louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02617082: Partial Breast Irradiation for Low-risk Ductal Carcinoma In Situ After Breast-conserving Surgery
Official title: Phase II Study of Partial Breast Irradiation for Low-risk Ductal Carcinoma In Situ After Breast-conserving Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: breast cancer
partial breast irradiation
DCIS
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2015-11-30
Enrollment: 828
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: DCIS breast cancer patients

Brief summary: This study is designed to evaluate the feasibility and safety of partial breast irradiation for low risk DCIS after breast-conserving surgery.

Detailed description: Randomized clinical trials have demonstrated that the recurrence of DCIS is low and most of the recurrence occurs around the tumor bed. Besides, cosmetic outcomes are reported better in partial breast irradiation group compared to whole breast irradiation group. However, whether or not partial breast irradiation is safety in DCIS is still unknown. The purpose of this study is to evaluate the feasibility and safety of partial breast irradiation for low risk DCIS after breast-conserving surgery.

Eligibility criteria: Inclusion Criteria:

* Female
* 18\~65 years old
* Pathologically confirmed DCIS, low- or intermediate- grade DCIS: (lesions of ≤2.5 cm diameter, resection margins of at least 3 mm, nuclei grade: 1-2), high grade DCIS: (lesions of ≤1 cm diameter, resection margins of at least 3 mm, nuclei grade: 3)
* Treated with breast conserving surgery
* Tumor bed is labeled with Titanium clips
* No malignancy history
* ECOG score 0\~1
* Written informed consent

Exclusion Criteria:

* DCIS of both breast
* invasive breast cancer
* Multicentric disease
* Patients underwent mastectomy
* Previous radiation therapy of breast
* Medical contraindication for radiotherapy
* Pregnant or nursing
* suspicious calcification after surgery

Primary outcomes:
measure: ipsilateral breast tumor recurrence
timeFrame: 5 years
Secondary outcomes:
measure: occurrence of contralateral breast tumor after PBI
timeFrame: 5 years
measure: Disease free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
measure: radiation-induced toxicity of breast assessed by CTCAE v4.0
timeFrame: baseline, 3 months, 6 months, and every half year to 5 years
measure: Complications
timeFrame: baseline，1，2，3，4，5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Xiaoli Yu, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01447082: General Practice Research Database Seroquel XR Safety Study
Official title: Epidemiology Study to Assess the Safety of a New Slow-release Form of Seroquel (Quetiapine) in the Post-marketing Phase in the UK
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Major Depressive Disorder
Bipolar Disorder
Keywords: atypical
antipsychotics
quetiapine
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Basel, Switzerland
First posted: 2011-10-05
Enrollment: 37372
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A sample of the general population in the UK consisting of 3 millions inhabitants.

Brief summary: The main objective of this observational study is to characterize new users of quetiapine XR as well as new users of other study drugs (i.e. the comparison group) and to quantify the risk of developing newly diagnosed outcomes of interest in new users of quetiapine XR as well as in other study drugs.

Detailed description: Epidemiology study to assess the safety of a new slow-release form of Seroquel (quetiapine) in the post-marketing phase in the UK.

Eligibility criteria: Inclusion Criteria:

* Episodes of new use (\>/=1 prescription) of quetiapine XR or other study drugs

Exclusion Criteria:

* Less than two years of recorded history before the start of the marketing of quetiapine XR (or cohort entry date)
* If the duration and dose of the antipsychotic drug cannot be determined

Primary outcomes:
measure: The outcome of interest will be evaluated by means of relative risk based on incidence rates estimates in users of quetiapine XR vs corresponding incidence rates in users of comparison drugs
timeFrame: During follow-up of a treatment episode estimated to be on average of 1.5 years
measure: Duration of treatment
timeFrame: During follow-up estimated to be on average of 1.5 years.
measure: Duration of treatment episode
timeFrame: During follow-up estimated to be on average of 1.5 years
measure: Comorbidities defined by clinical diagnosis or prescription
timeFrame: Baseline and during follow up of treatment estimated to be on average 1.5 years
measure: Age
timeFrame: Baseline
measure: Gender
timeFrame: Baseline
measure: Dose
timeFrame: During follow-up of treatment estimated to be on average 1.5 years
measure: Adherence
timeFrame: During follow-up of treatment estimated to be on average 1.5 years
measure: The number of subjects to whom the drug was prescribed by the general practitioners.
timeFrame: During follow-up of treatment estimated to be on average 1.5 years
measure: Indication for treatment
timeFrame: During follow-up of treatment estimated to be on averaged 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University hospital of Basel, Switzerland
name: Christoph R Meier, PROF DR PHIL
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02707731: Acute Effects of Neonatal Hydrokinesiotherapy in Newborn Preterm Hospitalized
Official title: Acute Effects of Neonatal Hydrokinesiotherapy in Newborn Preterm Hospitalized
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborn Preterm
Lead sponsor: Hospital Universitario Pedro Ernesto
Sponsor class: OTHER
First posted: 2016-03-14
Enrollment: 15
Sex: ALL
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to evaluate the acute effects of neonatal hydrokinesiotherapy in reducing stress in newborn preterm infants in the neonatal intensive care unit. Salivary cortisol samples were collected, pain applying the Neonatal Infant Pain Scale Scale (NIPS), heart rate, respiratory rate and oxygen saturation before and after hydrotherapy.

Detailed description: Newborns have the neurological maturity to perceive pain, including preterm. In the environment of the neonatal intensive care unit newborns are subject to environmental stress and numerous painful interventions. Based on the physiological properties of water, it is known that the hydrotherapy promotes comfort, reduces stress, and as a resource for treatment of various diseases. This study aims to evaluate the acute effects of neonatal hydrokinesiotherapy in reducing stress in newborn preterm infants in the neonatal intensive care unit.

Eligibility criteria: Inclusion Criteria:

* gestational age above 37 weeks
* clinically stable
* without ventilatory support

Exclusion Criteria:

* access deep below the shoulders
* umbilical catheterization
* neurological and cardiac disorders
* clinically unstable

Primary outcomes:
measure: Acute effects of heart rate after hydrokinesiotherapy in newborns preterm hospitalized
timeFrame: 4 months
measure: Acute effects of respiratory rate after hydrokinesiotherapy in newborns preterm hospitalized
timeFrame: 4 months
measure: Acute effects of salivary cortisol after hydrokinesiotherapy in newborns preterm hospitalized
timeFrame: 4 months
measure: Acute effects of peripheral oxygen saturation after hydrokinesiotherapy in newborns preterm hospitalized
timeFrame: 4 months
Secondary outcomes:
measure: Acute effects of scale NIPS after hydrokinesiotherapy in newborns preterm hospitalized
timeFrame: 4 months
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Welcy Cassiano Tobinaga
state: RJ
Study officials:
affiliation: University Hospital Pedro Ernesto
name: Welcy Cassiano Tobinaga, Student
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Oliveira Tobinaga WC, de Lima Marinho C, Abelenda VL, de Sa PM, Lopes AJ. Short-Term Effects of Hydrokinesiotherapy in Hospitalized Preterm Newborns. Rehabil Res Pract. 2016;2016:9285056. doi: 10.1155/2016/9285056. Epub 2016 Sep 8.
Clinical trial NCT03715231: NIDEK Gonioscope GS-1 for Glaucoma
Official title: NIDEK Gonioscope GS-1 for Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The Gonioscope GS-1 is an ophthalmic camera with gonioscopic prism that is intended to capture, display and store images of the anterior chamber angle and its peripheral part. This study evaluates the efficiency of Gonioscope GS-1 in glaucoma patients.With the captured images, the glaucoma diagnosis and post-operative observation are enabled.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with glaucoma or glaucoma suspect

Glaucoma Suspect

* Glaucomatous optic neuropathy as described in the glaucoma patients below
* AND/OR ocular hypertension (IOP \> 21 mm Hg)
* Normal visual field

Glaucoma Patients

* Clinical characteristics of glaucoma: ONH abnormalities: global rim thinning, rim notch, or disc hemorrhage; RNFL defect
* Typical glaucomatous field loss in reliable VF, reproducible glaucoma hemifield tests labeled outside normal limits on at least two consecutive tests.
* Both eyes will be included, except in cases where only one eye meets study criteria

Exclusion Criteria:

* Corneal opacities (scars, edema, etc.)
* Pregnant or planning to become pregnant
* Inability to fixate gaze

Primary outcomes:
measure: Inter-Observer Repeatability for NIDEK Gonioscope GS-1
timeFrame: 1 Day
measure: Inter-Observer Repeatability for Standard Digital Gonioscopic images
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYUMC Langone
name: Joel Schuman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01992731: IUI vs. IVF/ICSI in Women Aged 38-42 Years: a Prospective Randomized Controlled Trial.
Official title: IUI vs. IVF/ICSI in Women Aged 38-42 Years: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infertility
Keywords: Age (38-42 years)
pregnancy rates
3 IUI cycles
1 IVF/ICSI cycle
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 138
Sex: FEMALE
Minimum age (years): 38
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged 38-42 years.

Detailed description: Study design:

Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged 38-42 years. .

Group 1: 3 consecutive gonadotrophin stimulated IUI cycles (Follitropine Bèta, Puregon, MSD).

vs. Group 2: 1 IVF/ ICSI cycle - Recombinant FSH (Follitropine Bèta, Puregon, MSD) - Antagonist protocol.

Eligibility criteria: Inclusion Criteria:

Women aged between 38 and 42 years. Sperm: use of donor sperm or husband sperm reaching WHO criteria 2010.

Exclusion Criteria:

* Tubal infertility (even one tube).
* Major uterine or ovarian abnormalities
* Metabolic abnormalities

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UniversitairZB
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Michael De Brucker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04243031: QuantiFERON Access Clinical Performance Study Protocol
Official title: A Non-interventional, Prospective Clinical Performance Study of the QuantiFERON Access Kit to Demonstrate Clinical Accuracy Compared to a CE-marked In-Vitro Diagnostic Medical Device, in Participants With Varying Risk Factors for TB Infection and Disease.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Tuberculosis (TB)
Lead sponsor: QIAGEN Gaithersburg, Inc
Sponsor class: INDUSTRY
First posted: 2020-01-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants coming to clinic

Brief summary: Approximately 225 samples, obtained from participants with varying risk factors for TB infection and disease, will be tested using the QFT Access Kit and the comparator device QFT-Plus.


Eligibility criteria: Inclusion Criteria:

* 1. Be ≥ 18 years of age,
* 2. Have received no TB treatment or received treatment for less than 14 consecutive days.
* 3. Provide Informed Consent.

Exclusion Criteria:

* 1. They do not meet the inclusion criteria,
* 2. Blood handling was not completed using QFT-Plus
* 3. Incubation was \<16 and \>24 hours
* 4. Improperly collected and/or stored samples per Instructions For Use

Primary outcomes:
measure: TB Result
timeFrame: At time of enrollment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05897931: Effects of Two Different Applications in Fibromyalgia
Official title: Effects of Connective Tissue Massage and Taping in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to determine the effect of connective tissue massage and taping applications on the pain and depression complaints of fibromyalgia patients and to compare their impact on quality of life.


Eligibility criteria: Inclusion Criteria:

* Being diagnosed with fibromyalgia.
* Be in the age range of 20 - 55 years.
* To be a volunteer participant in the research.
* Being able to communicate comfortably.
* To be able to act independently.

Exclusion Criteria:

* Having had a surgical operation within the last year.
* Presence of significant infection.
* Being diagnosed with cancer.
* Being pregnant or breastfeeding.
* Being addicted to drugs or alcohol.
* Having a cognitive problem.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 4 weeks
Secondary outcomes:
measure: Fibromyalgia Impact Questionnaire
timeFrame: 4 weeks
measure: McGill Pain Questionnaire
timeFrame: 4 weeks
measure: Beck's Depression Inventory
timeFrame: 4 weeks
measure: Short Form-36 Quality of Life Scale
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yeditepe University
Study officials:
affiliation: Yeditepe University
name: Rasmi Muammer, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06406582: Treatment Result of Zirconia Laminate Veneer
Official title: Surface Conditioning Effectiveness, Accuracy and Treatment Result of Zirconia Laminate Veneer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dislocation, Tooth
Teeth, Endodontically-Treated
Tooth Fracture
Tooth Injuries
Tooth Abnormalities
Cracked Tooth Syndrome
Tooth Crowding
Keywords: ceramic laminate veneers
zirconia
lithium disilicate
computer-aided manufacturing
Lead sponsor: Hanoi Medical University
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Zirconia Group (Intervention): Participants receive zirconia laminate veneers. Lithium Disilicate Group (Control): Participants receive lithium disilicate laminate veneers. Lithium disilicate is a standard ceramic material for laminate veneers.
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the clinical performance of the zirconia laminate veneer, a minimally invasive prosthetic restoration

Detailed description: Patients with indications for single tooth restoration with ceramic laminate veneers are recruited for the study. These indications include spaced, discolored, malformed, root canal-treated, chipped, and mildly crowded teeth. After providing written informed consent, all patients are randomly divided into two groups in a double-blind manner (participants and the outcomes assessor) in a 1:1 ratio, including the Zirconia group (intervention) and the Lithium Disilicate group (control). Each patient's tooth is prepared and restored with the corresponding laminate veneer material, that is, zirconia and lithium disilicate.

Eligibility criteria: Inclusion Criteria:

* Spaced tooth
* Discolored tooth
* Malformed tooth
* Root canal-treated tooth
* Chipped tooth
* Mildly crowded tooth

Exclusion Criteria:

* Tooth bruxism
* Inadequate enamel for bonding
* Large restoration exists
* Bad oral habits harming restoration

Primary outcomes:
measure: Marginal and internal fit
timeFrame: Before veneer adhesion
measure: Gingival health
timeFrame: 2 weeks, 6 months, 12 months
measure: Periodontal pocket
timeFrame: 2 weeks, 6 months, 12 months
measure: Evaluation criteria based on the modified United States Public Health Standard
timeFrame: 2 weeks, 6 months, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: High Technical Center of Dentistry, School of Dentistry
Study officials:
References:
Clinical trial NCT00522782: Effect of Budesonide on Exhaled Nitric Oxide in Asthmatic Children
Official title: Phase IV Study of the Effect of Nebulized Budesonide on Exhaled Nitric Oxide in Children, Four to Six Years of Age, With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: AAADRS Clinical Research Center
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2007-08-30
Enrollment: 16
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To study the improvement in airway inflammation in children with asthma non-invasively with exhaled breath NO, a marker of inflammation, after therapy with nebulized budesonide as 0.5mg daily.

Detailed description: Comparisons will be made before and after 2 week therapy of nebulized budesonide in children not on prior anti-inflammatory medications.

Eligibility criteria: Inclusion Criteria:

* Asthma diagnosis previously for 6 months
* Past asthma medication without change for previous 6 months
* Increased NO levels and ability to perform maneuver
* ICF signed by parents

Exclusion Criteria:

* Systemic steroids in past 60 days,inhaled/nebulized steroids in past 4 weeks
* Hospitalization within 3 months
* Upper or lower airways active infection or cigarette smoke direct exposure
* Use of other asthma medications other than bronchodilators one month prior and during the trial
* Noncompliance

Primary outcomes:
measure: Exhaled breath nitric oxide pre- to post treatment
timeFrame: two weeks
Secondary outcomes:
measure: Spirometry with peak flow measurements and daily diary scores
timeFrame: two weeks
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: AAADRS Clinical Research Center
state: Florida
Study officials:
affiliation: Principal Investigator
name: Miguel J Lanz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02393482: Psychological Impact of Amenorrhea in Women With Endometriosis
Official title: Psychological Impact of Amenorrhea in Women With Endometriosis: Perspective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Amenorrhea
Endometriosis
Quality of Life
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the impact on quality of life, psychological health, sexuality and chronic pain of therapies which determine amenorrhea in symptomatic women with endometriosis, through the administration of self reported questionnaires. Amenorrhea in the first group is caused by balanced assumption of estroprogestins, in the second group is caused by GnRHa-induced hypoestrogenism.


Eligibility criteria: Inclusion Criteria:

* Clinical, echographical or surgical diagnosis of endometriosis

Exclusion Criteria:

* Comorbidity
* Psychiatric diseases
* Refusal or inability to sign informed consent

Primary outcomes:
measure: Quality of life (self reported questionnaires)
timeFrame: 180 days
measure: Sexual health (self reported questionnaires)
timeFrame: 180 days
measure: Psychological impact (self reported questionnaires)
timeFrame: 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Monserrato
country: Italy
facility: University of Cagliari,Obstetrics and Gynecological Department,
state: Cagliari
Study officials:
References:
citation: McWilliams LA, Cox BJ, Enns MW. Mood and anxiety disorders associated with chronic pain: an examination in a nationally representative sample. Pain. 2003 Nov;106(1-2):127-33. doi: 10.1016/s0304-3959(03)00301-4.