraine disease patient population at Scripps Clinic and around Southern California.

Brief summary: The objective of this study is to obtain blood or saliva samples to define genes for migraine and pain diseases.

Detailed description: It is estimated that over one-third of the world's population suffers from persistent or recurrent pain. Migraine is highly heritable and the majority of juveniles who suffer from the disorder have a mother or father who also have the disease. The blood or saliva samples will go through DNA analysis and be sequenced for candidate genes or subjected to whole-genome sequencing. By creating a MAPS GeneBank from these patients' blood/saliva donations we will ultimately be able to define genes for migraine and pain diseases.

Eligibility criteria: Inclusion Criteria:

1. Family members (genetic duo or trio), consisting of an adolescent 10 to 18 years of age and at least one of their biologic parents willing to be participate in trial
2. Adolescent and at least 1 biologic parent with Migraine diagnosis confirmed by Dr. Christy Jackson
3. Is reliable, cooperative and willing to comply with all protocol-specified procedures and/or sub-study if consented
4. Able to understand and grant informed consent

Exclusion Criteria:

1. Patient has been previously enrolled in the MAP GeneBank at Scripps Clinic Registry
2. Has a significant chronic medical condition (i.e.chronic meningitis or a secondary origin/cause of headache) which, in the investigator's option, may interfere with the patient's optimal participation in the study
3. Treatment with any investigational agents or devices within 30 days preceding enrollment in the study
4. Has undergone ECT within 90 days preceding enrollment in the study

Primary outcomes:
measure: Gene identification
timeFrame: end of study
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scrippshealth
state: California
Study officials:
affiliation: Scrippshealth
name: Christy M Jackson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03699735: Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - Sonova2018_31
Official title: Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2018-10-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment Each participant will be treated with each test condition in a randomized order.
Primary purpose: TREATMENT

Brief summary: A methodical evaluation of sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These sound changing principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and asses strength and weaknesses of these sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Objective laboratory measurements will be carried out. This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa


Eligibility criteria: Inclusion Criteria:

* Adult hearing impaired persons (minimum age: 18 years) with or without experience with hearing aids
* Sensorineural hearing loss (N4-N6 according to ISO 60118-15)
* Good written and spoken (Swiss) German language skills
* Healthy outer ear
* Informed Consent as documented by signature
* Symmetric hearing loss below 1000 Hz

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments on study site
* Inability to produce a reliable hearing test result
* Known psychological problems
* Central hearing disorders

Primary outcomes:
measure: Individual binaural Hearing abilities
timeFrame: 2 weeks
Secondary outcomes:
measure: Speechunderstanding for different beam form principles
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
state: Zürich
Study officials:
References:
Clinical trial NCT00343135: AUGMENTIN 1gm In Skin And Soft Tissue Infection
Official title: An Open, Non-comparative Study to Evaluate the Efficacy and Safety of AUGMENTIN 1gm (875mg Amoxicillin/125mg Clavulanic Acid) po q 12 Hours in the Treatment of Uncomplicated Skin and Soft Tissue Infections in Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Skin Diseases, Infectious
Infection, Soft Tissue
Keywords: Skin
AUGMENTIN
1gm
Soft
tissue
Infections
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-06-22
Enrollment: 195
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study to evaluate the effects of AUGMENTIN 1gm in the treatment of Skin and Soft tissue infections


Eligibility criteria: Inclusion Criteria:

* having diagnosed uncomplicated soft tissue infection (e.g furuncle, cellulitis)
* has given freely documented consent.

Exclusion Criteria:

* antibiotics
* have renal or hepatic insufficiency
* systemic toxicity
* pregnancy
* lactation
* hypersensitivity to penicillin or Beta-lactam antibiotics

Primary outcomes:
measure: Clinical response at 10 - 14 days post therapy
timeFrame: 10 - 14 days
Secondary outcomes:
measure: Clinical response at on-therapy evaluation visit (2 - 4 days following initiation of therapy and 48 - 96 hours post therapy) Bacteriological response at (2 - 4 days following initiation of therapy, 48 - 96 hours post therapy, 10 - 14 days post therapy)
timeFrame: 2 - 4 days
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: GSK Investigational Site
city: Lahore
country: Pakistan
facility: GSK Investigational Site
city: Lahore
country: Pakistan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05250635: Analysis of Breath Sound During Thoracic Surgery
Official title: Analysis of Breath Sound During Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thoracic Surgery
Keywords: double lumen endobronchial tube
stethoscope
fiberscope
electronic stethoscope
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2022-02-22
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergo thoracic surgery and general anesthesia using DLET

Brief summary: In modern thoracic surgery, double-lumen endobronchial tube (DLET) is the first choice for intubation. One lung ventilation can be perfectly performed by DLET, with the benefit of maintaining adequate gas exchange and establishing great surgical field. Traditionally, we use stethoscope and fiberscope for DLET site evaluation. However, there are some concerns over traditional methods. Stethoscope evaluation can be subjective from person to person; fiberscope, on the other hand, can cause additional bronchial injury as it is an invasive procedure. We hope to utilize patches, also known as electronic stethoscope, which provide non-invasive and visualized spectrum information, to assist anesthesiologists evaluate DLET insertion site more precisely in patients undergo thoracic surgery.

Detailed description: This is an observational study. We use electronic stethoscope, which stick on patient's anterior chest, to record breath sound after intubation. The soundtrack will then be transformed to visualized waveform, enabling us to analyze and compare with actual result confirmed by fiberscope.

Eligibility criteria: Inclusion Criteria:

* patients undergo thoracic surgery and general anesthesia using DLET

Exclusion Criteria:

* patients have no will to participate
* vulnerable groups, including physically disabled and mental diseased patients
* patients with abnormal breath sound, pulmonary disease or history of cardiothoracic surgery

Primary outcomes:
measure: Accuracy of DLET intubation
timeFrame: Intraoperative (Start record the first breath sound after intubation when supine. After changing patient's position to lateral decubitus, the second breath sound is recorded. The electronic stethoscope is retrieved before the operation starts.)
Secondary outcomes:
measure: Correlation of breath sound and airway pressure
timeFrame: Intraoperative (Start record the first breath sound after intubation when supine. After changing patient's position to lateral decubitus, the second breath sound is recorded. The electronic stethoscope is retrieved before the operation starts.)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Chien-Kun Ting
role: STUDY_CHAIR
References: